ROPINIROLE

N/A

Manufactured by Accord Healthcare Inc.

31,217 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ROPINIROLE

ROPINIROLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. The most commonly reported adverse reactions for ROPINIROLE include DRUG INEFFECTIVE, FALL, FATIGUE, NAUSEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROPINIROLE.

Top Adverse Reactions

DRUG INEFFECTIVE1,153 reports
FALL1,004 reports
FATIGUE921 reports
NAUSEA853 reports
DIZZINESS721 reports
HALLUCINATION711 reports
PAIN630 reports
DEATH623 reports
DIARRHOEA603 reports
DYSPNOEA591 reports
ASTHENIA568 reports
OFF LABEL USE541 reports
INSOMNIA537 reports
HEADACHE528 reports
GAIT DISTURBANCE512 reports
SOMNOLENCE503 reports
DYSKINESIA494 reports
CONDITION AGGRAVATED489 reports
TREMOR483 reports
MALAISE467 reports
VOMITING431 reports
CHRONIC KIDNEY DISEASE428 reports
PNEUMONIA415 reports
WEIGHT DECREASED410 reports
ANXIETY399 reports
CONFUSIONAL STATE397 reports
DEPRESSION385 reports
URINARY TRACT INFECTION385 reports
PARKINSON^S DISEASE382 reports
ARTHRALGIA376 reports
PAIN IN EXTREMITY365 reports
CONSTIPATION355 reports
FEELING ABNORMAL353 reports
ACUTE KIDNEY INJURY347 reports
MEMORY IMPAIRMENT341 reports
PRODUCT DOSE OMISSION ISSUE338 reports
COUGH325 reports
BALANCE DISORDER320 reports
RENAL FAILURE320 reports
BACK PAIN319 reports
RESTLESS LEGS SYNDROME318 reports
MUSCLE SPASMS299 reports
DECREASED APPETITE274 reports
HALLUCINATION, VISUAL263 reports
PRURITUS262 reports
WEIGHT INCREASED261 reports
PERIPHERAL SWELLING259 reports
RASH258 reports
DRUG INTERACTION241 reports
HYPOTENSION239 reports
GASTROOESOPHAGEAL REFLUX DISEASE222 reports
ON AND OFF PHENOMENON222 reports
HYPOAESTHESIA216 reports
MOBILITY DECREASED216 reports
COVID 19209 reports
OEDEMA PERIPHERAL207 reports
HYPERHIDROSIS191 reports
CHEST PAIN189 reports
DEHYDRATION189 reports
LOSS OF CONSCIOUSNESS188 reports
MUSCULAR WEAKNESS185 reports
HYPERTENSION183 reports
ABDOMINAL PAIN182 reports
PYREXIA181 reports
ASTHMA180 reports
MUSCULOSKELETAL STIFFNESS180 reports
ABDOMINAL DISCOMFORT172 reports
PARAESTHESIA172 reports
ABDOMINAL PAIN UPPER170 reports
DRUG HYPERSENSITIVITY170 reports
MUSCLE RIGIDITY168 reports
ALOPECIA165 reports
CEREBROVASCULAR ACCIDENT162 reports
PRODUCT USE IN UNAPPROVED INDICATION159 reports
SPEECH DISORDER159 reports
AGITATION156 reports
FREEZING PHENOMENON154 reports
UNEVALUABLE EVENT153 reports
VISION BLURRED150 reports
BLOOD PRESSURE INCREASED149 reports
MYALGIA148 reports
COGNITIVE DISORDER146 reports
DEVICE ISSUE146 reports
INCORRECT DOSE ADMINISTERED146 reports
ANAEMIA145 reports
DRY MOUTH145 reports
VISUAL IMPAIRMENT144 reports
ATRIAL FIBRILLATION143 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION143 reports
SLEEP DISORDER141 reports
DRUG DOSE OMISSION140 reports
NEUROPATHY PERIPHERAL140 reports
COMPLETED SUICIDE139 reports
CONTUSION138 reports
DYSPHAGIA138 reports
PRODUCT USE ISSUE138 reports
HOSPITALISATION137 reports
GENERAL PHYSICAL HEALTH DETERIORATION136 reports
NASOPHARYNGITIS135 reports
INJECTION SITE PAIN133 reports

Report Outcomes

Out of 14,658 classified reports for ROPINIROLE:

Serious 64.6%Non-Serious 35.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female8,371 (61.9%)
Male5,137 (38.0%)
Unknown9 (0.1%)

Reports by Age

Age 68359 reports
Age 76356 reports
Age 67315 reports
Age 75314 reports
Age 70310 reports
Age 69307 reports
Age 66303 reports
Age 73301 reports
Age 71289 reports
Age 72289 reports
Age 74282 reports
Age 77282 reports
Age 64275 reports
Age 63273 reports
Age 65267 reports
Age 62262 reports
Age 61247 reports
Age 78245 reports
Age 79208 reports
Age 60207 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ROPINIROLE?

This profile reflects 31,217 FDA FAERS reports that mention ROPINIROLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROPINIROLE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FALL, FATIGUE, NAUSEA, DIZZINESS, HALLUCINATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROPINIROLE?

Labeling and FAERS entries often list Accord Healthcare Inc. in connection with ROPINIROLE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.