SUMATRIPTAN SUCCINATE
Generic: SUMATRIPTAN SUCCINATE
Sun Pharmaceutical IndustriesManufacturer
SUBCUTANEOUSRoute
SUMATRIPTAN SUCCINATEActive Substance
2011-06-21Original Approval
SUMATRIPTAN SUCCINATE is FDA application ANDA090358, sponsored by SUN PHARM. 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 II2022-04-13
Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-cGMP deviations: Temperature abuse
Class II2019-12-26
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 counFailed Impurities/Degradation Specifications; out-of-specification results obtained for related subs
Top Reported Reactions
1
DRUG INEFFECTIVE
1,132 reports
2
HEADACHE
759 reports
3
MIGRAINE
642 reports
4
NAUSEA
567 reports
5
PRODUCT DOSE OMISSION ISSUE
556 reports
6
FATIGUE
488 reports
7
OFF LABEL USE
426 reports
8
PRODUCT QUALITY ISSUE
407 reports
9
PAIN
363 reports
10
DIZZINESS
351 reports