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ropinirole Side Effects

Also known as: Requip

Analysis of 14,664 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

14,664

Death-Related

1,369

9.3% of reports

Hospitalizations

4,485

30.6% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
1,153
FALL
1,004
FATIGUE
920
NAUSEA
852
DIZZINESS
721
HALLUCINATION
711
PAIN
630
DEATH
623
DIARRHOEA
602
DYSPNOEA
591
ASTHENIA
567
OFF LABEL USE
541
INSOMNIA
537
HEADACHE
528
GAIT DISTURBANCE
512
SOMNOLENCE
504
DYSKINESIA
494
CONDITION AGGRAVATED
488
TREMOR
483
MALAISE
467

Who Reports Side Effects

Gender Distribution

Female 8,371 (62%)
Male 5,136 (38%)
Unknown 9

Age Distribution

0-17 49 (1%)
18-44 639 (7%)
45-64 3,446 (35%)
65-74 3,021 (31%)
75+ 2,586 (27%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 1,369 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 622
COMPLETED SUICIDE 139
FALL 76
PNEUMONIA 74
CARDIAC ARREST 63
PARKINSON^S DISEASE 63
HALLUCINATION 56
ACUTE KIDNEY INJURY 53
TOXICITY TO VARIOUS AGENTS 52
RENAL FAILURE 49
DYSPNOEA 46
CHRONIC KIDNEY DISEASE 39
OFF LABEL USE 38
ASTHENIA 37
CARDIAC FAILURE CONGESTIVE 33
RESPIRATORY FAILURE 33
MYOCARDIAL INFARCTION 32
NAUSEA 32
SEPSIS 31
DIARRHOEA 30

Reactions in Hospitalization Reports

Top reactions in 4,485 reports where hospitalization was an outcome.

Reaction Reports
FALL 551
DYSPNOEA 328
PNEUMONIA 314
FATIGUE 285
NAUSEA 253
URINARY TRACT INFECTION 235
HALLUCINATION 224
ASTHENIA 223
PAIN 213
DRUG INEFFECTIVE 205
CONFUSIONAL STATE 196
WEIGHT DECREASED 195
DIZZINESS 194
DIARRHOEA 185
DYSKINESIA 179
GAIT DISTURBANCE 178
MALAISE 175
VOMITING 173
ACUTE KIDNEY INJURY 160
HYPOTENSION 152

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What the FAERS Data Reveals About ropinirole Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 14,664 voluntary reports linked to ropinirole and its brand equivalents (Requip), spanning 2004 through 2025. Of those, 1,369 (9.3%) listed death as an outcome and 4,485 (30.6%) 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, 62% were female and 38% male; age distribution skews toward 45-64, with 3,446 reports in that bracket. The single most reported reaction is drug ineffective with 1,153 submissions, followed by fall and fatigue.

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.