What the label lists and what reports show
Cabergoline side effects
Cabergoline's FDA label: “The most common adverse reactions (incidence >10%) are nausea, headache, and dizziness.” FAERS holds 4,839 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (339 reports).
- Generic listed
Check it at the source: the cabergoline FDA label on DailyMed (effective June 30, 2026, Mylan Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CABERGOLINE?CABERGOLINE can cause serious side effects, including: • Heart valve problems and fibrosis (scarring). CABERGOLINE can cause heart valve problems and fibrosis in the heart, chest, lungs or areas of the stomach (abdomen). Call your health care provider right away if you get any of the following signs or symptoms of heart valve problems and fibrosis: • shortness of breath • chest pain • persistent cough • difficulty with breathing when lying down • swelling in the arms or legs • pain in the side (flank) • lump or tenderness in abdomen • Decreased blood pressure (orthostatic hypotension). You may feel dizzy or lightheaded when you rise too quickly from a sitting or lying position. Talk to your health care provider if you have dizziness or lightheadedness. • Unusual and uncontrollable (compulsive) urges. […]
Source: FDA drug label, NDA020664 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective June 30, 2026 (SPL set e497366b-a124-4d7f-bd45-a883c392d4bb), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence >10%) are nausea, headache, and dizziness.
Table 2. Adverse Events Adverse events reported ≥1% in the CABERGOLINE group. Abbreviation: n=number of patients. During the 8-Week, Double-Blind Period of the Comparative Trial in Hyperprolactinemic Females
| Reaction | 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%) |
| Acne | 3 (1%) | 0% |
| Anorexia | 3 (1%) | 3 (1%) |
| Anxiety | 3 (1%) | 3 (1%) |
| Hypotension | 3 (1%) | 4 (2%) |
| Insomnia | 3 (1%) | 2 (1%) |
| Syncope | 3 (1%) | 3 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: • Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions (5.1) ]. • Pleural, Retroperitoneal, and Pulmonary Fibrosis [see Warnings and Precautions (5.2) ]. • Orthostatic Hypotension [see Warnings and Precautions (5.3) ]. • Impulse Control Disorders and Compulsive Behaviors [see Warnings and Precautions (5.5) ]. The most common adverse reactions (incidence >10%) are nausea, headache, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1‑877‑4‑INFO‑RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CABERGOLINE has been evaluated in more than 900 patients with hyperprolactinemic disorders. In a 4-week, double-blind, placebo-controlled trial (CABERGOLINE vs. placebo) [see Clinical Studies (14) ], the incidence of the most common adverse reactions during the placebo-controlled trial in patients with hyperprolactinemic disorders is presented in Table 1. Table 1. …
Source: FDA drug label, NDA020664 (Pfizer), as published by Mylan Pharmaceuticals Inc., effective June 30, 2026 (SPL set e497366b-a124-4d7f-bd45-a883c392d4bb), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,839 reports list cabergoline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 253 are coded as a death and 1,607 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cabergoline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions