ACETAZOLAMIDE
Generic: ACETAZOLAMIDE
Strides Pharma Science LimitedManufacturer
ORALRoute
ACETAZOLAMIDEActive Substance
2017-11-20Original Approval
ACETAZOLAMIDE is FDA application ANDA209734, sponsored by STRIDES PHARMA. 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 III2024-08-24
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Discoloration
Class II2021-03-15
AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. ECGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
OFF LABEL USE
724 reports
2
DRUG INEFFECTIVE
693 reports
3
CONDITION AGGRAVATED
301 reports
4
HEADACHE
287 reports
5
FATIGUE
256 reports
6
DYSPNOEA
253 reports
7
NAUSEA
251 reports
8
METABOLIC ACIDOSIS
208 reports
9
PRODUCT USE IN UNAPPROVED INDICATION
205 reports
10
DIARRHOEA
179 reports