This table shows all adverse reactions and indications (the condition being treated) reported to the FDA's Adverse Event Reporting System between 2004 and 2006 where the listed psychiatric drug was identified as the Primary Suspect Drug (FDA's term) responsible for causing these reactions. Where no indication is shown, none was present in the FDA data.
The Oxford English Dictionary defines a poison as "a substance
that causes death or harm when introduced into or absorbed by a
living organism." These psychiatric drugs fit that
definition.
Reported by: CN-Consumer, LW-Lawyer, MD-Physician, OT-Other
Healthcare Provider, PH-Pharmacist, Blank-Not Reported in ISR
(Individual Safety Report)
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 0 | Days | M | 4088957 | 4288525 | 01/03/04 | 02/05/04 | Fluoxetine | X | X | X | OT | Blood Bilirubin Increased, Drug Exposure During Pregnancy, Feeding Problem In Newborn, Thrombocytopenia | ||||
| 0 | Days | F | 5709787 | 4540735 | 12/22/04 | Fluoxetine | X | X | X | Congenital Eye Disorder, Drug Exposure During Pregnancy | ||||||
| 0 | Days | F | 6000593 | 4981102 | 07/30/05 | 04/18/06 | Prozac | X | X | X | OT | Branchial Cleft Cyst, Branchial Cleft Sinus, Caesarean Section, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Fistula, Infected Cyst, Maternal Condition Affecting Foetus, Neonatal Respiratory Distress Syndrome, Premature Baby, Small for Dates Baby, Wound Infection Staphylococcal | ||||
| 6 | Hours | F | 6026803 | 4964881 | 04/03/06 | Fluoxetine | X | X | X | Depression | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Feeling Jittery, Fever Neonatal, Hypertonia Neonatal, Sneezing, Vomiting, Vomiting Neonatal | |||||
| 6 | Hours | F | 6051627 | 5002322 | 05/12/06 | Fluoxetine | X | X | X | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Hypertonia Neonatal, Sneezing, Vomiting Neonatal | |||||
| 6 | Hours | F | 6133459 | 5103026 | 09/08/06 | Fluoxetine | X | X | X | Depression | Body Temperature Increased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Disorder Neonatal, Feeling Jittery, Hypertonia Neonatal, Neonatal Disorder, Sneezing, Vomiting Neonatal | |||||
| 10 | Hours | F | 6051628 | 5002327 | 12/20/05 | 05/12/06 | 12/20/05 | Fluoxetine HCL | X | X | X | MD | Depression | Cardiopulmonary Failure, Drug Exposure During Pregnancy, Haemorrhage, Persistent Foetal Circulation, Pulmonary Oedema | ||
| 10 | Hours | F | 6051628 | 5053858 | 12/20/05 | 07/12/06 | 12/20/05 | Fluoxetine HCL | X | X | X | MD | Depression | Cardiopulmonary Failure, Drug Exposure During Pregnancy, Haemorrhage, Malaise, Pulmonary Haemorrhage, Pulmonary Hypertension, Pulmonary Oedema, Streptococcal Infection | ||
| 1 | Day | 3783841 | 5088962 | 08/30/96 | 08/22/06 | 09/09/96 | Prozac | X | X | X | MD | Blood Gases Abnormal, Bradycardia Neonatal, Congenital Tricuspid Valve Atresia, Cyanosis Neonatal, Drug Exposure During Pregnancy, Heart Disease Congenital, Hypertension Neonatal, Metabolic Acidosis, Neonatal Disorder, Neonatal Hypotension, Oedema Neonatal, Oxygen Saturation Decreased, Pallor, Post Procedural Complication, Premature Baby, Pulmonary Vascular Disorder, Ventricular Fibrillation | ||||
| 1 | Day | F | 3783841 | 5113814 | 01/24/96 | 09/20/06 | 09/09/96 | Prozac | X | X | X | MD | Drug Use for Unknown Indication | Blood Gases Abnormal, Bradycardia Neonatal, Caesarean Section, Congenital Tricuspid Valve Atresia, Drug Exposure During Pregnancy, Heart Disease Congenital, Malaise, Maternal Condition Affecting Foetus, Metabolic Acidosis, Neonatal Disorder, Neonatal Hypotension, Oxygen Saturation Decreased, Premature Baby, Ventricular Fibrillation | ||
| 1 | Day | M | 4072963 | 4273868 | 05/25/02 | 01/15/04 | Prozac | X | X | X | Blood Pressure Increased, Cognitive Disorder, Developmental Delay, Difficulty In Walking, Expressive Language Disorder, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Arrest | |||||
| 1 | Day | F | 4077876 | 4277696 | 09/21/03 | 01/21/04 | Prozac | X | X | X | MD | Congenital Foot Malformation, Congenital Hand Malformation, Maternal Drugs Affecting Foetus | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 1 | Day | M | 4102199 | 4307046 | 10/09/96 | 02/25/04 | Prozac | X | X | X | MD | Cleft Lip, Congenital Anomaly, Maternal Drugs Affecting Foetus, Premature Baby | ||||
| 1 | Day | M | 4102242 | 4307140 | 02/25/04 | Prozac | X | X | X | MD | Congenital Anomaly, Congenital Bladder Anomaly, Maternal Drugs Affecting Foetus | |||||
| 1 | Day | M | 4122444 | 4332174 | 01/08/04 | 03/31/04 | Prozac | X | X | X | OT | Maternal Drugs Affecting Foetus, Syndactyly | ||||
| 1 | Day | F | 4141846 | 4348237 | 09/19/04 | 04/22/04 | Prozac | X | X | X | MD | Bradycardia Neonatal, Maternal Drugs Affecting Foetus | ||||
| 1 | Day | M | 4147943 | 4364814 | 01/13/04 | 05/21/04 | Prozac Weekly | X | X | X | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Premature Baby, Premature Rupture of Membranes | |||||
| 1 | Day | 4147943 | 4497048 | 01/13/04 | 11/08/04 | Prozac Weekly | X | X | X | Premature Baby | ||||||
| 1 | Day | M | 4164360 | 4386849 | 03/25/04 | 06/23/04 | Prozac | X | X | X | Agitation Neonatal, Drug Exposure During Pregnancy, Hypotonia Neonatal, Premature Baby, Respiratory Rate Increased, Tremor Neonatal, Umbilical Cord Abnormality | |||||
| 1 | Day | M | 4191182 | 4420081 | 05/28/04 | 08/04/04 | Fluoxetine | X | X | X | Drug Exposure During Pregnancy, Hypokinesia Neonatal, Hypotonia Neonatal, Neonatal Disorder, Nervous System Disorder, Poor Sucking Reflex | |||||
| 1 | Day | M | 4201901 | 4433970 | 08/10/04 | 08/25/04 | Prozac | X | X | X | MD | Drug Exposure During Pregnancy, Tracheo-Oesophageal Fistula | ||||
| 1 | Day | M | 4201974 | 4434065 | 04/21/04 | 08/25/04 | Prozac | X | X | X | MD | Body Temperature Decreased, Bradycardia Neonatal, Cerebral Haemorrhage Neonatal, Cerebral Thrombosis, Cerebral Ventricle Dilatation, Drug Exposure During Pregnancy, Maternal Condition Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||
| 1 | Day | M | 4201974 | 4483359 | 04/21/04 | 10/20/04 | Prozac | X | X | X | MD | Bradycardia Neonatal, Cerebral Thrombosis, Cerebral Ventricle Dilatation, Cyanosis Neonatal, Hypothermia Neonatal, Intraventricular Haemorrhage Neonatal, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Neonatal Disorder, Neonatal Respiratory Distress Syndrome, Premature Baby, Unwanted Pregnancy | ||||
| 1 | Day | M | 5569741 | 4422029 | 08/04/04 | Prozac | X | X | X | Autism, Drug Exposure During Pregnancy, Heart Rate Irregular, Hypoglycaemia Neonatal, Hypothermia Neonatal, Neonatal Disorder | ||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 1 | Day | 5672867 | 4494354 | 11/02/04 | Fluoxetine HCL | X | X | X | MD | Congenital Ventricular Septal Defect, Drug Exposure During Pregnancy | ||||||
| 1 | Day | 5672870 | 4494355 | 11/02/04 | Fluoxetine HCL | X | X | X | MD | Drug Exposure During Pregnancy, Patent Ductus Arteriosus | ||||||
| 1 | Day | M | 5688198 | 4510245 | 08/23/04 | 11/19/04 | Fluoxetine | X | X | X | MD | Drug Exposure During Pregnancy, Haemangioma Congenital, Large for Dates Baby, Tremor Neonatal | ||||
| 1 | Day | M | 5688198 | 4618328 | 08/23/04 | 03/24/05 | Fluoxetine | X | X | X | MD | Cow's Milk Intolerance, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Child, Haemangioma Congenital, Infantile Colic, Large for Dates Baby, Rash, Tremor Neonatal | ||||
| 1 | Day | M | 5691532 | 4517235 | 09/28/04 | 11/30/04 | Prozac | X | X | X | MD | Drug Exposure During Pregnancy, Feeling Jittery, Gastrooesophageal Reflux Disease, Moaning, Oxygen Saturation Decreased, Retching | ||||
| 1 | Day | F | 5753511 | 4595935 | 11/25/04 | 02/24/05 | Fluoxetine | X | X | X | MD | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Meconium In Amniotic Fluid | ||||
| 1 | Day | F | 5753511 | 4599931 | 11/25/04 | 03/03/05 | Fluoxetine | X | X | X | MD | Blood PH Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia, Tremor | ||||
| 1 | Day | F | 5753511 | 4613362 | 11/25/04 | 03/16/05 | Fluoxetine | X | X | X | MD | Agitation Neonatal, Amniocentesis Abnormal, Base Excess Increased, Blood Lactic Acid Increased, Blood PH Decreased, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Feeding Problem In Newborn, Haemoglobin Decreased, Hypertonia Neonatal, Neonatal Disorder, PCO2 Decreased, Tremor Neonatal | ||||
| 1 | Day | F | 5790381 | 4648979 | 02/16/05 | 04/27/05 | Sarafem | X | X | X | Caesarean Section, Drug Exposure During Pregnancy, Foetal Heart Rate Decreased, Small for Dates Baby | |||||
| 1 | Day | F | 5790381 | 4784963 | 02/16/05 | 09/28/05 | Sarafem | X | X | X | MD | Caesarean Section, Drug Exposure During Pregnancy, Foetal Heart Rate Deceleration | ||||
| 1 | Day | 5820728 | 4686762 | 06/06/05 | Fluoxetine HCL | X | X | X | MD | Coma, Drug Exposure During Pregnancy, Neonatal Disorder | ||||||
| 1 | Day | M | 5832301 | 4494276 | 11/02/04 | Prozac | X | X | X | MD | Agitation Neonatal, Apgar Score Low, Congenital Hand Malformation, Convulsion Neonatal, Drug Exposure During Pregnancy, Drug Toxicity, Dyskinesia, Hyperreflexia, Hypertonia, Jaundice Neonatal, Neonatal Respiratory Distress Syndrome, Neonatal Tachypnoea, Petechiae, Premature Baby, Rash Neonatal, Sepsis Neonatal, Tremor Neonatal | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 1 | Day | M | 5832303 | 4693001 | 05/17/05 | 06/15/05 | Prozac | X | X | X | MD | Antidepressant Drug Level Increased, Cyanosis Central, Cyanosis Neonatal, Drug Exposure During Pregnancy, Feeling Jittery, Neonatal Disorder, Premature Baby | ||||
| 1 | Day | 5837319 | 4708882 | 09/19/04 | 07/05/05 | 03/29/05 | Fluoxetine | X | X | X | OT | Anterior Chamber Cleavage Syndrome, Congenital Multiplex Arthrogryposis, Drug Exposure During Pregnancy | ||||
| 1 | Day | 5877815 | 4765256 | 08/15/05 | 09/06/05 | Prozac | X | X | X | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Laryngomalacia | ||||||
| 1 | Day | M | 5877815 | 4824590 | 07/15/05 | 11/08/05 | Prozac | X | X | X | Congenital Anomaly, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Dyspnoea, Feeding Disorder of Infancy Or Early Childhood, Hypoglycaemia Neonatal, Laryngomalacia, Sleep Apnoea Syndrome, Weight Gain Poor | |||||
| 1 | Day | F | 5882292 | 4770950 | 05/08/05 | 09/14/05 | Prozac | X | X | X | MD | Amimia, Apnoea, Cleft Uvula, Congenital Anomaly, Convulsion Neonatal, Drug Exposure During Pregnancy, Dysphagia, Eye Disorder, High Arched Palate, Hypertelorism of Orbit, Hypotonia Neonatal, Iiird Nerve Paralysis, Moebius II Syndrome, Neonatal Apnoeic Attack, Neonatal Disorder, Neonatal Infection, Neonatal Respiratory Distress Syndrome, Pierre Robin Syndrome, Retrognathia, Strabismus, Talipes, Unevaluable Event | ||||
| 1 | Day | M | 5910628 | 4806709 | 10/19/05 | Fluoxetine HCL | X | X | X | MD | Assisted Delivery, Cardiac Murmur, Drug Exposure During Pregnancy, Electrocardiogram QT Corrected Interval Prolonged | |||||
| 1 | Day | 5915093 | 4806978 | 05/01/05 | 10/19/05 | Prozac | X | X | X | MD | Drug Exposure During Pregnancy, Hip Dysplasia, Premature Baby | |||||
| 1 | Day | F | 5958601 | 4871124 | 12/29/05 | Fontex | X | X | X | Depression | Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal | |||||
| 1 | Day | 6036412 | 4979526 | 04/18/06 | Fontex | X | X | X | MD | Anomalous Pulmonary Venous Connection, Drug Exposure During Pregnancy | ||||||
| 1 | Day | F | 6062468 | 5016849 | 08/19/05 | 05/26/06 | Prozac | X | X | X | MD | Agitation Neonatal, Apgar Score Low, Caesarean Section, Drug Exposure During Pregnancy, Foetal Growth Retardation, Infantile Apnoeic Attack, Neonatal Respiratory Distress Syndrome, Premature Baby | ||||
| 1 | Day | F | 6102965 | 5071487 | 07/27/06 | 08/03/06 | Prozac | X | X | X | MD | Depression | Blood PH Decreased, Cardiac Murmur, Cyanosis Neonatal, Drug Exposure During Pregnancy, Heart Disease Congenital, Neonatal Disorder, PCO2 Increased, Persistent Foetal Circulation, Po2 Decreased, Pulmonary Hypertension | |||
| 1 | Day | 6107673 | 5074354 | 08/03/06 | Prozac | X | X | X | Drug Exposure During Pregnancy, Hypospadias | |||||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 1 | Day | 6107690 | 5074406 | 08/03/06 | Prozac | X | X | X | Drug Exposure During Pregnancy, Gastroschisis | |||||||
| 1 | Day | F | 6125908 | 5094409 | 05/18/06 | 08/30/06 | Prozac | X | X | X | Brain Oedema, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Extrapyramidal Disorder, Haematoma, Neonatal Disorder, Premature Baby | |||||
| 1 | Day | F | 6173556 | 5157437 | 11/27/06 | Prozac | X | X | X | MD | Drug Exposure During Pregnancy, Ventricular Septal Defect | |||||
| 1 | Day | F | 6174697 | 5151736 | 01/01/01 | 11/07/06 | Prozac | X | X | X | CN | Congenital Tracheomalacia, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Heart Disease Congenital, Hypertonia Neonatal, Premature Baby, Premature Labour | ||||
| 1 | Day | 6198477 | 5186436 | 09/15/98 | 12/20/06 | Prozac | X | X | X | MD | Agitation Neonatal, Apgar Score Low, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Foetal Growth Retardation, Infantile Apnoeic Attack, Premature Baby | |||||
| 30 | Hours | M | 5899292 | 4791869 | 10/05/05 | Fluoxetine | X | X | X | Depression | Cardiac Murmur, Drug Exposure During Pregnancy, Electrocardiogram QT Corrected Interval Prolonged, Neonatal Disorder | |||||
| 1 | Days | M | 5919206 | 4816167 | 01/01/04 | 10/26/05 | Fluoxetine | X | X | X | MD | Depression | Cardiac Murmur, Drug Exposure During Pregnancy, Electrocardiogram QT Prolonged, Neonatal Disorder, Vacuum Extractor Delivery | |||
| 2 | Days | M | 4159787 | 4382393 | 06/16/04 | 06/21/04 | Prozac | X | X | X | MD | Depression | Agitation Neonatal, Diarrhoea Neonatal, Irritability, Neonatal Disorder, Scratch | |||
| 2 | Days | M | 4197734 | 4431800 | 01/20/04 | 08/18/04 | Prozac | X | X | X | MD | Abdominal Pain, Agitation, Crying, Drug Exposure During Pregnancy, Hypospadias, Insomnia | ||||
| 2 | Days | M | 4197734 | 4595505 | 01/20/04 | 02/24/05 | Prozac | X | X | X | MD | Abdominal Pain, Agitation Neonatal, Drug Exposure During Pregnancy, Hypervigilance, Hypospadias, Neonatal Disorder, Restlessness, Sleep Disorder, Vomiting Neonatal | ||||
| 2 | Days | M | 6104922 | 5071784 | 06/09/06 | 08/01/06 | Fluoxetine | X | X | X | Agitation Neonatal, Blood Sodium Decreased, Drug Exposure During Pregnancy, Hypoglycaemia Neonatal | |||||
| 3 | Days | M | 4128244 | 4284527 | 10/03/03 | 01/30/04 | Prozac | X | X | X | MD | Agitation Neonatal, Anxiety, Blood Glucose Abnormal, Caesarean Section, Facial Dysmorphism, Foetal Arrhythmia, Gastrointestinal Disorder, Irritability, Malnutrition, Maternal Drugs Affecting Foetus, Neonatal Disorder, Premature Baby, Sleep Disorder, Tremor Neonatal | ||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 3 | Days | 5947047 | 4848732 | 08/22/05 | 12/06/05 | Prozac | X | X | X | MD | Drug Exposure During Pregnancy, Premature Baby, Somnolence Neonatal, Tremor Neonatal | |||||
| 5 | Days | M | 6075656 | 5031059 | 06/15/06 | Fluoxetine | X | X | X | Drug Exposure During Pregnancy, Electroencephalogram Abnormal, Feeding Disorder Neonatal, Feeling Jittery, Hypertonia Neonatal, Hypothermia Neonatal, Hypotonia Neonatal, Irritability, Myoclonus, Opisthotonus, Restlessness, Tardive Dyskinesia | ||||||
| 1 | Week | 4176442 | 4399937 | 09/03/03 | 07/14/04 | Prozac | X | X | X | MD | Clonus, Cyanosis Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hyperthermia, Neonatal Tachycardia | |||||
| 1 | Week | M | 5691652 | 4517627 | 10/22/04 | 11/30/04 | Prozac | X | X | X | MD | Convulsion Neonatal, Drug Exposure During Pregnancy | ||||
| 10 | Days | M | 5691652 | 4539544 | 10/22/04 | 12/22/04 | Prozac | X | X | X | MD | Convulsion Neonatal, Drug Exposure During Pregnancy, Premature Baby | ||||
| 3 | Weeks | F | 6200481 | 5189053 | 09/05/06 | 12/21/06 | Prozac | X | X | X | MD | Agitation Neonatal, Drug Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Hypertonia Neonatal, Vomiting Neonatal | ||||
| 11 | Weeks | F | 4140998 | 4357137 | 03/18/04 | 05/11/04 | Fluoxetine | X | X | X | Depression | Drug Toxicity | ||||
| 14 | Weeks | F | 4136907 | 4351330 | 01/01/04 | 04/28/04 | Fluoxetine | X | X | X | Drug Exposure Via Breast Milk, Haematochezia, Loose Stools, Rectal Haemorrhage, Somnolence | |||||
| 4 | Months | M | 5660959 | 4489615 | 09/18/04 | 10/26/04 | Fluoxetine | X | X | X | Abdominal Pain, Drug Exposure Via Breast Milk, Flatulence, Irritability, Sleep Disorder | |||||
| 6 | Months | 6162891 | 5145215 | 01/01/05 | 11/07/06 | Prozac Weekly | X | X | X | CN | Depression | Gastrooesophageal Reflux Disease, Transmission of Drug Via Semen, Unresponsive To Stimuli | ||||
| 33 | Weeks | M | 4182143 | 4409355 | 02/24/04 | 07/23/04 | Fluoxetine | X | X | X | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypoglycaemia Neonatal, Intraventricular Haemorrhage, Irritability | |||||
| 33 | Weeks | M | 4182143 | 4426311 | 02/24/04 | 08/11/04 | Fluoxetine | X | X | X | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypoglycaemia, Intraventricular Haemorrhage, Irritability | |||||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 33 | Weeks | M | 5710245 | 4542367 | 02/24/04 | 12/29/04 | Fluoxetine | X | X | X | Diabetes Mellitus Insulin-Dependent, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypocalcaemia, Hypoglycaemia Neonatal, Intraventricular Haemorrhage Neonatal, Irritability, Jaundice Neonatal, Meningitis Chemical, Meningitis Neonatal, Neonatal Diabetes Mellitus, Neonatal Disorder, Premature Baby, Subdural Haemorrhage Neonatal, Thalamus Haemorrhage | |||||
| 33 | Weeks | F | 5998821 | 4921127 | 04/13/05 | 02/17/06 | Fluoxetine | X | X | X | OT | Convulsion Neonatal, Drug Exposure During Pregnancy, Foetal Distress Syndrome, Hypoglycaemia Neonatal, Neonatal Respiratory Distress Syndrome, Small for Dates Baby | ||||
| 36 | Weeks | M | 4192104 | 4432737 | 02/28/04 | 08/20/04 | Fluoxetine | X | X | X | Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Hypoglycaemia Neonatal, Intraventricular Haemorrhage Neonatal, Irritability, Neonatal Disorder, Premature Baby | |||||
| 1 | Year | F | 5652911 | 4477382 | 09/22/04 | 10/13/04 | Prozac | X | X | X | Accidental Exposure, Overdose, Vomiting | |||||
| 1 | Year | F | 6103122 | 5067661 | 01/01/06 | 07/28/06 | Prozac | X | X | X | Malaise, Poisoning Deliberate, Victim of Child Abuse | |||||
| 3 | Years | 5735019 | 4570741 | 02/02/05 | Fluoxetine | X | X | X | CN | Drug Exposure During Pregnancy, Heart Disease Congenital | ||||||
| 3 | Years | Unk | 5958339 | 4870381 | 11/01/04 | 12/28/05 | Prozac | X | X | X | OT | Caesarean Section, Convulsion, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Grand Mal Convulsion, Myoclonic Epilepsy | ||||
| 3 | Years | M | 6103128 | 5067667 | 01/01/06 | 07/28/06 | Prozac | X | X | X | Poisoning Deliberate, Victim of Child Abuse | |||||
| 4 | Years | F | 5667515 | 4471400 | 10/07/04 | Fluoxetine | X | X | X | MD | Acute Stress Disorder | Agitation, Drug Interaction, Gaze Palsy, Mydriasis, Myoclonus, Restlessness | ||||
| 4 | Years | F | 5670055 | 4476092 | 10/12/04 | Fluoxetine | X | X | X | MD | Anxiety | Agitation, Drug Interaction, Dyskinesia, Mydriasis, Myoclonus, Nystagmus | ||||
| 4 | Years | F | 5681903 | 4503480 | 11/12/04 | Fluoxetine | X | X | X | MD | Anxiety | Agitation, Drug Interaction, Dyskinesia, Gaze Palsy, Mydriasis, Myoclonus, Nystagmus, Restlessness, Serotonin Syndrome | ||||
| 4 | Years | M | 5719069 | 4553232 | 11/01/04 | 01/12/05 | Prozac | X | X | X | MD | Anxiety | Platelet Count Decreased | |||
| Age | M/F | Case # | ISR | Date of Event | Recv'd by FDA | Date of Death | Drug Name | Black Box | Inc'd Risk | Not Appv'd | Rpt'd By | Indications | Reactions | |||
| 4 | Years | F | 5733650 | 4567790 | 01/28/05 | Fluoxetine | X | X | X | MD | Anxiety | Agitation, Drug Interaction, Gaze Palsy, Mydriasis, Myoclonic Epilepsy, Nystagmus, Serotonin Syndrome | ||||
| 4 | Years | F | 5940653 | 4827758 | 01/01/04 | 11/10/05 | Fluoxetine HCL | X | X | X | MD | Acute Stress Disorder | Drug Interaction, Post Procedural Complication, Serotonin Syndrome | |||
| 30 Males | 28 Females | 74 Cases (Gender was not reported for 16 Cases) | 86 Individual Safety Reports | |||||||||||||
Abdominal Pain, Abscess, Accidental Exposure, Agitation, Agitation Neonatal, Alcohol Use, Amimia, Amniocentesis Abnormal, Anomalous Pulmonary Venous Connection, Anterior Chamber Cleavage Syndrome, Antidepressant Drug Level Increased, Anxiety, Apgar Score Low, Apnoea, Assisted Delivery, Autism, Base Excess Increased, Blood Bilirubin Increased, Blood Gases Abnormal, Blood Glucose Abnormal, Blood Lactic Acid Increased, Blood PH Decreased, Blood Pressure Increased, Blood Sodium Decreased, Body Temperature Decreased, Body Temperature Increased, Bradycardia Neonatal, Brain Oedema, Branchial Cleft Cyst, Branchial Cleft Sinus, Caesarean Section, Cardiac Murmur, Cardiopulmonary Failure, Cerebral Haemorrhage Neonatal, Cerebral Thrombosis, Cerebral Ventricle Dilatation, Cleft Lip, Cleft Uvula, Clonus, Cognitive Disorder, Coma, Congenital Anomaly, Congenital Bladder Anomaly, Congenital Eye Disorder, Congenital Foot Malformation, Congenital Hand Malformation, Congenital Multiplex Arthrogryposis, Congenital Tracheomalacia, Congenital Tricuspid Valve Atresia, Congenital Ventricular Septal Defect, Convulsion, Convulsion Neonatal, Cow's Milk Intolerance, Crying, Cyanosis Central, Cyanosis Neonatal, Developmental Delay, Diabetes Mellitus Insulin-Dependent, Diarrhoea Neonatal, Difficulty In Walking, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Interaction, Drug Toxicity, Drug Withdrawal Syndrome Neonatal, Dyskinesia, Dysphagia, Dyspnoea, Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged, Electroencephalogram Abnormal, Expressive Language Disorder, Extrapyramidal Disorder, Eye Disorder, Facial Dysmorphism, Feeding Disorder Neonatal, Feeding Disorder of Infancy Or Early Childhood, Feeding Problem In Child, Feeding Problem In Newborn, Feeling Jittery, Fever Neonatal, Fistula, Flatulence, Foetal Arrhythmia, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Deceleration, Foetal Heart Rate Decreased, Gastrointestinal Disorder, Gastrooesophageal Reflux Disease, Gastroschisis, Gaze Palsy, Grand Mal Convulsion, Haemangioma Congenital, Haematochezia, Haematoma, Haemoglobin Decreased, Haemorrhage, Heart Disease Congenital, Heart Rate Irregular, High Arched Palate, Hip Dysplasia, Hyperreflexia, Hypertelorism of Orbit, Hypertension Neonatal, Hyperthermia, Hypertonia, Hypertonia Neonatal, Hypervigilance, Hypocalcaemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypokinesia Neonatal, Hypospadias, Hypothermia Neonatal, Hypotonia Neonatal, Iiird Nerve Paralysis, Infantile Apnoeic Attack, Infantile Colic, Infected Cyst, Insomnia, Intraventricular Haemorrhage, Intraventricular Haemorrhage Neonatal, Irritability, Jaundice Neonatal, Large for Dates Baby, Laryngomalacia, Loose Stools, Malaise, Malnutrition, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Meconium In Amniotic Fluid, Meningitis Chemical, Meningitis Neonatal, Metabolic Acidosis, Moaning, Moebius II Syndrome, Mydriasis, Myoclonic Epilepsy, Myoclonus, Neonatal Apnoeic Attack, Neonatal Diabetes Mellitus, Neonatal Disorder, Neonatal Hypotension, Neonatal Infection, Neonatal Respiratory Arrest, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Neonatal Tachypnoea, Nervous System Disorder, Nystagmus, Oedema Neonatal, Opisthotonus, Overdose, Oxygen Saturation Decreased, Pallor, Patent Ductus Arteriosus, PCO2 Decreased, PCO2 Increased, Persistent Foetal Circulation, Petechiae, Pierre Robin Syndrome, Platelet Count Decreased, Po2 Decreased, Poisoning Deliberate, Poor Sucking Reflex, Post Procedural Complication, Premature Baby, Premature Labour, Premature Rupture of Membranes, Pulmonary Haemorrhage, Pulmonary Hypertension, Pulmonary Oedema, Pulmonary Vascular Disorder, Rash, Rash Neonatal, Rectal Haemorrhage, Respiratory Rate Increased, Restlessness, Retching, Retrognathia, Scratch, Sepsis Neonatal, Serotonin Syndrome, Sleep Apnoea Syndrome, Sleep Disorder, Small for Dates Baby, Sneezing, Somnolence, Somnolence Neonatal, Staphylococcal Infection, Strabismus, Streptococcal Infection, Subdural Haemorrhage Neonatal, Syndactyly, Talipes, Tardive Dyskinesia, Thalamus Haemorrhage, Thrombocytopenia, Tracheo-Oesophageal Fistula, Transmission of Drug Via Semen, Tremor, Tremor Neonatal, Umbilical Cord Abnormality, Unevaluable Event, Unresponsive To Stimuli, Unwanted Pregnancy, Vacuum Extractor Delivery, Ventricular Fibrillation, Ventricular Septal Defect, Victim of Child Abuse, Vomiting, Vomiting Neonatal, Weight Gain Poor, Wound Infection Staphylococcal
| Top 10 | |
| Reaction | Cases |
| Drug Exposure During Pregnancy | 53 |
| Neonatal Disorder | 20 |
| Premature Baby | 18 |
| Drug Withdrawal Syndrome Neonatal | 12 |
| Agitation Neonatal | 10 |
| Maternal Drugs Affecting Foetus | 8 |
| Drug Exposure Via Breast Milk | 8 |
| Irritability | 7 |
| Hypoglycaemia Neonatal | 7 |
| Hypertonia Neonatal | 7 |
| 660 Males | 1,140 Females | 1,998 Cases | 2,290 Individual Safety Reports | ||||||||||||||
| (Gender was not reported for 198 Cases) | |||||||||||||||||
| Homicidal/Suicidal/Death/Mania Reactions | Reported By | |||||||||||||
| Reaction | SSRIs | SNRIs | Atypicals | Antidepressants | Antipsychotics | Stimulants | Others | Totals | MD | CN | OT | PH | LW | NR |
| Depression Suicidal/Suicidal Ideations: | 113 | 113 | 20 | 39 | 15 | 2 | 3 | 34 | ||||||
| Attempted Suicides (not completed): | 65 | 65 | 16 | 16 | 8 | 3 | 1 | 22 | ||||||
| Completed Suicides: | 187 | 187 | 54 | 19 | 24 | 23 | 15 | 55 | ||||||
| Deaths (not from Suicide): | 34 | 34 | 14 | 7 | 5 | 10 | ||||||||
| Homicidal Ideations: | 12 | 12 | 5 | 2 | 5 | |||||||||
| Homicides/Murders: | 17 | 17 | 4 | 3 | 2 | 2 | 6 | |||||||
| Hypomania/Mania: | 31 | 31 | 4 | 11 | 5 | 3 | 8 | |||||||
This table shows the homicidal/suicidal/death/mania reaction, drug category and report author totals. The Totals column lists the total for a row's Reaction; the Reported By combined column total may exceed this Reaction Total if there was more than one reporter of that Adverse Reaction for a Case. Multiple ISRs for a Case are identified by bolding the Case for subsequent ISRs. Each unique Adverse Reaction for a Case is only counted once in the tally regardless of the number of ISRs it appears in for a Case. If the reactions for an ISR include both Attempted and Completed Suicide (or Death), only the Completed Suicide/Death is added to the above tally.
MD = Physician, CN = Consumer, OT = Other Health-Provider, PH = Pharmacist, LW = Lawyer, NR = Author Not Reported.
The Death (not from Suicide) tallies are comprised of the Death and Cardiac Arrest/Failure reactions where the Date of Death was not blank and equaled the Event Date (since cardiac arrest may not have resulted in death). Completed Suicides/Deaths Reported By Consumer (CN) tallies are what is in the FDA data. Obviously not from the consumer (who died taking the drug), these reports were likely submitted by family, friends or other associates of the patient.
Note that the Homicides/Murders row is reporting the individual cases of homicide/murder committed by a patient, not the total number of people killed, which is not available from the FDA data.
Cloridrato De Fluoxetina (Fluoxetine), Fluctin (Fluoxetine), Fluctine (Fluoxetine), Fluctin-Oral (Fluoxetine), Fluoxetine (Fluoxetine), Fluoxetine 20 Mg (Fluoxetine), Fluoxetine 20 Ml (Fluoxetine), Fluoxetine 40 Mg (Fluoxetine), Fluoxetine Capsules 20 Mg (Fluoxetine), Fluoxetine Gelule (Fluoxetine), Fluoxetine HCL (Fluoxetine), Fluoxetine-Oral (Fluoxetine), Fontex (Fluoxetine), Ladose (Fluoxetine), Prozac (Fluoxetine), Prozac Weekly (Fluoxetine), Prozac-Oral (Fluoxetine), Sarafem (Fluoxetine), Symbyax (Fluoxetine), Zactin (Fluoxetine)
Abasia, Abdominal Adhesions, Abdominal Discomfort, Abdominal Distension, Abdominal Haematoma, Abdominal Hernia, Abdominal Pain, Abdominal Pain Upper, Abdominal Tenderness, Abnormal Behaviour, Abnormal Dreams, Abnormal Sensation In Eye, Abnormal Sleep-Related Event, Abortion Induced, Abortion Spontaneous, Abscess, Abscess Jaw, Accident, Accident at Work, Accidental Exposure, Accidental Overdose, Accommodation Disorder, Acidosis, Acne, Acquired Immunodeficiency Syndrome, Activated Partial Thromboplastin Time Prolonged, Activities of Daily Living Impaired, Acute Coronary Syndrome, Acute Myeloid Leukaemia, Acute Myocardial Infarction, Acute Prerenal Failure, Acute Psychosis, Acute Pulmonary Oedema, Acute Respiratory Distress Syndrome, Adnexa Uteri Pain, Adrenogenital Syndrome, Adverse Drug Reaction, Adverse Event, Affect Lability, Affective Disorder, Ageusia, Aggression, Agitation, Agitation Neonatal, Agoraphobia, Agranulocytosis, Air Embolism, Akathisia, Akinesia, Alanine Aminotransferase Increased, Alcohol Interaction, Alcohol Poisoning, Alcohol Problem, Alcohol Use, Alcohol Withdrawal Syndrome, Alcoholism, Alopecia, Alpha-1 Anti-Trypsin Increased, Amaurosis Fugax, Amenorrhoea, Amimia, Ammonia Increased, Amnesia, Amniocentesis Abnormal, Anaemia, Anaemia Vitamin B12 Deficiency, Anaphylactic Reaction, Anaphylactic Shock, Anencephaly, Aneurysm, Anger, Angina Pectoris, Angioneurotic Oedema, Angiopathy, Anhedonia, Animal Bite, Animal Scratch, Ankle Fracture, Ankle Operation, Anomalous Pulmonary Venous Connection, Anorectal Disorder, Anorexia, Anorgasmia, Anotia, Anterior Chamber Cleavage Syndrome, Anti Factor VIII Antibody Positive, Antibody Test Positive, Anticholinergic Syndrome, Anticonvulsant Drug Level Below Therapeutic, Anticonvulsant Drug Level Decreased, Antidepressant Drug Clearance Decreased, Antidepressant Drug Level Above Therapeutic, Antidepressant Drug Level Increased, Antineutrophil Cytoplasmic Antibody Positive, Antipsychotic Drug Level Below Therapeutic, Antipsychotic Drug Level Increased, Antisocial Behaviour, Anuria, Anxiety, Anxiety Disorder, Aortic Atherosclerosis, Aortic Calcification, Aortic Injury, Aortic Stenosis, Aortic Valve Incompetence, Apallic Syndrome, Apathy, Apgar Score Low, Aphagia, Aphasia, Aplasia Pure Red Cell, Apnoea, Appendicitis Perforated, Appetite Disorder, Apraxia, Areflexia, Arrested Labour, Arrhythmia, Arterial Occlusive Disease, Arterial Stent Insertion, Arterial Thrombosis Limb, Arteriosclerosis, Arteriosclerosis Coronary Artery, Arteriospasm Coronary, Arthralgia, Arthritis, Arthropathy, Arthropod Bite, Aspartate Aminotransferase Increased, Asphyxia, Aspiration, Assisted Delivery, Asthenia, Asthenopia, Asthma, Asthma Exacerbation Prophylaxis, Atelectasis, Atherosclerosis, Atrial Fibrillation, Atrial Flutter, Atrial Septal Defect, Atrial Tachycardia, Atrioventricular Block, Atrioventricular Block Complete, Atrioventricular Block First Degree, Atrioventricular Septal Defect, Attention Deficit Hyperactivity Disorder, Autism, Autoimmune Disorder, Autoimmune Hepatitis, Automatism (Command), Autonomic Nervous System Imbalance, Back Disorder, Back Pain, Bacterial Infection, Balance Disorder, Base Excess Increased, B-Cell Lymphoma, Bedridden, Benign Intracranial Hypertension, Benign Ovarian Tumour, Benign Prostatic Hyperplasia, Bereavement Reaction, Bile Duct Cancer, Bile Duct Obstruction, Biliary Colic, Biliary Dilatation, Biliary Tract Disorder, Binocular Eye Movement Disorder, Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Bite, Bleeding Time Prolonged, Blepharospasm, Blindness, Blindness Transient, Blindness Unilateral, Blister, Blood Albumin Decreased, Blood Albumin Increased, Blood Alcohol Increased, Blood Alkaline Phosphatase Increased, Blood Amylase Increased, Blood Bicarbonate Decreased, Blood Bicarbonate Increased, Blood Bilirubin Increased, Blood Blister, Blood Calcium Decreased, Blood Chloride Decreased, Blood Chloride Increased, Blood Cholesterol Increased, Blood Count Abnormal, Blood Creatine Decreased, Blood Creatine Increased, Blood Creatine Phosphokinase Abnormal, Blood Creatine Phosphokinase Increased, Blood Creatinine Abnormal, Blood Creatinine Decreased, Blood Creatinine Increased, Blood Culture Positive, Blood Disorder, Blood Electrolytes Decreased, Blood Follicle Stimulating Hormone Increased, Blood Gases Abnormal, Blood Glucose Abnormal, Blood Glucose Decreased, Blood Glucose Fluctuation, Blood Glucose Increased, Blood Growth Hormone Decreased, Blood Immunoglobulin E Increased, Blood Iron Decreased, Blood Lactate Dehydrogenase Increased, Blood Lactic Acid Increased, Blood Magnesium Increased, Blood Methanol Increased, Blood Osmolarity Decreased, Blood PH Decreased, Blood PH Increased, Blood Phosphorus Decreased, Blood Potassium Abnormal, Blood Potassium Decreased, Blood Pressure Abnormal, Blood Pressure Decreased, Blood Pressure Diastolic Decreased, Blood Pressure Fluctuation, Blood Pressure Increased, Blood Pressure Systolic Increased, Blood Prolactin Increased, Blood Sodium Decreased, Blood Test Abnormal, Blood Testosterone Decreased, Blood Thyroid Stimulating Hormone Increased, Blood Triglycerides Increased, Blood Urea Decreased, Blood Urea Increased, Blood Uric Acid Decreased, Blood Urine, Blunted Affect, Body Dysmorphic Disorder, Body Height Decreased, Body Temperature Decreased, Body Temperature Fluctuation, Body Temperature Increased, Bone Density Decreased, Bone Lesion, Bone Marrow Depression, Bone Marrow Failure, Bone Marrow Necrosis, Bone Pain, Borderline Personality Disorder, Boredom, Bottle Feeding, Bradycardia, Bradycardia Neonatal, Bradykinesia, Bradyphrenia, Brain Damage, Brain Death, Brain Hypoxia, Brain Neoplasm, Brain Oedema, Brain Operation, Branchial Cleft Cyst, Branchial Cleft Sinus, Breast Abscess, Breast Cancer, Breast Cancer Female, Breast Cancer In Situ, Breast Cancer Metastatic, Breast Discharge, Breast Enlargement, Breast Tenderness, Breath Odour, Breech Presentation, Brief Psychotic Disorder With Postpartum Onset, Bronchial Disorder, Bronchiectasis, Bronchiolitis, Bronchitis, Bronchitis Acute, Bronchopneumonia, Bronchospasm, Bruxism, Bundle Branch Block Left, Bundle Branch Block Right, Burning Sensation, Bursitis, Caesarean Section, Campylobacter Intestinal Infection, Carbohydrate Antigen 15-3 Increased, Carbohydrate Antigen 19-9 Increased, Carbon Dioxide Decreased, Carbon Dioxide Increased, Carbon Monoxide Poisoning, Cardiac Arrest, Cardiac Death, Cardiac Disorder, Cardiac Failure, Cardiac Failure Chronic, Cardiac Failure Congestive, Cardiac Fibrillation, Cardiac Flutter, Cardiac Murmur, Cardiac Operation, Cardiac Valve Disease, Cardiogenic Shock, Cardiomegaly, Cardiomyopathy, Cardiopulmonary Failure, Cardio-Respiratory Arrest, Cardiotoxicity, Cardiovascular Disorder, Carotid Artery Occlusion, Carpal Tunnel Decompression, Carpal Tunnel Syndrome, Cartilage Injury, Cataract Nuclear, Catatonia, Caustic Injury, Cd4 Lymphocytes Abnormal, Cell Death, Cellulitis, Central Pontine Myelinolysis, Central-Alveolar Hypoventilation, Cerebellar Syndrome, Cerebral Arteriosclerosis, Cerebral Atrophy, Cerebral Disorder, Cerebral Haematoma, Cerebral Haemorrhage, Cerebral Haemorrhage Neonatal, Cerebral Infarction, Cerebral Ischaemia, Cerebral Thrombosis, Cerebral Ventricle Dilatation, Cerebrovascular Accident, Cerebrovascular Disorder, Ceruloplasmin, Ceruloplasmin Increased, Cervical Vertebral Fracture, Change of Bowel Habit, Cheilitis, Chest Discomfort, Chest Pain, Chest X-Ray Abnormal, Child Abuse, Child Neglect, Chills, Choking, Cholangitis Sclerosing, Cholecystectomy, Cholelithiasis, Cholestasis, Chondropathy, Chorea, Chromosomal Mutation, Chronic Fatigue Syndrome, Chronic Obstructive Airways Disease Exacerbated, Chronic Obstructive Pulmonary Disease, Circulatory Collapse, Circumstance Or Information Capable of Leading To Medication Error, Cleft Lip, Cleft Uvula, Clitoral Engorgement, Clonic Convulsion, Clonus, Coagulation Time Prolonged, Coagulopathy, Coarctation of the Aorta, Cognitive Disorder, Cogwheel Rigidity, Cold Sweat, Colitis Ulcerative, Colon Cancer, Colon Operation, Colonic Polyp, Coma, Coma Neonatal, Communication Disorder, Completed Suicide, Complication of Pregnancy, Complications of Maternal Exposure To Therapeutic Drugs, Compulsions, Computerised Tomogram Abnormal, Concomitant Disease Progression, Concussion, Condition Aggravated, Confusional State, Congenital Absence of Bile Ducts, Congenital Anomaly, Congenital Atrial Septal Defect, Congenital Bladder Anomaly, Congenital Cystic Lung, Congenital Eye Disorder, Congenital Foot Malformation, Congenital Hand Malformation, Congenital Hepatobiliary Anomaly, Congenital Hydronephrosis, Congenital Multiplex Arthrogryposis, Congenital Neurological Disorder, Congenital Pulmonary Valve Atresia, Congenital Scoliosis, Congenital Spinal Cord Anomaly, Congenital Thrombocyte Disorder, Congenital Tracheomalacia, Congenital Tricuspid Valve Atresia, Congenital Ventricular Septal Defect, Connective Tissue Disorder, Constipation, Contact Lens Complication, Contusion, Conversion Disorder, C-Reactive Protein Increased, Convulsion, Convulsion Neonatal, Convulsive Threshold Lowered, Coordination Abnormal, Corneal Deposits, Corneal Infiltrates, Corneal Transplant, Corneal Ulcer, Coronary Artery Atherosclerosis, Coronary Artery Disease, Coronary Artery Occlusion, Coronary Artery Stenosis, Coronary Artery Surgery, Corynebacterium Infection, Cough, Cows Milk Free Diet, Cow's Milk Intolerance, Cranial Nerve Disorder, Creatine Phosphokinase Decreased, Creatinine Renal Clearance Decreased, Crohn's Disease, Crying, Cyanosis, Cyanosis Central, Cyanosis Neonatal, Cyst, Cystitis, Cytolytic Hepatitis, Cytomegalovirus Antibody Positive, Cytomegalovirus Antigen Positive, Dandy-Walker Syndrome, Deafness, Deafness Congenital, Deafness Neurosensory, Deafness Unilateral, Death, Death Neonatal, Death of Child, Death of Parent, Death of Spouse, Decerebration, Decreased Activity, Decreased Appetite, Decreased Interest, Deep Vein Thrombosis, Deformity Thorax, Dehydration, Delirium, Delusion, Delusion of Grandeur, Delusion of Reference, Delusional Disorder (Persecutory Type), Delusional Perception, Dementia Alzheimer's Type, Demyelinating Polyneuropathy, Demyelination, Dental Operation, Dental Treatment, Dependence, Dependent Personality Disorder, Depersonalisation, Depressed Level of Consciousness, Depressed Mood, Depression, Depression Suicidal, Depressive Symptom, Derealisation, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Exfoliative, Developmental Delay, Device Migration, Diabetes Mellitus, Diabetes Mellitus Inadequate Control, Diabetes Mellitus Insulin-Dependent, Diabetes Mellitus Non-Insulin-Dependent, Diabetic Ketoacidosis, Diabetic Retinopathy, Dialysis, Diarrhoea, Diarrhoea Haemorrhagic, Diarrhoea Neonatal, Difficulty In Walking, Dilatation Ventricular, Diplegia, Diplopia, Disability, Discomfort, Disease Progression, Disease Recurrence, Disinhibition, Disorientation, Disseminated Intravascular Coagulation, Dissociation, Disturbance In Attention, Disturbance In Sexual Arousal, Diverticulitis, Diverticulum Intestinal, Divorced, Dizziness, Dizziness Postural, Double Ureter, Drowning, Drug Abuser, Drug Administration Error, Drug Dependence, Drug Dispensing Error, Drug Dose Omission, Drug Effect Decreased, Drug Effect Increased, Drug Eruption, Drug Exposure Before Pregnancy, Drug Exposure During Pregnancy, Drug Exposure Via Breast Milk, Drug Hypersensitivity, Drug Ineffective, Drug Interaction, Drug Interaction Inhibition, Drug Interaction Potentiation, Drug Intolerance, Drug Level Above Therapeutic, Drug Level Below Therapeutic, Drug Level Decreased, Drug Level Increased, Drug Prescribing Error, Drug Resistance, Drug Screen Positive, Drug Tolerance Decreased, Drug Toxicity, Drug Withdrawal Syndrome, Drug Withdrawal Syndrome Neonatal, Dry Mouth, Dry Skin, Duodenal Ulcer, Duodenal Ulcer Haemorrhage, Dysarthria, Dysgeusia, Dysgraphia, Dyskinesia, Dyskinesia Neonatal, Dyspepsia, Dysphagia, Dysphemia, Dysphoria, Dyspnoea, Dyspnoea Exertional, Dysstasia, Dystonia, Dysuria, Ear Infection, Early Morning Awakening, Eating Disorder, Eating Disorder Symptom, Ecchymosis, Echocardiogram Abnormal, Echography Abnormal, Economic Problem, Ectopic Pregnancy, Eczema, Educational Problem, Ejaculation Disorder, Ejaculation Failure, Electrocardiogram Abnormal, Electrocardiogram Pr Shortened, Electrocardiogram Qrs Complex Prolonged, Electrocardiogram Qrs Complex Shortened, Electrocardiogram QT Corrected Interval Prolonged, Electrocardiogram QT Prolonged, Electrocardiogram Repolarisation Abnormality, Electrocardiogram St Segment Depression, Electrocardiogram St Segment Elevation, Electrocardiogram St-T Change, Electrocardiogram T Wave Inversion, Electroencephalogram Abnormal, Electrolyte Imbalance, Electromechanical Dissociation, Elevated Mood, Emotional Disorder, Emotional Distress, Emphysema, Encephalitis, Encephalitis Viral, Encephalomalacia, Encephalopathy, Encephalopathy Neonatal, Endocardial Disease, Endocarditis, Endocarditis Staphylococcal, Endodontic Procedure, Endometriosis, Energy Increased, Enteritis, Enterocele, Enuresis, Eosinophil Count Increased, Eosinophilia, Eosinophilic Pneumonia Acute, Epicondylitis, Epidermal Necrosis, Epilepsy, Epistaxis, Erectile Dysfunction, Erythema, Erythema Multiforme, Erythema Nodosum, Escherichia Infection, Escherichia Sepsis, Escherichia Urinary Tract Infection, Euphoric Mood, Excitability, Exophthalmos, Exostosis, Expressive Language Disorder, Exsanguination, Extensor Plantar Response, Extranodal Marginal Zone B-Cell Lymphoma (Malt Type), Extrapyramidal Disorder, Extrasystoles, Eye Disorder, Eye Haemorrhage, Eye Infection, Eye Inflammation, Eye Movement Disorder, Eye Operation, Eye Operation Complication, Eye Pain, Eye Pruritus, Eye Rolling, Eye Swelling, Eyelid Function Disorder, Eyelid Oedema, Face Injury, Face Oedema, Facial Bones Fracture, Facial Dysmorphism, Facial Pain, Facial Palsy, Faecal Incontinence, Faecal Occult Blood Positive, Faecaloma, Faeces Discoloured, Fall, Fallopian Tube Disorder, Family Stress, Fatigue, Fear, Fear of Disease, Febrile Bone Marrow Aplasia, Feeding Disorder, Feeding Disorder Neonatal, Feeding Disorder of Infancy Or Early Childhood, Feeding Problem In Child, Feeding Problem In Newborn, Feeling Abnormal, Feeling Cold, Feeling Drunk, Feeling Hot, Feeling Hot and Cold, Feeling Jittery, Feeling of Body Temperature Change, Feeling of Despair, Female Orgasmic Disorder, Female Sexual Arousal Disorder, Femur Fracture, Fever Neonatal, Fibroadenoma, Fibroadenoma of Breast, Fibromyalgia, Fibrosis, Fistula, Flank Pain, Flashback, Flat Affect, Flatulence, Fluid Intake Reduced, Fluid Retention, Flushing, Foetal Arrhythmia, Foetal Cystic Hygroma, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Retardation, Foetal Heart Rate Deceleration, Foetal Heart Rate Decreased, Folliculitis, Food Allergy, Food Aversion, Food Poisoning, Foot Operation, Forceps Delivery, Foreign Body Aspiration, Foreign Body Trauma, Formication, Fracture, Frequent Bowel Movements, Full Blood Count Abnormal, Fungal Infection, Gait Disturbance, Galactorrhoea, Gallbladder Operation, Gamma-Glutamyltransferase Increased, Gas Poisoning, Gastric Bypass, Gastric Haemorrhage, Gastric Operation, Gastric Ulcer, Gastritis, Gastritis Alcoholic, Gastritis Erosive, Gastroduodenal Haemorrhage, Gastroduodenitis, Gastrointestinal Carcinoma, Gastrointestinal Disorder, Gastrointestinal Haemorrhage, Gastrointestinal Malformation, Gastrointestinal Pain, Gastrointestinal Ulcer Haemorrhage, Gastrooesophageal Reflux Disease, Gastroschisis, Gaze Palsy, General Physical Condition Abnormal, General Physical Health Deterioration, General Symptom, Generalised Oedema, Genital Discharge, Genital Disorder Female, Genital Disorder Male, Gestational Diabetes, Gingival Bleeding, Glasgow Coma Scale Abnormal, Glaucoma, Glomerulonephritis Membranous, Glossodynia, Glossoptosis, Grand Mal Convulsion, Granulomatous Liver Disease, Grimacing, Grip Strength Decreased, Growth Retardation, Gun Shot Wound, Haemangioma Congenital, Haematemesis, Haematochezia, Haematocrit, Haematocrit Decreased, Haematoma, Haematuria, Haemodialysis, Haemodynamic Instability, Haemoglobin Decreased, Haemolytic Anaemia, Haemolytic Uraemic Syndrome, Haemoptysis, Haemorrhage, Haemorrhage Intracranial, Haemorrhagic Disorder, Haemorrhoidal Haemorrhage, Hair Colour Changes, Hair Texture Abnormal, Hallucination, Hallucination (Auditory), Hallucination (Olfactory), Hallucination (Visual), Hallucinations (Mixed), Hangover, Head Injury, Headache, Hearing Impaired, Heart Disease Congenital, Heart Rate Abnormal, Heart Rate Decreased, Heart Rate Increased, Heart Rate Irregular, Heart Valve Replacement, Hellp Syndrome, Hemianopia Heteronymous, Hemiparesis, Hemiplegia, Hepatic Cirrhosis, Hepatic Congestion, Hepatic Cyst, Hepatic Encephalopathy, Hepatic Enzyme Increased, Hepatic Failure, Hepatic Fibrosis, Hepatic Function Abnormal, Hepatic Pain, Hepatic Steatosis, Hepatitis, Hepatitis Acute, Hepatitis Alcoholic, Hepatitis C, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Toxic, Hepatocellular Damage, Hepato-Lenticular Degeneration, Hepatomegaly, Hepatorenal Failure, Hepatosplenomegaly, Hepatotoxicity, Herpes Virus Infection, Herpes Zoster, Hiatus Hernia, High Arched Palate, High Density Lipoprotein Decreased, Hip Arthroplasty, Hip Dysplasia, Hip Fracture, Hirsutism, Histrionic Personality Disorder, Hodgkin's Disease, Homeless, Homicidal Ideation, Homicide, Hospitalisation, Hostility, Hot Flush, Hunger, Huntington's Chorea, Hydrocephalus, Hydronephrosis, Hyperacusis, Hyperaemia, Hyperaesthesia, Hypercapnia, Hypercholesterolaemia, Hypercoagulation, Hypereosinophilic Syndrome, Hyperexplexia, Hyperglycaemia, Hyperhidrosis, Hyperkalaemia, Hyperkinesia, Hyperlactacidaemia, Hyperosmolar State, Hyperparathyroidism Primary, Hyperphagia, Hyperpyrexia, Hyperreflexia, Hypersensitivity, Hypersomnia, Hypertelorism of Orbit, Hypertension, Hypertension Neonatal, Hypertensive Crisis, Hypertensive Heart Disease, Hyperthermia, Hyperthyroidism, Hypertonia, Hypertonia Neonatal, Hypertriglyceridaemia, Hypertrophy Breast, Hyperventilation, Hypervigilance, Hypoacusis, Hypoaesthesia, Hypoaesthesia Oral, Hypoalbuminaemia, Hypocalcaemia, Hypocapnia, Hypochloraemia, Hypoglycaemia, Hypoglycaemia Neonatal, Hypoglycaemia Unawareness, Hypoglycaemic Coma, Hypogonadism, Hypokalaemia, Hypokinesia, Hypokinesia Neonatal, Hypomagnesaemia, Hypomania, Hyponatraemia, Hypophosphataemia, Hypoproteinaemia, Hyporeflexia, Hypospadias, Hypotension, Hypothermia, Hypothermia Neonatal, Hypothyroidism, Hypotonia, Hypotonia Neonatal, Hypotrichosis, Hypoventilation, Hypoventilation Neonatal, Hypoxia, Hysterectomy, Iatrogenic Infection, Iatrogenic Injury, Idiopathic Thrombocytopenic Purpura, Iiird Nerve Paralysis, Ileus Paralytic, Ill-Defined Disorder, Illogical Thinking, Illusion, Impaired Driving Ability, Impaired Gastric Emptying, Impaired Healing, Impaired Work Ability, Impatience, Imprisonment, Impulse-Control Disorder, Impulsive Behaviour, Inadequate Lubrication, Inappropriate Affect, Inappropriate Antidiuretic Hormone Secretion, Incoherent, Incontinence, Incorrect Dose Administered, Incorrect Route of Drug Administration, Increased Appetite, Increased Tendency To Bruise, Indifference, Infantile Apnoeic Attack, Infantile Colic, Infantile Spitting Up, Infected Cyst, Infection, Inflammation, Influenza, Influenza Like Illness, Infusion Related Reaction, Initial Insomnia, Injection Site Erythema, Injection Site Haemorrhage, Injection Site Pain, Injection Site Reaction, Injection Site Swelling, Injury, Injury Asphyxiation, Insomnia, Intentional Drug Misuse, Intentional Misuse, Intentional Overdose, Intentional Self-Injury, International Normalised Ratio Decreased, International Normalised Ratio Increased, Interstitial Lung Disease, Intervertebral Disc Compression, Intervertebral Disc Disorder, Intervertebral Disc Protrusion, Intervertebral Disc Space Narrowing, Intestinal Atresia, Intestinal Hypomotility, Intestinal Infarction, Intestinal Obstruction, Intestinal Perforation, Intestinal Resection, Intracranial Pressure Increased, Intra-Uterine Death, Intraventricular Haemorrhage, Intraventricular Haemorrhage Neonatal, Iron Deficiency, Iron Deficiency Anaemia, Irritability, Irritable Bowel Syndrome, Ischaemic Cardiomyopathy, Ischaemic Hepatitis, Ischaemic Stroke, Jaundice, Jaundice Cholestatic, Jaundice Neonatal, Jaw Disorder, Jaw Fracture, Job Change, Job Dissatisfaction, Joint Injury, Joint Lock, Joint Reconstruction, Joint Sprain, Joint Stiffness, Joint Swelling, Judgement Impaired, Juvenile Arthritis, Kaolin Cephalin Clotting Time Prolonged, Knee Arthroplasty, Knee Operation, Kyphosis, Labelled Drug-Drug Interaction Medication Error, Labile Blood Pressure, Labile Hypertension, Laboratory Test Abnormal, Laboratory Test Interference, Labour Complication, Laceration, Lacrimal Disorder, Lacrimation Increased, Lactic Acidosis, Langerhans' Cell Granulomatosis, Large for Dates Baby, Large Intestine Perforation, Laryngeal Disorder, Laryngeal Oedema, Laryngomalacia, Learning Disorder, Leg Amputation, Leg Crushing, Legal Problem, Lethargy, Leukaemoid Reaction, Leukocytosis, Leukoencephalopathy, Leukopenia, Libido Decreased, Libido Increased, Limb Discomfort, Limb Injury, Limb Reduction Defect, Lip Pain, Lipase Increased, Listless, Liver Disorder, Liver Function Test Abnormal, Liver Transplant, Living In Residential Institution, Localised Osteoarthritis, Logorrhoea, Loose Associations, Loose Stools, Loss of Consciousness, Loss of Employment, Loss of Libido, Low Density Lipoprotein Increased, Lower Limb Fracture, Lung Disorder, Lung Infection, Lung Infiltration, Lung Neoplasm, Lung Neoplasm Malignant, Lupus-Like Syndrome, Luteal Phase Deficiency, Lyme Disease, Lymph Node Palpable, Lymphadenopathy, Lymphocyte Count Decreased, Lymphocyte Count Increased, Lymphocyte Percentage Increased, Lymphoma, Lymphoma Cutis, Lymphomatoid Papulosis, Lymphopenia, Macrophages Increased, Macular Degeneration, Maculopathy, Major Depression, Malabsorption, Malaise, Male Sexual Dysfunction, Malignant Melanoma, Malignant Neoplasm Progression, Malnutrition, Mania, Marital Problem, Markedly Reduced Dietary Intake, Masked Facies, Mass, Mastectomy, Maternal Condition Affecting Foetus, Maternal Drugs Affecting Foetus, Measles Antibody Positive, Meconium In Amniotic Fluid, Medical Device Complication, Medication Error, Medullary Thyroid Cancer, Melaena, Melanodermia, Melanosis Coli, Memory Impairment, Meningeal Disorder, Meningitis, Meningitis Chemical, Meningitis Neonatal, Menstrual Disorder, Mental Disorder, Mental Impairment, Mental Status Changes, Metabolic Acidosis, Metabolic Disorder, Metabolic Encephalopathy, Metabolic Function Test Abnormal, Metastases To Bone, Metastases To Liver, Metastases To Neck, Metastases To Spine, Metastatic Neoplasm, Methicillin-Resistant Staphylococcal Aureus Test Positive, Metrorrhagia, Microcephaly, Microcytic Anaemia, Micrognathia, Microtia, Micturition Disorder, Micturition Urgency, Middle Insomnia, Migraine, Miosis, Mitral Valve Incompetence, Mitral Valve Prolapse, Moaning, Mobility Decreased, Moebius II Syndrome, Monocyte Count Increased, Monocyte Percentage Increased, Mood Altered, Mood Swings, Morbid Thoughts, Morton's Neuroma, Mouth Haemorrhage, Mouth Ulceration, Movement Disorder, Mucosal Dryness, Multi-Organ Failure, Multiple Allergies, Multiple Drug Overdose, Multiple Drug Overdose Intentional, Multiple Myeloma, Multiple Sclerosis, Murder, Muscle Atrophy, Muscle Contractions Involuntary, Muscle Cramp, Muscle Haemorrhage, Muscle Rigidity, Muscle Spasms, Muscle Tightness, Muscle Twitching, Muscular Weakness, Musculoskeletal Chest Pain, Musculoskeletal Pain, Musculoskeletal Stiffness, Myalgia, Mycosis Fungoides, Mydriasis, Myocardial Fibrosis, Myocardial Infarction, Myocardial Ischaemia, Myocarditis Bacterial, Myoclonic Epilepsy, Myoclonus, Myofascial Pain Syndrome, Myopathy, Nail Infection, Narcolepsy, Nasal Congestion, Nasopharyngeal Disorder, Nasopharyngitis, Nausea, Neck Deformity, Neck Pain, Negative Thoughts, Negativism, Neglect of Personal Appearance, Neonatal Apnoeic Attack, Neonatal Diabetes Mellitus, Neonatal Disorder, Neonatal Hypotension, Neonatal Infection, Neonatal Respiratory Acidosis, Neonatal Respiratory Arrest, Neonatal Respiratory Depression, Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Neonatal Tachypnoea, Neoplasm, Neoplasm Malignant, Neoplasm Recurrence, Nephritis, Nephritis Interstitial, Nephrosclerosis, Nephrotic Syndrome, Nerve Injury, Nerve Root Lesion, Nervous System Disorder, Nervousness, Neural Tube Defect, Neuralgia, Neuroleptic Malignant Syndrome, Neurological Symptom, Neuropathy, Neuropathy Peripheral, Neurosis, Neurotoxicity, Neutropenia, Neutrophil Count Decreased, Neutrophil Percentage Decreased, Neutrophil Percentage Increased, Night Sweats, Nightmare, Nitrite Urine Present, No Adverse Drug Effect, No Therapeutic Response, Non-Cardiac Chest Pain, Nonspecific Reaction, Normal Pressure Hydrocephalus, Normochromic Normocytic Anaemia, Nosocomial Infection, Nuclear Magnetic Resonance Imaging Abnormal, Nuclear Magnetic Resonance Imaging Brain Abnormal, Nystagmus, Obesity, Obsessive-Compulsive Disorder, Obstruction, Obstructive Airways Disorder, Ocular Hyperaemia, Ocular Icterus, Oculogyration, Oedema, Oedema Genital, Oedema Neonatal, Oedema Peripheral, Oesophageal Atresia, Oesophageal Candidiasis, Oesophageal Disorder, Oesophageal Pain, Oesophageal Spasm, Oesophageal Ulcer, Oesophagitis, Off Label Use, Oligohydramnios, Oliguria, Onychomycosis, Oophorectomy, Open Angle Glaucoma, Operative Haemorrhage, Opisthotonus, Optic Atrophy, Optic Ischaemic Neuropathy, Optic Nerve Sheath Haemorrhage, Optic Neuritis, Oral Infection, Oral Intake Reduced, Orgasm Abnormal, Orgasmic Sensation Decreased, Orthopedic Procedure, Orthostatic Hypotension, Osteoarthritis, Osteomyelitis, Osteopenia, Osteoporosis, Ovarian Cancer, Ovarian Cyst, Ovarian Disorder, Ovarian Enlargement, Overdose, Overweight, Overwork, Oxygen Saturation Decreased, Pain, Pain In Extremity, Pain In Jaw, Pain of Skin, Palindromic Rheumatism, Pallor, Palpitations, Pancreatic Disorder, Pancreatic Pseudocyst, Pancreatitis, Pancreatitis Acute, Pancreatitis Chronic, Pancytopenia, Panic Attack, Panic Disorder, Panic Reaction, Papilloedema, Paraesthesia, Paraesthesia Circumoral, Paraesthesia Oral, Paralysis, Paranoia, Paraplegia, Parathyroid Tumour Benign, Parent-Child Problem, Parkinsonism, Parkinson's Disease, Partial Seizures, Partner Stress, Patent Ductus Arteriosus, Pathological Fracture, PCO2 Decreased, PCO2 Increased, Pelvic Fracture, Pemphigoid, Pemphigus, Penis Disorder, Performance Status Decreased, Pericardial Effusion, Periorbital Haematoma, Peripheral Coldness, Peripheral Motor Neuropathy, Peripheral Sensory Neuropathy, Peritoneal Haemorrhage, Peritonitis, Peroneal Nerve Palsy, Persecutory Delusion, Persistent Foetal Circulation, Personality Change, Personality Disorder, Petechiae, Petit Mal Epilepsy, Pharmaceutical Product Complaint, Pharyngeal Candidiasis, Pharyngeal Oedema, Pharyngitis, Pharyngitis Streptococcal, Pharyngolaryngeal Pain, Phlebothrombosis, Phlebotomy, Phobia, Phobia of Driving, Photophobia, Photosensitivity Reaction, Physical Assault, Pierre Robin Syndrome, Piloerection, Pitting Oedema, Pituitary Tumour, Pituitary Tumour Benign, Placenta Praevia, Placenta Praevia Haemorrhage, Placental Disorder, Plastic Surgery To the Face, Platelet Count Decreased, Platelet Count Increased, Pleural Effusion, Pleural Fibrosis, Pneumoconiosis, Pneumonia, Pneumonia Anthrax, Pneumonia Aspiration, Pneumonia Staphylococcal, Pneumonitis, Po2 Decreased, Po2 Increased, Poisoning, Poisoning Deliberate, Pollakiuria, Polyarthritis, Polydipsia Psychogenic, Polyneuropathy, Polyserositis, Polytraumatism, Polyuria, Poor Quality Sleep, Poor Sucking Reflex, Poor Venous Access, Post Concussion Syndrome, Post Procedural Complication, Post Procedural Haemorrhage, Post Procedural Pain, Postictal State, Postoperative Adhesion, Postoperative Infection, Postpartum Depression, Postpartum Disorder, Post-Traumatic Stress Disorder, Posture Abnormal, Prealbumin Decreased, Pre-Eclampsia, Pregnancy, Pregnancy On Oral Contraceptive, Premature Baby, Premature Closure of Cranial Sutures, Premature Labour, Premature Menopause, Premature Rupture of Membranes, Premature Separation of Placenta, Premenstrual Syndrome, Prescribed Overdose, Pressure of Speech, Procedural Complication, Proctocolectomy, Productive Cough, Promiscuity, Prostate Cancer Recurrent, Prostatism, Prostatitis, Protein Total Decreased, Protein Total Increased, Protein Urine Present, Proteinuria, Prothrombin Level Abnormal, Prothrombin Time Abnormal, Prothrombin Time Prolonged, Prothrombin Time Ratio, Prothrombin Time Ratio Decreased, Prothrombin Time Shortened, Prurigo, Pruritus, Pseudo Lymphoma, Pseudolymphoma, Pseudomonas Infection, Psoriasis, Psoriatic Arthropathy, Psychiatric Symptom, Psychogenic Pain Disorder, Psychomotor Agitation, Psychomotor Hyperactivity, Psychomotor Retardation, Psychomotor Skills Impaired, Psychosomatic Disease, Psychotic Disorder, Psychotic Disorder Due To A General Medical Condition, Pulmonary Alveolar Haemorrhage, Pulmonary Artery Atresia, Pulmonary Artery Stenosis Congenital, Pulmonary Congestion, Pulmonary Embolism, Pulmonary Eosinophilia, Pulmonary Fibrosis, Pulmonary Haemorrhage, Pulmonary Hypertension, Pulmonary Hypoplasia, Pulmonary Infarction, Pulmonary Malformation, Pulmonary Mass, Pulmonary Oedema, Pulmonary Oedema Neonatal, Pulmonary Thrombosis, Pulmonary Valve Stenosis, Pulmonary Valve Stenosis Congenital, Pulmonary Vascular Disorder, Pulse Abnormal, Pupillary Disorder, Pupillary Light Reflex Tests Abnormal, Pupillary Reflex Impaired, Pupils Unequal, Purpura, Pyelonephritis, Pyelonephritis Acute, Pyramidal Tract Syndrome, Pyrexia, Pyromania, Quadriparesis, Quadriplegia, Quadruple Vessel Bypass Graft, Radial Nerve Palsy, Rapid Eye Movements Sleep Abnormal, Rash, Rash Erythematous, Rash Generalised, Rash Maculo-Papular, Rash Neonatal, Rash Papular, Rash Pruritic, Rash Pustular, Rectal Haemorrhage, Red Blood Cell Count Decreased, Red Blood Cell Count Increased, Red Blood Cell Sedimentation Rate Increased, Red Man Syndrome, Reflex Sympathetic Dystrophy, Reflux Oesophagitis, Refusal of Treatment By Patient, Regressive Behaviour, Regurgitation of Food, Relationship Breakdown, Renal Arteritis, Renal Artery Stenosis, Renal Cyst, Renal Disorder, Renal Failure, Renal Failure Acute, Renal Failure Chronic, Renal Function Test Abnormal, Renal Impairment, Renal Infarct, Renal Pain, Renal Tubular Acidosis, Renal Vessel Disorder, Respiration Abnormal, Respiratory Acidosis, Respiratory Alkalosis, Respiratory Arrest, Respiratory Depression, Respiratory Disorder, Respiratory Disorder Neonatal, Respiratory Distress, Respiratory Failure, Respiratory Rate Decreased, Respiratory Rate Increased, Respiratory Sighs, Respiratory Tract Congestion, Respiratory Tract Haemorrhage Neonatal, Respiratory Tract Infection, Restless Legs Syndrome, Restlessness, Resuscitation, Retching, Reticulocyte Count Increased, Retinal Degeneration, Retinal Haemorrhage, Retinal Ischaemia, Retinal Vascular Thrombosis, Retrognathia, Reversible Posterior Leukoencephalopathy Syndrome, Rhabdomyolysis, Rhinitis, Rhinorrhoea, Rhonchi, Rib Fracture, Road Traffic Accident, Rotator Cuff Repair, Rotator Cuff Syndrome, Ruptured Cerebral Aneurysm, Salivary Hypersecretion, Salpingitis, Scab, Scar, Schizoaffective Disorder, Schizophrenia, Schizophrenia (Paranoid Type), Sciatica, Scotoma, Scratch, Scrotal Oedema, Sedation, Self Esteem Decreased, Self Injurious Behaviour, Self Mutilation, Self-Injurious Ideation, Self-Medication, Sensation of Foreign Body, Sensation of Heaviness, Sensation of Pressure, Sensory Disturbance, Sensory Loss, Sepsis, Sepsis Neonatal, Septoplasty, Serotonin Syndrome, Serum Serotonin Decreased, Serum Serotonin Increased, Sexual Assault Victim, Sexual Dysfunction, Shock, Shoulder Pain, Single Umbilical Artery, Sinus Bradycardia, Sinus Disorder, Sinus Tachycardia, Sinusitis, Skin Atrophy, Skin Bacterial Infection, Skin Burning Sensation, Skin Chapped, Skin Desquamation, Skin Discolouration, Skin Disorder, Skin Exfoliation, Skin Infection, Skin Injury, Skin Laceration, Skin Lesion, Skin Necrosis, Skin Odour Abnormal, Skin Ulcer, Skin Warm, Skull Fracture, Skull Malformation, Sleep Apnoea Syndrome, Sleep Disorder, Sleep Talking, Sleep Walking, Small Cell Lung Cancer Stage Unspecified, Small for Dates Baby, Small Intestinal Obstruction, Small Intestinal Perforation, Smoker, Sneezing, Social Avoidant Behaviour, Social Phobia, Social Problem, Somatic Hallucination, Somnolence, Somnolence Neonatal, Sopor, Speech Disorder, Sperm Analysis Abnormal, Spina Bifida, Spinal Column Stenosis, Spinal Compression Fracture, Spinal Cord Injury, Spinal Fracture, Spinal Fusion Surgery, Spinal Osteoarthritis, Spinal Shock, Spleen Congestion, Splenomegaly, Spontaneous Penile Erection, Sports Injury, Sputum Culture Positive, Staphylococcal Infection, Status Epilepticus, Stereotypic Movement Disorder, Sterilisation, Stevens-Johnson Syndrome, Stillbirth, Stomach Discomfort, Strabismus, Streptococcal Infection, Stress, Stress Fracture, Stress Symptoms, Stupor, Subarachnoid Haemorrhage, Subclavian Vein Thrombosis, Subcutaneous Haematoma, Subdural Haemorrhage Neonatal, Sudden Cardiac Death, Sudden Death, Suffocation Feeling, Suicidal Behaviour, Suicidal Ideation, Suicide Attempt, Superinfection, Superinfection Lung, Supraventricular Extrasystoles, Supraventricular Tachycardia, Surgery, Sweat Gland Disorder, Swelling, Swelling Face, Swollen Tongue, Syncope, Syncope Vasovagal, Syndactyly, Synovitis, Systemic Lupus Erythematosus, Tachycardia, Tachypnoea, Talipes, Tangentiality, Tardive Dyskinesia, Tearfulness, Telangiectasia, Temperature Regulation Disorder, Temporal Lobe Epilepsy, Temporomandibular Joint Syndrome, Tendonitis, Tension, Tension Headache, Thalamus Haemorrhage, Thanatophobia, Theft, Therapeutic Agent Toxicity, Therapeutic Product Ineffective, Therapeutic Response Decreased, Therapeutic Response Increased, Therapeutic Response Unexpected, Therapeutic Response Unexpected With Drug Substitution, Therapy Cessation, Therapy Non-Responder, Therapy Regimen Changed, Thermal Burn, Thinking Abnormal, Thirst, Thought Insertion, Threat of Redundancy, Throat Irritation, Throat Tightness, Thrombocytopenia, Thrombosis, Thrombotic Microangiopathy, Thrombotic Stroke, Thrombotic Thrombocytopenic Purpura, Thymus Hypoplasia, Thyroid Cyst, Thyroid Disorder, Thyroid Gland Cancer, Thyroiditis, Tic, Tinea Cruris, Tinnitus, Tongue Biting, Tongue Discolouration, Tongue Disorder, Tongue Injury, Tongue Spasm, Tongue Ulceration, Tonic Clonic Movements, Tonsillitis, Tooth Disorder, Tooth Extraction, Tooth Infection, Tooth Injury, Toothache, Torsade De Pointes, Torticollis, Toxic Dilatation of Colon, Toxic Epidermal Necrolysis, Toxic Induced Encephalopathy, Toxicologic Test Abnormal, Tracheal Disorder, Tracheitis, Tracheo-Oesophageal Fistula, Transfusion, Transient Ischaemic Attack, Transient Tachypnoea of the Newborn, Transmission of Drug Via Semen, Transposition of the Great Vessels, Traumatic Fracture, Traumatic Haematoma, Treatment Noncompliance, Tremor, Tremor Neonatal, Trichotillomania, Tricuspid Valve Incompetence, Trigeminal Neuralgia, Trismus, Trisomy 21, Troponin Increased, Troponin T Increased, Tunnel Vision, Ulcer, Umbilical Cord Abnormality, Umbilical Cord Compression, Unemployment, Unequal Limb Length, Unevaluable Event, Unexpected Therapeutic Drug Effect, Unintended Pregnancy, Unresponsive To Pain Stimuli, Unresponsive To Stimuli, Unwanted Pregnancy, Upper Gastrointestinal Haemorrhage, Upper Respiratory Tract Infection, Ureteric Diversion Operation, Urethritis, Urinary Hesitation, Urinary Incontinence, Urinary Retention, Urinary Tract Infection, Urinary Tract Infection Neonatal, Urine Abnormality, Urine Flow Decreased, Urine Osmolarity Decreased, Urine Osmolarity Increased, Urine Output Decreased, Urine Potassium Increased, Urine Sodium Decreased, Urosepsis, Urticaria, Urticaria Generalised, Uterine Cancer, Uterine Enlargement, Uterine Haemorrhage, Uterine Pain, Uveitis, Vacuum Extractor Delivery, Vaginal Haemorrhage, Varices Oesophageal, Vascular Calcification, Vascular Occlusion, Vascular Purpura, Vasculitis, Ventricular Extrasystoles, Ventricular Failure, Ventricular Fibrillation, Ventricular Hypertrophy, Ventricular Septal Defect, Ventricular Tachycardia, Verbal Abuse, Vertigo, Victim of Child Abuse, Victim of Crime, Victim of Homicide, Victim of Sexual Abuse, Victim of Spousal Abuse, Viral Infection, Viral Upper Respiratory Tract Infection, Vision Blurred, Visual Acuity Reduced, Visual Disturbance, Visual Field Defect, Visual Field Tests Abnormal, Vocal Cord Disorder, Vocal Cord Thickening, Vomiting, Vomiting Neonatal, Von Willebrand's Disease, Vulval Disorder, Vulvovaginal Dryness, Walking Aid User, Weight, Weight Decreased, Weight Fluctuation, Weight Gain Poor, Weight Increased, Weight Loss Poor, Wheelchair User, Wheezing, White Blood Cell Count Decreased, White Blood Cell Count Increased, Wound, Wound Complication, Wound Infection Staphylococcal, Wrist Fracture, Wrong Drug Administered, Xanthogranuloma, Xyy Syndrome, Yawning
| Top 20 | |
| Reaction | Cases |
| Completed Suicide | 187 |
| Drug Exposure During Pregnancy | 182 |
| Pharmaceutical Product Complaint | 170 |
| Depression | 166 |
| Drug Ineffective | 161 |
| Anxiety | 117 |
| Suicidal Ideation | 113 |
| Drug Interaction | 113 |
| Agitation | 101 |
| Condition Aggravated | 87 |
| Nausea | 79 |
| Headache | 77 |
| Feeling Abnormal | 77 |
| Tremor | 72 |
| Insomnia | 72 |
| Serotonin Syndrome | 70 |
| Somnolence | 68 |
| Overdose | 67 |
| Suicide Attempt | 65 |
| Confusional State | 65 |