bromocriptine mesylate
Pharmaranks rates Bromocriptine Mesylate 2.8/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Bromocriptine Mesylate is an ergot derivative used to treat Acromegaly, Adenoma, Amenorrhea, Galactorrhea.
Ergot Derivative · by Zydus Pharms USA Inc
Generic of Cycloset
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Bromocriptine Mesylate
- Drug class
- Ergot Derivative
- Form
- Tablet, Capsule
- Strength
- Bromocriptine Mesylate EQ 5MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- acromegaly, adenoma, amenorrhea
- Manufacturer
- Zydus Pharms USA Inc
- Half-life
- about 4.85 hours (how long it stays in your system)
- What the pharmacy pays
- ~$52.02 for 30 — not your price
- FDA application
- ANDA078899
What is Bromocriptine Mesylate?
From the FDA label:Bromocriptine mesylate is an ergot derivative with potent dopamine receptor agonist activity. Bromocriptine mesylate is chemically designated as Ergotaman-3΄, 6΄, 18-trione, 2-bromo-12΄-hydroxy-2΄-(1-methylethyl)-5΄-(2-methylpropyl)-, (5΄α)-mono-methanesulfonate (salt). The structural formula is: C 32 H 40 BrN 5 O 5 .CH 4 SO 3 Mol. wt. 750.70 Bromocriptine mesylate, USP is white or slightly colored, fine crystalline powder and odorless or having a weak, characteristic odor. Each bromocriptine mesylate capsule USP, 5 mg intended for oral administration contains bromocriptine mesylate equivalent to 5 mg of bromocriptine. In addition, each capsule contains the following inactive ingredients: carrageenan, colloidal silicon dioxide, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, maleic acid, potassium hydroxide and titanium dioxide. Each capsule is printed with black pharmaceutical ink and has following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. image
How to use
Bromocriptine Mesylate is sold in more than one form (Tablet and Capsule), and each is dosed differently. The instructions below come from the FDA label for application ANDA078899 — follow the label that came with the product you were actually prescribed.
Before initiating bromocriptine mesylate capsules, evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer bromocriptine mesylate ( 2.1 ). Take bromocriptine mesylate capsules orally with food ( 2.2 ) Recommended dosage for hyperprolactinemia-associated dysfunction is 1.25 mg (one-half of a tablet) to 2.5 mg once daily. Increase the dosage up to 2.5 mg once daily every two to seven days within a recommended dosage of 2.5 mg to 15 mg once daily ( 2.3 ) Recommended dosage for prolactin-secreting adenomas is 1.25 mg to 2.5 mg once daily. Increase the dosage within a recommended dosage of 2.5 mg to 10 mg once daily ( 2.4 ) Recommended dosage for acromegaly is 1.25 mg to 2.5 mg once at bedtime for 3 days. Increase the dosage 1.25 mg to 2.5 mg once daily every 3 days to 7 days up to the maximum recommended dosage is 100 mg/daily ( 2.5 ). Recommended starting dosage for idiopathic or postencephalitic Parkinson's disease is 1.25 mg twice daily. Increase the dosage by 1.25 mg twice daily every 14 days to 28 days up to the maximum recommended daily dosage of 100 mg/day ( 2.6 ) For dosage modifications for concomitant use of bromocriptine mesylate with moderate CYP3A4 inhibitors, see Full Prescribing Information ( 2.7 , 7 ) 2.1 Recommended Evaluation Before Initiating bromocriptine mesylate Before initiating bromocriptine…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions ( 5.1 )] Pleural, Pulmonary, and Retroperitoneal Fibrosis [see Warnings and Precautions ( 5.2 )] Hypotension/Orthostatic Hypotension [see Warnings and Precautions ( 5.3 )] Risks with Use of bromocriptine mesylate for Postpartum Lactation Inhibition or Suppression [see Warnings and Precautions ( 5.4 )] Impulse Control Disorders and Compulsive Behaviors [see Warnings and Precautions ( 5.5 )] Falling Asleep During Activities of Daily Living [see Warnings and Precautions ( 5.6 )] Visual Impairment in Patients with Prolactin-secreting Adenomas [see Warnings and Precautions ( 5.7 )] Exacerbation of Psychosis in Patients with Severe Psychotic Disorders [see Warnings and Precautions ( 5.8 )] Risks in Patients with Hereditary Problems of Galactose Intolerance, Severe Lactase Deficiency, or Glucose-Galactose Malabsorption [see Warnings and Precautions ( 5.9 )] Additional Clinically Significant Adverse Reactions and Risks in Patients with Acromegaly [see Warnings and Precautions ( 5.10 )] Additional Clinically Significant Adverse Reactions and Risks in Patients with Idiopathic Parkinson's Disease or Postencephalitic Parkinsonism [see Warnings and Precautions ( 5.11 )] Most common adverse reactions: ( 6.1 )…
Warnings
Important safety information
Cardiac Valvulopathy and Pericardial Fibrosis: During bromocriptine mesylate treatment, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated and monitor for chest pain and signs and symptoms of heart failure (if heart failure occurs, exclude valvular fibrosis and pericarditis). Consider additional clinical and diagnostic monitoring at baseline and as necessary during bromocriptine mesylate treatment. Use bromocriptine mesylate in patients treated with other drugs associated with valvulopathy is not recommended. Discontinue bromocriptine mesylate if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. ( 5.1 ) Pleural, Pulmonary and Retroperitoneal Fibrosis: During bromocriptine mesylate treatment monitor for signs and symptoms of progressive fibrosis, (e.g., pleuro-pulmonary disease, renal impairment, ureteral/abdominal vascular obstruction). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis at baseline and as necessary during bromocriptine mesylate treatment. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue bromocriptine mesylate ( 5.2 ) Hypotension/Orthostatic Hypotension: Check blood pressure at baseline and during treatment with bromocriptine mesylate and monitor for hypotension. Patients with Parkinson's disease being treated with bromocriptine mesylate should be monitored for signs and symptoms of orthostatic hypotension ( 5.3 ) Risks with Use of bromocriptine mesylate for Postpartum Lactation Inhibition or Suppression: Avoid use of bromocriptine mesylate for the inhibition or suppression of physiologic lactation. Use of bromocriptine, another dopamine agonist for this unapproved use has been associated with cases of hypertension, stroke, myocardial infarction, seizures, and death. ( 5.4 ) Impulse Control Disorders and Compulsive Behaviors: Specifically ask patients about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating or other urges while being treated with bromocriptine mesylate. Consider dosage reduction or stopping bromocriptine mesylate if a patient develops such urges while taking bromocriptine mesylate. ( 5.5 ) Falling Asleep During Activities of Daily Living: If symptoms of daytime sleepiness or episodes of falling asleep occur while taking bromocriptine mesylate, advise patients not to drive or perform dangerous activities. Consider reducing the dosage or stopping bromocriptine mesylate if patients experience somulence or sudden sleep onset ( 5.6 ). Visual Impariment in Patients with Prolactin-Secreting Adenomas: Recommend monitoring of visual fields in bromocriptine mesylate-treated patients with macroprolactinoma for an early recognition of secondary field loss due to chiasmal herniation. bromocriptine mesylate-patients with rapidly progressive visual field loss should be evaluated by a neurosurgeon to help decide on the most appropriate therapy ( 5.7 ) Exacerbation of Psychosis in Patients with Severe Psychotic Disorders: Use of bromocriptine mesylate in patients with severe psychotic disorders in not recommended ( 5.8 ) 5.1 Cardiac Valvulopathy and Pericardial Cardiac Fibrosis Before initiating bromocriptine mesylate, perform a cardiovascular evaluation, including with an echocardiogram, to evaluate for valvular disease. Bromocriptine mesylate is contraindicated in the presence of valvular disease or pericardial fibrosis . bromocriptine mesylate is not recommended in patients treated with other drugs associated with valvulopathy. Following bromocriptine mesylate treatment initiation, monitor for the development of valvulopathy with a cardiac echocardiogram at intervals of 6 to 12 months or as clinically indicated with new onset edema, cardiac murmur, dyspnea, or heart failure. During bromocriptine mesylate treatment, monitor for chest pain and signs and symptoms of heart failure and if heart failure occurs, valvular fibrosis and pericarditis should be excluded. Consider clinical and diagnostic monitoring such as erythrocyte sedimentation rate, serum creatinine measurements, chest-x-ray, and other investigations and cardiac imaging at baseline and as necessary while patients are treated with during bromocriptine mesylate treatment. Discontinue bromocriptine mesylate capsules if the patient has a new diagnosis of valvular regurgitation, valvular restriction, valve leaflet thickening, or pericarditis. Cases of cardiac valvulopathy have occurred in bromocriptine mesylate-treated patients. Pericardial effusions, as well as constrictive pericarditis, have been reported in bromocriptine mesylate-treated patients, particularly those on long-term and high-dosage treatment. 5.2 Pleural, Pulmonary, and Retroperitoneal Fibrosis Bromocriptine mesylate is contraindicated in patients with a history of pleural, pulmonary, or retroperitoneal fibrosis. During bromocriptine mesylate treatment monitor for signs and symptoms of progressive fibrosis, including: Pleuro-pulmonary disease (e.g., dyspnea, shortness of breath, persistent cough, chest pain). Renal impairment or ureteral/abdominal vascular obstruction (e.g., pain in the loin/flank, lower limb edema, abdominal masses or tenderness that may indicate retroperitoneal fibrosis). Consider clinical and diagnostic monitoring for pleural, pulmonary, and retroperitoneal fibrosis such as with erythrocyte sedimentation rate, serum creatinine measurements, chest-x-ray, and other investigations at baseline and as necessary during bromocriptine mesylate treatment. If pleural, pericardial, retroperitoneal, or pulmonary fibrosis occur, discontinue bromocriptine mesylate. Pleural and Pulmonary Fibrosis Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of bromocriptine mesylate therapy should be considered. Pleural effusions, pleural fibrosis, and pulmonary fibrosis have been reported in bromocriptine mesylate-treated patients, particularly those on long-term and high-dosage treatment. In those instances, in which bromocriptine mesylate treatment was stopped, the changes slowly reverted towards normal. Retroperitoneal Fibrosis To ensure recognition of retroperitoneal fibrosis at an early reversible stage recommend that patients on long-term and high-dosage treatment should be monitored for its manifestations (e.g., back pain, lower limb edema, impaired kidney function). bromocriptine mesylate should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected. Retroperitoneal fibrosis has been reported in a few bromocriptine mesylate-treated patients, particularly those on long-term and high-dosage treatment. Retroperitoneal fibrosis has been reported in a few patients with Parkinson's disease who received long-term bromocriptine mesylate therapy (2 years to 10 years) in dosages that ranged from 30 mg daily to 140 mg daily (9.3 times, 1.4 times, and 1.4 times the maximum recommended bromocriptine mesylate dosage for the hyperprolactionemia-associate dysfunction, acromegaly, and idiopathic Parkinson's disease or postencephalitic parkinsonism indications, respectively [see Dosage and Administration ( 2.6 )]). 5.3 Hypotension/Orthostatic Hypotension Hypotension/Orthostatic Hypotension Check blood pressure at baseline and during treatment with bromocriptine mesylate and monitor for hypotension. Instruct patients to report dizziness or lightheadedness with changes in position to their healthcare provider. Particular care should be exercised in bromocriptine mesylate-treated patients when driving a vehicle or operating hazardous machinery. Hypotensive reactions may occur during bromocriptine mesylate treatment, especially during the first days of treatment. Orthostatic Hypotension in Patients with Parkinson's Disease Patients with Parkinson's disease…
Who should not take Bromocriptine Mesylate
Bromocriptine mesylate capsules are contraindicated in patients with: History of cardiac valvular disorders or a history of pericardial fibrosis [see Warnings and Precautions ( 5.1 )]. History of pleural, pulmonary, or retroperitoneal fibrotic disorders [see Warnings and Precautions ( 5.2 )]. Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )]. Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate capsules or sensitivity to other ergot alkaloids. Bromocriptine mesylate capsules is contraindicated in patients with: History of cardiac valvular disorders or a history of pericardial fibrosis ( 4 , 5.1 ). History of pleural, pulmonary, or retroperitoneal fibrotic disorders ( 4 , 5.2 ) Uncontrolled hypertension ( 4 , 5.3 ) Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate capsules or sensitivity to other ergot alkaloids ( 4 ).
Overdose — what happens if you take too much
The most commonly reported signs and symptoms associated with acute bromocriptine mesylate overdose are nausea, vomiting, constipation, diaphoresis, dizziness, pallor, severe hypotension, malaise, confusion, lethargy, drowsiness, delusions, hallucinations, and repetitive yawning. Overdose signs and symptoms from isolated reports of children who accidentally ingested bromocriptine mesylate included vomiting, somnolence and fever. The children recovered either spontaneously within a few hours or after appropriate management. If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Alcohol Alcohol may potentiate bromocriptine mesylate -associated adverse reactions. Dopamine Antagonists The concomitant use of bromocriptine mesylate with dopamine antagonists resulted in a decreased efficacy of bromocriptine mesylate. Strong and Moderate CYP3A4 Inhibitors Avoid concomitant use of bromocriptine mesylate with strong CYP3A4 inhibitors. Follow the recommended bromocriptine mesylate dosage modifications during concomitant use with moderate CYP3A4 inhibitors [see Dosage and Administration ( 2.7 )]. Bromocriptine is a substrate of CYP3A4 [see Clinical Pharmacology ( 12.3 )] . Concomitant use with strong and moderate CYP3A4 inhibitors increases bromocriptine exposure [see Clinical Pharmacology ( 12.3 )], which may increase the risk of bromocriptine mesylate-associated adverse reactions. Ergot Alkaloids Concomitant use of bromocriptine mesylate with other ergot alkaloids is not recommended. If use is unavoidable, dosage reduction may be necessary in those cases where high dosages of bromocriptine mesylate are being used (such as patients with Parkinson's disease). Alcohol: Alcohol may potentiate bromocriptine mesylate adverse reactions ( 7 ). Dopamine Antagonists: Concomitant use of bromocriptine mesylate with dopamine antagonists: decreased efficacy of bromocriptine mesylate ( 7 ). Strong and Moderate CYP3A4 Inhibitors: Avoid concomitant use of bromocriptine mesylate with strong CYP3A4 inhibitors. Dosage modifications are recommended for bromocriptine mesylate when used with a concomitant moderate CYP3A4 inhibitor ( 7 ). Ergot Alkaloids: Concomitant use of bromocriptine mesylate with other ergot alkaloids is not recommended. If use is unavoidable, dosage reduction may be needed where high bromocriptine mesylate dosages are used ( 7 ).
How long does Bromocriptine Mesylate stay in your body?
The elimination half-life of bromocriptine mesylate is about 4.85 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Single value from one small study (5 healthy fasted adults, single 5 mg dose); the label reports it simply as the "elimination half-life" and gives no separate distribution/terminal phases. Bromocriptine is not a prodrug. It has an active metabolite profile from extensive first-pass CYP3A metabolism, but the label explicitly states the pharmacokinetics of its metabolites "have not been reported," so no metabolite half-life is available — do not assume the parent value covers them. Special populations: the label says the effect of renal impairment, hepatic impairment, age, race, and gender on PK was NOT evaluated. It notes renal impairment likely has little impact (only ~6% renal excretion), but hepatic impairment may increase bromocriptine plasma levels since it is cleared mainly by metabolism, so caution is advised.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Bromocriptine Mesylate Tablet — DailyMed Label, Clinical Pharmacology / Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Bromocriptine Mesylate ranks — best-rated ergot derivative for:
Dosage forms
Tablet and Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Bromocriptine Mesylate treat?
- Bromocriptine Mesylate (Bromocriptine Mesylate) may be used to treat acromegaly, adenoma, amenorrhea, galactorrhea, hyperprolactinemia, hypogonadism, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Bromocriptine Mesylate rated?
- pharmaranks gives Bromocriptine Mesylate a composite score of 2.8 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Bromocriptine Mesylate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $52.02 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Bromocriptine Mesylate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bromocriptine Mesylate. To pay less, Bromocriptine Mesylate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Bromocriptine Mesylate?
- Bromocriptine Mesylate is marketed by Zydus Pharms USA Inc. You can see Zydus Pharms USA Inc's full profile, rating, and other products on pharmaranks.
- Is Bromocriptine Mesylate a brand-name or generic drug?
- Bromocriptine Mesylate is a generic medication; its active ingredient is Bromocriptine Mesylate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Bromocriptine Mesylate available over the counter?
- No. Bromocriptine Mesylate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Bromocriptine Mesylate come in?
- Bromocriptine Mesylate is currently marketed as tablet and capsule, per the FDA's National Drug Code Directory.
- What class of drug is Bromocriptine Mesylate?
- Bromocriptine Mesylate is classified as ergot derivative, per the FDA's Established Pharmacologic Class.
- Is Bromocriptine Mesylate FDA-registered?
- Bromocriptine Mesylate is on record with the U.S. FDA under application number ANDA078899. You can verify this on its official FDA label.
- Has Bromocriptine Mesylate been recalled by the FDA?
- Yes. Bromocriptine Mesylate has 2 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Bromocriptine Mesylate safe?
- There's no single safe-or-not verdict. pharmaranks gives Bromocriptine Mesylate a recall-safety score of 56/100, based on its FDA recall history (2 recorded recall events) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Bromocriptine Mesylate?
- Bromocriptine Mesylate's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions ( 5.1 )] Pleural, Pulmonary,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about Bromocriptine Mesylate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 554 reports naming Bromocriptine Mesylate, and the FDA flagged 86% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nausea37 reports
- headache33 reports
- vomiting32 reports
- pyrexia29 reports
- drug exposure during pregnancy25 reports
- neuroleptic malignant syndrome24 reports
- dizziness21 reports
- fatigue21 reports
Read these as a signal, not a rate. A report does not mean Bromocriptine Mesylate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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56/100