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Dopamine Agonist — Hyperprolactinaemia / OHSS Pregnancy: UK SPC 4.6: "There are no adequate and well-controlled studies from the use of cabergoline in pregnant women." Animal studies have not demonstrated teratogenic effects, but reduced fertility and embryo-toxicity were observed in association with pharmacodynamic activity. In a twelve-year observational study, 17 of 256 pregnancies (6.6%) eventuated in major congenital malformations or abortion, against a reported general-population prevalence of major congenital malformations of 6.9% or greater; no control group was included, so an increased risk cannot be accurately determined. "It is recommended that contraception is used whilst on treatment with cabergoline. Cabergoline should only be used during pregnancy if clearly indicated and after an accurate benefit/risk evaluation." "Due to the long half-life of the drug and limited data on in utero exposure, women planning to become pregnant should discontinue cabergoline one month before intended conception. If conception occurs during therapy, treatment should be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug." Breastfeeding: no information is available on excretion in human breast milk, but "lactation is expected to be inhibited/suppressed by cabergoline, in view of its dopamine agonist properties. Mothers should be advised not to breast-feed while being treated with cabergoline." US label: Pregnancy Category B - maternotoxic but not teratogenic effects in mice at up to 8 mg/kg/day; increased post-implantation embryofetal loss in rats at 0.012 mg/kg/day; increased malformations in rabbits at 4 mg/kg/day.

Cabergoline (Hyperprolactinaemia / OHSS Prevention)

Brand names: Dostinex

This page concerns cabergoline, a long-acting ergot-derived dopamine agonist, used for hyperprolactinaemia and, in assisted reproduction, to help prevent ovarian hyperstimulation syndrome (OHSS).

Adult dose

Dose: Hyperprolactinaemic disorders only: 0.25 mg twice a week to initiate. "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", with increases no more frequent than every 4 weeks. NO DOSE IS PUBLISHED FOR OHSS PREVENTION - see notes.
Route: Oral - the UK SPC in this bundle notes that "the tolerability of dopaminergic agents is improved when administered with food", so cabergoline is recommended to be taken with meals
Frequency: Twice weekly (hyperprolactinaemic disorders). "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."
Max: Up to 1 mg twice a week for hyperprolactinaemic disorders - US label: "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"
SCOPE - READ BEFORE USING THE DOSE. This page carries two indications; only the first, hyperprolactinaemia, is dosed here. OHSS PREVENTION: NO DOSE IS STATED IN EITHER FETCHED SOURCE. Neither the US label nor the UK SPC in this bundle mentions ovarian hyperstimulation syndrome; that use is outside both labels. The twice-weekly hyperprolactinaemia dose above must NOT be carried across to OHSS prophylaxis - it is a different regimen for a different purpose, and applying it would substantially under-treat a patient at risk of a life-threatening complication. To dose the OHSS half of this page a separate source is required (national fertility guidance or an assisted-conception unit protocol) stating the dose, the start day relative to the trigger, and the duration. SOURCE PROVENANCE: the dose is US labelling. The UK record fetched into this bundle is Cabaser 1 mg Tablets, licensed for PARKINSON'S DISEASE, whose section 4.2 gives "starting doses of 1 mg daily", increments of 0.5-1 mg at weekly or bi-weekly intervals, and "The recommended therapeutic dosage is 2 mg to 3 mg/day for patients with signs and symptoms of Parkinson's disease", given as a single daily dose. Those are Parkinson's doses, roughly an order of magnitude above hyperprolactinaemia dosing, and must never be applied to this page. A UK SPC for a cabergoline product licensed for hyperprolactinaemic disorders must be obtained and the figures above reconciled with it before publication. TITRATION AND STOPPING (US label): "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." "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." CARDIAC PRECAUTION BEFORE STARTING (US label): "Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease." LACTATION SUPPRESSION: no dose for inhibition or suppression of lactation appears in either source fetched into this bundle, so none is published here. INTERACTIONS: US label - "Cabergoline should not be administered concurrently with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide"; UK SPC 4.4 - care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure, as postural hypotension can occur particularly during the first days of administration.

Dose adjustments

Renal

No renal dose adjustment is given in either source. The UK SPC in this bundle (Cabaser) recommends baseline investigation of renal function before initiating long-term treatment, and notes that "Serum creatinine measurements can also be used to help in the diagnosis of fibrotic disorder". The US label advises that dose selection for an elderly patient should be cautious, "usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function". Renal guidance should be re-checked against a UK SPC for the hyperprolactinaemia product, which was not fetched into this bundle.

Hepatic

UK SPC 4.4 (Cabaser): "Lower doses of cabergoline should be considered in patients with severe hepatic insufficiency. Compared to normal volunteers and those with lesser degrees of hepatic insufficiency, an increase in AUC has been seen in patients with severe hepatic insufficiency (Child-Pugh Class C) who received a single 1 mg dose." No numerical reduction is given. Note that the UK SPC for the hyperprolactinaemia product was not fetched into this bundle; some cabergoline SPCs list hepatic insufficiency as an outright contraindication, so the hepatic position must be confirmed against the correct product SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to cabergoline, to any of the excipients, or to any ergot alkaloid (UK SPC 4.3); the US label bars use in patients with "known hypersensitivity to ergot derivatives"
  • History of pulmonary, pericardial and retroperitoneal fibrotic disorders (UK SPC 4.3; US label)
  • History of cardiac valvular disorders - US label: "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". UK SPC 4.3, for long-term treatment: "Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography"
  • Uncontrolled hypertension (US label)
  • Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption - these patients "should not take this medicine" (UK SPC 4.4)
  • Breastfeeding - lactation is expected to be inhibited or suppressed by cabergoline, and "Mothers should be advised not to breast-feed while being treated with cabergoline" (UK SPC 4.6)

Side effects

  • US label, in more than 900 patients with hyperprolactinaemic disorders (4-week double-blind placebo-controlled trial, 0.125 to 1 mg twice a week): nausea 27%, headache 26%, dizziness 15%, constipation 10%, asthenia 9%, fatigue 7%, abdominal pain 5%, somnolence 5%, postural hypotension 4%, depression 3%, dyspepsia 2%, vomiting 2%, nervousness 2%, paraesthesia 1%, vertigo 1%, hot flushes 1%, breast pain 1%, dysmenorrhoea 1%. "Most adverse events were mild or moderate in severity"
  • Valvulopathy including regurgitation, and related disorders - pericarditis and pericardial effusion (very common in the UK SPC for the long-term, higher-dose Parkinson's licence); angina pectoris (common when used with levodopa) (UK SPC 4.8)
  • Fibrotic and serosal inflammatory disorders - pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis "have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline"; valvulopathy has been associated with cumulative doses, so patients should be treated with the lowest effective dose (UK SPC 4.4)
  • Nausea (very common); constipation, dyspepsia, gastritis and vomiting (common) (UK SPC 4.8)
  • Headache, somnolence, dizziness/vertigo (common); sudden sleep onset, syncope and tremor (frequency not known) (UK SPC 4.8)
  • Postural hypotension (common) - "Cabergoline generally exerts a hypotensive effect in patients on long-term treatment"; erythromelalgia (uncommon); digital vasospasm (frequency not known) (UK SPC 4.8)
  • Impulse control disorders - "Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists" (UK SPC 4.4, 4.8); hallucinations, sleep disturbances, increased libido and confusion (common); delusions and psychotic disorder (uncommon); aggression (frequency not known)
  • Peripheral oedema (very common); asthenia (common); oedema and fatigue (uncommon) (UK SPC 4.8)
  • Abnormal hepatic function (uncommon); abnormal liver function tests and decreased haemoglobin, haematocrit and/or red blood cells of more than 15% versus baseline (common); increased blood creatinine phosphokinase (frequency not known) (UK SPC 4.8)
  • Rash (uncommon); alopecia and leg cramps (frequency not known); visual impairment (frequency not known); hypersensitivity reaction (uncommon) (UK SPC 4.8)

Monitoring

  • Serum prolactin - the dose is titrated "according to the patient's serum prolactin level", and after a normal level has been maintained for 6 months cabergoline may be discontinued with periodic prolactin monitoring to determine whether or when to reinstitute treatment (US label)
  • Cardiovascular evaluation with echocardiography considered BEFORE initiating treatment, to assess for valvular disease (US label). UK SPC 4.4, before long-term treatment: "All patients must undergo a cardiovascular evaluation, including echocardiogram, to assess the potential presence of asymptomatic valvular disease"
  • Periodic assessment of cardiac status during long-term treatment, with echocardiography considered (US label); at each visit "the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment" (UK SPC 4.4)
  • Baseline erythrocyte sedimentation rate or other inflammatory markers, lung function / chest X-ray and renal function before starting long-term therapy; "Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values" (UK SPC 4.4)
  • Impulse control disorders - patients and carers should be made aware of pathological gambling, increased libido, hypersexuality, compulsive spending or buying and binge eating, and dose reduction or tapered discontinuation considered if they develop (UK SPC 4.4)
  • Blood pressure, particularly during the first days of administration, and when co-prescribing other drugs known to lower blood pressure (UK SPC 4.4)
  • Contraception status - "It is recommended that contraception is used whilst on treatment with cabergoline" (UK SPC 4.6)
  • Dose escalation interval - do not increase the dose more often than every 4 weeks, so that the response to each dose level can be assessed (US label)

Clinical monograph

How it works

It is a potent, selective dopamine D2 receptor agonist that suppresses pituitary prolactin secretion; in OHSS prevention it reduces vascular endothelial growth factor-mediated capillary permeability.

Prescribing in practice

  • Long-term higher-dose use for prolactinoma has been associated with cardiac valve fibrosis, so echocardiographic surveillance is advised for prolonged therapy, whereas short OHSS-prevention courses carry far lower fibrotic risk.
  • Postural hypotension can occur at initiation, and impulse-control disorders are a recognised dopamine-agonist effect requiring counselling.
  • Restored fertility and pregnancy planning should be addressed, and concomitant dopamine antagonists reduce efficacy.

Monitoring

Monitor prolactin and symptoms, blood pressure, and cardiac valves by echocardiography during prolonged higher-dose treatment.

Counselling the patient

  • Rise slowly initially to avoid dizziness, and report breathlessness, swollen ankles or persistent headache.
  • Tell your clinician about any new gambling, shopping or other impulsive urges.
  • Discuss contraception or pregnancy plans as fertility may return.

Evidence & guidelines

Cabergoline is a preferred dopamine agonist for hyperprolactinaemia and is supported by evidence for reducing OHSS incidence in assisted reproduction.

Reference: MHRA Drug Safety Update (dopamine agonists); RCOG Green-top 5 (OHSS 2016); Alvarez et al. (cabergoline OHSS prevention); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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