Short answer: In the label's 4-week placebo-controlled trial in women with high prolactin, the most common cabergoline side effects were nausea (27% vs 20% on placebo), headache (26% vs 25%), dizziness (15% vs 5%), constipation (10% vs 0%) and fatigue (7% vs 0%). There is no boxed warning, but the label warns about heart valve disease and fibrosis and requires a heart check before starting.
What Cabergoline is approved for: Cabergoline is an ergot-derived dopamine agonist approved to treat hyperprolactinemic disorders (high prolactin), either with no known cause or due to pituitary adenomas, in adults (section 1). The label says to avoid it for stopping or suppressing breast milk after childbirth because of the risk of serious adverse reactions (sections 1, 5.4).
Source
CABERGOLINE tablets, for oral use, prescribing information and Patient Information. Mylan Pharmaceuticals (Viatris). DailyMed, version published July 1, 2026. DailyMed setid e497366b-a124-4d7f-bd45-a883c392d4bb
No. The current Cabergoline label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Cabergoline.
| Adverse reaction | CABERGOLINE (n=168) | Placebo (n=20) |
|---|---|---|
| Nausea | 45 (27%) | 4 (20%) |
| Headache | 43 (26%) | 5 (25%) |
| Dizziness | 25 (15%) | 1 (5%) |
| Constipation | 16 (10%) | 0% |
| Fatigue | 12 (7%) | 0% |
| Postural hypotension | 6 (4%) | 0% |
| Dyspepsia | 4 (2%) | 0% |
| Vomiting | 4 (2%) | 0% |
| Nervousness | 4 (2%) | 0% |
| Vertigo | 2 (1%) | 0% |
| Paresthesia | 2 (1%) | 0% |
| Breast pain | 2 (1%) | 0% |
| Dysmenorrhea | 2 (1%) | 0% |
| Abnormal vision | 2 (1%) | 0% |
Reactions in at least 1% on cabergoline and more often than on placebo. The placebo group had 20 women.
| Adverse event | CABERGOLINE (n=221) | Bromocriptine (n=231) |
|---|---|---|
| Nausea | 63 (29%) | 100 (43%) |
| Headache | 58 (26%) | 62 (27%) |
| Dizziness | 38 (17%) | 42 (18%) |
| Constipation | 15 (7%) | 21 (9%) |
| Asthenia | 13 (6%) | 15 (6%) |
| Abdominal pain | 12 (5%) | 19 (8%) |
| Dyspepsia | 11 (5%) | 16 (7%) |
| Fatigue | 10 (5%) | 18 (8%) |
| Vertigo | 9 (4%) | 10 (4%) |
| Vomiting | 9 (4%) | 16 (7%) |
| Depression | 7 (3%) | 5 (2%) |
| Hot flashes | 6 (3%) | 3 (1%) |
| Breast pain | 5 (2%) | 8 (3%) |
| Dry mouth | 5 (2%) | 2 (1%) |
| Paresthesia | 5 (2%) | 6 (3%) |
| Somnolence | 5 (2%) | 5 (2%) |
| Diarrhea | 4 (2%) | 7 (3%) |
| Flatulence | 4 (2%) | 3 (1%) |
| Pain | 4 (2%) | 6 (3%) |
Cabergoline 0.5 mg twice weekly vs bromocriptine 2.5 mg twice daily. Rows shown are those at 2% or more on cabergoline; the label's table also lists events at 1%. Stopping because of side effects: 2% (4/221) on cabergoline vs 6% (14/231) on bromocriptine.
In the 4-week placebo-controlled trial, 4% on cabergoline developed low blood pressure on standing vs 0% on placebo. The risk is greater with other medicines that lower blood pressure.
In a 12-year study of people with Parkinson's disease (not an approved use, usually at doses above 2 mg a day), leaky heart valves occurred at 68 per 10,000 person-years on cabergoline vs 10 on non-ergot dopamine agonists and 11 on levodopa. Cases have also been reported at the lower doses used for high prolactin.
The most common reasons for stopping cabergoline in the bromocriptine comparison were headache, nausea and vomiting (3, 2 and 2 patients).
Reported after approval: impulse control problems including hypersexuality, increased libido and pathological gambling; psychotic disorder; aggression; and hair loss.
Reported in under 1% in clinical studies: facial swelling, low blood pressure, fainting, palpitations, weight loss or gain, nosebleeds, acne and increased libido, among others.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. People with uncontrolled high blood pressure, a known allergy to ergot derivatives, a history of heart valve disease or pericardial fibrosis, or a history of fibrosis of the lining of the lungs, the lungs or the back of the abdomen.
Heart valve disease and pericardial fibrosis. An echocardiogram is done before starting, and cabergoline is not given if valve disease is found. Echocardiograms are repeated every 6 to 12 months or as needed, and new swelling, a heart murmur, shortness of breath or heart failure prompt a check. Cabergoline is stopped if new valve leaking, restriction, thickening or pericarditis is diagnosed.
Lung and abdominal fibrosis. Fibrosis of the lining of the lungs, the lungs and the back of the abdomen has been reported. Shortness of breath, persistent cough, chest pain, flank pain, leg swelling or abdominal lumps are watched for, and cabergoline is stopped if fibrosis occurs. People who stopped had better lung symptoms.
Low blood pressure on standing. Cabergoline can cause dizziness or light-headedness on standing up. Blood pressure is checked at the start and during treatment.
Not for stopping breast milk after childbirth. The label says to avoid cabergoline to suppress milk after delivery. Bromocriptine, another dopamine agonist, used this way has been linked to high blood pressure, stroke, heart attack, seizures and death.
Impulse control problems. Intense urges to gamble, spend money, have sex or binge eat, and being unable to control them, have been reported with dopamine drugs including cabergoline. People may not recognize these as abnormal, so prescribers ask about them; a lower dose or stopping is considered, and some urges stopped when that was done.
Liver impairment. Use is not recommended in severe liver impairment (Child-Pugh C), and side effects are watched more closely in moderate impairment, because cabergoline levels rise.
From the Patient Information that comes with Cabergoline:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.