Cabergoline

Macroprolactinomas and men with prolactinoma

Five of the prolactinoma studies cited in this guide come from Annamaria Colao's group at Federico II University of Naples (PMID: 9360509, PMID: 15070934, PMID: 14764772, PMID: 14627787, PMID: 25592453). The two 2004 studies of 51 men report the same numbers of patients and control men, so they may describe one cohort (PMID: 15070934, PMID: 14764772).

• In a 1997 open-label study by Colao in 23 patients with macroprolactinoma, treated for 12 to 24 months, tumor volume fell by more than 80 percent in 14 of 23 patients (61 percent), and visual field defects improved in 9 of 10 (PMID: 9360509).
• A 2004 study by Colao followed 51 men with prolactinoma for 24 months, with 51 control men for semen analysis. Prolactin normalized in 75.6 percent with macroprolactinomas and 80 percent with microprolactinomas, maximal tumor diameter fell by about 73 percent, testosterone normalized in about 60 percent by 6 months, and 20 men needed testosterone or gonadotropin replacement (PMID: 15070934).
• In a 6-month study by De Rosa (2004) in 51 men with hyperprolactinemia, testosterone normalized in 68.6 percent, and nighttime erections measured by nocturnal penile tumescence normalized in 60.6 percent of men whose prolactin normalized against 7.7 percent of those whose prolactin did not (PMID: 14764772).
• In a 2026 retrospective study by Fedai in 84 men with prolactinoma, testosterone recovered to at least 300 ng/dL in 30.7 percent at 6 months, 44 percent at 12 months and 59.5 percent at 24 months on cabergoline, and once 6-month values were included, testosterone at 6 months was the only remaining predictor of recovery at 12 months (PMID: 41926073).

Men taking testosterone

A search of PubMed and ClinicalTrials.gov on 27 October 2026 found no randomized trial of cabergoline in men on testosterone therapy. The published reports are these:

• A 2016 retrospective review by Hollander covered 131 men treated off-label for delayed orgasm or anorgasmia at one andrology clinic. Of these men, 65.6 percent were also on testosterone therapy, and 66.4 percent reported subjective improvement in orgasm; the authors reported concomitant testosterone therapy as associated with response, but they also noted that a larger share of non-responders than responders used testosterone, that testosterone could confound the result, and that the study had no placebo group or validated questionnaire (PMID: 26944776).
• In studies of men with prolactinoma, men whose testosterone stayed low on cabergoline were given testosterone or gonadotropin replacement (PMID: 15070934), and in a 24-month study of 32 men, testosterone replacement was started in those who remained hypogonadal on cabergoline and insulin sensitivity measures improved further between 12 and 24 months (PMID: 25592453). In 10 men with macroprolactinoma and persistent hypogonadism on cabergoline, clomiphene citrate was used in place of testosterone, and 8 kept testosterone above 300 ng/dL (PMID: 38578401).
• In a single-blind crossover study of 10 healthy men, one dose of cabergoline lowered prolactin and increased measures of sexual drive and function during a laboratory session compared with placebo (PMID: 14656205). It was a laboratory study in healthy men and did not test testosterone therapy.

Other uses studied

• A European study group reported on lactation inhibition in 272 women after childbirth (BMJ 1991). A single dose of cabergoline was compared with 14 days of bromocriptine; complete success occurred in 106 of 136 against 94 of 136 women, and rebound breast symptoms in 5 against 23 (PMID: 1676318). The current US label advises against this use (US prescribing information for cabergoline tablets).
• A 2021 Cochrane review by Tang on ovarian hyperstimulation syndrome included 22 trials in 3,171 women at high risk. Dopamine agonists such as cabergoline probably lowered moderate or severe ovarian hyperstimulation syndrome compared with placebo or no treatment (odds ratio 0.32; 10 trials, 1,202 participants; moderate-quality evidence), with uncertain effects on live birth (PMID: 33851429).
• In acromegaly, a 2011 meta-analysis by Sandret of 15 nonrandomized studies with 237 patients found that cabergoline alone normalized IGF-I in 34 percent, and added to a somatostatin analog in 52 percent (PMID: 21325455).
• In Cushing's disease, a 2009 study by Pivonello in 20 patients after unsuccessful surgery found cortisol control sustained for 24 months in 8 of 20 (40 percent) (PMID: 18957500).
• A 2003 review describes cabergoline as indicated for early and advanced Parkinson's disease (PMID: 12844325), while the US label states that cabergoline is not approved for Parkinson's disease (US prescribing information for cabergoline tablets).

Products sold for post-cycle use

Of 63 seized samples sold for post-cycle use after anabolic steroids and tested by Poland's official medicines control laboratory, some labels declared cabergoline, and 34.9 percent of the samples did not contain the declared active ingredient (PMID: 40177353).

Heart valves at Parkinson's disease doses

The label states that postmarketing cases of cardiac valvulopathy have generally occurred at high doses above 2 mg a day used for Parkinson's disease, for which cabergoline is not approved in the US, and it cites a 12-year multi-country cohort in Parkinson's disease with 68 cases of valve regurgitation per 10,000 person-years on cabergoline against 10 on non-ergot dopamine agonists and 11 on levodopa (US prescribing information for cabergoline tablets). In a UK nested case-control study of people prescribed Parkinson's drugs, current cabergoline use was associated with newly diagnosed valve regurgitation (incidence rate ratio 4.9, 95% CI 1.5 to 15.6) (PMID: 17202453). In an Italian echocardiography study of Parkinson's patients, moderate to severe regurgitation of any valve was found in 28.6 percent of 49 patients on cabergoline, 23.4 percent on pergolide, none on non-ergot agonists and 5.6 percent of controls, and patients with grade 3 to 4 regurgitation had received higher cumulative doses (PMID: 17202454). A 2015 systematic review of observational studies judged the evidence strong that pergolide and cabergoline are associated with a higher risk of valve regurgitation in Parkinson's disease, with higher risk at longer treatment duration and higher dose (PMID: 26585874).

Heart valves at the lower doses used for high prolactin

The label states that valvulopathy has also been reported at the lower doses used for hyperprolactinemic disorders (US prescribing information for cabergoline tablets). A 2018 meta-analysis of 13 case-control studies found more tricuspid regurgitation in patients treated with cabergoline for high prolactin than in controls (odds ratio 3.74), none diagnosed because of symptoms, and no increase in other valve disease (PMID: 30215804). A UK follow-up of 192 patients with repeat echocardiograms found no link between cumulative cabergoline dose (median 232 mg at the second scan) and valve abnormalities (PMID: 27571182). Among 1,811 patients with prolactinoma, a 2015 systematic review counted 2 confirmed cases of cabergoline-associated valvulopathy (0.11 percent) (PMID: 25466526). In a 2021 London primary care study of 646 patients treated with cabergoline for prolactinoma for more than 6 months, valve surgery or heart failure occurred in 2.8 percent against 2.33 percent of matched controls (relative risk 0.78, not significant), at a median weekly dose of 2.1 mg (PMID: 33247916).

Label monitoring and fibrosis

The current label contraindicates cabergoline in people with a history of heart valve disease or of pericardial, pleural, pulmonary or retroperitoneal fibrosis, and it calls for an echocardiogram before treatment and every 6 to 12 months during treatment, or as clinically indicated (US prescribing information for cabergoline tablets). Pleural, pulmonary and retroperitoneal fibrosis have been reported after marketing, some in patients previously treated with other ergot dopamine agonists, and patients with pleural effusion or pulmonary fibrosis improved after stopping cabergoline (US prescribing information for cabergoline tablets).

Impulse control disorders

The label warns that people taking cabergoline or other drugs that increase dopamine activity can experience intense urges to gamble, spend money, binge eat or have sex (US prescribing information for cabergoline tablets). In a cross-sectional study of 308 patients with prolactinoma treated with dopamine agonists, 17 percent screened positive for an impulse control disorder, most often hypersexuality (6.5 percent), which was more common in men (PMID: 30848825). In an Australian study, 22.1 percent of 113 treated patients and 8.1 percent of 99 community controls screened positive for hypersexuality, and male sex was the strongest risk factor (odds ratio 13.85) (PMID: 31580439). A 2025 meta-analysis of 8 observational studies found a higher prevalence of impulse control disorders with dopamine agonist treatment (risk ratio 1.71), mainly hypersexuality and punding (PMID: 40480033).

Psychiatric and other postmarketing reports

Postmarketing reports also include psychotic disorder, aggression and hair loss (US prescribing information for cabergoline tablets).

Postpartum use

The label advises against cabergoline to inhibit or suppress breast milk after childbirth, because bromocriptine, another dopamine agonist, used this way has been associated with high blood pressure, stroke, heart attack, seizures and death (US prescribing information for cabergoline tablets).

Pregnancy

The label states that published case reports have not shown a clear association between cabergoline in early pregnancy and major birth defects or miscarriage, and that dopamine agonists should in general be avoided during pregnancy and after delivery (US prescribing information for cabergoline tablets). In a 12-year observational study of 380 pregnancies, neonatal abnormalities were recorded in 9 percent of infants with no apparent pattern, and the authors found no increase in miscarriage or malformation (PMID: 17760883). A 2025 systematic review of 1,662 exposed pregnancies found no increase in major malformations or spontaneous abortions but rated study quality as low (PMID: 40116053).