QUETIAPINE

Quetiapine Adverse Events Reported to the FDA Over Time

How are Quetiapine adverse event reports trending over time?

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

Most Common Quetiapine Adverse Events Reported to the FDA

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

Diabetes Mellitus	10283 (4.17%)
Drug Dose Omission	7720 (3.13%)
Insomnia	6129 (2.49%)
Type 2 Diabetes Mellitus	4917 (2%)
Pancreatitis	4443 (1.8%)
Weight Increased	3778 (1.53%)
Off Label Use	3154 (1.28%)
Somnolence	2919 (1.18%)
Malaise	2481 (1.01%)
Depression	2462 (1%)
Anxiety	2285 (.93%)
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Death	2159 (.88%)
Feeling Abnormal	2136 (.87%)
Completed Suicide	1976 (.8%)
Blood Cholesterol Increased	1953 (.79%)
Suicidal Ideation	1848 (.75%)
Fatigue	1693 (.69%)
Dizziness	1691 (.69%)
Ill-defined Disorder	1679 (.68%)
Diabetic Ketoacidosis	1675 (.68%)
Drug Ineffective	1674 (.68%)
Headache	1602 (.65%)
Ketoacidosis	1589 (.64%)
Overdose	1575 (.64%)
Convulsion	1567 (.64%)
Suicide Attempt	1536 (.62%)
Fall	1534 (.62%)
Intentional Drug Misuse	1490 (.6%)
Obesity	1453 (.59%)
Hyperglycaemia	1449 (.59%)
Nausea	1442 (.59%)
Agitation	1380 (.56%)
Tremor	1380 (.56%)
Vomiting	1337 (.54%)
Diabetic Coma	1194 (.48%)
Tardive Dyskinesia	1149 (.47%)
Diabetes Mellitus Inadequate Contro...	1113 (.45%)
Hypertension	1094 (.44%)
Confusional State	1082 (.44%)
Incorrect Dose Administered	1045 (.42%)
Bipolar Disorder	1040 (.42%)
Hyperlipidaemia	1000 (.41%)
Loss Of Consciousness	982 (.4%)
Neuropathy Peripheral	979 (.4%)
Wrong Technique In Drug Usage Proce...	966 (.39%)
Diabetic Neuropathy	955 (.39%)
Blood Triglycerides Increased	932 (.38%)
Drug Interaction	917 (.37%)
Aggression	913 (.37%)
Dyspnoea	890 (.36%)
Weight Decreased	884 (.36%)
Pain	863 (.35%)
Neuroleptic Malignant Syndrome	862 (.35%)
Mania	845 (.34%)
Type 1 Diabetes Mellitus	834 (.34%)
Hallucination	827 (.34%)
Mental Disorder	809 (.33%)
Adverse Event	793 (.32%)
Therapeutic Response Unexpected	788 (.32%)
Pneumonia	784 (.32%)
Memory Impairment	779 (.32%)
Drug Withdrawal Syndrome	778 (.32%)
Diarrhoea	774 (.31%)
Irritability	761 (.31%)
Panic Attack	754 (.31%)
Blood Glucose Increased	752 (.31%)
Asthenia	741 (.3%)
Psychotic Disorder	741 (.3%)
Hypotension	737 (.3%)
Dry Mouth	724 (.29%)
Constipation	718 (.29%)
Chest Pain	712 (.29%)
Amnesia	703 (.29%)
Nervousness	698 (.28%)
Road Traffic Accident	688 (.28%)
Back Pain	687 (.28%)
Cardiac Arrest	686 (.28%)
Hyperhidrosis	679 (.28%)
Tachycardia	661 (.27%)
Abnormal Behaviour	655 (.27%)
Dyskinesia	655 (.27%)
Sleep Disorder	638 (.26%)
Sedation	627 (.25%)
Vision Blurred	626 (.25%)
Neutropenia	615 (.25%)
Crying	614 (.25%)
Coma	611 (.25%)
Intentional Overdose	606 (.25%)
Pain In Extremity	598 (.24%)
Pyrexia	594 (.24%)
Cerebrovascular Accident	583 (.24%)
Hypersomnia	579 (.23%)
Pancreatitis Acute	576 (.23%)
Leukopenia	571 (.23%)
Mood Swings	568 (.23%)
Anger	562 (.23%)
Gait Disturbance	560 (.23%)
Myocardial Infarction	552 (.22%)
Nightmare	552 (.22%)
Restlessness	544 (.22%)
Drug Toxicity	541 (.22%)

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

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

Glucose Metabolism Disorders	19661 (7.98%)
Neurological	14518 (5.89%)
Medication Errors	14204 (5.76%)
Sleep Disorders	8457 (3.43%)
Therapeutic And Nontherapeutic Effe...	6848 (2.78%)
Anxiety Disorders	6674 (2.71%)
Suicidal And Self-injurious Behavio...	5892 (2.39%)
Gastrointestinal Signs	5579 (2.26%)
Exocrine Pancreas Conditions	5381 (2.18%)
Movement Disorders	5090 (2.07%)
Physical Examination Topics	4969 (2.02%)
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Injuries	4502 (1.83%)
Respiratory	4017 (1.63%)
Infections - Pathogen Unspecified	3836 (1.56%)
Therapeutic Procedures And Supporti...	3754 (1.52%)
Psychiatric	3715 (1.51%)
Depressed Mood Disorders	3511 (1.42%)
Cardiac Arrhythmias	3203 (1.3%)
Lipid Analyses	3081 (1.25%)
Disturbances In Thinking	3077 (1.25%)
Appetite And General Nutritional	2871 (1.17%)
Mental Impairment	2859 (1.16%)
Musculoskeletal And Connective Tiss...	2613 (1.06%)
Muscle	2575 (1.05%)
Fatal Outcomes	2423 (.98%)
Mood Disorders	2377 (.96%)
Personality Disorders	2270 (.92%)
Diabetic Complications	2262 (.92%)
Gastrointestinal Motility And Defec...	2251 (.91%)
Peripheral Neuropathies	2187 (.89%)
Manic And Bipolar Mood Disorders	2184 (.89%)
Seizures	2021 (.82%)
Cardiac And Vascular Investigations	2020 (.82%)
Headaches	2018 (.82%)
Bone And Joint Injuries	1896 (.77%)
Deliria	1833 (.74%)
Epidermal And Dermal Conditions	1815 (.74%)
Acid-base	1764 (.72%)
Vision	1591 (.65%)
Lifestyle Issues	1550 (.63%)
White Blood Cell	1517 (.62%)
Joint	1508 (.61%)
Hematology Investigations	1483 (.6%)
Chemical Injury And Poisoning	1480 (.6%)
Lipid Metabolism	1416 (.57%)
Schizophrenia And Other Psychotic	1386 (.56%)
Hepatobiliary	1364 (.55%)
Neuromuscular	1346 (.55%)
Urinary Tract Signs	1344 (.55%)
Hepatic And Hepatobiliary	1321 (.54%)
Metabolic, Nutritional And Blood Ga...	1291 (.52%)
Skin Appendage Conditions	1268 (.51%)
Decreased And Nonspecific Blood Pre...	1258 (.51%)
Vascular Hypertensive	1183 (.48%)
Central Nervous System Vascular	1133 (.46%)
Renal Disorders	1133 (.46%)
Cardiac Disorder Signs	1119 (.45%)
Electrolyte And Fluid Balance Condi...	1051 (.43%)
Coronary Artery	992 (.4%)
Psychiatric And Behavioural Symptom...	916 (.37%)
Changes In Physical Activity	900 (.37%)
Sleep Disturbances	844 (.34%)
Salivary Gland Conditions	840 (.34%)
Body Temperature Conditions	825 (.33%)
Viral Infectious	707 (.29%)
Bronchial Disorders	663 (.27%)
Lower Respiratory Tract Disorders	648 (.26%)
Upper Respiratory Tract Disorders	628 (.25%)
Anemias Nonhemolytic And Marrow Dep...	617 (.25%)
Toxicology And Therapeutic Drug Mon...	578 (.23%)
Enzyme	575 (.23%)
Thyroid Gland	569 (.23%)
Sexual Function And Fertility	562 (.23%)
Bacterial Infectious	481 (.2%)
Allergic Conditions	477 (.19%)
Musculoskeletal And Connective Tiss...	454 (.18%)
Eye	433 (.18%)
Pulmonary Vascular	427 (.17%)
Breast	424 (.17%)
Vascular	413 (.17%)
Gastrointestinal Conditions	404 (.16%)
Heart Failures	402 (.16%)
Tongue Conditions	396 (.16%)
Ocular Neuromuscular	389 (.16%)
Gallbladder	384 (.16%)
Communication Disorders	382 (.16%)
Anterior Eye Structural Change, Dep...	381 (.15%)
Embolism And Thrombosis	370 (.15%)
Water, Electrolyte And Mineral	366 (.15%)
Gastrointestinal Hemorrhages	358 (.15%)
Oral Soft Tissue Conditions	355 (.14%)
Myocardial	345 (.14%)
Bone Disorders	330 (.13%)
Arteriosclerosis, Stenosis, Vascula...	305 (.12%)
Inner Ear And Viiith Cranial Nerve	303 (.12%)
Dental And Gingival Conditions	300 (.12%)
Miscellaneous And Site Unspecified ...	300 (.12%)
Bone And Joint Therapeutic Procedur...	289 (.12%)
Platelet	283 (.11%)
Metabolism	271 (.11%)
Gastrointestinal Inflammatory Condi...	265 (.11%)

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