SUMATRIPTAN
Generic: SUMATRIPTAN
Hikma Pharmaceuticals USA Inc.Manufacturer
SUBCUTANEOUSRoute
SUMATRIPTAN SUCCINATEActive Substance
2013-09-16Original Approval
SUMATRIPTAN is FDA application ANDA200183, sponsored by HIKMA. 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
2,814 reports
2
HEADACHE
2,153 reports
3
MIGRAINE
1,828 reports
4
NAUSEA
1,775 reports
5
FATIGUE
1,494 reports
6
DIZZINESS
1,194 reports
7
OFF LABEL USE
1,173 reports
8
PAIN
1,171 reports
9
PRODUCT DOSE OMISSION ISSUE
1,005 reports
10
VOMITING
945 reports