BIMATOPROST

Generic: BIMATOPROST

Somerset TherapeuticsManufacturer
OPHTHALMICRoute
BIMATOPROSTActive Substance
2019-06-19Original Approval

BIMATOPROST is FDA application ANDA207601, sponsored by SOMERSET THERAPS LLC. 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 III2019-10-17
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC

Labeling: Incorrect or missing package insert.

Top Reported Reactions

1
DRUG INEFFECTIVE
238 reports
2
OCULAR HYPERAEMIA
84 reports
3
DYSPNOEA
78 reports
4
NAUSEA
78 reports
5
EYE IRRITATION
75 reports
6
DIARRHOEA
71 reports
7
FATIGUE
67 reports
8
MADAROSIS
61 reports
9
EYE PAIN
60 reports
10
HEADACHE
60 reports