PAROXETINE

Paroxetine Adverse Events Reported to the FDA Over Time

How are Paroxetine adverse event reports trending over time?

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

Most Common Paroxetine Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	7467 (4.53%)
Drug Withdrawal Syndrome	5218 (3.17%)
Drug Ineffective	2805 (1.7%)
Anxiety	2592 (1.57%)
Dizziness	2583 (1.57%)
Congenital Anomaly	2471 (1.5%)
Atrial Septal Defect	2327 (1.41%)
Suicidal Ideation	2224 (1.35%)
Nausea	2178 (1.32%)
Completed Suicide	1874 (1.14%)
Depression	1805 (1.1%)
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Headache	1707 (1.04%)
Tremor	1639 (.99%)
Insomnia	1626 (.99%)
Aggression	1604 (.97%)
Paraesthesia	1550 (.94%)
Ventricular Septal Defect	1511 (.92%)
Cardiac Murmur	1380 (.84%)
Fatigue	1374 (.83%)
Agitation	1360 (.83%)
Hyperhidrosis	1330 (.81%)
Patent Ductus Arteriosus	1271 (.77%)
Suicide Attempt	1134 (.69%)
Weight Increased	1127 (.68%)
Confusional State	1123 (.68%)
Somnolence	1042 (.63%)
Irritability	1035 (.63%)
Feeling Abnormal	1026 (.62%)
Vomiting	1017 (.62%)
Heart Disease Congenital	966 (.59%)
Diarrhoea	950 (.58%)
Disturbance In Attention	920 (.56%)
Nightmare	825 (.5%)
Convulsion	811 (.49%)
Asthenia	783 (.48%)
Malaise	774 (.47%)
Drug Interaction	764 (.46%)
Ill-defined Disorder	758 (.46%)
Memory Impairment	718 (.44%)
Panic Attack	701 (.43%)
Crying	686 (.42%)
Serotonin Syndrome	681 (.41%)
Overdose	652 (.4%)
Pyrexia	650 (.39%)
Nervousness	647 (.39%)
Pain	636 (.39%)
Anger	634 (.38%)
Vertigo	634 (.38%)
Sleep Disorder	626 (.38%)
Dyspnoea	619 (.38%)
Multiple Congenital Abnormalities	608 (.37%)
Pulmonary Valve Stenosis	553 (.34%)
Adverse Event	533 (.32%)
Emotional Disorder	525 (.32%)
Lethargy	510 (.31%)
Mood Swings	500 (.3%)
Abnormal Behaviour	493 (.3%)
Withdrawal Syndrome	485 (.29%)
Persistent Foetal Circulation	484 (.29%)
Premature Baby	484 (.29%)
Loss Of Consciousness	469 (.28%)
Hyponatraemia	467 (.28%)
Depressed Level Of Consciousness	453 (.27%)
Maternal Drugs Affecting Foetus	453 (.27%)
Cyanosis	450 (.27%)
Fall	442 (.27%)
Tinnitus	432 (.26%)
Respiratory Distress	430 (.26%)
Cardiac Failure Congestive	429 (.26%)
Palpitations	429 (.26%)
Developmental Delay	426 (.26%)
Tricuspid Valve Incompetence	426 (.26%)
Cardiomegaly	425 (.26%)
Dependence	419 (.25%)
Decreased Appetite	418 (.25%)
Hallucination	413 (.25%)
Restlessness	406 (.25%)
Cardiac Disorder	405 (.25%)
Pulmonary Artery Stenosis Congenita...	404 (.25%)
Lung Disorder	397 (.24%)
Amnesia	394 (.24%)
Migraine	393 (.24%)
Abnormal Dreams	386 (.23%)
Respiratory Failure	379 (.23%)
Abdominal Pain	377 (.23%)
Disorientation	373 (.23%)
Condition Aggravated	371 (.23%)
Death	368 (.22%)
Mania	365 (.22%)
Vision Blurred	362 (.22%)
Hypoaesthesia	352 (.21%)
Weight Decreased	351 (.21%)
Anorexia	349 (.21%)
Depressed Mood	347 (.21%)
Hypoplastic Left Heart Syndrome	342 (.21%)
Intentional Overdose	340 (.21%)
Coarctation Of The Aorta	330 (.2%)
Dyskinesia	329 (.2%)
Influenza	322 (.2%)
Drug Dependence	315 (.19%)
Chills	306 (.19%)

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This graph shows the top adverse events submitted to the FDA for Paroxetine, 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 Paroxetine 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 Paroxetine

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

Neurological	11614 (7.05%)
Cardiac And Vascular Disorders Cong...	10320 (6.26%)
Therapeutic And Nontherapeutic Effe...	10284 (6.24%)
Chemical Injury And Poisoning	8317 (5.05%)
Anxiety Disorders	6557 (3.98%)
Suicidal And Self-injurious Behavio...	5729 (3.48%)
Gastrointestinal Signs	4600 (2.79%)
Respiratory	3727 (2.26%)
Sleep Disorders	3666 (2.22%)
Movement Disorders	3259 (1.98%)
Congenital And Hereditary	3150 (1.91%)
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Depressed Mood Disorders	2818 (1.71%)
Mood Disorders	2809 (1.7%)
Personality Disorders	2723 (1.65%)
Cardiac And Vascular Investigations	2559 (1.55%)
Mental Impairment	2519 (1.53%)
Headaches	2145 (1.3%)
Cardiac Valve	2121 (1.29%)
Cardiac Arrhythmias	2120 (1.29%)
Medication Errors	1889 (1.15%)
Skin Appendage Conditions	1790 (1.09%)
Injuries	1777 (1.08%)
Psychiatric	1758 (1.07%)
Deliria	1756 (1.07%)
Physical Examination Topics	1726 (1.05%)
Gastrointestinal Motility And Defec...	1553 (.94%)
Muscle	1495 (.91%)
Myocardial	1481 (.9%)
Disturbances In Thinking	1468 (.89%)
Appetite And General Nutritional	1459 (.89%)
Epidermal And Dermal Conditions	1451 (.88%)
Musculoskeletal And Connective Tiss...	1412 (.86%)
Cardiac Disorder Signs	1352 (.82%)
Seizures	1312 (.8%)
Neuromuscular	1229 (.75%)
Lifestyle Issues	1115 (.68%)
Inner Ear And Viiith Cranial Nerve	1105 (.67%)
Electrolyte And Fluid Balance Condi...	1017 (.62%)
Infections - Pathogen Unspecified	1006 (.61%)
Hepatic And Hepatobiliary	883 (.54%)
Hepatobiliary	846 (.51%)
Hematology Investigations	812 (.49%)
Vision	794 (.48%)
Neonatal And Perinatal Conditions	787 (.48%)
Body Temperature Conditions	780 (.47%)
Musculoskeletal And Connective Tiss...	751 (.46%)
Heart Failures	719 (.44%)
Psychiatric And Behavioural Symptom...	710 (.43%)
Changes In Physical Activity	615 (.37%)
Manic And Bipolar Mood Disorders	586 (.36%)
Sexual Function And Fertility	584 (.35%)
Lower Respiratory Tract Disorders	560 (.34%)
Sexual Dysfunctions, Disturbances A...	558 (.34%)
Gastrointestinal Tract Disorders Co...	555 (.34%)
Urinary Tract Signs	553 (.34%)
Viral Infectious	500 (.3%)
Central Nervous System Vascular	496 (.3%)
Neurological Disorders Congenital	496 (.3%)
Neonatal Respiratory	492 (.3%)
Enzyme	490 (.3%)
Renal Disorders	482 (.29%)
Vascular	475 (.29%)
Bronchial Disorders	470 (.29%)
Decreased And Nonspecific Blood Pre...	458 (.28%)
Ocular Neuromuscular	450 (.27%)
Fatal Outcomes	439 (.27%)
Pulmonary Vascular	423 (.26%)
Water, Electrolyte And Mineral	414 (.25%)
Metabolic, Nutritional And Blood Ga...	411 (.25%)
Respiratory Disorders Congenital	394 (.24%)
Legal Issues	366 (.22%)
Pleural	337 (.2%)
Communication Disorders	321 (.19%)
Hypothalamus And Pituitary Gland	318 (.19%)
Salivary Gland Conditions	308 (.19%)
Vascular Hypertensive	307 (.19%)
Renal And Urinary Tract Investigati...	292 (.18%)
Hearing	288 (.17%)
Joint	279 (.17%)
Eating Disorders	263 (.16%)
Schizophrenia And Other Psychotic	263 (.16%)
Impulse Control	262 (.16%)
Dissociative	257 (.16%)
Fetal Complications	256 (.16%)
Renal And Urinary Tract Disorders C...	256 (.16%)
Anemias Nonhemolytic And Marrow Dep...	255 (.15%)
Reproductive Tract And Breast Disor...	254 (.15%)
Glucose Metabolism Disorders	253 (.15%)
Sleep Disturbances	250 (.15%)
Oral Soft Tissue Conditions	246 (.15%)
Abortions And Stillbirth	237 (.14%)
Bacterial Infectious	236 (.14%)
Upper Respiratory Tract Disorders	231 (.14%)
Toxicology And Therapeutic Drug Mon...	230 (.14%)
Product Quality Issues	228 (.14%)
Gastrointestinal Conditions	225 (.14%)
Eye	218 (.13%)
Bone And Joint Injuries	212 (.13%)
Gastrointestinal Hemorrhages	212 (.13%)
Allergic Conditions	209 (.13%)
Arteriosclerosis, Stenosis, Vascula...	209 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Paroxetine, 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 Paroxetine 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.