Drug Safety Information for ZYPREXA (Olanzapine)

REMS for Zyprexa Relprevv (OLANZAPINE PAMOATE) Rx Drug: FDA Link

FDA Risk Evaluation and Mitigation Strategy REMS

Safety-related Labeling Changes for LYBALVI (OLANZAPINE; SAMIDORPHAN L-MALATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZYPREXA (OLANZAPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZYPREXA ZYDIS (OLANZAPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZYPREXA RELPREVV (OLANZAPINE PAMOATE) Rx Drug: FDA 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
1Diabetes mellitus4575
2Weight increased*2979
3Type 2 diabetes mellitus2183
4Overdose2095
5Pancreatitis1628
6Hypertension1492
7Death1343
8Hyperglycaemia1270
9Somnolence*1211
10Drug interaction1161
11Anxiety1141
12Drug ineffective1135
13Depression1109
14Fall1086
15Toxicity to various agents1061
16Agitation1061
17Blood cholesterol increased1060
18Confusional state1031
19Completed suicide1009
20Blood triglycerides increased996

* 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
1Schizophrenia*18050
2Bipolar disorder*12432
3Product used for unknown indication11621
4Depression*9189
5Psychotic disorder*6900
6Schizophrenia, paranoid type3198
7Schizoaffective disorder*3084
8Anxiety*2425
9Bipolar i disorder*2236
10Mental disorder1455

*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.

Click to go back to search results and ZYPREXA Reviews and Review Summary .

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.