BROMOCRIPTINE MESYLATE · Viatris
Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism . Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate tablets therapy may be used to reduce the tumor mass prior to surgery.
Details
- Status
- Prescription
- First Approved
- 1978-06-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
BROMOCRIPTINE MESYLATE Approval History
What BROMOCRIPTINE MESYLATE Treats
8 indicationsBROMOCRIPTINE MESYLATE is approved for 8 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperprolactinemia
- Amenorrhea
- Galactorrhea
- Infertility
- Hypogonadism
- Prolactin-Secreting Adenoma
- Acromegaly
- Parkinson's Disease
BROMOCRIPTINE MESYLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BROMOCRIPTINE MESYLATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02078440 | VS-PEDS BA-2010 | Ph 1 | completed | Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BROMOCRIPTINE MESYLATE FDA Label Details
Indications & Usage
Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism . Bromocriptine mesylate tablets treatment is indicated in patients with prolactin-secreting adenomas , which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptin...
Looking for the branded version?
PARLODEL
Full clinical data, patents, trials, and competitive landscape for bromocriptine mesylate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.