PIRFENIDONE
Generic: PIRFENIDONE
Sandoz IncManufacturer
ORALRoute
PIRFENIDONEActive Substance
2022-04-28Original Approval
PIRFENIDONE is FDA application ANDA212560, sponsored by SANDOZ. 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 II2023-02-07
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277CGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-02-07
Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 ManufaCGMP Deviations: recalling drug products following an FDA inspection.
Top Reported Reactions
1
DEATH
733 reports
2
DYSPNOEA
418 reports
3
NAUSEA
340 reports
4
COUGH
316 reports
5
DIARRHOEA
279 reports
6
FATIGUE
257 reports
7
PNEUMONIA
243 reports
8
DECREASED APPETITE
242 reports
9
IDIOPATHIC PULMONARY FIBROSIS
198 reports
10
WEIGHT DECREASED
187 reports