Bromocriptine Mesylate 2.5 mg Tablet, 100-count
Other active recalls for Bromocriptine Mesylate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Ergot Derivative class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Bromocriptine (Parlodel) is used to treat symptoms of hyperprolactinemia (high levels of a natural substance called prolactin in the body) including lack of menstrual periods, discharge from the nipples, infertility (difficulty becoming pregnant) and hypogonadism (low levels of certain natural substances needed for normal development and sexual function). Bromocriptine (Parlodel) may be used to treat hyperprolactinemia caused by certain types of tumors that produce prolactin, and may shrink these tumors. Bromocriptine (Parlodel) is also used alone or with other treatments to treat acromegaly (...
Read the full MedlinePlus article ↗- It's really important to take it with food — a large number of people vomit when they take bromocriptine on an empty stomach. Food helps your stomach tolerate it much better. If yo...
- Why do I have to take bromocriptine with food? Can I just take it on an empty stomach if I forget?
- Yes, dizziness when you stand up is one of the most common early side effects — it's called orthostatic hypotension, where your blood pressure drops briefly with position changes....
- I feel dizzy when I stand up after starting this medication. Is that normal, and will it go away?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Maleic acid is an organic acid derived from maleic anhydride. In medicines, it acts as a buffer to help maintain the proper pH level and may also serve as a preservative or stabilizing agent in the formulation.
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Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.606 | $160.58 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $1.89 | $188.61 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $1.86 | $185.74 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bromocriptine mesylate 2.5 mg 00574-0106-01 | Padagis | 100 tablets | $1.606 | AB | Availability likely | — |
| Bromocriptine Mesylate 2.5 mg 60687-0931-21 | American | 30 tablets | $1.606 | AB | Availability likely | — |
| Bromocriptine Mesylate 2.5 mgthis 70954-0978-20 | ANI | 100 tablets | $1.606 | AB | Availability likely | — |
| Bromocriptine mesylate 2.5 mg 00781-5325-01 | Sandoz | 100 tablets | $1.889 | AB | FDA listed | +18% |
| Bromocriptine mesylate 2.5 mg 70518-4628-00 | REMEDYREPACK | 50 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 70954-0978-10 | 30 TABLET in 1 BOTTLE (70954-978-10) | $1.61 / ea | $48.17 | 2025-06-15 | Active |
| 70954-0978-20 You're viewing this | 100 TABLET in 1 BOTTLE (70954-978-20) | $1.61 / ea | $160.58 | 2025-06-15 | Active |
You're viewing the largest of 2 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($1.61 NADAC).
This pack accounts for about 33% of this product's recent Medicaid fills; most go to the 30 tablets pack. See all packs ↓
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What quantity is in NDC 70954-0978-20?
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Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Bromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults (1.1) Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older (1.2). Acromegaly in adults (1.3). Signs and symptoms of idiopathic Parkinson’s disease or postencephalitic parkinsonism in adults (1.4).
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 (1.1, 5.4)
1.1Hyperprolactinemia-Associated Dysfunction Bromocriptine mesylate is 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 [see Warnings and Precautions (5.4)].
1.2Prolactin-Secreting Adenomas Bromocriptine mesylate is indicated for the treatment of prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older.
1.3Acromegaly Bromocriptine mesylate is indicated for the treatment of acromegaly in adults.
1.4Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism Bromocriptine mesylate is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease or postencephalitic parkinsonism in adults.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Before initiating bromocriptine mesylate, evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer bromocriptine mesylate (2.1). Take bromocriptine mesylate 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 to 2.5 mg once at bedtime for 3 days. Increase the dosage 1.25 mg to 2.5 mg once daily every 3 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 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)
2.1Recommended Evaluation Before Initiating Bromocriptine Mesylate Before initiating bromocriptine mesylate evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer bromocriptine mesylate [see Contraindications (4) and Warnings and Precautions (5.1)] .
2.2Important Administration Instructions Take bromocriptine mesylate orally with food because a high percentage of patients vomited after they received bromocriptine mesylate under fasting conditions.
2.3Recommended Dosage for Hyperprolactinemia-Associated Dysfunction The recommended starting dosage of bromocriptine mesylate in adults with hyperprolactinemia-associated dysfunction is 1.25 mg (one-half of a tablet) to 2.5 mg once daily. Increase the bromocriptine mesylate dosage up to 2.5 mg once daily every two to seven days as tolerated until an optimal therapeutic response is achieved within a recommended dosage of 2.5 mg to 15 mg once daily.
2.4Recommended Dosage for Prolactin-Secreting Adenomas The recommended starting dosage of bromocriptine mesylate in adult and pediatric patients 11 years of age and older with prolactin-secreting adenomas is 1.25 mg (one-half of a tablet) to 2.5 mg once daily. Increase the bromocriptine mesylate dosage as tolerated until an optimal therapeutic response is achieved within a recommended dosage of 2.5 mg to 10 mg once daily. In cases where adenectomy is elected for prolactin-secreting adenomas, a course of bromocriptine mesylate therapy may be used to reduce the tumor mass prior to surgery.
2.5Recommended Dosage for Acromegaly The recommended starting dosage of bromocriptine mesylate in adults for acromegaly is 1.25 mg (one-half of a tablet) to 2.5 mg once at bedtime for 3 days. Increase the dosage 1.25 mg to 2.5 mg once daily every 3 to 7 days, as tolerated, until an optimal therapeutic response is achieved. Reevaluate patients monthly and modify the dosage based on growth hormone levels and clinical response.
For adults with acromegaly, the usual optimal therapeutic dosage range varies from 20-30 mg once at bedtime in most patients, and the maximum recommended dosage is 100 mg/daily. After a brief trial with bromocriptine mesylate therapy in adults with acromegaly, if there is no significant reduction in growth hormone levels and no changes in the clinical features of acromegaly consider increasing the dosage or discontinuing bromocriptine mesylate. For patients with acromegaly treated with pituitary irradiation, withdraw bromocriptine mesylate (e.g., for four to eight weeks) on a yearly basis to assess the clinical effects of radiation on the disease process as well as the effects of bromocriptine mesylate therapy.…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Tablets: 2.5 mg of bromocriptine, off-white, round, flat-faced, beveled-edge tablets, debossed “E” above the score and “280” below the score on one side and debossed “2.5” on the other side. Capsules: 5 mg of bromocriptine, hard gelatin capsule size 3 with caramel opaque cap imprinted “102” on the cap and white opaque body, imprinted with “PARLODEL” over “5 mg” on the body. Tablets:2.5 mg of bromocriptine (functionally scored) (3) Capsules: 5 mg of bromocriptine (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS Bromocriptine mesylate is 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 tablets or capsules or sensitivity to other ergot alkaloids. Bromocriptine mesylate 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 tablets or capsules or sensitivity to other ergot alkaloids (4).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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)
5.1Cardiac Valvulopathy and Pericardial 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 treatm…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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) Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas: (incidence >5%) are nausea, headache, dizziness, fatigue, lightheadedness, and vomiting.
Acromegaly: (incidence >5%) are nausea, constipation, and postural/orthostatic hypotension. Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism: nausea, abnormal involuntary movements, hallucinations, confusion To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Studies of Patients with Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas Bromocriptine mesylate therapy was discontinued in approximately 5% of patients with hyperprolactinemia-associated dysfunctions.
The most common adverse reactions in bromocriptine mesylate-treated patients with hyperprolactinemia-associated dysfunctions were nausea (49%), headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), vomiting (5%), abdominal cramps (4%), nasal congestion (3%), constipation (3%), diarrhea (3%) and drowsiness (3%). A few cases of cerebrospinal fluid rhinorrhea have been reported in bromocriptine mesylate-treated patients with large prolactinomas who have received previous transsphenoidal surgery, pituitary radiation, or both.
Adverse Reactions in Studies of Patients with Acromegaly The most frequent adverse reactions in bromocriptine mesylate-treated patients with acromegaly were nausea (18%), constipation (14%), postural/orthostatic hypotension (6%), anorexia (4%), dry mouth/nasal stuffiness (4%), indigestion/dyspepsia (4%), digital vasospasm (3%), drowsiness/tiredness (3%) and vomiting (2%). Adverse reactions that occurred in less than 2% of bromocriptine mesylate-treated patients with acromegaly were gastrointestinal bleeding, dizziness, exacerbation of Raynaud’s syndrome, headache, and syncope.
Adverse reactions that occured in less than 1% of bromocriptine mesylate-treated patients with acromegaly were hair loss, alcohol potentiation, faintness, lightheadedness, arrhythmia, ventricular tachycardia, decreased sleep requirement, visual hallucinations, lassitude, shortness of breath, bradycardia, vertigo, paresthesia, sluggishness, vasovagal attack, delusional psychosis, paranoia, insomnia, heavy heade…
🔄 Drug Interactions ▾
7 DRUG 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).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: See the Full Prescribing Information regarding the recommendations for using bromocriptine mesylate during pregnancy (8.1) Lactation: Avoid the use of bromocriptine mesylate during lactation in postpartum females.(8.2). Females of Reproductive Potential: A pregnancy test is recommended in bromocriptine mesylate-treated patients at least every 4 weeks during the amenorrheic period. Advise females of reproductive potential not seeking pregnancy, or those harboring large adenomas, to use appropriate contraceptive measures during bromocriptine mesylate treatment (8.3).
8.1Pregnancy Risk Summary Pregnancy in Patients with Hyperprolactinemia-Associated Dysfunction and Prolactin-Secreting Adenomas: In patients being treated with bromocriptine mesylate for hyperprolactinemia, bromocriptine mesylate should generally be withdrawn when pregnancy is diagnosed. If bromocriptine mesylate is continued or reinstituted in select patients to manage a prolactin-secreting macroadenoma and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing bromocriptine mesylate should be weighed against the possible risk of its use during a hypertensive disorder of pregnancy.
Pregnancy in Patients with Acromegaly : In patients being treated with bromocriptine mesylate for acromegaly who subsequently become pregnant, a decision should be made as to whether bromocriptine mesylate continues to be medically necessary or can be withdrawn. Bromocriptine mesylate should be withdrawn in those who experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless bromocriptine mesylate use is necessary. Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism: In patients being treated with bromocriptine mesylate for idiopathic Parkinson’s disease or postencephalitic parkinsonism, there are no adequate data on the developmental risk associated with the use of the bromocriptine mesylate in pregnant women.
If the decision is made to discontinue bromocriptine mesylate, adverse reactions associated with rapid dosage reduction or withdrawal should be considered [see Warnings and Precatutions (5.11)]. Risk of Major Birth Defects and Miscarriage: The estimated background risk of major birth defects and miscarriage in patients with hyperprolactinemia-associated dysfunctions, prolactin-secreting ademonas, acromegaly, or idiopathic Parkinson’s disease or postencephalitic parkinsonism is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The incidence of birth defects in 1,109 live births was 3.3% in neonates/infants born to mothers who received bromocriptine mesylate during pregnancy (see Data) . Clinical Considerations Maternal Adverse Reactions: Bromocriptine mesylate-treated patients should be monitored closely throughout pregnancy for signs and symptoms that may signal the enlargement of a previously undetected or existing prolactin-secreting tumor.
Discontinuation of bromocriptine mesylate treatment in patients with known macroadenomas has been associated with rapid regrowth of tumor and increase in serum prolactin in most cases. Prolactin-secreting adenomas may expand and compression of the optic or other cranial nerves may occur, emergency pituitary surgery becoming necessary. In most cases, the compression resolves following delivery.
Reinitiation of bromocriptine mesylate treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy. Postpartum Period: Avoid use of bromocriptine mesylate for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4)] . Br…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Pregnancy in Patients with Hyperprolactinemia-Associated Dysfunction and Prolactin-Secreting Adenomas: In patients being treated with bromocriptine mesylate for hyperprolactinemia, bromocriptine mesylate should generally be withdrawn when pregnancy is diagnosed. If bromocriptine mesylate is continued or reinstituted in select patients to manage a prolactin-secreting macroadenoma and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing bromocriptine mesylate should be weighed against the possible risk of its use during a hypertensive disorder of pregnancy.
Pregnancy in Patients with Acromegaly : In patients being treated with bromocriptine mesylate for acromegaly who subsequently become pregnant, a decision should be made as to whether bromocriptine mesylate continues to be medically necessary or can be withdrawn. Bromocriptine mesylate should be withdrawn in those who experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless bromocriptine mesylate use is necessary. Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism: In patients being treated with bromocriptine mesylate for idiopathic Parkinson’s disease or postencephalitic parkinsonism, there are no adequate data on the developmental risk associated with the use of the bromocriptine mesylate in pregnant women.
If the decision is made to discontinue bromocriptine mesylate, adverse reactions associated with rapid dosage reduction or withdrawal should be considered [see Warnings and Precatutions (5.11)]. Risk of Major Birth Defects and Miscarriage: The estimated background risk of major birth defects and miscarriage in patients with hyperprolactinemia-associated dysfunctions, prolactin-secreting ademonas, acromegaly, or idiopathic Parkinson’s disease or postencephalitic parkinsonism is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The incidence of birth defects in 1,109 live births was 3.3% in neonates/infants born to mothers who received bromocriptine mesylate during pregnancy (see Data) . Clinical Considerations Maternal Adverse Reactions: Bromocriptine mesylate-treated patients should be monitored closely throughout pregnancy for signs and symptoms that may signal the enlargement of a previously undetected or existing prolactin-secreting tumor.
Discontinuation of bromocriptine mesylate treatment in patients with known macroadenomas has been associated with rapid regrowth of tumor and increase in serum prolactin in most cases. Prolactin-secreting adenomas may expand and compression of the optic or other cranial nerves may occur, emergency pituitary surgery becoming necessary. In most cases, the compression resolves following delivery.
Reinitiation of bromocriptine mesylate treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy. Postpartum Period: Avoid use of bromocriptine mesylate for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4)] . Bromocriptine mesylate should not be used during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless bromocriptine mesylate use is necessary.
Symptomatic hypotension can occur in bromocriptine mesylate-treated patients. In postpartum studies, decreases in supine systolic blood pressure (SBP) and diastolic blood pressure of greater than 20 mm and 10 mm Hg, respectively, were observed in almost 30% of bromocriptine mesylate-treated patients. On occasion, the drop in supine SBP was as much as 50-59 mm of Hg.
Data Human Data : The following i…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of bromocriptine mesylate have been established for the treatment of prolactin-secreting pituitary adenomas in pediatric patients 11 years of age and older. Use of bromocriptine mesylate for this indication is supported by evidence from adequate and well-controlled trials of bromocriptine mesylate in adults with hyerprolactinemia-associated dysfunction, with additional data in 14 bromocriptine mesylate-treated pediatric patients 11 to 15 years of age with prolactin-secreting pituitary macro-and microadenomas.
Chronic hypopituitarism complicated macroadenoma treatment in 5 of the responders, in patients treated with bromocriptine mesylate alone and in those treated with bromocriptine mesylate in combination with surgical treatment and/or pituitary irradiation. The safety and effectiveness of bromocriptine mesylate have not been established for the treatment of prolactin-secreting adenomas in pediatric patients less than 11 years of age. The safety and effectiveness of bromocriptine mesylate have not been established in pediatric patients for the treatment of hyperprolactiniemia-associated dysfunction, acromegaly, or idiopathic Parkinson’s disease or postencephalitic parkinsonism.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of bromocriptine mesylate did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bromocriptine mesylate contains bromocriptine, an ergot derivative and dopamine receptor agonist, which activates post-synaptic dopamine receptors. Dopaminergic neurons in the tuberoinfundibular process release dopamine that modulates the secretion of prolactin from the anterior pituitary; in the corpus striatum the dopaminergic neurons are involved in the control of motor function. Bromocriptine induces stereotyped behavior in rodents and turning behavior in rats (e.g., rats move in circles) that have unilateral lesions in the substantia nigra.
These actions, characteristic of those produced by dopamine, are inhibited by dopamine antagonists and suggest a direct action of bromocriptine on striatal dopamine receptors. Bromocriptine inhibits the secretion of prolactin in humans, with little or no effect on other pituitary hormones, except in patients with acromegaly, where bromocriptine lowers elevated blood levels of growth hormone in the majority of patients. Bromocriptine produces its therapeutic effect in the treatment of idiopathic Parkinson’s disease or postencephalitic parkinsonism, a clinical condition characterized by a progressive deficiency in dopamine synthesis in the substantia nigra, by directly stimulating the dopamine receptors in the corpus striatum.
12.2Pharmacodynamics Clinically, bromocriptine mesylate significantly reduces plasma levels of prolactin in patients with hyperprolactinemia. The inhibition of physiological lactation as well as galactorrhea in pathological hyperprolactinemic states is obtained at dose levels that do not affect secretion of other tropic hormones from the anterior pituitary. Cardiac Electrophysiology There is insufficient information to characterize the effect of bromocriptine mesylate on the QTc interval.
12.3Pharmacokinetics Following single 5 mg bromocriptine mesylate dose (two 2.5 mg tablets) to five healthy volunteers under fasted conditions, the mean peak bromocriptine plasma levels, time to reach peak bromocriptine plasma concentrations and elimination half-life were 465 pg/mL ± 226, 2.5 hours ± 2 and 4.9 hours, respectively. Linear relationship was found between single doses of bromocriptine mesylate and Cmax and AUC in the dose range of 1 to 7.5 mg. The pharmacokinetics of bromocriptine metabolites is unknown.
Following administration of 5 mg of bromocriptine mesylate twice daily for 14 days, the bromocriptine Cmax and AUC at steady-state were 628 ± 375 pg/mL and 2377 ± 1186 pg*hr/mL, respectively. Absorption Effect of Food: Food did not significantly affect the systemic bromocriptine exposure following administration of 2.5 mg of bromocriptine mesylate. Distribution In vitro experiments showed that bromocriptine was 90% -96% bound to serum albumin.
Elimination Metabolism: Bromocriptine undergoes extensive first-pass biotransformation, reflected by complex metabolite profiles and by almost complete absence of parent drug in urine and feces. In vitro studies using human liver microsomes showed that bromocriptine has a high affinity for CYP3A and hydroxylations at the proline ring of the cyclopeptide moiety constituted a main metabolic pathway. The participation of other major CYP enzymes such as 2D6, 2C8, and 2C19 in the metabolism of bromocriptine has not been evaluated.
Excretion: About 82% and 6% of the radioactive bromocriptine dose orally administered was recovered in feces and urine, respectively. Bromolysergic acid and bromoisolysergic acid accounted for half of the radioactivity in urine. Specific Populations The effect of age, race, and sex on the pharmacokinetics of bromocriptine and its metabolites has not been evaluated.
Patients with Renal Impairment: The effect of renal function on the pharmacokinetics of bromocriptine has not been evaluated. Because parent drug and metabolites are almost completely excreted via metabolism, and only 6% eliminated via the kidney, renal impairment may not have a significant impa…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bromocriptine mesylate contains bromocriptine, an ergot derivative and dopamine receptor agonist, which activates post-synaptic dopamine receptors. Dopaminergic neurons in the tuberoinfundibular process release dopamine that modulates the secretion of prolactin from the anterior pituitary; in the corpus striatum the dopaminergic neurons are involved in the control of motor function. Bromocriptine induces stereotyped behavior in rodents and turning behavior in rats (e.g., rats move in circles) that have unilateral lesions in the substantia nigra.
These actions, characteristic of those produced by dopamine, are inhibited by dopamine antagonists and suggest a direct action of bromocriptine on striatal dopamine receptors. Bromocriptine inhibits the secretion of prolactin in humans, with little or no effect on other pituitary hormones, except in patients with acromegaly, where bromocriptine lowers elevated blood levels of growth hormone in the majority of patients. Bromocriptine produces its therapeutic effect in the treatment of idiopathic Parkinson’s disease or postencephalitic parkinsonism, a clinical condition characterized by a progressive deficiency in dopamine synthesis in the substantia nigra, by directly stimulating the dopamine receptors in the corpus striatum.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bromocriptine Mesylate Tablets, USP 2.5 mg Tablets contain 2.5 mg of bromocriptine and are off-white, round, flat-faced, beveled-edge tablets, debossed “E” above the score and “280” below the score on one side and debossed “2.5” on the other side. Bottles of 30 ……….NDC 70954-978-10 Bottles of 100………NDC 70954-978-20 Bromocriptine Mesylate Capsules, USP 5 mg Bottles of 30……..…NDC 70954-951-10 Bottles of 100………NDC 70954-951-20 Store and Dispense Store at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature].
Protect from light. Dispense in a tight, light-resistant container.
📋 Description ▾
11 DESCRIPTION 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)-monomethanesulfonate (salt). The structural formula is: Complies with USP dissolution test 1.
Bromocriptine mesylate tablets and Bromocriptine mesylate capsules are for oral administration. Bromocriptine mesylate tablets: Each tablet contains 2.5 mg of bromocriptine (equivalent to 2.87 mg of bromocriptine mesylate) and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate [see Warnings and Precautions (5.9)], magnesium stearate, maleic acid, povidone and corn starch. Bromocriptine mesylate capsules: Each capsule contains 5 mg of bromocriptine (equivalent to 5.74 mg of bromocriptine mesylate) and the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate [see Warnings and Precautions (5.9)] , magnesium stearate, and maleic acid.
The hard gelatin capsule contains gelatin, iron oxide red, titanium dioxide and purified water. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol and shellac. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Fibrotic Conditions There is a risk of cardiac valvulopathy, and pericardial, pleural, pulmonary, and retroperitoneal fibrosis with bromocriptine mesylate treatment Advise patients to notify their healthcare provider if they develop shortness of breath, chest pain, persistent cough, difficulty with breathing when lying down, or swelling in their extremities [see Warnings and Precautions (5.1, 5.2)]. Hypotension/Hypotension Warn patients about the risk of hypotension and orthostatic hypotension and instruct patients to rise slowly from a supine or sitting position.
Advise patients to notify their healthcare provider if they develop dizziness or lightheadedness [see Warnings and Precautions (5.3)]. Impulse Control Disorders and Compulsive Behaviors Patients and their caregivers should be alerted to the possibility that patients may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking bromocriptine mesylate. Advise patients and their caregivers to inform their health care provider if they develop new or increased uncontrolled spending, gambling urges, sexual urges, or other urges while being treated with bromocriptine mesylate [see Warnings and Precautions (5.5)].
Falling Asleep During Activities of Daily Living Advise patients of the risk of falling asleep while engaged in activities of daily living, including the operation of motor vehicles while taking bromocriptine mesylate. Ask patients about factors that may increase the risk for somnolence with dopaminergic therapy, such as concomitant sedating drugs or the presence of a sleep disorder. If symptoms of somnolence or sudden sleep onset occur, advise patients not to drive or perform potentially dangerous activities while taking bromocriptine mesylate [see Warnings and Precautions (5.6)].
Visual Impairment in Patients with Prolactin-secreting Adenomas Advise patients that bromocriptine mesylate treatment of a macroprolactinoma may lead to visual impairment.If patients experience visual impairment, they should seek immediate medical attention [see Warnings and Precautions (5.7)] . Withdrawal Adverse Reactions After Rapid Dosage Reduction or Discontinuation in Patients with Patients with Idiopathic or Postencephalitic Parkinson’s Disease or Acromegaly Advise patients with with idiopathic or postencephalitic Parkinson’s disease or acromegaly to contact their health care provider if they wish to discontinue bromocriptine mesylate or decrease the bromocriptine mesylate dosage because suddenly stopping bromocriptine mesylate can lead to withdrawal symptoms such as fever, muscular rigidity, altered consciousness, apathy, anxiety, depression, fatigue, insomnia, sweating, or pain [see Warnings and Precautions (5.11)] .
Pregnancy Advise patients to notify their health care provider if they suspect they are pregnant, become pregnant, or intend to become pregnant during bromocriptine mesylate therapy. A pregnancy test should be done if there is any suspicion of pregnancy and continuation of bromocriptine mesylate treatment should be discussed with their health care provider [see Use in Specific Populations (8.1)]. Manufactured by: Esjay Pharma Private Limited, India Distributed by: ANI Pharmaceuticals, Inc.
Baudette, MN 56623 P3374/01/25 Rev. 07/2026 logo