BIDIL
Generic: HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE
Azurity PharmaceuticalsManufacturer
ORALRoute
HYDRALAZINE HYDROCHLORIDEActive Substance
2005-06-23Original Approval
BIDIL is FDA application NDA020727, sponsored by AZURITY. 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 II2017-03-08
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APPTemperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were i
Class III2015-07-28
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius KaIncorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is
Top Reported Reactions
1
ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS
420 reports
2
DIARRHOEA
205 reports
3
DYSPNOEA
199 reports
4
HYPERTENSION
187 reports
5
NAUSEA
184 reports
6
OFF LABEL USE
180 reports
7
DRUG INEFFECTIVE
178 reports
8
MALAISE
153 reports
9
ARTHRALGIA
151 reports
10
HEADACHE
143 reports