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Bromocriptine mesylate 5 mg Capsule, 100-count — NDC 68382-0110-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bromocriptine mesylate 5 mg Capsule, 100-count — NDC 68382-110-01 (Billing 68382-0110-01)

by Zydus Pharmaceuticals USA Inc. · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Bromocriptine mesylate 5 mg Capsule from Zydus Pharmaceuticals USA Inc., marketed since Jan 2009 and currently FDA-listed.

NDC 68382-0110-01
🏷️ FDA NDC (as labeled) 68382-110-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $4.14/unit — full pricing hub ↓
Product page 68382-0110-06 Also comes in: 30 capsules 68382-110-06
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Oct 23, 2025 — Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0159-2026
Lots / codes: Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26 · reported Nov 26, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68382-110-01
Product NDC 68382-110
11-digit billing NDC 68382011001
NCPDP billing unit EA — each (per item)
RxCUI 197412
UNII FFP983J3OD
UPC 0368382110015
Application # ANDA078899
SPL Set ID d69003ee-0b6f-47a9-834e-ba59c02f566c
Established class (EPC) Ergot Derivative
Chemical class Ergolines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-01-23
Route ORAL
Dosage form CAPSULE
Substance BROMOCRIPTINE MESYLATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 006603
GCN 26070
HICL code 002834
Ingredient (HICL) Bromocriptine Mesylate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6A
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Other
AHFS code 28:36.20.04
AHFS class Ergot-Deriv. Dopamine Receptor Agonists
FDB label name BROMOCRIPTINE 5 MG CAPSULE
FDB brand name Bromocriptine Mesylate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006603
  • GCN: 26070
  • HICL (First Databank): 002834
  • AHFS class code: 28:36.20.04
  • RxCUI (RxNorm): 197412
Why two NDCs? The FDA registers this code as 68382-110-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68382-0110-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Ergot Derivative class.

Pharmacologic class Ergot Derivative
Drug family (ATC) Prolactine inhibitors, Dopamine agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BROMOCRIPTINE 5 MG CAPSULE Ingredient Bromocriptine Mesylate
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Bromocriptine mesylate treats high prolactin problems, prolactin-secreting pituitary tumors, acromegaly and Parkinson's disease. The Cycloset brand is us...
  • Yes. Taking it with food helps, because many people vomited when they took it on an empty stomach. Cycloset should be taken within two hours of waking, with food.
  • Nausea, headache, dizziness, tiredness and constipation are the most common, and they are usually mild to moderate. Dizziness on standing is most likely early on. Tell me if side e...
  • Call right away for sudden sleepiness, fainting, severe headache with vision changes, chest pain, trouble breathing, leg swelling or new urges to gamble or overspend. Don't drive i...
📖 Read our full Bromocriptine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $4.14 $414.30 / 100 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68382-0110-01 You're viewing this 100 CAPSULE in 1 BOTTLE — — 2009-01-23 — Active
68382-0110-06 68382-110-06 Main listing 30 CAPSULE in 1 BOTTLE $4.12 / ea $123.50 2009-01-23 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 30 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 68382-0110-06?
Both are Bromocriptine mesylate 5 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 68382-0110-06 is the 30 capsules package.
What NDC number is used to bill for this package of Bromocriptine mesylate 5 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bromocriptine Mesylate 5 mg 00378-7096-01 Mylan 100 capsules $4.117 AB Availability likely —
Bromocriptine mesylate 5 mg 65841-0654-01 Zydus 100 capsules — AB FDA listed —
Bromocriptine mesylate 5 mgthis 68382-0110-01 Zydus 100 capsules — AB FDA listed —
Bromocriptine Mesylate 5 mg 70954-0951-10 ANI 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Jan 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Brown / White
ShapeCapsule
ImprintZA17;5mg
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 5C69YCD2YJ
    Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • 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.
  • 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.
  • UNII 91XW058U2C
    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.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerZydus Pharmaceuticals USA Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA078899 (ANDA)
Labeler code68382
First marketedJan 2009
Product typeHuman Prescription Drug
Portfolio454 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND 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 capsule 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 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 [see Warnings and Precautions ( 5.4 )].

1.2Prolactin-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.

1.3Acromegaly Bromocriptine mesylate capsules are indicated for the treatment of acromegaly in adults.

1.4Idiopathic 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.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 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 )

2.1Recommended 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 days 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 mg to 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 pro… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Bromocriptine Mesylate Capsules USP, 5 mg are white to off-white powder filled in size "3" empty Cellulose capsules with tan colored cap printed with "ZA 17" in black ink and white colored body printed with "5 mg" in black ink. Capsules: 5 mg of bromocriptine mesylate ( 3 )

⛔ Contraindications 137 words ▾

4 CONTRAINDICATIONS 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 ).

⚠️ Warnings and Cautions ~2 min read ▾

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 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 bromo… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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 capsules 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, light headedness, arrhythmia, ventricular tachycardia, decreased sleep requirement, visual hallucinations, lassitude, shortness of breath, bradycardia, vertigo, paresthesia, sluggishness, vasovagal attack, delusional ps… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

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 ~2 min read ▾

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 capsules 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 capsules 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 capsules, 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 capsules 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 capsules 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 capsules 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 capsules for the inhibition or suppression of postpartum physiologic lactation because of the ris… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Pregnancy in Patients with Hyperprolactinemia-Associated Dysfunction and Prolactin-Secreting Adenomas: In patients being treated with bromocriptine mesylate capsules 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 capsules 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 capsules, 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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 capsules 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, th… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 165 words ▾

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 years 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 capsules alone and in those treated with bromocriptine mesylate capsules in combination with surgical treatment and/or pituitary irradiation. The safety and effectiveness of bromocriptine mesylate capsules 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 31 words ▾

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 84 words ▾

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 ~3 min read ▾

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 capsules 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 and C max 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 capsules twice daily for 14 days, the bromocriptine C max 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% to 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 sign… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 177 words ▾

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 99 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bromocriptine Mesylate Capsules USP, 5 mg are white to off-white powder filled in size "3" empty Cellulose capsules with tan colored cap printed with "ZA 17" in black ink and white colored body printed with "5 mg" in black ink and are supplied as follows: NDC 68382-110-06 in bottle of 30 capsules with child-resistant closure NDC 68382-110-01 in bottle of 100 capsules Storage: 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 140 words ▾

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)-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

💬 Information for Patients ~2 min read ▾

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 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 )].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following single 5 mg bromocriptine mesylate capsules 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 and C max 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 capsules twice daily for 14 days, the bromocriptine C max 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% to 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 impact on the PK of bromocriptine and its metabolites. Patients with Hepatic Impairment: The effect of hepatic impairment on the PK of bromocriptine and its metabolites has not been evaluated. Drug Interaction Studies Inhibitors and/or potent substrates for CYP3A4 might inhibit the clearance of bromocriptine and lead to increased bromocriptine levels [see Drug Interactions (( 7 )].

Bromocriptine is a CYP3A4 inhibitor with a calculated IC50 value of 1.69 μM.6 Given the low therapeutic bromocriptine concentrations in patients (C max =0.82 nM), a significant alteration of the metabolism of a second drug whose clearance is mediated by CYP3A4 is not be expected. The potential effect of bromocriptine and its metabolites to act as CYP inducers has not been reported. The concomitant use of erythromycin, a moderate CYP3A4 inhibitor, with bromocriptine mesylate was shown to increase the plasma levels of bromocriptine (mean AUC and C max values increased 3.7-fold and 4.6 -fold, respectively) [see Dosage and Administration ( 2.6 ) and Drug Interactions ( 7 )].

The concomitant use of bromocriptine mesylate and octreotide in patients with acromegaly led to increased plasma bromocriptine levels (bromocriptine AUC increased about 38%). These changes in bromocriptione levels are not clinically significant.

🧬 Pharmacodynamics 63 words ▾

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.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES

14.1Clinical Studies in Patients with Hyperprolactinemia-Associated Dysfunctions and Prolactin-secreting Adenomas In about 75% of cases of amenorrhea and galactorrhea, bromocriptine mesylate suppressed galactorrhea completely, or almost completely, and reinitiated normal ovulatory menstrual cycles. Menses were usually reinitiated prior to complete suppression of galactorrhea; the time for this on average was 6 weeks to 8 weeks. However, some patients responded within a few days, and other patients responded in up to 8 months.

At least a 75% reduction in secretion was observed after 8 weeks to 12 weeks; however, some patients failed to respond even after 12 months of bromocriptine mesylate therapy. Reduction in tumor size of prolactin-secreting adenomas has been demonstrated in both bromocriptine mesylate-treated male and female patients with macroadenomas.

14.2Clinical Studies in Patients with Acromegaly Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduced serum growth hormone by 50% or more in approximately 50% of patients with acromegaly, although not usually to normal levels. Because the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate offers potential benefit before the effects of irradiation are manifested. Virtually all acromegalic patients who received therapeutic benefit from bromocriptine mesylate also had reductions in circulating levels of growth hormone.

14.3Clinical Studies in Patients with Idiopathic Parkinson’s Disease or Postencephalitic Parkinsonism Bromocriptine mesylate in combination with levodopa or in combination with levodopa and a peripheral decarboxylase inhibitor may provide additional therapeutic benefits in patients with idiopathic Parkinson's disease or postencephalitic parkinsonism who are maintained on therapeutic levodopa dosages, who develop levodopa tolerance, or experience "end of dose failure'' on levodopa therapy.

🔒 Drug Abuse and Dependence 118 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Bromocriptine mesylate contains bromocriptine, which is not a controlled substance.

9.3Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Apathy, anxiety, depression, fatigue, insomnia, sweating, and pain have been reported during taper or after discontinuation of dopamine agonists, including bromocriptine mesylate. A symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability) has been reported in association with rapid dosage reduction or withdrawal of bromocriptine mesylate [see Warnings and Precautions ( 5.11 )].

🔒 Controlled Substance 13 words ▾

9.1Controlled Substance Bromocriptine mesylate contains bromocriptine, which is not a controlled substance.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 74-week study was conducted in mice using dietary levels of bromocriptine mesylate equivalent to oral doses of 10 mg/kg/day and 50 mg/kg/day. A 100-week study in rats was conducted using dietary levels of bromocriptine mesylate equivalent to oral doses of 1.7 mg/kg/day, 9.8 mg/kg/day, and 44 mg/kg/day. The highest doses of bromocriptine mesylate tested in mice and rats were approximately 2.5 times and 4.4 times, respectively, the maximum recommended human dose (MRHD) of bromocriptine mesylate administered in controlled clinical trials in patients with acromegaly (100 mg/day) based on body surface area.

Malignant uterine tumors, endometrial and myometrial, were found in rats as follows: 0/50 control females, 2/50 females given 1.7 mg/kg daily, 7/49 females given 9.8 mg/kg daily, and 9/50 females given 44 mg/kg daily. The occurrence of these neoplasms is probably attributable to the high estrogen/progesterone ratio which occurs in rats as a result of the prolactin-inhibiting action of bromocriptine mesylate. The endocrine mechanisms believed to be involved in the rats are not present in humans.

There is no known correlation between uterine malignancies that occurred in bromocriptine-treated rats and human risk. In contrast to the findings in rats, the uteri from mice killed after 74 weeks of treatment did not exhibit evidence of drug-related changes. Mutagenesis Bromocriptine mesylate was evaluated for mutagenic potential in the battery of tests that included Ames bacterial mutation assay, mutagenic activity in vitro on V79 Chinese hamster fibroblasts, cytogenetic analysis of Chinese hamster bone marrow cells following in vivo treatment, and an in vivo micronucleus test for mutagenic potential in mice.

No mutagenic effects were observed in any of these tests. Impairment of Fertility Fertility and reproductive performance in female rats were not influenced adversely by bromocriptine treatment beyond the predicted decrease in pup weight due to lactation suppression. In males treated with 50 mg/kg of bromocriptine, mating and fertility were within the normal range.

Increased perinatal loss was produced in the subgroups of dams, sacrificed on day 21 postpartum after mating with males treated with the highest bromocriptine dose (50mg/kg).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 74-week study was conducted in mice using dietary levels of bromocriptine mesylate equivalent to oral doses of 10 mg/kg/day and 50 mg/kg/day. A 100-week study in rats was conducted using dietary levels of bromocriptine mesylate equivalent to oral doses of 1.7 mg/kg/day, 9.8 mg/kg/day, and 44 mg/kg/day. The highest doses of bromocriptine mesylate tested in mice and rats were approximately 2.5 times and 4.4 times, respectively, the maximum recommended human dose (MRHD) of bromocriptine mesylate administered in controlled clinical trials in patients with acromegaly (100 mg/day) based on body surface area.

Malignant uterine tumors, endometrial and myometrial, were found in rats as follows: 0/50 control females, 2/50 females given 1.7 mg/kg daily, 7/49 females given 9.8 mg/kg daily, and 9/50 females given 44 mg/kg daily. The occurrence of these neoplasms is probably attributable to the high estrogen/progesterone ratio which occurs in rats as a result of the prolactin-inhibiting action of bromocriptine mesylate. The endocrine mechanisms believed to be involved in the rats are not present in humans.

There is no known correlation between uterine malignancies that occurred in bromocriptine-treated rats and human risk. In contrast to the findings in rats, the uteri from mice killed after 74 weeks of treatment did not exhibit evidence of drug-related changes. Mutagenesis Bromocriptine mesylate was evaluated for mutagenic potential in the battery of tests that included Ames bacterial mutation assay, mutagenic activity in vitro on V79 Chinese hamster fibroblasts, cytogenetic analysis of Chinese hamster bone marrow cells following in vivo treatment, and an in vivo micronucleus test for mutagenic potential in mice.

No mutagenic effects were observed in any of these tests. Impairment of Fertility Fertility and reproductive performance in female rats were not influenced adversely by bromocriptine treatment beyond the predicted decrease in pup weight due to lactation suppression. In males treated with 50 mg/kg of bromocriptine, mating and fertility were within the normal range.

Increased perinatal loss was produced in the subgroups of dams, sacrificed on day 21 postpartum after mating with males treated with the highest bromocriptine dose (50mg/kg).

📄 Recent Major Changes 57 words ▾

RECENT MAJOR CHANGES Dosage and Administration, recommended evaluation before initiating bromocriptine mesylate (2.1) 06/2026 Dosage and Administration, dosage modification for strong and moderate CYP3A4 inhibitors (2.7) 06/2026 Contraindications, history of cardiac valvular disorders; pericardial fibrosis; pleural, pulmonary, or retroperitoneal fibrotic disorders (4, 5.1, 5.2) 06/2026 Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.8, 5.9) 06/2026

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 capsules68382-0110-06 1,218 Rx · $295,472
100 capsules this page68382-0110-01 No Medicaid data
Drug total (last 4 qtrs): 1,218 Rx · 82,070 units · $295,472 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bromocriptine Mesylate — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Bromocriptine Mesylate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.4M
Claims incl. refills
8.5K
Beneficiaries
4.4K
Spend / beneficiary
$317.64
Spend / claim
$165.55
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Bromocriptine Mesylate — the ingredient across all brands.

Top reported reactions

Nausea46
Headache35
Vomiting33
Dizziness31
Pyrexia29
Fatigue28
Drug Exposure During Pregnancy25

Age at onset

Neonate7
Infant1
Adult46
Elderly9

Reporter sex

646 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization234
Death30
Life-threatening22
Disabling13
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 45 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (68382-0110-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Pharmaceuticals USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68382-0109-01 · Zydus 68382-0112-01 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.