BROMOCRIPTINE MESYLATE

Generic: BROMOCRIPTINE MESYLATE

Sandoz IncManufacturer
ORALRoute
BROMOCRIPTINE MESYLATEActive Substance
1998-01-13Original Approval

BROMOCRIPTINE MESYLATE is FDA application ANDA074631, sponsored by SANDOZ. 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 II2016-05-09
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad

Failed impurities/degradation specifications: Out of specification results noticed in related substa

Class II2025-10-23
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., A

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Brom

Top Reported Reactions

1
NAUSEA
34 reports
2
DRUG INEFFECTIVE
31 reports
3
HEADACHE
30 reports
4
PYREXIA
29 reports
5
VOMITING
28 reports
6
DRUG EXPOSURE DURING PREGNANCY
25 reports
7
NEUROLEPTIC MALIGNANT SYNDROME
24 reports
8
FATIGUE
21 reports
9
DIZZINESS
20 reports
10
TREMOR
19 reports