Drug Safety Information for ZYPREXA (Olanzapine)
REMS for Zyprexa Relprevv (OLANZAPINE PAMOATE) Rx Drug: Safety Information Link
FDA Risk Evaluation and Mitigation Strategy REMS
FDA Safety-related Labeling Changes for LYBALVI (OLANZAPINE; SAMIDORPHAN L-MALATE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ZYPREXA (OLANZAPINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ZYPREXA ZYDIS (OLANZAPINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for ZYPREXA RELPREVV (OLANZAPINE PAMOATE) Rx Drug: Safety Information Link
Adverse Drug Reactions for ZYPREXA* (Olanzapine)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with ZYPREXA
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Diabetes mellitus | 4575 |
2 | Weight increased* | 2979 |
3 | Type 2 diabetes mellitus | 2183 |
4 | Overdose | 2095 |
5 | Pancreatitis | 1628 |
6 | Hypertension | 1492 |
7 | Death | 1343 |
8 | Hyperglycaemia | 1270 |
9 | Somnolence* | 1211 |
10 | Drug interaction | 1161 |
11 | Anxiety | 1141 |
12 | Drug ineffective | 1135 |
13 | Depression | 1109 |
14 | Fall | 1086 |
15 | Toxicity to various agents | 1061 |
16 | Agitation | 1061 |
17 | Blood cholesterol increased | 1060 |
18 | Confusional state | 1031 |
19 | Completed suicide | 1009 |
20 | Blood triglycerides increased | 996 |
* This side effect also appears in "Top 10 Side Effects of ZYPREXA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ZYPREXA
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Schizophrenia* | 18050 |
2 | Bipolar disorder* | 12432 |
3 | Product used for unknown indication | 11621 |
4 | Depression* | 9189 |
5 | Psychotic disorder* | 6900 |
6 | Schizophrenia, paranoid type | 3198 |
7 | Schizoaffective disorder* | 3084 |
8 | Anxiety* | 2425 |
9 | Bipolar i disorder* | 2236 |
10 | Mental disorder | 1455 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ZYPREXA
Total Reports Filed with FDA: 174970
Number of FDA Adverse Event Reports by Patient Age for ZYPREXA
Total Reports Filed with FDA: 174970*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Olanzapine (Zyprexa zydis, Olanzapine, Zyprexa)
Charts are based on 174970 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.