ESZOPICLONE
Generic: ESZOPICLONE
Macleods Pharmaceuticals LimitedManufacturer
ORALRoute
ESZOPICLONEActive Substance
2015-01-30Original Approval
ESZOPICLONE is FDA application ANDA202929, sponsored by MACLEODS PHARMS. 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 III2024-06-04
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 Failed Impurities/Degradation Specifications: Related Substances
Class II2022-06-16
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., PlaiShortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Top Reported Reactions
1
DRUG INEFFECTIVE
436 reports
2
COMPLETED SUICIDE
435 reports
3
FATIGUE
238 reports
4
NAUSEA
227 reports
5
INSOMNIA
195 reports
6
TOXICITY TO VARIOUS AGENTS
190 reports
7
OFF LABEL USE
168 reports
8
DIARRHOEA
162 reports
9
ANXIETY
153 reports
10
HEADACHE
147 reports