This table shows all Adverse Drug Reactions reported to the FDA's Adverse Event Reporting System between 2004 and the 2nd Quarter of 2008 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) deemed responsible for causing or inducing these reactions and where one or more of the Adverse Reactions reported for the Case described a congenital, prenatal or neonatal condition. Where no Age, Date of Event or Indication (the condition being treated) are shown, none were present in the FDA records.
Reported By: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR (Individual Safety Report).
The Oxford English Dictionary defines a poison as "a substance that causes death or harm when introduced into or absorbed by a living organism." This psychiatric drug fits that definition.
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 4035498 | 4332618 | 09/10/2003 | 03/30/2004 | Cipramil | OT | Panic Attack | Base Excess Negative, Blood Sodium Increased, Congenital Hand Malformation, Congenital Hydrocephalus, Feeding Problem In Newborn, Maternal Drugs Affecting Foetus, Protein Urine Present, Somnolence, Synovitis | ||||||
| M | 4035498 | 5538375 | 09/10/2003 | 12/05/2007 | Citalopram | OT | Panic Attack | Congenital Hand Malformation, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Protein Urine, Synovitis | ||||||
| M | 4074663 | 4276834 | 10/01/2003 | 01/20/2004 | Celexa | MD | Depression | Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy | ||||||
| M | 4074663 | 4418049 | 10/01/2003 | 08/03/2004 | Celexa | MD | Depression | Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||||
| M | 4104623 | 4313000 | 01/26/2004 | 03/05/2004 | Citalopram | PH | Depression | Anaemia, Failure To Thrive, Hyponatraemia, Weight Decreased | ||||||
| 4134792 | 4348466 | 04/23/2004 | Celexa | MD | Depression | Congenital Anomaly of Inner Ear, Deafness Congenital, Maternal Drugs Affecting Foetus, Spinal Disorder, Vascular Anomaly | ||||||||
| M | 4148585 | 4365944 | 03/25/2004 | 05/20/2004 | Cipramil | OT | Drug Exposure During Pregnancy, Dyspnoea, Hypertonia Neonatal, Hypopnoea, Irritability, Neonatal Apnoeic Attack, Tremor Neonatal | |||||||
| M | 4148585 | 4375833 | 03/25/2004 | 06/07/2004 | Citalopram | Apgar Score Low, Bloody Discharge, Drug Exposure During Pregnancy, Dyspnoea, Hypertonia Neonatal, Hypopnoea, Irritability, Neonatal Apnoeic Attack, Neonatal Disorder, Tremor Neonatal | ||||||||
| M | 4148585 | 4380002 | 03/25/2004 | 06/14/2004 | Citalopram | Apnoea, Dyspnoea, Hypopnoea, Hypotonia Neonatal, Irritability, Maternal Drugs Affecting Foetus, Respiratory Depth Decreased, Respiratory Rate Decreased, Tremor | ||||||||
| M | 4159057 | 4379305 | 05/01/2004 | 06/14/2004 | Celexa | MD | Anxiety, Depression | Clonus, Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder | ||||||
| M | 4159057 | 4418051 | 05/09/2004 | 08/03/2004 | Celexa | MD | Anxiety, Depression | Clonus, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Neonatal Disorder, Pyrexia, Tremor Neonatal | ||||||
| M | 4160075 | 4381574 | 06/15/2004 | Celexa | MD | Cleft Lip and Palate, Drug Exposure During Pregnancy, Failure To Thrive | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 4167393 | 4390710 | 06/30/2004 | Celexa | MD | Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome | |||||||||
| M | 4182821 | 4411420 | 06/14/2004 | 07/27/2004 | Citalopram | PH | Depression | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||||
| M | 4182821 | 4432253 | 06/14/2004 | 08/20/2004 | Citalopram | OT | Depression | Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dyskinesia Neonatal, Hypotonia Neonatal, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||||
| F | 4195416 | 4427572 | 08/12/2004 | Citalopram | OT | Abortion Spontaneous, Drug Exposure During Pregnancy, Stress Symptoms | ||||||||
| M | 4201505 | 4433463 | 08/04/2002 | 08/24/2004 | Citalopram | OT | Panic Attack | Breech Presentation, Diaphragmatic Hernia, Drug Exposure During Pregnancy, Intestinal Transposition | ||||||
| F | 4213429 | 4449428 | 09/14/2004 | Citalopram | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||
| 4222980 | 4462053 | 05/12/2004 | 09/24/2004 | Celexa | MD | Depression | Amniocentesis Abnormal, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Hip Dysplasia, Jaundice Neonatal, Neonatal Disorder | |||||||
| M | 4222980 | 4612409 | 05/17/2004 | 03/16/2005 | Celexa | MD | Depression | Amniotic Fluid Volume Decreased, Breech Presentation, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Foetal Growth Retardation, Foetal Heart Rate Decreased, Hip Dysplasia, Jaundice Neonatal, Ultrasound Scan Abnormal | ||||||
| M | 5654667 | 4480458 | 10/06/2004 | 10/18/2004 | Celexa | MD | Anxiety | Drug Exposure During Pregnancy, Hypertonia Neonatal, Hypotonia Neonatal, Neonatal Disorder, Posturing | ||||||
| 5658869 | 4488269 | 10/01/2004 | 10/26/2004 | Celexa | MD | Anxiety, Depression | Drug Exposure During Pregnancy, Heart Disease Congenital, Limb Reduction Defect | |||||||
| 5658869 | 4503284 | 10/01/2004 | 11/12/2004 | Celexa | MD | Anxiety, Depression | Caesarean Section, Drug Exposure During Pregnancy, Fallot's Tetralogy, Phalangeal Hypoplasia | |||||||
| M | 5684788 | 4505389 | 08/16/2004 | 11/16/2004 | Citalopram | OT | Caesarean Section, Drug Exposure During Pregnancy, Hypertonia Neonatal, Irritability, Musculoskeletal Stiffness, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Depression | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 5692632 | 4518151 | 01/01/2002 | 11/30/2004 | Celexa | CN | Drug Exposure During Pregnancy | Blood Glucose Increased, Drug Exposure During Pregnancy, Pulmonary Oedema Neonatal | ||||||
| 5754861 | 4596457 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||||
| 5754907 | 4596452 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||||
| M | 5768876 | 4616050 | 03/17/2003 | 03/21/2005 | Cipramil | OT | Congenital Anomaly, Congenital Arterial Malformation, Drug Exposure During Pregnancy, Poland's Syndrome | |||||||
| 5825657 | 4692102 | 06/14/2005 | Celexa | MD | Congenital Anomaly, Drug Exposure During Pregnancy | |||||||||
| M | 5830991 | 4702790 | 05/31/2005 | 06/28/2005 | Celexa | MD | Caesarean Section, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Neonatal Hypoxia, Neonatal Tachypnoea | |||||||
| F | 5839317 | 4710736 | 07/07/2005 | Akarin | PH | Depression | Premature Labour, Premature Rupture of Membranes | |||||||
| F | 5839317 | 4746639 | 08/15/2005 | Akarin | OT | Depression | Drug Exposure During Pregnancy, Premature Labour, Premature Rupture of Membranes | |||||||
| M | 5844795 | 4710733 | 04/05/2005 | 07/07/2005 | Akarin | PH | Depression | Apgar Score Low, Convulsion Neonatal, Dacryocystitis Infective, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Encephalitis Post Varicella, Hypocalcaemia, Neonatal Asphyxia, Neonatal Candida Infection, Ophthalmia Neonatorum, Oral Candidiasis, Premature Baby | ||||||
| M | 5844795 | 4724861 | 04/05/2005 | 07/22/2005 | Akarin | OT | Depression | Acidosis, Convulsion Neonatal, Dacryocystitis Infective, Drug Exposure During Pregnancy, Encephalitis Post Varicella, Hypocalcaemia, Neonatal Asphyxia, Neonatal Disorder, Ophthalmia Neonatorum, Oral Candidiasis, Premature Baby, Psychomotor Hyperactivity | ||||||
| M | 5844795 | 4746650 | 04/05/2005 | 08/15/2005 | Akarin | OT | Depression | Acidosis, Apgar Score Low, Convulsion Neonatal, Dacryocystitis Infective, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypocalcaemia, Hypotonia Neonatal, Neonatal Asphyxia, Ophthalmia Neonatorum, Oral Candidiasis, Premature Baby, Premature Rupture of Membranes | ||||||
| M | 5866540 | 4747929 | 04/08/2005 | 08/16/2005 | Celexa | CN | Depression | Caesarean Section, Drug Exposure During Pregnancy, Immature Respiratory System, Infantile Colic, Premature Baby | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 5886706 | 4778180 | 05/02/2005 | 09/23/2005 | Citalopram | PH | Depression, Post-Traumatic Stress Disorder | Abortion Induced, Asthenia, Confusional State, Diarrhoea, Drug Ineffective, Headache, Influenza, Irritability, Malaise, Musculoskeletal Stiffness, Myalgia, Nausea, Neck Pain, Pain, Vomiting | ||||||
| F | 5917502 | 4816729 | 10/24/2005 | 10/31/2005 | Celexa | OT | Caesarean Section, Drug Exposure During Pregnancy, Feeding Disorder Neonatal, Feeling Jittery, Foetal Cardiac Disorder, Hypoglycaemia Neonatal, Neonatal Disorder | |||||||
| M | 5918152 | 4811856 | 06/22/2004 | 10/26/2005 | Celexa | CN | Panic Attack | Blood Cortisol Decreased, Drug Exposure During Pregnancy, Premature Baby | ||||||
| M | 5918152 | 4855131 | 06/22/2004 | 12/14/2005 | Celexa | MD | Panic Attack | Blood Cortisol Decreased, Drug Exposure During Pregnancy, Neonatal Disorder, Premature Baby | ||||||
| F | 5918180 | 4811697 | 08/15/2005 | 10/25/2005 | Celexa | CN | Depression | Apgar Score Low, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Flatulence, Meconium In Amniotic Fluid, Neonatal Candida Infection, Respiratory Disorder Neonatal, Somnolence Neonatal | ||||||
| F | 5918180 | 4872011 | 08/15/2005 | 12/30/2005 | Celexa | CN | Depression | Apgar Score Low, Candidiasis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Eructation, Flatulence, Meconium In Amniotic Fluid, Neonatal Disorder, Respiration Abnormal, Respiratory Disorder Neonatal, Somnolence Neonatal | ||||||
| F | 5918180 | 4959995 | 08/15/2005 | 03/27/2006 | Celexa | MD | Depression | Apgar Score Low, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Labour Complication, Meconium In Amniotic Fluid, Neonatal Respiratory Depression, Postmature Baby, Precipitate Labour | ||||||
| F | 5951339 | 4855595 | 12/14/2005 | Citalopram | MD | Panic Disorder | Acute Psychosis, Antidepressant Drug Level Decreased, Completed Suicide, Drug Exposure During Pregnancy | |||||||
| M | 5957800 | 4871268 | 09/06/2005 | 12/29/2005 | Celexa | OT | Convulsion Neonatal, Drug Exposure During Pregnancy, Grand Mal Convulsion | |||||||
| M | 5957800 | 4880374 | 09/06/2005 | 01/11/2006 | Celexa | OT | Convulsion Neonatal, Drug Exposure During Pregnancy | |||||||
| 5969913 | 4885933 | 11/15/2005 | 01/17/2006 | Citalopram | Congenital Pulmonary Valve Atresia, Drug Exposure During Pregnancy, Ventricular Septal Defect | |||||||||
| F | 5970271 | 4886604 | 01/19/2006 | Citalopram | Depression | Drug Exposure During Pregnancy, Stillbirth | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 5970274 | 4886606 | 01/19/2006 | Citalopram | Depression | Drug Exposure During Pregnancy, Exomphalos, Hernia Congenital, Inguinal Hernia, Umbilical Hernia | ||||||||
| 5976117 | 4893357 | 01/24/2006 | Citalopram | MD | Brachial Plexopathy, Congenital Anomaly, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Tachypnoea | |||||||||
| M | 5976117 | 4899936 | 01/31/2006 | Citalopram | MD | Apgar Score Low, Brachial Plexopathy, Drug Exposure During Pregnancy, Hypotonia Neonatal, Transient Tachypnoea of the Newborn | ||||||||
| F | 5984528 | 4903436 | 10/24/2005 | 02/06/2006 | Celexa | PH | Agitation Neonatal, Blood Glucose Abnormal, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Feeding Disorder Neonatal, Temperature Regulation Disorder | |||||||
| F | 5989945 | 4907903 | 02/08/2006 | Citalopram | OT | Postpartum Depression | Developmental Delay, Drug Exposure During Pregnancy, Head Deformity, Synostosis | |||||||
| M | 6004043 | 4937125 | 10/29/2005 | 03/07/2006 | Celexa | MD | Anxiety, Depression | Apgar Score Low, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Neonatal Hypoxia, Neonatal Tachypnoea | ||||||
| F | 6019158 | 4953788 | 01/01/2005 | 03/21/2006 | Celexa | MD | Apgar Score Low, Coombs Test Positive, C-Reactive Protein Increased, Crying, Drug Exposure During Pregnancy, Haematocrit Decreased, Hypotonia Neonatal, Jaundice Neonatal, Maternal Condition Affecting Foetus, Neonatal Aspiration, Neonatal Pneumonia, Neonatal Tachypnoea, Poor Peripheral Circulation | |||||||
| F | 6019158 | 4963004 | 01/01/2005 | 03/31/2006 | Celexa | MD | Apgar Score Low, Coombs Test Positive, Drug Exposure During Pregnancy, Hypotonia Neonatal, Jaundice Neonatal, Mean Arterial Pressure Decreased, Neonatal Aspiration, Neonatal Disorder, Neonatal Pneumonia, Neonatal Respiratory Depression, Neonatal Tachypnoea, Peripheral Vascular Disorder | |||||||
| F | 6019158 | 5078570 | 01/01/2005 | 08/08/2006 | Celexa | MD | Apgar Score Low, Cardiovascular Disorder, Coombs Test Positive, Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypotonia Neonatal, Inspiratory Capacity Decreased, Jaundice Neonatal, Maternal Drugs Affecting Foetus, Mean Arterial Pressure Decreased, Neonatal Respiratory Depression, Neonatal Tachypnoea, Pneumonia Aspiration, White Blood Cell Count Increased | |||||||
| M | 6026609 | 4927978 | 02/23/2006 | Akarin | OT | Drug Exposure During Pregnancy, Polydactyly | ||||||||
| F | 6035640 | 4978052 | 03/23/2006 | 04/14/2006 | Sepram | OT | Drug Exposure During Pregnancy, Dyspnoea, Haemoglobin Increased, Neonatal Infection, Patent Ductus Arteriosus, Platelet Count Decreased, Respiratory Disorder Neonatal, White Blood Cell Count Decreased | |||||||
| F | 6035640 | 4995861 | 03/23/2006 | 05/04/2006 | Citalopram | OT | Drug Exposure During Pregnancy, Haematocrit Decreased, Haemoglobin Decreased, Infantile Apnoeic Attack, Patent Ductus Arteriosus, Platelet Count Increased, Premature Baby, White Blood Cell Count Increased | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6047077 | 4994218 | 05/03/2006 | Cipramil | OT | Drug Exposure During Pregnancy, Premature Baby | |||||||||
| M | 6047077 | 5008915 | 04/17/2006 | 05/18/2006 | Cipramil | OT | Congenital Scoliosis, Congenital Spinal Fusion, Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Patent Ductus Arteriosus, Premature Baby, Sepsis Neonatal | |||||||
| M | 6047077 | 5015064 | 04/17/2006 | 05/30/2006 | Cipramil | OT | Drug Exposure During Pregnancy, Neonatal Respiratory Distress Syndrome, Patent Ductus Arteriosus, Premature Baby, Sepsis Neonatal | |||||||
| 6094830 | 5060979 | 07/20/2006 | Citalopram | PH | Drug Exposure During Pregnancy | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Respiratory Disorder Neonatal, Sleep Disorder | ||||||||
| F | 6102742 | 5067548 | 07/27/2006 | Citalopram | Depression | Drug Exposure During Pregnancy, Heart Disease Congenital | ||||||||
| F | 6102742 | 5071847 | 08/01/2006 | Citalopram | Depression | Drug Exposure During Pregnancy, Heart Disease Congenital | ||||||||
| F | 6102742 | 5072873 | 08/02/2006 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Heart Disease Congenital | |||||||
| F | 6114353 | 5082971 | 07/14/2006 | 08/14/2006 | Citalopram | Depression | Anal Atresia, Drug Exposure During Pregnancy, Premature Baby | |||||||
| F | 6114353 | 5096534 | 07/14/2006 | 08/30/2006 | Citalopram | OT | Depression | Anal Atresia, Drug Exposure During Pregnancy, Premature Baby | ||||||
| 6125432 | 5093433 | 08/29/2006 | Citalopram | Congenital Anomaly, Drug Exposure During Pregnancy | ||||||||||
| F | 6130030 | 5097917 | 05/09/2004 | 09/05/2006 | Celexa | MD | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Fallot's Tetralogy | ||||||
| F | 6142696 | 5116938 | 08/07/2006 | 09/25/2006 | Citalopram | Crying, Drug Exposure During Pregnancy, Dystonia, Feeling Abnormal, Small for Dates Baby | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6142696 | 5130092 | 08/07/2006 | 10/13/2006 | Citalopram | OT | Crying, Drug Exposure During Pregnancy, Dystonia, Feeling Abnormal, Neonatal Disorder, Small for Dates Baby | |||||||
| M | 6145681 | 5120550 | 10/02/2006 | Citalopram | OT | Drug Exposure During Pregnancy, Hyperbilirubinaemia Neonatal, Premature Baby | ||||||||
| F | 6149581 | 5126057 | 02/20/2006 | 10/10/2006 | Celexa | OT | Depression | Abortion Induced, Anophthalmos, Congenital Anomaly, Congenital Eye Disorder, Drug Exposure During Pregnancy, Head Circumference Abnormal | ||||||
| M | 6164381 | 5139801 | 09/02/2003 | 10/25/2006 | 06/06/2004 | Celexa | LW | Acute Respiratory Failure, Atrial Septal Defect, Brain Damage, Bronchopulmonary Dysplasia, Caesarean Section, Cerebral Palsy, Chronic Respiratory Failure, Congenital Anomaly, Convulsion, Drug Exposure During Pregnancy, Optic Nerve Hypoplasia, Pneumonia, Pulmonary Hypertension, Ventricular Septal Defect | ||||||
| M | 6164381 | 5165116 | 09/02/2003 | 11/24/2006 | 06/06/2004 | Celexa | LW | Abdominal Distension, Acute Respiratory Failure, Agitation, Apgar Score Low, Aspiration, Atelectasis, Atrial Septal Defect, Bacterial Infection, Base Excess Decreased, Blood Alkaline Phosphatase Increased, Blood PH Decreased, Bradycardia Neonatal, Brain Damage, Bronchial Obstruction, Bronchopulmonary Dysplasia, Caesarean Section, Cardiac Arrest, Cardiomegaly, Cephalhaematoma, Cerebral Palsy, Chromosome Abnormality, Chronic Respiratory Failure, Congenital Central Nervous System Anomaly, Convulsion Neonatal, Coordination Abnormal, Cor Pulmonale, Cyanosis Neonatal, Developmental Delay, Drug Exposure During Pregnancy, Dysmorphism, Eye Rolling, Feeling Cold, Fluid Overload, Foetal Distress Syndrome, Frequent Bowel Movements, Gastrooesophageal Reflux Disease, General Physical Health Deterioration, Haematocrit Decreased, Hydronephrosis, Hyperbilirubinaemia Neonatal, Hypercapnia, Hypotonia, Hypoxia, Increased Bronchial Secretion, Lethargy, Livedo Reticularis, Loss of Consciousness, Low Set Ears, Memory Impairment, Mental Retardation Severity Unspecified, Neonatal Disorder, Neonatal Hepatomegaly, Neonatal Pneumonia, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Oedema, Ophthalmia Neonatorum, Optic Nerve Hypoplasia, Oxygen Saturation Decreased, Persistent Foetal Circulation, Prothrombin Time Prolonged, Pulmonary Oedema Neonatal, Pulse Absent, Pupillary Reflex Impaired, Rash Pustular, Respiratory Acidosis, Respiratory Arrest, Right Ventricular Systolic Pressure, Sepsis Neonatal, Sinus Tachycardia, Sputum Abnormal, Supraventricular Extrasystoles, Tachycardia Foetal, Tricuspid Valve Incompetence, Ventricular Septal Defect | ||||||
| M | 6175116 | 5152504 | 11/09/2006 | Citalopram | OT | Drug Use for Unknown Indication | Apgar Score Low, Drug Exposure During Pregnancy, Gastrointestinal Malformation | |||||||
| 6189594 | 5165190 | 11/24/2006 | Citalopram | OT | Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Foetal Disorder, Infantile Spasms | |||||||||
| F | 6227519 | 5216827 | 05/04/2005 | 01/19/2007 | Celexa | MD | Drug Exposure During Pregnancy, Premature Baby | |||||||
| M | 6241976 | 5232364 | 01/13/2007 | 02/05/2007 | Citalopram | OT | Drug Exposure During Pregnancy, Hydrocele | |||||||
| F | 6258850 | 5249278 | 01/01/2001 | 02/23/2007 | Citalopram | Abortion Induced, Appetite Disorder, Completed Suicide, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Irritability, Overdose, Tearfulness, Weight Fluctuation | ||||||||
| F | 6258850 | 5292630 | 01/01/2001 | 04/04/2007 | Citalopram | Abortion Induced, Apathy, Appetite Disorder, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome, Intentional Overdose, Irritability, Mental Disorder, Suicide Attempt, Tearfulness, Weight Fluctuation | ||||||||
| F | 6258945 | 5248910 | 02/23/2007 | Citalopram | Abortion Induced, Apathy, Appetite Disorder, Completed Suicide, Drug Withdrawal Syndrome, Emotional Distress, Irritability, Overdose, Tearfulness, Weight Fluctuation | |||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6292744 | 5292632 | 09/19/2006 | 04/04/2007 | Citalopram | Depression | Amniotic Cavity Disorder, Drug Exposure During Pregnancy, Foetal Malformation, Inflammation, Intra-Uterine Death, Placental Disorder | |||||||
| F | 6292744 | 5383144 | 09/19/2006 | 07/05/2007 | Citalopram | OT | Depression | Chorioamnionitis, Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Skull Malformation | ||||||
| F | 6302493 | 5306047 | 04/17/2007 | Citalopram | OT | Drug Exposure During Pregnancy, Poland's Syndrome | ||||||||
| F | 6307828 | 5314196 | 04/25/2007 | Citalopram | MD | Congenital Anomaly, Drug Exposure During Pregnancy, Facial Paresis | ||||||||
| M | 6334136 | 5348462 | 03/14/2007 | 06/05/2007 | Citalopram | Drug Exposure During Pregnancy, Hydronephrosis, Neonatal Disorder, Pyelectasia, Rhesus Antibodies Positive | ||||||||
| M | 6334136 | 5473150 | 03/14/2007 | 09/27/2007 | Citalopram | Drug Exposure During Pregnancy, Hydronephrosis, Pyelectasia, Vesicoureteric Reflux | ||||||||
| 6363136 | 5389794 | 02/02/2007 | 07/13/2007 | Citalopram | Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Premature Baby | |||||||||
| 6363136 | 5390010 | 02/02/2007 | 07/13/2007 | Citalopram | OT | Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Premature Baby | ||||||||
| M | 6363136 | 5446081 | 02/02/2007 | 09/04/2007 | Citalopram | OT | Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Premature Baby | |||||||
| 6369160 | 5397296 | 07/23/2007 | Citalopram | Drug Exposure During Pregnancy, Foetal Growth Retardation | ||||||||||
| F | 6371067 | 5399964 | 07/25/2007 | Citalopram | OT | Abortion Induced, Drug Exposure During Pregnancy | ||||||||
| M | 6374840 | 5402035 | 05/23/2007 | 07/27/2007 | Citalopram | OT | Drug Exposure During Pregnancy | Apnoea, Asthenia, Drug Exposure During Pregnancy, Pallor | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| M | 6376765 | 5404092 | 05/23/2007 | 07/31/2007 | Citalopram | OT | Asthenia, Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Neonatal Disorder, Pallor | |||||||
| F | 6379050 | 5407004 | 08/01/2007 | Citalopram | Transmission of Drug Via Semen | Acquired Epileptic Aphasia, Drug Exposure During Pregnancy, Transmission of Drug Via Semen | ||||||||
| M | 6379606 | 5406787 | 05/23/2007 | 08/02/2007 | Citalopram | OT | Apnoea, Asthenia, Drug Exposure During Pregnancy, Neonatal Disorder, Pallor | |||||||
| M | 6379606 | 5526181 | 05/23/2007 | 11/20/2007 | Citalopram | OT | Amniorrhoea, Apgar Score Low, Apnoea, Asthenia, Blood Bilirubin Increased, C-Reactive Protein Increased, Drug Exposure During Pregnancy, Hypotonia Neonatal, Infantile Apnoeic Attack, Neonatal Disorder, Pallor, Premature Baby | |||||||
| 6406466 | 5429857 | 08/27/2007 | Citalopram | Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||||||||
| 6406967 | 5430392 | 08/28/2007 | Citalopram | Drug Exposure During Pregnancy | Cleft Lip and Palate, Drug Exposure During Pregnancy | |||||||||
| 6410595 | 5442918 | 08/30/2007 | Citalopram | Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||||||||
| 6414103 | 5447592 | 09/05/2007 | Citalopram | Depression | Cleft Lip, Cleft Palate, Drug Exposure During Pregnancy | |||||||||
| F | 6414402 | 5446077 | 09/04/2007 | Citalopram | OT | Depression | Drug Exposure During Pregnancy | |||||||
| F | 6440674 | 5475916 | 10/01/2007 | Celexa | Apgar Score Low, Drug Exposure During Pregnancy, Meconium Increased, Somnolence Neonatal | |||||||||
| 6474407 | 5518319 | 11/13/2007 | Citalopram | PH | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||||||
| 6474407 | 5530430 | 11/27/2007 | Citalopram | Drug Exposure During Pregnancy | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6475049 | 5519150 | 11/14/2007 | Citalopram | Drug Exposure During Pregnancy, Trisomy 18 | ||||||||||
| 6475049 | 5530433 | 11/27/2007 | Citalopram | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | ||||||||||
| 6475956 | 5522851 | 11/15/2007 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||||||
| 6476845 | 5523272 | 11/16/2007 | Citalopram | OT | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||||||
| 6477965 | 5524809 | 11/16/2007 | Citalopram | Depression | Drug Exposure During Pregnancy, Trisomy 18 | |||||||||
| M | 6483560 | 5528109 | 09/10/2003 | 11/23/2007 | Citalopram | OT | Panic Attack | Congenital Hand Malformation, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Synovitis | ||||||
| F | 6483972 | 5530391 | 09/30/2007 | 11/27/2007 | Citalopram | OT | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Neonatal Respiratory Depression | ||||||
| 6484629 | 5530418 | 11/27/2007 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Trisomy 18 | ||||||||
| F | 6490456 | 5532151 | 09/30/2007 | 11/28/2007 | Citalopram | OT | Drug Exposure During Pregnancy, Neonatal Respiratory Depression | |||||||
| F | 6506357 | 5537008 | 12/04/2007 | Citalopram | Depression | Drug Exposure During Pregnancy, Premature Labour | ||||||||
| 6506358 | 5536999 | 12/04/2007 | Citalopram | Drug Exposure During Pregnancy, Premature Baby | ||||||||||
| F | 6510517 | 5552419 | 12/10/2007 | Citalopram | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 6510591 | 5552430 | 12/10/2007 | Citalopram | OT | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||||||
| M | 6511564 | 5550872 | 10/18/2003 | 12/10/2007 | Citalopram | OT | Ammonia Increased, Culture Urine Positive, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Escherichia Infection, Feeding Disorder Neonatal, Maternal Condition Affecting Foetus, Protein Urine Present, Red Blood Cells Urine, Uterine Infection, White Blood Cells Urine | |||||||
| F | 6513306 | 5552426 | 12/10/2007 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Intra-Uterine Death | |||||||
| M | 6513746 | 5590827 | 01/10/2008 | Citalopram | MD | Abscess, Anomaly of External Ear Congenital, Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Hypotonia Neonatal, Neonatal Disorder, Perianal Abscess, Prominent Epicanthal Folds, Visual Acuity Reduced, Visual Disturbance | ||||||||
| F | 6514086 | 5557371 | 07/31/2006 | 12/11/2007 | 08/10/2006 | Citalopram | PH | Depression | Drug Exposure During Pregnancy, Premature Baby, Sepsis Neonatal | |||||
| M | 6520468 | 5576138 | 12/26/2007 | Citalopram | CN | Drug Exposure During Pregnancy, Hydrocele | ||||||||
| 6538991 | 5589480 | 11/25/2007 | 01/09/2008 | Citalopram | Drug Exposure During Pregnancy, Drug Ineffective, Premature Labour | |||||||||
| 6538991 | 5599627 | 11/25/2007 | 01/18/2008 | Citalopram | OT | Drug Exposure During Pregnancy, Premature Baby | ||||||||
| 6538991 | 5613397 | 11/25/2007 | 01/29/2008 | Citalopram | Drug Exposure During Pregnancy, Premature Baby | |||||||||
| F | 6604728 | 5679864 | 03/24/2008 | Citalopram | CN | Drug Exposure During Pregnancy, Premature Labour | ||||||||
| 0 | Days | M | 4074663 | 4443542 | 10/01/2003 | 09/01/2004 | Celexa | MD | Depression | Apgar Score Low, Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||
| 0 | Days | 4092070 | 4293376 | 02/10/2004 | Celexa | MD | Depression | Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 0 | Days | M | 4134792 | 4507351 | 11/18/2004 | Celexa | MD | Depression | Arnold-Chiari Malformation, Congenital Anomaly of Inner Ear, Congenital Atrial Septal Defect, Congenital Cardiovascular Anomaly, Congenital Elevation of Scapula, Congenital Torticollis, Deafness Congenital, Deafness Unilateral, Drug Exposure During Pregnancy, Spine Malformation | |||||
| 0 | Days | F | 4148585 | 4386273 | 03/25/2004 | 06/22/2004 | Cipramil | Agitation Neonatal, Apgar Score Low, Drug Exposure During Pregnancy, Feeling Jittery, Hypotonia Neonatal, Irritability, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Poor Sucking Reflex, Tremor Neonatal, Vacuum Extractor Delivery | ||||||
| 0 | Days | F | 4211025 | 4446922 | 07/26/2004 | 09/08/2004 | Citalopram | Depression | Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy | |||||
| 0 | Days | M | 4222980 | 4511901 | 05/17/2004 | 11/23/2004 | Celexa | MD | Depression | Amniotic Fluid Volume Decreased, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Hip Dysplasia, Jaundice Neonatal, Neonatal Disorder, Small for Dates Baby | ||||
| 0 | Days | F | 5658869 | 4577015 | 10/06/2004 | 02/08/2005 | Celexa | Anxiety, Depression | Caesarean Section, Drug Exposure During Pregnancy, Fallot's Tetralogy, Limb Malformation, Placenta Praevia, Placental Insufficiency | |||||
| 0 | Days | M | 5667865 | 4471956 | 12/01/2003 | 10/07/2004 | Citalopram | OT | Panic Disorder | Blood Bilirubin Increased, Feeding Problem In Newborn, Jaundice Neonatal, Neonatal Disorder | ||||
| 0 | Days | M | 5710155 | 4541905 | 09/20/2004 | 12/27/2004 | Citalopram | PH | Cardiac Murmur, Drug Exposure During Pregnancy, Heart Disease Congenital | |||||
| 0 | Days | 5731094 | 4565915 | 01/28/2005 | Citalopram | PH | Depression | Camptodactyly Congenital, Congenital Anomaly, Congenital Hand Malformation, Congenital Pulmonary Hypertension, Drug Exposure During Pregnancy, Foetal Movements Decreased, Joint Hyperextension, Polyhydramnios, Premature Baby | ||||||
| 0 | Days | 5755143 | 4596464 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||
| 0 | Days | 5755958 | 4596445 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||
| 0 | Days | 5755967 | 4596449 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||
| 0 | Days | 5755974 | 4596453 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 0 | Days | 5755977 | 4596456 | 02/28/2005 | Citalopram | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||||
| 0 | Days | M | 5798380 | 4659271 | 01/23/2004 | 05/10/2005 | Citalopram | OT | Drug Exposure During Pregnancy, Pierre Robin Syndrome | |||||
| 0 | Days | M | 5800139 | 4661119 | 01/12/2004 | 05/11/2005 | Citalopram | OT | Congenital Central Nervous System Anomaly, Congenital Eye Disorder, Corneal Disorder, Drug Exposure During Pregnancy, Haemangioma Congenital, Microphthalmos | |||||
| F | 6604728 | 5701188 | 04/07/2008 | Citalopram | OT | Drug Exposure During Pregnancy, Premature Labour | ||||||||
| F | 6604728 | 5739699 | 05/13/2008 | Citalopram | Depressive Symptom | Depression, Drug Exposure During Pregnancy, Premature Labour | ||||||||
| F | 6609429 | 5736314 | 05/08/2008 | Akarin | Abnormal Faeces, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Maternal Drugs Affecting Foetus, Neonatal Tachycardia, Psychomotor Hyperactivity, Respiratory Rate Increased, Restlessness, Tremor Neonatal | |||||||||
| F | 6624314 | 5705910 | 07/02/2002 | 04/11/2008 | Cipramil | OT | Drug Exposure During Pregnancy, Duane's Syndrome, Strabismus Congenital | |||||||
| 6648547 | 5736931 | 05/09/2008 | Citalopram | Abortion Induced, Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities | ||||||||||
| 6649397 | 5738005 | 05/09/2008 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy, Maternal Drugs Affecting Foetus, Multiple Congenital Abnormalities | |||||||||
| M | 6650110 | 5736837 | 02/22/2008 | 05/08/2008 | Citalopram | Caesarean Section, Diarrhoea Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus, Premature Baby | ||||||||
| 6650262 | 5739582 | 05/13/2008 | Citalopram | Abortion Induced, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities | ||||||||||
| M | 6657757 | 5748898 | 05/22/2008 | Celexa | OT | Drug Use for Unknown Indication | Drug Withdrawal Syndrome Neonatal, Feeling Jittery, Maternal Drugs Affecting Foetus, Opisthotonus, Red Blood Cells CSF Positive | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| F | 6661296 | 5753464 | 05/27/2008 | Citalopram | MD | Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome Neonatal, Extrapyramidal Disorder, Grunting, Hypertonia, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Neonatal Respiratory Distress Syndrome | ||||||||
| F | 6663112 | 5755185 | 01/01/2007 | 05/28/2008 | Celexa | MD | Caesarean Section, Jaundice Neonatal, Maternal Drugs Affecting Foetus, Talipes | |||||||
| F | 6663112 | 5756367 | 01/01/2007 | 05/29/2008 | Celexa | MD | Jaundice Neonatal, Maternal Drugs Affecting Foetus, Talipes | |||||||
| F | 6664912 | 5757203 | 05/29/2008 | Citalopram | Drug Exposure During Pregnancy | Drug Interaction, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Extrapyramidal Disorder, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Respiratory Disorder Neonatal, Small for Dates Baby | ||||||||
| F | 6676025 | 5769008 | 06/10/2008 | Citalopram | MD | Drug Exposure During Pregnancy | Apgar Score Low, Autonomic Nervous System Imbalance, Drug Interaction, Drug Withdrawal Syndrome Neonatal, Electroencephalogram Abnormal, Extrapyramidal Disorder, Maternal Drugs Affecting Foetus, Metabolic Acidosis, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Pupillary Reflex Impaired | |||||||
| 1 | Hours | F | 6125469 | 5093458 | 08/28/2006 | Citalopram | Agitation Neonatal, Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Growth Retardation, Neonatal Asphyxia, Premature Baby | |||||||
| 1 | Hours | F | 6125469 | 5107777 | 09/14/2006 | Citalopram | Agitation Neonatal, Apgar Score Low, Bradycardia Neonatal, Caesarean Section, Drug Exposure During Pregnancy, Foetal Cardiac Disorder, Growth Retardation, Neonatal Asphyxia, Neonatal Disorder, Oligohydramnios, Premature Baby, Premature Rupture of Membranes | |||||||
| 1 | Day | M | 5731094 | 4727698 | 09/08/2004 | 07/27/2005 | 09/21/2004 | Citalopram | Depression | Areflexia, Caesarean Section, Camptodactyly Congenital, Cerebral Haemorrhage, Cholestasis, Cleft Palate, Congenital Multiplex Arthrogryposis, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Gastrointestinal Motility Disorder, Hand Deformity, Hip Dysplasia, Hypokinesia Neonatal, Hypoxia, Ischaemia, Joint Hyperextension, Muscular Dystrophy, Muscular Weakness, Myasthenic Syndrome, Mydriasis, Polyhydramnios, Premature Baby, Pulmonary Hypertension | ||||
| 1 | Day | M | 5731094 | 4758951 | 09/08/2004 | 08/26/2005 | 09/21/2004 | Citalopram | OT | Depression | Aids Related Complex, Akinesia, Amniocentesis Abnormal, Apgar Score Low, Areflexia, Arthropathy, Blood PH Decreased, Caesarean Section, Camptodactyly Congenital, Cerebral Haemorrhage Neonatal, Cerebrovascular Disorder, Combined Immunodeficiency, Congenital Hand Malformation, Congenital Multiplex Arthrogryposis, Death Neonatal, Deformity Thorax, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Gastrointestinal Motility Disorder, Haemoglobin Increased, Hip Dysplasia, Hypokinesia Neonatal, Ischaemia, Joint Hyperextension, Mydriasis, Myopathy, Neonatal Cholestasis, Neonatal Hypoxia, Neuromyopathy, Obstructive Airways Disorder, Oculocephalogyric Reflex Absent, Palatal Disorder, PCO2 Decreased, PO2 Decreased, Polyhydramnios, Premature Baby, Pulmonary Hypertension | |||
| 1 | Day | M | 5731094 | 4759161 | 09/08/2004 | 08/31/2005 | 09/21/2004 | Citalopram | PH | Depression | Akinesia, Amniocentesis Abnormal, Apgar Score Low, Areflexia, Blood PH Decreased, Caesarean Section, Camptodactyly Congenital, Cerebral Haemorrhage, Cholestasis, Congenital Multiplex Arthrogryposis, Congenital Neurological Disorder, Congenital Oral Malformation, Congenital Pulmonary Hypertension, Death Neonatal, Deformity Thorax, Drug Exposure During Pregnancy, Feeding Tube Complication, Gastrointestinal Motility Disorder, Haemoglobin Increased, Hand Deformity, Hip Dysplasia, Hypokinesia Neonatal, Immobile, Ischaemia, Joint Hyperextension, Mydriasis, Myopathy, Neonatal Hypoxia, Obstruction, Polyhydramnios, Premature Baby | |||
| 1 | Day | M | 5731094 | 4785157 | 09/08/2004 | 09/28/2005 | 09/21/2004 | Citalopram | OT | Depression | Akinesia, Amniocentesis Abnormal, Apgar Score Low, Blood PH Decreased, Camptodactyly Congenital, Cerebral Haemorrhage, Cholestasis, Congenital Multiplex Arthrogryposis, Death Neonatal, Drug Exposure During Pregnancy, Foetal Disorder, Gastrointestinal Motility Disorder, Hand Deformity, Hip Dysplasia, Hyporeflexia, Hypoxia, Immobile, Ischaemia, Joint Hyperextension, Loss of Proprioception, Mydriasis, Myopathy, Palatal Disorder, PCO2 Decreased, PO2 Decreased, Polyhydramnios, Premature Baby, Pulmonary Hypertension, Respiratory Tract Malformation, Small for Dates Baby | |||
| 1 | Day | F | 5850779 | 4724507 | 07/21/2005 | Celexa | Drug Exposure During Pregnancy, Neonatal Disorder | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 1 | Day | F | 5850786 | 4724523 | 07/21/2005 | Celexa | Crying, Depersonalisation, Drug Exposure During Pregnancy, Neonatal Disorder | |||||||
| 1 | Day | F | 5850786 | 4726488 | 07/26/2005 | Celexa | Crying, Depersonalisation, Drug Exposure During Pregnancy, Neonatal Disorder | |||||||
| 1 | Day | M | 5859865 | 4736978 | 07/12/2005 | 08/04/2005 | Citalopram | OT | Panic Disorder | Apgar Score Low, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hyperthermia, Hypotonia Neonatal, Irritability, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Respiratory Disorder Neonatal, Tremor Neonatal | ||||
| 1 | Day | M | 5859865 | 4865793 | 07/12/2005 | 12/20/2005 | Citalopram | PH | Apgar Score Low, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Hypotonia Neonatal, Irritability, Neonatal Asphyxia, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Regurgitation of Food, Tremor Neonatal | |||||
| 1 | Day | M | 6600947 | 5677141 | 03/18/2008 | Citalopram | Agitation, Crying, Drug Exposure During Pregnancy, Hypoventilation, Infantile Apnoeic Attack, Neonatal Respiratory Distress Syndrome, Premature Baby | |||||||
| 1 | Day | F | 6604726 | 5701189 | 03/07/2008 | 04/07/2008 | Citalopram | OT | Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby, Skin Discolouration | |||||
| 1 | Day | F | 6604726 | 5739584 | 03/07/2008 | 05/13/2008 | Citalopram | Drug Exposure Via Breast Milk, Infantile Apnoeic Attack, Maternal Drugs Affecting Foetus, Premature Baby | ||||||
| 2 | Days | M | 6650110 | 5762094 | 03/22/2008 | 06/04/2008 | Citalopram | OT | Caesarean Section, Diarrhoea Neonatal, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus, Premature Baby | |||||
| 2 | Days | M | 6650110 | 5766477 | 03/22/2008 | 06/06/2008 | Citalopram | PH | Caesarean Section, Diarrhoea Neonatal, Drug Withdrawal Syndrome Neonatal, Maternal Drugs Affecting Foetus, Premature Baby | |||||
| 4 | Days | 6604726 | 5679863 | 03/24/2008 | Citalopram | CN | Apnoea, Drug Exposure During Pregnancy, Premature Baby | |||||||
| 4 | Days | 6604726 | 5692875 | 04/01/2008 | Citalopram | Drug Exposure During Pregnancy, Infantile Apnoeic Attack, Premature Baby | ||||||||
| 5 | Days | F | 6514086 | 5574067 | 08/05/2006 | 12/21/2007 | 08/10/2006 | Citalopram | Depression | Death Neonatal, Drug Exposure During Pregnancy, Premature Baby, Premature Rupture of Membranes, Sepsis Neonatal | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 5 | Days | F | 6514086 | 5574088 | 08/05/2006 | 12/21/2007 | 08/10/2006 | Seropram | Depression | Drug Exposure During Pregnancy, Premature Baby, Sepsis Neonatal | ||||
| 7 | Days | F | 4211020 | 4446921 | 07/19/2004 | 09/08/2004 | Citalopram | Drug Exposure During Pregnancy, Fever Neonatal, Haemorrhage Intracranial, Hydrocephalus, Neonatal Disorder, Thrombocythaemia | ||||||
| 7 | Days | F | 4211020 | 4544797 | 07/19/2004 | 12/30/2004 | Citalopram | OT | Cerebral Haemorrhage Neonatal, Drug Exposure During Pregnancy, Fever Neonatal, Hydrocephalus, Meningorrhagia, Neonatal Disorder, Neonatal Infection, Thrombocythaemia | |||||
| 7 | Days | F | 4211020 | 4553262 | 07/19/2004 | 01/13/2005 | Citalopram | OT | Cerebral Haemorrhage Neonatal, Congenital Hydrocephalus, Drug Exposure During Pregnancy, Fever Neonatal, Neonatal Disorder, Neonatal Infection, Thrombocythaemia | |||||
| 7 | Days | F | 4211020 | 4883385 | 07/19/2004 | 01/13/2006 | Citalopram | Drug Exposure Before Pregnancy, Fever Neonatal, Haemorrhage Intracranial, Hydrocephalus, Infection, Meningorrhagia, Neonatal Disorder, Thrombocythaemia | ||||||
| 2 | Months | F | 6138342 | 5108655 | 05/04/2006 | 09/15/2006 | 05/04/2006 | Celexa | Drug Exposure During Pregnancy, Sudden Infant Death Syndrome | |||||
| 3 | Months | F | 6513746 | 5557438 | 12/11/2007 | Citalopram | MD | Abscess, Anomaly of External Ear Congenital, Congenital Eyelid Malformation, Drug Exposure During Pregnancy, Visual Acuity Reduced | ||||||
| 3 | Months | F | 4144693 | 4363638 | 02/15/2004 | 05/24/2004 | 02/15/2004 | Citalopram | CN | Depression | Abnormal Behaviour, Brain Damage, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Withdrawal Syndrome, Eye Redness, Eye Rolling, Feeling Cold, Hypotonia, Movement Disorder, Screaming, Sedation, Somnolence, Staring | |||
| 4 | Months | 4134785 | 4348465 | 04/01/2004 | 04/23/2004 | Celexa | PH | Drug Exposure Via Breast Milk, Maternal Drugs Affecting Foetus, Rash, Splenomegaly, White Blood Cell Count Decreased | ||||||
| 4 | Months | 4134785 | 4446761 | 04/01/2004 | 09/10/2004 | Celexa | PH | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Rash, Splenomegaly, White Blood Cell Count Decreased | ||||||
| 6 | Months | M | 5783124 | 4639213 | 04/18/2005 | Citalopram | OT | Abdominal Pain, Anorexia, Crying, Drug Exposure Via Breast Milk, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Insomnia, Weight Decreased | ||||||
| 6 | Months | M | 6189594 | 5178912 | 09/01/2006 | 12/11/2006 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Infantile Spasms | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 9 | Months | F | 6091233 | 5054514 | 07/14/2006 | Citalopram | OT | Panic Disorder With Agoraphobia | Chromosome Abnormality, Congenital Anomaly, Convulsion, Lissencephaly, Transmission of Drug Via Semen | |||||
| 9 | Months | F | 6091233 | 5104215 | 09/11/2006 | Seropram | OT | Panic Disorder With Agoraphobia | Chromosomal Deletion, Congenital Anomaly, Convulsion, Lissencephaly, Transmission of Drug Via Semen | |||||
| 39 | Weeks | M | 6689682 | 5786759 | 03/14/2007 | 06/18/2008 | Citalopram | Panic Disorder | Congenital Hydronephrosis, Maternal Drugs Affecting Foetus, Neonatal Disorder, Pyelocaliectasis | |||||
| 1 | Year | M | 4115344 | 4323149 | 04/01/2002 | 03/22/2004 | Celexa | CN | Depression | Autism, Maternal Drugs Affecting Foetus, Pervasive Developmental Disorder, Premature Baby | ||||
| 1 | Year | F | 5827210 | 4698300 | 05/01/2003 | 06/21/2005 | Citalopram | OT | Diabetes Mellitus, Drug Exposure During Pregnancy | |||||
| 2 | Years | F | 6609429 | 5688132 | 03/27/2008 | Akarin | OT | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Neonatal Disorder, Neonatal Tachycardia, Restlessness, Tremor Neonatal | ||||||
| 3 | Years | F | 6518592 | 5382662 | 07/03/2007 | Celexa | OT | Depression | Autism, Breech Delivery, Drug Exposure During Pregnancy, Macrocephaly | |||||
| 4 | Years | F | 5827210 | 4692932 | 05/01/2005 | 06/15/2005 | Citalopram | Diabetes Mellitus, Drug Exposure During Pregnancy | ||||||
| 100 | Years | F | 6151680 | 5128262 | 07/12/2006 | 10/11/2006 | Seropram | OT | Apgar Score Low, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Growth Retardation, Hypertonia Neonatal, Neonatal Respiratory Distress Syndrome | |||||
| 13 | Years | 6065223 | 5019195 | 05/31/2006 | Celexa | OT | Aspiration, Death Neonatal, Drug Exposure During Pregnancy, Neonatal Aspiration | |||||||
| 22 | Years | F | 6192005 | 5147655 | 05/23/2006 | 09/15/2006 | Celexa | CN | Drug Use for Unknown Indication | Drug Exposure During Pregnancy, Intentional Overdose, Nausea, Vomiting | ||||
| 22 | Years | F | 6192005 | 5486265 | 05/23/2006 | 09/17/2007 | Celexa | CN | Drug Exposure During Pregnancy, Intentional Overdose, Nausea, Vomiting | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 22 | Years | F | 6390299 | 5420837 | 08/16/2007 | Citalopram | Depression | Cleft Lip and Palate, Drug Exposure During Pregnancy | ||||||
| 25 | Years | F | 6035531 | 4977889 | 03/19/2006 | 04/14/2006 | Citalopram | OT | Panic Disorder | Amniocentesis Abnormal, Drug Exposure During Pregnancy, Dyspnoea, Haemoglobin Increased, Hyperaemia, Neonatal Disorder, Neonatal Infection, Patent Ductus Arteriosus, Platelet Count Decreased, Premature Baby, White Blood Cell Count Decreased | ||||
| 25 | Years | F | 6035531 | 4995814 | 03/19/2006 | 05/04/2006 | Citalopram | OT | Panic Disorder | Drug Exposure During Pregnancy, Haematocrit Increased, Haemoglobin Decreased, Infection, Platelet Count Increased, Premature Labour | ||||
| 25 | Years | F | 6167085 | 5141875 | 10/27/2006 | Citalopram | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 26 | Years | F | 6481467 | 5528421 | 11/21/2007 | Citalopram | Depression | Amniorrhoea, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Mental Disorder, Premature Baby | ||||||
| 26 | Years | F | 6600862 | 5677412 | 03/18/2008 | Citalopram | OT | Caesarean Section, Drug Exposure During Pregnancy, Postmature Baby | ||||||
| 26 | Years | F | 5918149 | 4811853 | 10/12/2003 | 10/26/2005 | Celexa | CN | Panic Attack | Drug Exposure During Pregnancy, Premature Labour | ||||
| 26 | Years | F | 5918149 | 4847164 | 10/12/2003 | 12/05/2005 | Celexa | CN | Panic Attack | Drug Exposure During Pregnancy, Premature Labour | ||||
| 26 | Years | F | 6144823 | 5117812 | 09/26/2006 | Citalopram | Agitation, Akathisia, Anhedonia, Asthenia, Bipolar II Disorder, Crying, Disease Recurrence, Disturbance In Attention, Dysphoria, Homicidal Ideation, Hypomania, Insomnia, Irritability, Major Depression, Marital Problem, Obsessive Thoughts, Postpartum Depression, Restlessness, Thinking Abnormal | |||||||
| 27 | Years | F | 6529883 | 5589493 | 11/25/2007 | 01/09/2008 | Citalopram | Depression | Drug Exposure Before Pregnancy, Drug Ineffective, Premature Labour | |||||
| 27 | Years | F | 6529883 | 5600985 | 11/25/2007 | 01/18/2008 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Drug Ineffective, Premature Labour | ||||
| 27 | Years | F | 6529883 | 5613398 | 11/25/2007 | 01/29/2008 | Citalopram | Depression | Drug Exposure During Pregnancy, Premature Labour | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 27 | Years | F | 5771198 | 4620882 | 01/01/2004 | 03/25/2005 | Celexa | Drug Exposure During Pregnancy, Haemorrhage, Umbilical Cord Abnormality | ||||||
| 27 | Years | F | 5771198 | 4678779 | 01/01/2004 | 05/31/2005 | Celexa | OT | Bleeding Peripartum, Drug Exposure During Pregnancy, Premature Separation of Placenta | |||||
| 27 | Years | F | 5771198 | 4694916 | 01/01/2004 | 06/17/2005 | Celexa | OT | Antepartum Haemorrhage, Drug Exposure During Pregnancy, Haemorrhage, Placental Disorder, Umbilical Cord Abnormality | |||||
| 27 | Years | F | 5918176 | 4811696 | 11/04/2004 | 10/25/2005 | Celexa | CN | Depression | Candidiasis, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Emotional Disorder, Euphoric Mood, Feeling Abnormal, Galactostasis, Haemorrhage, Nausea, Nephrolithiasis, Nipple Pain, Prolonged Labour, Vaginal Haemorrhage | ||||
| 27 | Years | F | 5918176 | 4872020 | 11/04/2004 | 12/30/2005 | Celexa | CN | Depression | Abnormal Behaviour, Amenorrhoea, Anxiety, Bipolar Disorder, Candidiasis, Complication of Pregnancy, Condition Aggravated, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Euphoric Mood, False Labour, Galactostasis, Haemorrhage, Labour Pain, Mania, Nausea, Nephrolithiasis, Nipple Disorder, Nipple Pain, Panic Attack, Paraesthesia, Paranoia, Postpartum Depression, Postpartum Haemorrhage, Thinking Abnormal | ||||
| 27 | Years | F | 5918176 | 4885803 | 11/04/2004 | 01/17/2006 | Celexa | MD | Depression | Anxiety, Bipolar II Disorder, Condition Aggravated, Crying, Depression, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Emotional Distress, Euphoric Mood, False Labour, Galactostasis, Haemorrhage, Inadequate Analgesia, Induced Labour, Mania, Nausea, Nephrolithiasis, Nipple Disorder, Nipple Pain, Obsessive-Compulsive Disorder, Pain, Panic Attack, Paraesthesia, Paranoia, Postpartum Depression, Postpartum Haemorrhage, Vaginal Haemorrhage | ||||
| 27 | Years | F | 5918176 | 4960000 | 11/04/2004 | 03/27/2006 | Celexa | MD | Depression | Anxiety, Bipolar II Disorder, Breast Haemorrhage, Calculus Urinary, Candidiasis, Crying, Drug Exposure During Pregnancy, Drug Ineffective, Euphoric Mood, Fatigue, Galactostasis, Hydronephrosis, Mania, Nausea, Nephrolithiasis, Nipple Disorder, Nipple Pain, Pain, Panic Attack, Paraesthesia, Paranoia, Postpartum Depression, Postpartum Haemorrhage, Streptococcal Serology Positive, Vaginal Haemorrhage | ||||
| 27 | Years | F | 5926606 | 4825149 | 11/09/2005 | Citalopram | OT | Depression | Abortion Induced, Cystic Lymphangioma, Drug Exposure During Pregnancy, Trisomy 21 | |||||
| 28 | Years | F | 4222981 | 4462056 | 09/24/2004 | Celexa | MD | Depression | Amniocentesis Abnormal, Breech Delivery, Caesarean Section, Headache, Insomnia | |||||
| 28 | Years | F | 4222981 | 4511899 | 09/01/2003 | 11/23/2004 | Celexa | MD | Depression | Amniotic Fluid Volume Decreased, Breast Mass, Breech Presentation, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Headache, Insomnia | ||||
| 28 | Years | F | 4222981 | 4612408 | 09/01/2003 | 03/16/2005 | Celexa | MD | Depression | Amniotic Fluid Volume Decreased, Beta Haemolytic Streptococcal Infection, Breech Presentation, Caesarean Section, Haematocrit Decreased, Headache, Insomnia, Post Procedural Complication | ||||
| 28 | Years | F | 5692635 | 4518152 | 01/01/2002 | 11/30/2004 | Celexa | CN | Depression | Abortion Spontaneous, Blood Glucose Increased, Caesarean Section, Drug Exposure During Pregnancy, Labour Induction | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 28 | Years | F | 5928800 | 4831224 | 12/01/2004 | 11/16/2005 | Celexa | MD | Postpartum Depression | Diarrhoea, Drug Exposure During Pregnancy, Post Procedural Hypothyroidism, Thyroidectomy, Vertigo | ||||
| 28 | Years | F | 5928800 | 4877695 | 12/01/2004 | 01/09/2006 | Celexa | MD | Postpartum Depression | Diarrhoea, Drug Exposure During Pregnancy, Post Procedural Hypothyroidism, Road Traffic Accident, Thyroid Gland Cancer, Vertigo | ||||
| 28 | Years | F | 5928800 | 4905559 | 12/01/2004 | 02/03/2006 | Celexa | MD | Postpartum Depression | Anaemia, Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Hypothyroidism, Road Traffic Accident, Thyroid Gland Cancer, Vertigo | ||||
| 28 | Years | F | 5928800 | 4915685 | 12/01/2004 | 02/14/2006 | Celexa | MD | Postpartum Depression | Caesarean Section, Diarrhoea, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Hypothyroidism, Thyroid Gland Cancer, Umbilical Cord Around Neck, Vertigo | ||||
| 28 | Years | F | 6114017 | 5081342 | 09/06/2005 | 08/11/2006 | Celexa | MD | Depression | Arrested Labour, Caesarean Section, Cephalo-Pelvic Disproportion, Complication of Pregnancy, Drug Exposure During Pregnancy, Gestational Diabetes, Weight Increased | ||||
| 29 | Years | F | 4116649 | 4323719 | 12/01/2002 | 03/23/2004 | Cipramil | PH | Depression | Abortion Spontaneous, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Foetal Malposition, Maternal Drugs Affecting Foetus | ||||
| 29 | Years | F | 4116649 | 4337681 | 12/01/2002 | 04/08/2004 | Cipramil | Depression | Abortion Spontaneous, Caesarean Section, Complications of Maternal Exposure To Therapeutic Drugs, Drug Exposure During Pregnancy, Foetal Malposition, Maternal Drugs Affecting Foetus | |||||
| 29 | Years | F | 6141807 | 5114623 | 04/01/2005 | 09/21/2006 | Citalopram | Depression | Abortion Induced, Drug Dose Omission, Drug Exposure During Pregnancy | |||||
| 29 | Years | F | 6168974 | 5144628 | 10/31/2006 | Citalopram | OT | Depression | Caesarean Section, Drug Exposure During Pregnancy | |||||
| 30 | Years | F | 5687962 | 4510259 | 01/01/2002 | 11/19/2004 | Citalopram | OT | Depression | Antepartum Haemorrhage, Drug Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Infection, Intra-Uterine Death, Neonatal Aspiration, Placental Insufficiency, Pleural Haemorrhage, Umbilical Cord Abnormality, Umbilical Cord Around Neck | ||||
| 30 | Years | F | 5695403 | 4522799 | 01/01/2002 | 12/08/2004 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Intra-Uterine Death, Placental Disorder, Uterine Contractions During Pregnancy, Vaginal Haemorrhage | ||||
| 30 | Years | F | 5704847 | 4532081 | 05/01/2004 | 12/17/2004 | Cipramil | Depression | Drug Exposure During Pregnancy, Gestational Diabetes | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 30 | Years | F | 5704847 | 4621382 | 05/01/2004 | 03/25/2005 | Cipramil | OT | Depression | Caesarean Section, Drug Exposure During Pregnancy, Gestational Diabetes | ||||
| 30 | Years | F | 5865545 | 4747046 | 10/19/2004 | 08/15/2005 | Celexa | CN | Depression | Back Pain, Caesarean Section, Dehydration, Drug Exposure During Pregnancy, Drug Ineffective, Kidney Infection, Nausea, Premature Labour, Vomiting | ||||
| 30 | Years | F | 3922549 | 5343626 | 01/01/2001 | 05/31/2007 | Cipramil | OT | Depression | Cholestasis, Drug Exposure During Pregnancy | ||||
| 30 | Years | F | 6252650 | 5244847 | 02/16/2007 | Citalopram | Depression | Drug Exposure During Pregnancy, Intra-Uterine Death | ||||||
| 30 | Years | F | 6252650 | 5281136 | 03/23/2007 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Stillbirth | |||||
| 30 | Years | F | 6252650 | 5290349 | 04/02/2007 | Citalopram | OT | Depression | Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 30 | Years | F | 6356185 | 5382685 | 07/03/2007 | Celexa | OT | Premenstrual Syndrome | Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Metrorrhagia, Nausea, Progesterone Decreased, Vomiting | |||||
| 31 | Years | F | 5921607 | 4819965 | 08/25/2005 | 11/02/2005 | Citalopram | OT | Congenital Central Nervous System Anomaly, Congenital Hydrocephalus, Drug Exposure During Pregnancy | |||||
| 31 | Years | F | 5921607 | 4942905 | 08/25/2005 | 03/09/2006 | Citalopram | OT | Abortion Induced, Cleft Lip and Palate, Congenital Central Nervous System Anomaly, Congenital Hydrocephalus, Drug Exposure Before Pregnancy, Hypoxia, Macrocephaly, Placental Disorder | |||||
| 31 | Years | F | 5953750 | 4866823 | 12/22/2005 | Citalopram | OT | Drug Exposure During Pregnancy, Intra-Uterine Death | ||||||
| 31 | Years | F | 6227520 | 5216828 | 09/07/2004 | 01/19/2007 | Celexa | MD | Anxiety, Depression | Drug Exposure During Pregnancy, Haemorrhoids, Premature Labour, Sinusitis | ||||
| 31 | Years | F | 6422727 | 5449784 | 09/06/2006 | 09/10/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 32 | Years | F | 5658874 | 4488271 | 01/01/2004 | 10/26/2004 | Celexa | MD | Anxiety, Depression | Cystocele, Drug Exposure During Pregnancy, Placenta Praevia | ||||
| 32 | Years | F | 5658874 | 4503281 | 01/01/2004 | 11/12/2004 | Celexa | MD | Anxiety, Depression | Caesarean Section, Cystocele, Drug Exposure During Pregnancy, Placenta Praevia | ||||
| 32 | Years | F | 5658874 | 4577036 | 12/31/2003 | 02/08/2005 | Celexa | MD | Anxiety, Depression | Caesarean Section, Cervix Disorder, Cystocele, Drug Exposure During Pregnancy, Placenta Praevia, Placental Insufficiency, Post Procedural Pain, Sinusitis | ||||
| 32 | Years | F | 6114354 | 5082973 | 08/14/2006 | Citalopram | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Foetal Disorder, Hydrocephalus, Intracranial Aneurysm | ||||||
| 32 | Years | F | 6114354 | 5147138 | 11/03/2006 | Citalopram | OT | Depression | Congenital Hydrocephalus, Drug Exposure During Pregnancy, Intracranial Aneurysm | |||||
| 33 | Years | F | 6049490 | 5557373 | 01/29/2006 | 12/11/2007 | Citalopram | PH | Depression | Drug Exposure During Pregnancy, Premature Rupture of Membranes, Sepsis Neonatal | ||||
| 33 | Years | F | 6049490 | 5574065 | 01/29/2006 | 12/12/2007 | Citalopram | Depression | Drug Exposure During Pregnancy, Premature Labour, Premature Rupture of Membranes | |||||
| 33 | Years | F | 6049490 | 5574086 | 01/29/2006 | 12/21/2007 | Seropram | Depression | Drug Exposure During Pregnancy, Premature Rupture of Membranes, Sepsis | |||||
| 33 | Years | F | 6227025 | 5216515 | 01/01/2005 | 01/18/2007 | Citalopram | OT | Conduct Disorder, Depression | Drug Exposure During Pregnancy, Polyhydramnios, Premature Baby | ||||
| 33 | Years | F | 6045161 | 4990938 | 10/14/2005 | 04/28/2006 | Celexa | MD | Obsessive-Compulsive Disorder | Caesarean Section, Drug Exposure During Pregnancy, Labour Complication | ||||
| 33 | Years | F | 6049490 | 4998545 | 01/29/2006 | 05/08/2006 | Citalopram | OT | Depression | Depression, Drug Exposure During Pregnancy | ||||
| 33 | Years | F | 6067821 | 5022543 | 06/05/2006 | Citalopram | Depression | Drug Exposure During Pregnancy, Ectopic Pregnancy | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 33 | Years | F | 6209154 | 5188511 | 07/01/2006 | 12/14/2006 | Celexa | MD | Depression | Abortion Incomplete, Contusion, Drug Exposure During Pregnancy, Overdose, Physical Assault | ||||
| 33 | Years | F | 6630664 | 5725458 | 05/01/2008 | Citalopram | OT | Depression | Multiple Congenital Abnormalities | |||||
| 33 | Years | F | 6648187 | 5733181 | 05/07/2008 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities | |||||
| 33 | Years | F | 6649262 | 5738052 | 04/03/2008 | 05/08/2008 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy, Multiple Congenital Abnormalities | |||||
| 33 | Years | F | 6651626 | 5740107 | 05/13/2008 | Citalopram | OT | Depression | Abortion Induced, Congenital Anomaly, Maternal Drugs Affecting Foetus | |||||
| 33 | Years | F | 6651818 | 5739952 | 05/13/2008 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy | ||||||
| 34 | Years | F | 5762620 | 4607722 | 01/01/2004 | 03/09/2005 | Seropram | Depression | Congenital Anomaly, Drug Exposure During Pregnancy, Microphthalmos | |||||
| 34 | Years | F | 5990197 | 4907893 | 02/08/2006 | Citalopram | OT | Major Depression | Drug Exposure During Pregnancy, Premature Labour | |||||
| 34 | Years | F | 5990197 | 4920847 | 01/12/2006 | 02/17/2006 | Citalopram | PH | Major Depression | Drug Exposure During Pregnancy, Premature Labour, Uterine Contractions Abnormal | ||||
| 34 | Years | F | 6147541 | 5119993 | 09/29/2006 | Citalopram | OT | Drug Exposure During Pregnancy, Premature Labour | ||||||
| 35 | Years | F | 6096154 | 5060067 | 07/19/2006 | Citalopram | PH | Drug Exposure During Pregnancy, Heart Disease Congenital | ||||||
| 35 | Years | F | 6096154 | 5094494 | 08/29/2006 | Seropram | Drug Exposure During Pregnancy, Migraine | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 35 | Years | F | 6213429 | 5193626 | 12/21/2006 | Citalopram | MD | Depression | Bradykinesia, Coordination Abnormal, Depressed Mood, Depression, Disturbance In Attention, Dizziness, Drug Toxicity, Drug Withdrawal Syndrome, Electric Shock, Emotional Disorder, Fatigue, Feeling Abnormal, Heart Rate Irregular, Hyperhidrosis, Hypokinesia, Insomnia, Memory Impairment, Muscle Spasms, Muscle Twitching, Musculoskeletal Stiffness, Nervous System Disorder, Pain In Extremity, Paraesthesia, Premature Baby, Psychomotor Retardation, Respiratory Tract Infection, Sleep Disorder, Somnolence, Thinking Abnormal | |||||
| 35 | Years | F | 6213429 | 5196540 | 12/27/2006 | Citalopram | MD | Depression | Bradykinesia, Coordination Abnormal, Depressed Mood, Disturbance In Attention, Dizziness, Drug Toxicity, Drug Withdrawal Syndrome, Emotional Disorder, Feeling Abnormal, Heart Rate Increased, Heart Rate Irregular, Insomnia, Memory Impairment, Muscle Spasms, Musculoskeletal Stiffness, Nervous System Disorder, Pain In Extremity, Paraesthesia, Psychomotor Retardation, Sleep Disorder, Somnolence | |||||
| 35 | Years | F | 6650112 | 5736840 | 06/26/2007 | 05/08/2008 | Citalopram | PH | Depression | Caesarean Section, Drug Exposure During Pregnancy | ||||
| 35 | Years | F | 6650112 | 5762093 | 06/26/2007 | 06/04/2008 | Citalopram | OT | Depression | Caesarean Section, Drug Exposure During Pregnancy, Premature Labour | ||||
| 35 | Years | F | 6650112 | 5766478 | 06/26/2007 | 06/06/2008 | Citalopram | Depression | Caesarean Section, Drug Exposure During Pregnancy | |||||
| 36 | Years | F | 5936429 | 4837296 | 12/31/2004 | 11/22/2005 | Citalopram | OT | Depression | Caesarean Section, Drug Exposure During Pregnancy, Fear | ||||
| 36 | Years | F | 6216415 | 5199518 | 10/02/2006 | 12/29/2006 | Citalopram | OT | Depression | Anaemia, Anosmia, Drug Exposure During Pregnancy, Epistaxis | ||||
| 36 | Years | F | 6216415 | 5222880 | 10/02/2006 | 01/24/2007 | Citalopram | Depression | Anaemia, Drug Exposure During Pregnancy, Epistaxis | |||||
| 37 | Years | F | 6288181 | 5285133 | 01/01/2006 | 03/28/2007 | Citalopram | PH | Depression | Abortion Spontaneous, Drug Exposure Before Pregnancy | ||||
| 37 | Years | F | 6356841 | 5383153 | 07/05/2007 | Citalopram | Depression | Agitation, Anxiety, Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome, Dystonia, Hyperemesis Gravidarum, Self-Injurious Ideation | ||||||
| 37 | Years | F | 6356841 | 5392852 | 06/18/2007 | Citalopram | Depression | Agitation, Anxiety, Cyclothymic Disorder, Drug Exposure During Pregnancy, Drug Interaction, Dystonia, Hyperemesis Gravidarum | ||||||
| 37 | Years | F | 6412582 | 5443315 | 08/31/2007 | Citalopram | OT | Abortion Induced, Amniotic Fluid Volume Increased, Breast Malformation, Congenital Muscle Absence, Congenital Scoliosis, Drug Exposure During Pregnancy, Echography Abnormal, Motor Neurone Disease, Multiple Congenital Abnormalities, Oedema Peripheral, Pectus Excavatum, Pterygium, Retrognathia, Spine Malformation | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 37 | Years | F | 5917366 | 4810387 | 12/27/2004 | 10/24/2005 | Citalopram | Anxiety | Drug Exposure During Pregnancy, Intentional Overdose, Pregnancy Induced Hypertension | |||||
| 37 | Years | F | 6356841 | 5714817 | 04/21/2008 | Citalopram | Depression | Agitation, Anxiety, Drug Exposure During Pregnancy, Drug Interaction, Drug Withdrawal Syndrome, Dystonia, Hyperemesis Gravidarum, Suicidal Ideation | ||||||
| 38 | Years | F | 5731092 | 4565914 | 01/28/2005 | Citalopram | PH | Depression | Drug Exposure During Pregnancy, Polyhydramnios, Premature Baby | |||||
| 38 | Years | F | 5731092 | 4758425 | 08/26/2005 | Citalopram | OT | Depression | Caesarean Section, Drug Exposure During Pregnancy, Nausea, Polyhydramnios, Premature Labour, Vomiting | |||||
| 38 | Years | F | 5731092 | 4759162 | 08/31/2005 | Citalopram | PH | Depression | Caesarean Section, Complication of Pregnancy, Drug Exposure During Pregnancy, Nausea, Polyhydramnios, Premature Labour, Vomiting In Pregnancy | |||||
| 38 | Years | F | 5852295 | 4727700 | 07/27/2005 | Citalopram | Depression | Caesarean Section, Drug Exposure During Pregnancy, Nausea, Polyhydramnios, Premature Labour, Vomiting | ||||||
| 38 | Years | F | 5865002 | 4747558 | 08/10/2005 | 08/17/2005 | Citalopram | CN | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | ||||
| 38 | Years | F | 6041671 | 4988325 | 04/25/2006 | Citalopram | OT | Depression | Congenital Anomaly, Congenital Aortic Atresia, Drug Exposure During Pregnancy | |||||
| 38 | Years | F | 6041671 | 5009812 | 05/22/2006 | Citalopram | OT | Depression | Drug Exposure During Pregnancy | |||||
| 38 | Years | F | 6685292 | 5776262 | 01/01/2007 | 06/16/2008 | Citalopram | OT | Depression | Abortion Spontaneous, Amenorrhoea, Drug Exposure During Pregnancy, Intra-Uterine Death | ||||
| 38 | Years | F | 6452587 | 5486017 | 10/12/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Intra-Uterine Death | |||||
| 40 | Years | F | 6036536 | 4979110 | 04/18/2006 | Citalopram | OT | Depression | Abortion Spontaneous, Drug Exposure During Pregnancy | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 41 | Years | F | 6137795 | 5243085 | 02/13/2007 | Citalopram | OT | Anxiety Disorder | Drug Exposure During Pregnancy, Premature Labour | |||||
| 41 | Years | F | 6137795 | 5367695 | 06/19/2007 | Citalopram | OT | Anxiety, Anxiety Disorder | Drug Exposure During Pregnancy, Neonatal Disorder, Premature Labour, Screaming | |||||
| 41 | Years | F | 6475050 | 5519164 | 11/14/2007 | Citalopram | Depression | Abortion, Drug Exposure During Pregnancy | ||||||
| 41 | Years | F | 6475050 | 5530428 | 11/27/2007 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy | ||||||
| 41 | Years | F | 6476850 | 5523278 | 11/16/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||
| 41 | Years | F | 6476853 | 5523279 | 11/16/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||
| 41 | Years | F | 6478248 | 5525461 | 11/19/2007 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | ||||||
| 41 | Years | F | 6478248 | 5532152 | 11/28/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||
| 41 | Years | F | 6478253 | 5525466 | 11/19/2007 | Citalopram | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | ||||||
| 41 | Years | F | 6478253 | 5531628 | 11/28/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||
| 41 | Years | F | 6510538 | 5552421 | 12/10/2007 | Citalopram | OT | Depression | Abortion Induced, Drug Exposure During Pregnancy, Trisomy 18 | |||||
| 41 | Years | F | 6137795 | 5106256 | 09/12/2006 | Citalopram | OT | Anxiety Disorder | Drug Exposure During Pregnancy, Premature Labour, Tocolysis | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Rpt'd By | Indications | Adverse Reactions | ||||
| 41 | Years | F | 6137795 | 5154551 | 11/13/2006 | Citalopram | OT | Anxiety Disorder | Drug Exposure During Pregnancy, Premature Labour | |||||
| 46 | Years | F | 6126444 | 5093457 | 07/25/2006 | 08/28/2006 | Citalopram | Caesarean Section, Drug Exposure During Pregnancy, Oligohydramnios, Premature Labour | ||||||
| 46 | Years | F | 6126444 | 5107776 | 07/25/2006 | 09/14/2006 | Seropram | Caesarean Section, Drug Exposure During Pregnancy, Infection, Oligohydramnios, Premature Labour, Prolonged Labour | ||||||
| 43 Males | 121 Females | 204 Cases (Gender was not reported for 40 Cases) | 315 Individual Safety Reports | |||||||||||
Akarin (citalopram), Celexa (citalopram), Cipramil (citalopram), Citalopram (citalopram), Sepram (citalopram), Seropram (citalopram)
Abdominal Distension, Abdominal Pain, Abnormal Behaviour, Abnormal Faeces, Abortion, Abortion Incomplete, Abortion Induced, Abortion Spontaneous, Abscess, Acidosis, Acquired Epileptic Aphasia, Acute Psychosis, Acute Respiratory Failure, Agitation, Agitation Neonatal, Aids Related Complex, Akathisia, Akinesia, Amenorrhoea, Ammonia Increased, Amniocentesis Abnormal, Amniorrhoea, Amniotic Cavity Disorder, Amniotic Fluid Volume Decreased, Amniotic Fluid Volume Increased, Anaemia, Anal Atresia, Anhedonia, Anomaly of External Ear Congenital, Anophthalmos, Anorexia, Anosmia, Antepartum Haemorrhage, Antidepressant Drug Level Decreased, Anxiety, Apathy, Apgar Score Low, Apnoea, Appetite Disorder, Areflexia, Arnold-Chiari Malformation, Arrested Labour, Arthropathy, Aspiration, Asthenia, Atelectasis, Atrial Septal Defect, Autism, Autonomic Nervous System Imbalance, Back Pain, Bacterial Infection, Base Excess Decreased, Base Excess Negative, Beta Haemolytic Streptococcal Infection, Bipolar Disorder, Bipolar II Disorder, Bleeding Peripartum, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Cortisol Decreased, Blood Glucose Abnormal, Blood Glucose Increased, Blood PH Decreased, Blood Sodium Increased, Bloody Discharge, Brachial Plexopathy, Bradycardia Neonatal, Bradykinesia, Brain Damage, Breast Haemorrhage, Breast Malformation, Breast Mass, Breech Delivery, Breech Presentation, Bronchial Obstruction, Bronchopulmonary Dysplasia, Caesarean Section, Calculus Urinary, Camptodactyly Congenital, Candidiasis, Cardiac Arrest, Cardiac Murmur, Cardiomegaly, Cardiovascular Disorder, Cephalhaematoma, Cephalo-Pelvic Disproportion, Cerebral Haemorrhage, Cerebral Haemorrhage Neonatal, Cerebral Palsy, Cerebrovascular Disorder, Cervix Disorder, Cholestasis, Chorioamnionitis, Chromosomal Deletion, Chromosome Abnormality, Chronic Respiratory Failure, Cleft Lip, Cleft Lip and Palate, Cleft Palate, Clonus, Combined Immunodeficiency, Completed Suicide, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Condition Aggravated, Confusional State, Congenital Anomaly, Congenital Anomaly of Inner Ear, Congenital Aortic Atresia, Congenital Arterial Malformation, Congenital Atrial Septal Defect, Congenital Cardiovascular Anomaly, Congenital Central Nervous System Anomaly, Congenital Elevation of Scapula, Congenital Eye Disorder, Congenital Eyelid Malformation, Congenital Hand Malformation, Congenital Hydrocephalus, Congenital Hydronephrosis, Congenital Multiplex Arthrogryposis, Congenital Muscle Absence, Congenital Neurological Disorder, Congenital Oral Malformation, Congenital Pulmonary Hypertension, Congenital Pulmonary Valve Atresia, Congenital Scoliosis, Congenital Spinal Fusion, Congenital Torticollis, Congenital Ventricular Septal Defect, Contusion, C-Reactive Protein Increased, Convulsion, Convulsion Neonatal, Coombs Test Positive, Coordination Abnormal, Cor Pulmonale, Corneal Disorder, Crying, Culture Urine Positive, Cyanosis Neonatal, Cyclothymic Disorder, Cystic Lymphangioma, Cystocele, Dacryocystitis Infective, Deafness Congenital, Deafness Unilateral, Death Neonatal, Deformity Thorax, Dehydration, Depersonalisation, Depressed Mood, Depression, Developmental Delay, Diabetes Mellitus, Diaphragmatic Hernia, Diarrhoea, Diarrhoea Neonatal, Disease Recurrence, Disturbance In Attention, Dizziness, Drug Dose Omission, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Ineffective, Drug Interaction, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Duane's Syndrome, Dyskinesia, Dyskinesia Neonatal, Dysmorphism, Dysphoria, Dyspnoea, Dystonia, Echography Abnormal, Ectopic Pregnancy, Electric Shock, Electroencephalogram Abnormal, Emotional Disorder, Emotional Distress, Encephalitis Post Varicella, Epistaxis, Eructation, Escherichia Infection, Euphoric Mood, Exomphalos, Extrapyramidal Disorder, Eye Redness, Eye Rolling, Facial Paresis, Failure To Thrive, Fallot's Tetralogy, False Labour, Fatigue, Fear, Feeding Disorder Neonatal, Feeding Problem In Newborn, Feeding Tube Complication, Feeling Abnormal, Feeling Cold, Feeling Jittery, Fever Neonatal, Flatulence, Fluid Overload, Foetal Cardiac Disorder, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Decreased, Foetal Malformation, Foetal Malposition, Foetal Movements Decreased, Frequent Bowel Movements, Galactostasis, Gastrointestinal Disorder, Gastrointestinal Malformation, Gastrointestinal Motility Disorder, Gastrooesophageal Reflux Disease, General Physical Health Deterioration, Gestational Diabetes, Grand Mal Convulsion, Growth Retardation, Grunting, Haemangioma Congenital, Haematocrit Decreased, Haematocrit Increased, Haemoglobin Decreased, Haemoglobin Increased, Haemorrhage, Haemorrhage Intracranial, Haemorrhoids, Hand Deformity, Head Circumference Abnormal, Head Deformity, Headache, Heart Disease Congenital, Heart Rate Increased, Heart Rate Irregular, Hernia Congenital, Hip Dysplasia, Homicidal Ideation, Hydrocele, Hydrocephalus, Hydronephrosis, Hyperaemia, Hyperbilirubinaemia Neonatal, Hypercapnia, Hyperemesis Gravidarum, Hyperhidrosis, Hyperthermia, Hypertonia, Hypertonia Neonatal, Hypocalcaemia, Hypoglycaemia Neonatal, Hypokinesia, Hypokinesia Neonatal, Hypomania, Hyponatraemia, Hypopnoea, Hyporeflexia, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hypoventilation, Hypoxia, Immature Respiratory System, Immobile, Inadequate Analgesia, Increased Bronchial Secretion, Induced Labour, Infantile Apnoeic Attack, Infantile Colic, Infantile Spasms, Infection, Inflammation, Influenza, Inguinal Hernia, Insomnia, Inspiratory Capacity Decreased, Intentional Overdose, Intestinal Transposition, Intracranial Aneurysm, Intra-Uterine Death, Irritability, Ischaemia, Jaundice Neonatal, Joint Hyperextension, Kidney Infection, Labour Complication, Labour Induction, Labour Pain, Lethargy, Limb Malformation, Limb Reduction Defect, Lissencephaly, Livedo Reticularis, Loss of Consciousness, Loss of Proprioception, Low Set Ears, Macrocephaly, Major Depression, Malaise, Mania, Marital Problem, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Mean Arterial Pressure Decreased, Meconium In Amniotic Fluid, Meconium Increased, Memory Impairment, Meningorrhagia, Mental Disorder, Mental Retardation Severity Unspecified, Metabolic Acidosis, Metrorrhagia, Microphthalmos, Migraine, Motor Neurone Disease, Movement Disorder, Multiple Congenital Abnormalities, Muscle Spasms, Muscle Twitching, Muscular Dystrophy, Muscular Weakness, Musculoskeletal Stiffness, Myalgia, Myasthenic Syndrome, Mydriasis, Myopathy, Nausea, Neck Pain, Neonatal Apnoeic Attack, Neonatal Asphyxia, Neonatal Aspiration, Neonatal Candida Infection, Neonatal Cholestasis, Neonatal Disorder, Neonatal Hepatomegaly, Neonatal Hypoxia, Neonatal Infection, Neonatal Pneumonia, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Respiratory Failure, Neonatal Tachycardia, Neonatal Tachypnoea, Nephrolithiasis, Nervous System Disorder, Neuromyopathy, Nipple Disorder, Nipple Pain, Obsessive Thoughts, Obsessive-Compulsive Disorder, Obstruction, Obstructive Airways Disorder, Oculocephalogyric Reflex Absent, Oedema, Oedema Peripheral, Oligohydramnios, Ophthalmia Neonatorum, Opisthotonus, Optic Nerve Hypoplasia, Oral Candidiasis, Overdose, Oxygen Saturation Decreased, Pain, Pain In Extremity, Palatal Disorder, Pallor, Panic Attack, Paraesthesia, Paranoia, Patent Ductus Arteriosus, PCO2 Decreased, Pectus Excavatum, Perianal Abscess, Peripheral Vascular Disorder, Persistent Foetal Circulation, Pervasive Developmental Disorder, Phalangeal Hypoplasia, Physical Assault, Pierre Robin Syndrome, Placenta Praevia, Placental Disorder, Placental Insufficiency, Platelet Count Decreased, Platelet Count Increased, Pleural Haemorrhage, Pneumonia, Pneumonia Aspiration, PO2 Decreased, Poland's Syndrome, Polydactyly, Polyhydramnios, Poor Peripheral Circulation, Poor Sucking Reflex, Post Procedural Complication, Post Procedural Hypothyroidism, Post Procedural Pain, Postmature Baby, Postpartum Depression, Postpartum Haemorrhage, Posturing, Precipitate Labour, Pregnancy Induced Hypertension, Premature Baby, Premature Labour, Premature Rupture of Membranes, Premature Separation of Placenta, Progesterone Decreased, Prolonged Labour, Prominent Epicanthal Folds, Protein Urine, Protein Urine Present, Prothrombin Time Prolonged, Psychomotor Hyperactivity, Psychomotor Retardation, Pterygium, Pulmonary Hypertension, Pulmonary Oedema Neonatal, Pulse Absent, Pupillary Reflex Impaired, Pyelectasia, Pyelocaliectasis, Pyrexia, Rash, Rash Pustular, Red Blood Cells CSF Positive, Red Blood Cells Urine, Regurgitation of Food, Respiration Abnormal, Respiratory Acidosis, Respiratory Arrest, Respiratory Depth Decreased, Respiratory Disorder Neonatal, Respiratory Rate Decreased, Respiratory Rate Increased, Respiratory Tract Infection, Respiratory Tract Malformation, Restlessness, Retrognathia, Rhesus Antibodies Positive, Right Ventricular Systolic Pressure, Road Traffic Accident, Screaming, Sedation, Self-Injurious Ideation, Sepsis, Sepsis Neonatal, Sinus Tachycardia, Sinusitis, Skin Discolouration, Skull Malformation, Sleep Disorder, Small for Dates Baby, Somnolence, Somnolence Neonatal, Spinal Disorder, Spine Malformation, Splenomegaly, Sputum Abnormal, Staring, Stillbirth, Strabismus Congenital, Streptococcal Serology Positive, Stress Symptoms, Sudden Infant Death Syndrome, Suicidal Ideation, Suicide Attempt, Supraventricular Extrasystoles, Synostosis, Synovitis, Tachycardia Foetal, Talipes, Tearfulness, Temperature Regulation Disorder, Thinking Abnormal, Thrombocythaemia, Thyroid Gland Cancer, Thyroidectomy, Tocolysis, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Tremor, Tremor Neonatal, Tricuspid Valve Incompetence, Trisomy 18, Trisomy 21, Ultrasound Scan Abnormal, Umbilical Cord Abnormality, Umbilical Cord Around Neck, Umbilical Hernia, Uterine Contractions Abnormal, Uterine Contractions During Pregnancy, Uterine Infection, Vacuum Extractor Delivery, Vaginal Haemorrhage, Vascular Anomaly, Ventricular Septal Defect, Vertigo, Vesicoureteric Reflux, Visual Acuity Reduced, Visual Disturbance, Vomiting, Vomiting In Pregnancy, Weight Decreased, Weight Fluctuation, Weight Increased, White Blood Cell Count Decreased, White Blood Cell Count Increased, White Blood Cells Urine
| Definitions | |
| Abortion Spontaneous | Miscarriage means loss of an embryo or fetus before the 20th week of pregnancy. Most miscarriages occur during the first 14 weeks of pregnancy. The medical term for miscarriage is spontaneous abortion. |
| Akinesia | Loss of normal motor function, resulting in impaired muscle movement. |
| Apgar Score | A system of assessing the general physical condition of a newborn infant based on a rating of 0, 1, or 2 for five criteria: heart rate, respiration, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. (After Virginia Apgar (1909–1974), American physician) |
| Anal Atresia | The anus is either not present or it is in the wrong place. |
| Anophthalmos | A congenital absence of all tissues of the eyes. |
| Apgar Score | A system of assessing the general physical condition of a newborn infant based on a rating of 0, 1, or 2 for five criteria: heart rate, respiration, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. (After Virginia Apgar (19091974), American physician) |
| Areflexia | The absence of reflexes. |
| Arnold-Chiari Malformation | Arnold-Chiari malformation is a rare genetic disorder in which parts of the brain are formed abnormally. Malformations may occur in the lower portion of the brain (cerebellum) or in the brain stem. |
| Atelectasis | Atelectasis is a collapse of lung tissue affecting part or all of one lung. This condition prevents normal oxygen absoption to healthy tissues. |
| Atrial Septal Defect | An atrial septal defect is an abnormal opening in the wall separating the left and right upper changers (atria) of the heart. |
| Congenital | A physical abnormality that is present at birth. |
| Congenital Anomaly | Medical term for a birth defect which is a physical abnormality that is present at birth; they are also called congenital abnormalities. When multiple birth defects occur together and have a similar cause, they are called syndromes (e.g. Foetal Distress Syndrome, Neonatal Respiratory Distress Syndrome, Pierre Robin Syndrome). |
| Congenital Aortic Atresia | The congenital absence of the normal valvular orifice into the aorta. |
| Congenital Atrial Septal Defect | An abnormal opening in the wall separating the left and right upper chambers (atria) of the heart. |
| Congenital Hydrocephalus | Hydrocephalus is an abnormal expansion of cavities (ventricles) within the brain that is caused by the accumulation of cerebrospinal fluid. |
| Drug Withdrawal Syndrome Neonatal | Refers to the characteristic signs and symptoms that appear when a drug that causes physical dependence is regularly used for a long time and then suddenly discontinued or decreased in dosage. Also known as abstinence syndrome. A group of unpleasant symptoms produced by the abrupt termination of drug taking. These symptoms, commonly called withdrawal symptoms, include anxiety, muscle weakness, nausea, vomiting, tremor, and a rapid heart beat. |
| Dyspnoea | Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath. Also called air hunger. |
| Fallot's Tetralogy | A congenital malformation of the heart characterized by a defect in the ventricular septum, misplacement of the origin of the aorta, narrowing of the pulmonary artery, and enlargement of the right ventricle. |
| Foetal Distress Syndrome | An abnormal condition of a fetus during gestation or at the time of delivery, marked by altered heart rate or rhythm and leading to compromised blood flow or changes in blood chemistry. |
| Hydronephrosis | Hydronephrosis is the swelling of the kidneys when urine flow is obstructed in any of part of the urinary tract. Swelling of the ureter, which always accompanies hydronephrosis, is called hydroureter. Hydronephrosis implies that a ureter and the renal pelvis (the connection of the ureter to the kidney) are overfilled with urine. |
| Hypercapnia | A condition marked by an unusually high concentration of carbon dioxide in the blood as a result of hypoventilation (abnormally slow and shallow respiration). |
| Hypertonia Neonatal | Hypertonia is a condition marked by an abnormal increase in the tightness of muscle tone and a reduced ability of a muscle to stretch (i.e. an increased stiffness). |
| Hypotonia Neonatal | Hypotonia is a condition of abnormally low muscle tone (the amount of tension or resistance to movement in a muscle), often involving reduced muscle strength. Hypotonia is not a specific medical disorder, but a potential manifestation of many different diseases and disorders that affect motor nerve control by the brain or muscle strength. |
| Hypoxia | Deficiency in the amount of oxygen reaching body tissues. |
| Microphthalmia | Microphthalmia refers to an abnormally small eye. Microphthalmia results from a developmental defect after formation of the optic vesicle. The developmental abnormality causes the optic vesicle to fold inwards, resulting in the formation of a cyst. The cyst will progressively swell from birth, and it may be situated along the optic nerve. The cyst may also be situated along other important eye structures. |
| Neonatal Respiratory Distress Syndrome | Respiratory distress syndrome (RDS) of the newborn, also known as infant RDS, is an acute lung disease present at birth, which usually affects premature babies. Layers of tissue called hyaline membranes keep the oxygen that is breathed in from passing into the blood. The lungs are said to be "airless." Without treatment, the infant will die within a few days after birth. |
| Persistent Foetal Circulation | The circulation of blood in the foetus is somewhat different from that of the baby after birth. This transition from foetal to neonatal circulation is one of the major physiologic changes after delivery. Before birth, the lungs are collapsed and the blood pressure in the lungs is quite high. This results in a very low blood flow through the lungs. After delivery, the lungs expand and the blood pressure in the lungs decreases. |
| In some babies, although the lungs expand the blood vessels in the lungs remain constricted resulting in persistently high blood pressure in the lungs. This reduces the amount of blood that the infant can pump through the lungs. This decreased blood flow through the lungs after birth is called persistent foetal circulation because it is a persistence of the pattern of blood flow normally seen prior to birth during the foetal period. | |
| Pierre Robin Syndrome | Pierre Robin Syndrome (PRS) is a congenital condition of facial abnormalities in humans. As PRS is not caused by a single defect gene, it is not a genetic syndrome, but rather a chain of certain developmental malformations, one entailing the next. |
| Pierre Robin Syndrome | Pierre Robin Syndrome (PRS) is a congenital condition of facial abnormalities in humans. As PRS is not caused by a single defect gene, it is not a genetic syndrome, but rather a chain of certain developmental malformations, one entailing the next. [images] |
| Pulmonary Hypertension | Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right ventricle) to the lungs where it picks up oxygen ... the disorder results in thickening of the pulmonary arteries and narrowing of these blood vessels. In response, the right side of the heart works harder to move the blood through these arteries and it becomes enlarged. Eventually overworking the right side of the heart may lead to right-sided heart failure, resulting in death. |
| Trisomy | A condition in which an extra copy of a chromosome is present in the cell nuclei, causing developmental abnormalities. |
| Trisomy 18 | Edwards' syndrome is caused by an extra (third) copy of chromosome 18. The extra chromosome is lethal for most babies born with this condition. It causes major physical abnormalities and severe mental retardation. Very few children afflicted with this syndrome survive beyond the first year. |
| Trisomy 21 | Down syndrome is the most common cause of mental retardation and malformation in a newborn. It occurs because of the presence of an extra chromosome. The extra chromosome in Down syndrome is labeled number 21. For this reason, the existence of three such chromosomes is sometimes referred to as Trisomy 21. |
| Ventricular Septal Defect | A ventricular septal defect is a hole in the wall of the heart (septum) that separates the left lower chamber (left ventricle) from the right lower chamber (right ventricle). The hole allows blood to flow from the left ventricle to the right ventricle instead of entering the aorta for distribution throughout the body. This blood recycles through the lungs before returning to the left ventricle. This results in less oxygenated blood reaching the body. If the hole is sufficiently large, the lack of oxygen being delivered to the body can cause severe problems, including heart failure and breathlessness. |
| Williams Syndrome | Typical facial features seen in children with Williams syndrome include a wide mouth with full lips, a small chin, and a short, slightly upturned nose. Children with blue or green eyes often times show a starburst pattern in the colored part (iris) of the eyes. An unusual narrowing of the aorta called supravalvular aortic stenosis is often present, and hernias are often seen in the inguinal area of the abdomen. The blood vessels and abdominal wall often show weakness or altered development. Muscle tone is typically low, and children are often on the low end of birth weight, with relatively poor weight gain and growth in their early years. |
| Top 20 Adverse Reactions | |
| Adverse Reaction | Cases |
| Drug Exposure During Pregnancy | 185 |
| Neonatal Disorder | 29 |
| Caesarean Section | 28 |
| Abortion Induced | 28 |
| Premature Baby | 27 |
| Maternal Drugs Affecting Foetus | 20 |
| Drug Withdrawal Syndrome Neonatal | 18 |
| Premature Labour | 17 |
| Apgar Score Low | 16 |
| Congenital Anomaly | 14 |
| Drug Exposure Via Breast Milk | 12 |
| Trisomy 18 | 11 |
| Neonatal Respiratory Distress Syndrome | 11 |
| Hypotonia Neonatal | 11 |
| Convulsion Neonatal | 11 |
| Abortion Spontaneous | 11 |
| Intra-Uterine Death | 9 |
| Multiple Congenital Abnormalities | 8 |
| Nausea | 7 |
| Irritability | 7 |
MedWatch is the Food and Drug Administration's program for reporting any undesirable experience associated with the use of a medical product. If you think you or someone in your family has experienced an adverse reaction from taking Citalopram and it has not been reported to the FDA, see this page for instructions on reporting the adverse event through your doctor or directly to the FDA using an online form.
A May 2006 USA Today article states that "drug companies are required to file any reports they have to the FDA, but consumers and doctors report such events on a voluntary basis. Studies suggest the FDA's Adverse Events Reporting System database captures only 1% to 10% of drug-induced side effects and deaths, "maybe even less than 1%," says clinical pharmacologist Alastair J.J. Wood, an associate dean at Vanderbilt Medical School in Nashville. So the real number of cases is almost certainly much higher".