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OLANZAPINE

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Olanzapine Adverse Events Reported to the FDA Over Time

How are Olanzapine adverse event reports trending over time?

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

Most Common Olanzapine Adverse Events Reported to the FDA

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

Diabetes Mellitus
2864 (2.73%)
Weight Increased
2646 (2.52%)
Overdose
1822 (1.74%)
Death
1110 (1.06%)
Pancreatitis
965 (.92%)
Off Label Use
955 (.91%)
Somnolence
938 (.89%)
Hypertension
911 (.87%)
Hyperglycaemia
880 (.84%)
Completed Suicide
876 (.83%)
Drug Exposure During Pregnancy
795 (.76%)
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Hospitalisation
781 (.74%)
Agitation
771 (.73%)
Neuroleptic Malignant Syndrome
764 (.73%)
Confusional State
710 (.68%)
Fall
709 (.68%)
Drug Ineffective
696 (.66%)
Drug Interaction
665 (.63%)
Diabetic Ketoacidosis
637 (.61%)
Psychotic Disorder
636 (.61%)
Suicide Attempt
620 (.59%)
Blood Triglycerides Increased
613 (.58%)
Anxiety
584 (.56%)
Loss Of Consciousness
579 (.55%)
Dizziness
578 (.55%)
Pulmonary Embolism
577 (.55%)
Depression
569 (.54%)
Tremor
567 (.54%)
Blood Cholesterol Increased
563 (.54%)
Sedation
554 (.53%)
Blood Glucose Increased
542 (.52%)
Pyrexia
535 (.51%)
Pneumonia
528 (.5%)
Convulsion
526 (.5%)
Aggression
510 (.49%)
Myocardial Infarction
506 (.48%)
Type 2 Diabetes Mellitus
504 (.48%)
Insomnia
502 (.48%)
Alanine Aminotransferase Increased
501 (.48%)
Coma
500 (.48%)
Asthenia
470 (.45%)
Hypotension
467 (.44%)
Aspartate Aminotransferase Increase...
464 (.44%)
Fatigue
459 (.44%)
Blood Creatine Phosphokinase Increa...
454 (.43%)
Vomiting
454 (.43%)
Neutropenia
450 (.43%)
Weight Decreased
448 (.43%)
Abnormal Behaviour
447 (.43%)
Renal Failure
445 (.42%)
Suicidal Ideation
442 (.42%)
Tachycardia
425 (.4%)
Dyspnoea
416 (.4%)
Condition Aggravated
412 (.39%)
White Blood Cell Count Decreased
398 (.38%)
Intentional Overdose
391 (.37%)
Dysarthria
390 (.37%)
Cardiac Arrest
388 (.37%)
Cerebrovascular Accident
381 (.36%)
Rhabdomyolysis
370 (.35%)
Depressed Level Of Consciousness
367 (.35%)
Nausea
363 (.35%)
Diabetic Coma
361 (.34%)
Leukopenia
360 (.34%)
Oedema Peripheral
353 (.34%)
Drug Toxicity
348 (.33%)
Gait Disturbance
344 (.33%)
Malaise
329 (.31%)
Metabolic Disorder
328 (.31%)
Vision Blurred
327 (.31%)
Disorientation
325 (.31%)
Feeling Abnormal
324 (.31%)
Extrapyramidal Disorder
323 (.31%)
Electrocardiogram Qt Prolonged
316 (.3%)
Obesity
316 (.3%)
Restlessness
315 (.3%)
Anaemia
311 (.3%)
Dysphagia
311 (.3%)
General Physical Health Deteriorati...
304 (.29%)
Hyperhidrosis
298 (.28%)
Syncope
297 (.28%)
Delirium
293 (.28%)
Headache
289 (.28%)
Platelet Count Decreased
282 (.27%)
Hallucination
276 (.26%)
Akathisia
275 (.26%)
Dehydration
272 (.26%)
Mania
271 (.26%)
Thrombocytopenia
271 (.26%)
Schizophrenia
264 (.25%)
White Blood Cell Count Increased
259 (.25%)
Speech Disorder
258 (.25%)
Hepatic Steatosis
248 (.24%)
Hyponatraemia
247 (.24%)
Cardio-respiratory Arrest
245 (.23%)
Respiratory Arrest
243 (.23%)
Deep Vein Thrombosis
242 (.23%)
Chest Pain
240 (.23%)
Dyskinesia
240 (.23%)
Mental Disorder
239 (.23%)
Intentional Drug Misuse
233 (.22%)

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

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

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

Common Uses of Olanzapine According to Those Reporting Adverse Events

Why are people taking Olanzapine, according to those reporting adverse events to the FDA?

Schizophrenia
4384
Bipolar Disorder
2720
Depression
1922
Psychotic Disorder
1629
Drug Use For Unknown Indication
1127
Schizophrenia, Paranoid Type
756
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Schizoaffective Disorder
698
Product Used For Unknown Indication
632
Anxiety
551
Bipolar I Disorder
505
Agitation
406
Major Depression
361
Mental Disorder
317
Mania
275
Affective Disorder
160
Dementia
153
Sleep Disorder
152
Delusion
146
Abnormal Behaviour
127
Insomnia
122
Ill-defined Disorder
118
Hallucination
113
Paranoia
90
Delirium
90
Aggression
89
Personality Disorder
89
Post-traumatic Stress Disorder
88
Obsessive-compulsive Disorder
81
Dementia Alzheimers Type
76
Acute Psychosis
68
Borderline Personality Disorder
63
Delusional Disorder, Persecutory Ty...
61
Hallucination, Auditory
53
Delusional Disorder, Unspecified Ty...
52
Mood Swings
51
Anxiety Disorder
46
Psychomotor Hyperactivity
37
Anorexia Nervosa
37
Schizophrenia, Catatonic Type
35
Panic Disorder
33
Nervousness
33
Attention Deficit/hyperactivity Dis...
32
Suicide Attempt
31
Bipolar Ii Disorder
29
Psychiatric Symptom
28
Brief Psychotic Disorder With Marke...
28
Autism
27
Restlessness
26
Schizophrenia, Disorganised Type
26
Mood Altered
25
Suicidal Ideation
24

Drug Labels

LabelLabelerEffective
ZyprexaPhysicians Total Care, Inc.30-NOV-09
ZyprexaSTAT RX USA LLC21-JUL-10
ZyprexaRebel Distributors Corp01-DEC-10
Zyprexa PD-Rx Pharmaceuticals, Inc.21-JUN-11
ZyprexaDispensing Solutions, Inc.04-OCT-11
Olanzapine Teva Pharmaceuticals USA24-OCT-11
OlanzapineDr.Reddy's Laboratories Limited25-OCT-11
Zyprexa H.J. Harkins Company, Inc.25-OCT-11
OlanzapineSandoz Inc02-NOV-11
OlanzapineGolden State Medical Supply, Inc.09-JAN-12
OlanzapineApotex Corp.02-FEB-12
OlanzapineSun Pharmaceutical Industries Limited 28-FEB-12
OlanzapineTorrent Pharmaceuticals Limited01-MAR-12
OlanzapineGreenstone LLC15-MAR-12
OlanzapineMylan Pharmaceuticals Inc.27-MAR-12
Zyprexa Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC30-MAR-12
OlanzapineMylan Institutional Inc.06-APR-12
OlanzapineRebel Distributors Corp18-APR-12
OlanzapineRebel Distributors Corp18-APR-12
OlanzapineDr.Reddy's laboratories Ltd.24-APR-12
OlanzapineAmerican Health Packaging24-APR-12
OlanzapineDr.Reddy's laboratories Ltd.24-APR-12
OlanzapineSun Pharmaceutical Industries Limited 26-APR-12
OlanzapineApotex Corp.30-APR-12
OlanzapineAmerican Health Packaging02-MAY-12
ZyprexazydisCardinal Health08-MAY-12
ZyprexaCardinal Health08-MAY-12
OlanzapineRebel Distributors Corp15-MAY-12
OlanzapineMajor Pharmaceuticals17-MAY-12
OlanzapineMajor Pharmaceuticals17-MAY-12
OlanzapineAurobindo Pharma Limited19-JUN-12
OlanzapineAmerican Regent, Inc.05-JUL-12
OlanzapinePrasco Laboratories12-JUL-12
OlanzapineTeva Pharmaceuticals USA Inc20-JUL-12
OlanzapineTeva Pharmaceuticals USA Inc08-AUG-12
OlanzapinePhysicians Total Care, Inc.10-AUG-12
OlanzapineMylan Pharmaceuticals Inc.15-AUG-12
OlanzapinePar Pharmaceutical, Inc.31-AUG-12
OlanzapineNorthstar Rx LLC31-AUG-12
Olanzapine Prasco Laboratories04-SEP-12
Olanzapine Prasco Laboratories04-SEP-12
Olanzapine Jubilant Cadista Pharmaceuticals Inc13-SEP-12
OlanzapineBryant Ranch Prepack23-OCT-12
Zyprexa Bryant Ranch Prepack23-OCT-12
OlanzapineLake Erie Medical DBA Quality Care Products LLC20-NOV-12
Zyprexa Intramuscular Eli Lilly and Company 17-DEC-12
Zyprexa Eli Lilly and Company 17-DEC-12
Zyprexa Zydis Eli Lilly and Company 17-DEC-12
ZyprexarelprevvEli Lilly and Company17-DEC-12
SymbyaxEli Lilly and Company03-JAN-13
OlanzapineREMEDYREPACK INC. 04-JAN-13
Olanzapine And FluoxetineSandoz Inc29-JAN-13
Olanzapine And FluoxetinePar Pharmaceutical, Inc27-FEB-13
OlanzapineDispensing Solutions, Inc.15-MAR-13
OlanzapineCardinal Health15-MAR-13
OlanzapineREMEDYREPACK INC. 28-MAR-13
OlanzapineREMEDYREPACK INC. 29-MAR-13
OlanzapineREMEDYREPACK INC. 01-APR-13
OlanzapineREMEDYREPACK INC. 01-APR-13
OlanzapineREMEDYREPACK INC. 01-APR-13
OlanzapineREMEDYREPACK INC. 01-APR-13
OlanzapineDispensing Solutions, Inc.08-APR-13
Olanzapine And FluoxetineTeva Pharmaceuticals USA Inc08-APR-13
Zyprexa REMEDYREPACK INC. 10-APR-13
Zyprexa REMEDYREPACK INC. 10-APR-13
OlanzapineREMEDYREPACK INC. 22-APR-13
Olanzapine REMEDYREPACK INC. 29-APR-13
OlanzapineREMEDYREPACK INC. 01-MAY-13

Olanzapine Case Reports

What Olanzapine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Olanzapine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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