OLANZAPINE
Generic: OLANZAPINE
Torrent Pharmaceuticals LimitedManufacturer
ORALRoute
OLANZAPINEActive Substance
2012-04-23Original Approval
OLANZAPINE is FDA application ANDA091434, sponsored by TORRENT PHARMS LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2022-02-16
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08cGmp Deviations
Class III2016-10-13
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, BachFailed impurities/degradation specifications: due to out-of-specification result for the Related Sub
Class III2026-08-27
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class II2024-11-25
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0854Failed Impurities/Degradation Specifications
Top Reported Reactions
1
DRUG INEFFECTIVE
5,869 reports
2
OFF LABEL USE
4,219 reports
3
TOXICITY TO VARIOUS AGENTS
3,872 reports
4
DRUG INTERACTION
3,338 reports
5
WEIGHT INCREASED
2,788 reports
6
NAUSEA
2,734 reports
7
SOMNOLENCE
2,714 reports
8
CONDITION AGGRAVATED
2,338 reports
9
VOMITING
2,337 reports
10
FATIGUE
2,311 reports