FDA label
What is bromocriptine used for?
The FDA-approved uses of bromocriptine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for bromocriptine mesylate (capsule) lists 4 uses: Hyperprolactinemia-Associated Dysfunction; Prolactin-Secreting Adenomas; Acromegaly; Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism.
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Bromocriptine Mesylate, capsule
Indications and Usage, quoted from the label by Zydus Pharmaceuticals USA Inc. (ANDA078899). Cross-references to other label sections are left out.
Hyperprolactinemia-Associated Dysfunction
Bromocriptine mesylate capsules are indicated for the treatment of hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility or hypogonadism in adults.
Limitations of Use
Avoid use of bromocriptine mesylate for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions.
Prolactin-Secreting Adenomas
Bromocriptine mesylate capsules are indicated for the treatment of prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older.
Acromegaly
Bromocriptine mesylate capsules are indicated for the treatment of acromegaly in adults.
Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism
Bromocriptine mesylate capsules are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease or postencephalitic parkinsonism in adults.
Source: DailyMed label, set id d69003ee-0b6f-47a9-834e-ba59c02f566c, version 14, effective July 28, 2026. NDC 68382-110, one of 3 listings for this product.
Bromocriptine Mesylate, tablet
Indications and Usage, quoted from the label by Sandoz Inc (ANDA074631). Cross-references to other label sections are left out.
Hyperprolactinemia-Associated Dysfunctions
Bromocriptine mesylate tablets, USP are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.
Acromegaly
Bromocriptine mesylate tablets, USP are indicated in the treatment of acromegaly.
Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate tablets, USP offers potential benefit before the effects of irradiation are manifested.
Parkinson's Disease
Bromocriptine mesylate tablets, USP are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate tablets, USP therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing "end of dose failure" on levodopa therapy.
Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with bromocriptine mesylate tablets, USP. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate tablets, USP-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate tablets, USP therapy.
Source: DailyMed label, set id c43c300d-8aec-4020-984a-42c1a917c08f, version 10, effective June 30, 2024. NDC 0781-5325, one of 3 listings for this product.
Questions
What is bromocriptine used for?
The FDA label for bromocriptine mesylate (capsule) lists 4 uses: Hyperprolactinemia-Associated Dysfunction; Prolactin-Secreting Adenomas; Acromegaly; Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism.
What drug class is bromocriptine?
FDA lists bromocriptine in the Ergot Derivative established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.