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Drug side effects

cabergoline Side Effects

The reactions most often reported to the FDA for cabergoline (also sold as Dostinex), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

4,670
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of cabergoline come from 4,670 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 4,670 reports to the FDA Adverse Event Reporting System (FAERS) for cabergoline (Dostinex): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

4,670

Reports Mentioning Death

245

5.2% of reports — not proof the medicine caused the death

Hospitalizations

1,549

33.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

HEADACHE
319
FATIGUE
275
NAUSEA
274
DIZZINESS
224
MALAISE
209
PAIN
195
DIARRHOEA
175
CONDITION AGGRAVATED
170
ANXIETY
158
RASH
155
VOMITING
154
FALL
150
ABDOMINAL DISCOMFORT
148
DRUG INTERACTION
142
WEIGHT DECREASED
138
ASTHENIA
133
ARTHRALGIA
128

Who Reports Side Effects

Gender Distribution

Female 2,447 (59%)
Male 1,693 (41%)
Unknown 32

Age Distribution

0-17 79 (2%)
18-44 1,209 (37%)
45-64 1,090 (34%)
65-74 559 (17%)
75+ 303 (9%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 245 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
LUNG NEOPLASM MALIGNANT 46
CONDITION AGGRAVATED 45
ARTHROPATHY 42
ABDOMINAL DISCOMFORT 41
DEATH 41
INFLAMMATION 41
LOWER RESPIRATORY TRACT INFECTION 41
RASH 41
COVID-19 40
PULMONARY PAIN 40
OVERDOSE 39
RADIATION INFLAMMATION 39
DRUG ABUSE 38
INTENTIONAL PRODUCT MISUSE 37
SCHIZOPHRENIA 36
KNEE ARTHROPLASTY 29
MALAISE 27
DIARRHOEA 26

Reactions in Hospitalization Reports

Top reactions in 1,549 reports where hospitalization was an outcome.

Reaction Reports
DRUG ABUSE 111
RASH 110
ARTHROPATHY 103
FALL 102
LOWER RESPIRATORY TRACT INFECTION 98
PULMONARY PAIN 96
ABDOMINAL DISCOMFORT 95
INTENTIONAL PRODUCT MISUSE 95
OVERDOSE 92
HEADACHE 90
CONDITION AGGRAVATED 88
FATIGUE 86
MALAISE 85
DIZZINESS 83
VOMITING 77
KNEE ARTHROPLASTY 73
ANXIETY 68

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What the FAERS Data Reveals About cabergoline Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 4,670 voluntary reports linked to cabergoline and its brand equivalents (Dostinex), spanning 2004 through 2025. Of those, 245 (5.2%) listed death as an outcome and 1,549 (33.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 59% were female and 41% male; age distribution skews toward 18-44, with 1,209 reports in that bracket. The single most reported reaction is headache with 319 submissions, followed by fatigue and nausea.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to cabergoline's 4,670.