FDA — authorised 28 June 1978
- Application: NDA017962
- Marketing authorisation holder: ESJAY PHARMA
- Status: supplemented
🇺🇸 BROMOCRIPTINE MESYLATE in United States
FDA authorised BROMOCRIPTINE MESYLATE on 28 June 1978 · 276 US adverse-event reports
Marketing authorisations
FDA — authorised 13 January 1998
- Application: ANDA074631
- Marketing authorisation holder: SANDOZ
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2004
- Application: ANDA076962
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 April 2005
- Application: ANDA077226
- Marketing authorisation holder: MYLAN
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 July 2008
- Application: ANDA078899
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 October 2008
- Application: ANDA077646
- Marketing authorisation holder: PADAGIS US
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 276
Most-reported reactions
- Nausea — 37 reports (13.41%)
- Drug Ineffective — 34 reports (12.32%)
- Headache — 33 reports (11.96%)
- Vomiting — 32 reports (11.59%)
- Pyrexia — 29 reports (10.51%)
- Drug Exposure During Pregnancy — 25 reports (9.06%)
- Neuroleptic Malignant Syndrome — 24 reports (8.7%)
- Dizziness — 21 reports (7.61%)
- Fatigue — 21 reports (7.61%)
- Tremor — 20 reports (7.25%)
Frequently asked questions
Is BROMOCRIPTINE MESYLATE approved in United States?
Yes. FDA authorised it on 28 June 1978; FDA authorised it on 13 January 1998; FDA authorised it on 24 September 2004.
Who is the marketing authorisation holder for BROMOCRIPTINE MESYLATE in United States?
ESJAY PHARMA holds the US marketing authorisation.