PROPAFENONE HYDROCHLORIDE
Generic: PROPAFENONE HYDROCHLORIDE
Glenmark Pharmaceuticals Inc.Manufacturer
ORALRoute
PROPAFENONE HYDROCHLORIDEActive Substance
2017-09-08Original Approval
PROPAFENONE HYDROCHLORIDE is FDA application ANDA205268, sponsored by GLENMARK 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 II2025-03-13
Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark PharmaceutCGMP Deviations
Class II2025-03-13
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark PharmaceuticaCGMP Deviations
Class II2025-03-13
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, MemCGMP Deviations
Class II2025-03-13
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark PharmaceuCGMP Deviations
Top Reported Reactions
1
ATRIAL FIBRILLATION
354 reports
2
DRUG INEFFECTIVE
340 reports
3
DRUG INTERACTION
325 reports
4
DIZZINESS
264 reports
5
TOXICITY TO VARIOUS AGENTS
238 reports
6
DYSPNOEA
233 reports
7
NAUSEA
210 reports
8
FATIGUE
206 reports
9
OFF LABEL USE
191 reports
10
ASTHENIA
188 reports