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cabergoline Side Effects

Also known as: Dostinex

Analysis of 4,670 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

4,670

Death-Related

245

5.2% of reports

Hospitalizations

1,549

33.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
390
OFF LABEL USE
351
HEADACHE
319
FATIGUE
275
NAUSEA
274
DIZZINESS
224
MALAISE
209
PAIN
195
DIARRHOEA
175
CONDITION AGGRAVATED
170
ANXIETY
158
RASH
155
VOMITING
154
PRODUCT DOSE OMISSION ISSUE
152
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
OFF LABEL USE 55
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
PRODUCT DOSE OMISSION ISSUE 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
OFF LABEL USE 180
DRUG ABUSE 111
RASH 110
PRODUCT DOSE OMISSION ISSUE 107
ARTHROPATHY 103
FALL 102
LOWER RESPIRATORY TRACT INFECTION 98
PULMONARY PAIN 96
ABDOMINAL DISCOMFORT 95
INTENTIONAL PRODUCT MISUSE 95
DRUG INEFFECTIVE 92
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 drug ineffective with 390 submissions, followed by off label use and headache.

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.