ELETRIPTAN HYDROBROMIDE

Generic: ELETRIPTAN HYDROBROMIDE

Aurobindo Pharma LimitedManufacturer
ORALRoute
ELETRIPTAN HYDROBROMIDEActive Substance
2019-01-15Original Approval

ELETRIPTAN HYDROBROMIDE is FDA application ANDA210708, sponsored by AUROBINDO 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 II2021-03-15
Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharm

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DRUG INEFFECTIVE
103 reports
2
HEADACHE
67 reports
3
NAUSEA
46 reports
4
PAIN
46 reports
5
OFF LABEL USE
40 reports
6
MIGRAINE
38 reports
7
VOMITING
32 reports
8
PARAESTHESIA
31 reports
9
ANXIETY
26 reports
10
PRODUCT USE IN UNAPPROVED INDICATION
26 reports