Inhibition/Suppression of Lactation:
Approximately 14% of women treated in clinical trials with a single 1 mg dose of cabergoline for inhibition of physiologic lactation reported at least one adverse event. Reported adverse events were transient and mild to moderate in severity. The most frequent adverse events were dizziness/vertigo, headache, nausea, and abdominal pain. Palpitations, epigastric pain, epistaxis, and transient hemianopsia were also reported. Cabergoline is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes. (See Somnolence/Sudden Sleep Onset and Effects on ability to drive and use machines under Precautions).
Asymptomatic decreases in blood pressure (≥20 mmHg systolic and ≥10 mmHg diastolic) may occur during the first 3 to 4 days post-partum.
Adverse events have been observed in approximately 14% of nursing women treated with 0.25 mg of cabergoline every 12 hours for 2 days for suppression of lactation. Most adverse events were transient and mild to moderate in severity. The most frequent adverse events were dizziness/vertigo, headache, nausea, somnolence (See Somnolence/Sudden Sleep Onset and Effects on ability to drive and use machines under Precautions) and abdominal pain. Vomiting, syncope, asthenia, and hot flushes were also reported.
Data obtained in a controlled clinical trial of 6 months therapy, with doses ranging between 1 and 2 mg per week given in two weekly administrations, indicate a 68% incidence of adverse events during therapy with cabergoline. The adverse events were generally mild to moderate in severity, mainly appearing during the first 2 weeks of therapy. Most disappeared with continued therapy. Severe adverse events were reported at least once during therapy by 14% of patients. Therapy was discontinued because of adverse events in approximately 3% of patients. Adverse events subsided upon discontinuation of cabergoline, usually within a few days.
The most common adverse events reported, in decreasing order of frequency, were: nausea, headache, dizziness/vertigo, abdominal pain/dyspepsia/gastritis, asthenia/fatigue, constipation, vomiting, breast pain, hot flushes, depression and paresthesia.
Adverse events are generally dose-related (See General under Dosage & Administration).
Cabergoline generally exerts a hypotensive effect in patients on long-term therapy; however, postural hypotension (See Postural Hypotension and Inhibition/Suppression of Physiologic Lactation under Precautions) or fainting has been rarely reported.
Being an ergot derivative, cabergoline may act as a vasoconstrictor. Digital vasospasm and leg cramps have been reported.
Alterations in standard laboratory tests are uncommon during long term therapy with cabergoline; a decrease in hemoglobin values have been observed in amenorrheic women during the first few months after menses resumption.
The following events have been reported in association with cabergoline: aggression, alopecia, blood creatinine phosphokinase increased, delusions, dyspnea, edema, fibrosis, hepatic function abnormal, hypersensitivity reaction, impulse control disorders such as hypersexuality, increased libido and pathological gambling, liver function tests abnormal, psychotic disorder, rash, respiratory disorder, respiratory failure, and valvulopathy (See Contraindications and Fibrosis/Valvulopathy and Psychiatric under Precautions).
The prevalence of asymptomatic valvular regurgitation is significantly greater than that of non-ergot dopamine agonists (See Contraindications and Fibrosis/Valvulopathy under Precautions).