pharmacopeia
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/api/v1/drug/cabergoline

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Dopamine Agonists.

Dopamine

Indications

Sourced from openFDA
  • Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.

Contraindications

Sourced from openFDA
  • Cabergoline Tablets, USP are contraindicated in patients with Uncontrolled hypertension or known hypersensitivity to ergot derivatives. History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis (See WARNINGS ).contraindicated

Dosage & administration

Sourced from openFDA

The recommended dosage of Cabergoline Tablets, USP for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient’s serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease. Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with Cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered. After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established.

Warnings & precautions

Sourced from openFDA

1. Pregnancy: Dopamine agonists in general should not be used in patients with pregnancy-induced hypertension, for example, preeclampsia, eclampsia, and postpartum hypertension, unless the potential benefit is judged to outweigh the possible risk. 2. Fibrotic Complications: a. Cardiac Valvulopathy: All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with Cabergoline (See CONTRAINDICATIONS ) . Post-marketing cases of cardiac valvulopathy have been reported in patients receiving Cabergoline. These cases have generally occurred during administration of high doses of Cabergoline (>2mg/day) used for the treatment of Parkinson’s disease. Cases of cardiac valvulopathy have also been reported in patients receiving lower doses for the treatment of hyperprolactinemic disorders. A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n=27,812) for Parkinson’s disease and hyperprolactinemia and cardiac valvular regurgitation (CVR), other fibroses, and other cardiopulmonary events over a maximum of 12 years of follow up.

Adverse reactions

Sourced from openFDA

The safety of Cabergoline Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity. In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table. Incidence of Reported Adverse Events During the 4-Week, Double-Blind, Placebo-Controlled Trial Adverse Event Reported at ≥1% for cabergoline Cabergoline (n=168) 0.125 to 1 mg two times a week Placebo (n=20) Number (percent) Gastrointestinal Nausea 45 (27) 4 (20) Constipation 16 (10) 0 Abdominal pain 9 (5) 1 (5) Dyspepsia 4 (2) 0 Vomiting 4 (2) 0 Central and Peripheral Nervous System Headache 43 (26) 5 (25) Dizziness 25 (15) 1 (5) Paresthesia 2 (1) 0 Vertigo 2 (1) 0 Body As a Whole Asthenia 15 (9) 2 (10) Fatigue 12 (7) 0 Hot flashes 2 (1) 1 (5) Psychiatric Somnolence 9 (5) 1 (5) Depression 5 (3) 1 (5) Nervousness 4 (2) 0 Autonomic Nervous System Postural hypotension 6 (4) 0 Reproductive – Female Breast pain 2 (1) 0 Dysmenorrhea 2 (1) 0 Vision Abnormal vision 2 (1) 0 In the 8-week, double-blind period of the comparative trial with bromocriptine, cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocr…

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects: Category B. Reproduction studies have been performed with cabergoline in mice, rats, and rabbits administered by gavage. (Multiples of the maximum recommended human dose in this section are calculated on a body surface area basis using total mg/m 2 /week for animals and mg/m 2 /week for a 50 kg human.) There were maternotoxic effects but no teratogenic effects in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis. A dose of 0.012 mg/kg/day (approximately 1/7 the maximum recommended human dose) during the period of organogenesis in rats caused an increase in post-implantation embryofetal losses. These losses could be due to the prolactin inhibitory properties of cabergoline in rats. At daily doses of 0.5 mg/kg/day (approximately 19 times the maximum recommended human dose) during the period of organogenesis in the rabbit, cabergoline caused maternotoxicity characterized by a loss of body weight and decreased food consumption. Doses of 4 mg/kg/day (approximately 150 times the maximum recommended human dose) during the period of organogenesis in the rabbit caused an increased occurrence of various malformations.

Overdosage

Sourced from openFDA

Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.

Approval history

Sourced from openFDA
  • Dec 23, 1996NDANDA020664Pfizer
  • Dec 29, 2005ANDAANDA076310Strides Pharma Intl
  • Mar 7, 2007ANDAANDA077750Ivax Sub Teva Pharms
  • Aug 1, 2018ANDAANDA204735Ingenus Pharms Llc
  • Jun 25, 2024ANDAANDA218618Amneal
  • Sep 9, 2024ANDAANDA218109Somerset Theraps Llc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,760 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3958.3%
  2. 2Off Label Use3707.8%
  3. 3Headache3256.8%
  4. 4Fatigue2805.9%
  5. 5Nausea2775.8%
  6. 6Dizziness2254.7%
  7. 7Malaise2124.5%
  8. 8Pain1984.2%
  9. 9Diarrhoea1783.7%
  10. 10Condition Aggravated1723.6%
  11. 11Rash1663.5%
  12. 12Product Dose Omission Issue1643.4%
  13. 13Anxiety1603.4%
  14. 14Abdominal Discomfort1593.3%
  15. 15Vomiting1573.3%

Literature

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Recent PubMed references pinned to Cabergoline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 82 ClinicalTrials.gov registrations naming Cabergoline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cabergoline work?
Mechanism-of-action class: Dopamine Agonists.
What is Cabergoline used for?
According to FDA labeling, Cabergoline carries indications including: Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cabergoline?
Cabergoline is classified as Dopamine agonists, Prolactine inhibitors, Ergot Derivative, Dopamine Agonists, Decreased Prolactin Secretion, Increased Dopamine Activity.
What are the contraindications for Cabergoline?
Cabergoline labeling lists contraindications including: Cabergoline Tablets, USP are contraindicated in patients with Uncontrolled hypertension or known hypersensitivity to ergot derivatives. History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis (See WARNINGS ).. Always consult the full prescribing information and a clinician.
Note. Data for cabergoline is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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