ENTECAVIR
Generic: ENTECAVIR
EPIC PHARMAManufacturer
ORALRoute
ENTECAVIRActive Substance
2019-09-25Original Approval
ENTECAVIR is FDA application ANDA212126, sponsored by BRIGHTGENE. 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 II2025-09-04
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DistributFailed Impurity/Degradation Specifications
Class II2025-09-24
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DiFailed impurity/degradation specifications:Out of Specification result for an individual organic imp
Class II2017-07-20
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W)
Class II2025-09-24
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DistFailed impurity/degradation specifications:Out of Specification result for an individual organic imp
Class II2025-09-04
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, DistribFailed Impurity/Degradation Specifications
Top Reported Reactions
1
OFF LABEL USE
412 reports
2
DRUG INEFFECTIVE
355 reports
3
DRUG RESISTANCE
353 reports
4
DEATH
291 reports
5
PYREXIA
252 reports
6
HEPATITIS B
251 reports
7
DIARRHOEA
245 reports
8
FATIGUE
221 reports
9
PLATELET COUNT DECREASED
220 reports
10
PNEUMONIA
211 reports