SERTRALINE

Sertraline Adverse Events Reported to the FDA Over Time

How are Sertraline adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Sertraline, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Sertraline is flagged as the suspect drug causing the adverse event.

Most Common Sertraline Adverse Events Reported to the FDA

What are the most common Sertraline adverse events reported to the FDA?

Drug Ineffective	1668 (1.63%)
Depression	1586 (1.55%)
Drug Exposure During Pregnancy	1486 (1.46%)
Anxiety	1478 (1.45%)
Nausea	986 (.97%)
Insomnia	950 (.93%)
Drug Interaction	898 (.88%)
Dizziness	892 (.87%)
Feeling Abnormal	885 (.87%)
Atrial Septal Defect	864 (.85%)
Suicidal Ideation	823 (.81%)
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Completed Suicide	781 (.77%)
Headache	781 (.77%)
Tremor	775 (.76%)
Diarrhoea	683 (.67%)
Agitation	654 (.64%)
Fatigue	649 (.64%)
Ventricular Septal Defect	641 (.63%)
Vomiting	623 (.61%)
Serotonin Syndrome	574 (.56%)
Somnolence	565 (.55%)
Suicide Attempt	563 (.55%)
Confusional State	562 (.55%)
Convulsion	555 (.54%)
Fall	553 (.54%)
Patent Ductus Arteriosus	546 (.54%)
Weight Increased	532 (.52%)
Malaise	510 (.5%)
Overdose	502 (.49%)
Condition Aggravated	478 (.47%)
Aggression	475 (.47%)
Irritability	459 (.45%)
Cardiomegaly	455 (.45%)
Weight Decreased	454 (.44%)
Death	453 (.44%)
Loss Of Consciousness	451 (.44%)
Pain	449 (.44%)
Dyspnoea	441 (.43%)
Hyperhidrosis	419 (.41%)
Asthenia	400 (.39%)
Cardiac Arrest	384 (.38%)
Panic Attack	370 (.36%)
Hypertension	360 (.35%)
Drug Withdrawal Syndrome	358 (.35%)
Heart Disease Congenital	348 (.34%)
Abnormal Behaviour	345 (.34%)
Paraesthesia	343 (.34%)
Tricuspid Valve Incompetence	339 (.33%)
Pneumonia	337 (.33%)
Developmental Delay	330 (.32%)
Congenital Anomaly	327 (.32%)
Gastrooesophageal Reflux Disease	327 (.32%)
Hyponatraemia	326 (.32%)
Nervousness	322 (.32%)
Crying	321 (.31%)
Maternal Drugs Affecting Foetus	319 (.31%)
Decreased Appetite	316 (.31%)
Drug Toxicity	309 (.3%)
Pyrexia	286 (.28%)
Constipation	283 (.28%)
Anger	275 (.27%)
Hypotension	268 (.26%)
Respiratory Distress	267 (.26%)
Lethargy	265 (.26%)
Withdrawal Syndrome	263 (.26%)
Restlessness	255 (.25%)
Blood Cholesterol Increased	241 (.24%)
Failure To Thrive	238 (.23%)
Gait Disturbance	233 (.23%)
Respiratory Arrest	229 (.22%)
Disturbance In Attention	228 (.22%)
Amnesia	226 (.22%)
Memory Impairment	224 (.22%)
Rash	223 (.22%)
Drug Effect Decreased	220 (.22%)
Tachycardia	220 (.22%)
Jaundice Neonatal	219 (.21%)
Abdominal Pain Upper	216 (.21%)
Hallucination	215 (.21%)
Pulmonary Oedema	215 (.21%)
Sleep Disorder	215 (.21%)
Disorientation	214 (.21%)
Palpitations	213 (.21%)
Neonatal Respiratory Distress Syndr...	211 (.21%)
Pruritus	211 (.21%)
Jaundice	207 (.2%)
Otitis Media	207 (.2%)
Anaemia	206 (.2%)
Hypoaesthesia	206 (.2%)
Muscle Spasms	206 (.2%)
Blood Pressure Increased	205 (.2%)
Intentional Overdose	205 (.2%)
Premature Baby	205 (.2%)
Heart Rate Increased	204 (.2%)
Mania	204 (.2%)
Myalgia	203 (.2%)
Syncope	201 (.2%)
Dysphagia	200 (.2%)
Nightmare	200 (.2%)
Rhabdomyolysis	200 (.2%)
Vision Blurred	200 (.2%)

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This graph shows the top adverse events submitted to the FDA for Sertraline, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sertraline is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Sertraline

What are the most common Sertraline adverse events reported to the FDA?

Neurological	5853 (5.74%)
Cardiac And Vascular Disorders Cong...	4396 (4.31%)
Therapeutic And Nontherapeutic Effe...	3814 (3.74%)
Anxiety Disorders	3775 (3.7%)
Gastrointestinal Signs	2849 (2.79%)
Respiratory	2489 (2.44%)
Suicidal And Self-injurious Behavio...	2431 (2.38%)
Chemical Injury And Poisoning	2309 (2.26%)
Infections - Pathogen Unspecified	2120 (2.08%)
Depressed Mood Disorders	2035 (1.99%)
Movement Disorders	1931 (1.89%)
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Cardiac Arrhythmias	1830 (1.79%)
Medication Errors	1758 (1.72%)
Sleep Disorders	1731 (1.7%)
Injuries	1545 (1.51%)
Epidermal And Dermal Conditions	1505 (1.47%)
Gastrointestinal Motility And Defec...	1480 (1.45%)
Cardiac Valve	1372 (1.34%)
Muscle	1360 (1.33%)
Myocardial	1249 (1.22%)
Physical Examination Topics	1221 (1.2%)
Mood Disorders	1137 (1.11%)
Appetite And General Nutritional	1118 (1.1%)
Personality Disorders	1094 (1.07%)
Mental Impairment	1093 (1.07%)
Cardiac And Vascular Investigations	1069 (1.05%)
Hepatic And Hepatobiliary	1053 (1.03%)
Psychiatric	1044 (1.02%)
Headaches	940 (.92%)
Seizures	912 (.89%)
Deliria	911 (.89%)
Disturbances In Thinking	896 (.88%)
Neuromuscular	881 (.86%)
Musculoskeletal And Connective Tiss...	809 (.79%)
Electrolyte And Fluid Balance Condi...	788 (.77%)
Lifestyle Issues	785 (.77%)
Musculoskeletal And Connective Tiss...	778 (.76%)
Skin Appendage Conditions	777 (.76%)
Lower Respiratory Tract Disorders	713 (.7%)
Neonatal And Perinatal Conditions	679 (.67%)
Hematology Investigations	670 (.66%)
Vision	661 (.65%)
Fatal Outcomes	573 (.56%)
Renal Disorders	570 (.56%)
Hepatobiliary	567 (.56%)
Cardiac Disorder Signs	548 (.54%)
Joint	525 (.51%)
Decreased And Nonspecific Blood Pre...	500 (.49%)
Neonatal Respiratory	499 (.49%)
Central Nervous System Vascular	477 (.47%)
Changes In Physical Activity	467 (.46%)
Manic And Bipolar Mood Disorders	463 (.45%)
Congenital And Hereditary	448 (.44%)
Urinary Tract Signs	447 (.44%)
Gastrointestinal Tract Disorders Co...	436 (.43%)
Psychiatric And Behavioural Symptom...	432 (.42%)
Viral Infectious	421 (.41%)
Toxicology And Therapeutic Drug Mon...	398 (.39%)
Vascular Hypertensive	386 (.38%)
Lipid Analyses	379 (.37%)
Body Temperature Conditions	377 (.37%)
Pulmonary Vascular	373 (.37%)
Allergic Conditions	372 (.36%)
Heart Failures	366 (.36%)
Metabolic, Nutritional And Blood Ga...	357 (.35%)
Bronchial Disorders	344 (.34%)
Sexual Function And Fertility	344 (.34%)
Bone And Joint Injuries	335 (.33%)
Product Quality Issues	321 (.31%)
Ocular Neuromuscular	317 (.31%)
Abortions And Stillbirth	316 (.31%)
Vascular	313 (.31%)
Upper Respiratory Tract Disorders	308 (.3%)
Bacterial Infectious	305 (.3%)
Coronary Artery	300 (.29%)
Oral Soft Tissue Conditions	293 (.29%)
Inner Ear And Viiith Cranial Nerve	276 (.27%)
Enzyme	275 (.27%)
Anemias Nonhemolytic And Marrow Dep...	270 (.26%)
Glucose Metabolism Disorders	263 (.26%)
Musculoskeletal And Connective Tiss...	254 (.25%)
Obstetric And Gynecological Therape...	243 (.24%)
Gastrointestinal Hemorrhages	238 (.23%)
Bone Disorders	235 (.23%)
Salivary Gland Conditions	231 (.23%)
Sexual Dysfunctions, Disturbances A...	231 (.23%)
Procedural And Device Related Injur...	218 (.21%)
Neurological Disorders Congenital	217 (.21%)
Water, Electrolyte And Mineral	214 (.21%)
Hearing	213 (.21%)
Hypothalamus And Pituitary Gland	210 (.21%)
Schizophrenia And Other Psychotic	210 (.21%)
Eye	202 (.2%)
Pregnancy, Labour, Delivery And Pos...	196 (.19%)
Gastrointestinal Inflammatory Condi...	183 (.18%)
Legal Issues	183 (.18%)
Gastrointestinal Conditions	179 (.18%)
Therapeutic Procedures And Supporti...	174 (.17%)
Arteriosclerosis, Stenosis, Vascula...	173 (.17%)
Renal And Urinary Tract Investigati...	170 (.17%)
Thyroid Gland	167 (.16%)

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This graph shows the top categories of adverse events submitted to the FDA for Sertraline, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sertraline is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.