From the FDA Drug Label
The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson's disease in controlled and uncontrolled studies at dosages of up to 11. 5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson's disease were dyskinesia, hallucinations, confusion, and peripheral edema Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported. Post-marketing Surveillance data The following events have been reported in association with cabergoline: cardiac valvulopathy and extracardiac fibrotic reactions, (See WARNINGS, Cardiac Valvulopathy and Extracardiac Fibrotic Reactions) Other events have been reported in association with cabergoline: impulse control/compulsive behavior symptoms, including hypersexuality, increased libido and pathological gambling (See PRECAUTIONS, Psychiatric). In addition, cases of alopecia, aggression, and psychotic disorder have been reported in patients taking cabergoline
The long term side effects of cabergoline in someone using it without a prolactin tumor may include:
- Cardiac valvulopathy and extracardiac fibrotic reactions
- Impulse control/compulsive behavior symptoms, including hypersexuality, increased libido, and pathological gambling
- Alopecia, aggression, and psychotic disorder
- Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer (rarely)
- Constrictive pericarditis (one case reported) These side effects are based on post-marketing surveillance data and studies in patients with Parkinson's disease 1.
From the Research
Cabergoline should not be used long-term without a prolactin tumor due to potential side effects, and its use requires careful medical supervision and monitoring. The most significant risks associated with long-term cabergoline use include heart valve problems (valvulopathy) due to its action on serotonin receptors in heart tissue, which can lead to regurgitation or stenosis 2. Psychiatric disturbances may occur, including impulse control disorders such as compulsive gambling, hypersexuality, or excessive shopping. Some users experience persistent dizziness, headaches, nausea, or fatigue. Cardiovascular effects like orthostatic hypotension or irregular heartbeat can develop. Without medical supervision, cabergoline may disrupt normal hormonal balance, potentially affecting fertility or sexual function. The medication can also cause gastrointestinal issues and, rarely, pulmonary fibrosis. These risks increase with higher doses and longer duration of use. Key points to consider:
- The safety profile of cabergoline is better established for treating conditions like hyperprolactinemia, where benefits outweigh risks 3, 4, 5.
- Using this medication without a medical indication or proper monitoring is not recommended as these side effects can develop gradually and may become irreversible, particularly the cardiac valve changes.
- A study on the long-term use of cabergoline in patients with prolactinoma and idiopathic hyperprolactinemia found no clinically relevant alterations in cardiac valve function or valvular calcifications 2.
- The efficacy and tolerability of long-term cabergoline therapy in hyperprolactinemic disorders have been demonstrated in several studies 3, 4, 5.
- Withdrawal of long-term cabergoline therapy for tumoral and nontumoral hyperprolactinemia has been shown to be safe and effective in some patients, but close monitoring is necessary to detect potential recurrence or tumor growth 6.