ROTIGOTINE

N/A

Manufactured by UCB, Inc.

28,260 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ROTIGOTINE

ROTIGOTINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UCB, Inc.. The most commonly reported adverse reactions for ROTIGOTINE include PRODUCT ADHESION ISSUE, DRUG INEFFECTIVE, FALL, DEATH, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROTIGOTINE.

Top Adverse Reactions

PRODUCT ADHESION ISSUE1,793 reports
DRUG INEFFECTIVE1,097 reports
FALL941 reports
DEATH907 reports
OFF LABEL USE809 reports
PARKINSON^S DISEASE759 reports
HALLUCINATION684 reports
DYSKINESIA622 reports
TREMOR604 reports
NAUSEA517 reports
DIZZINESS480 reports
SOMNOLENCE440 reports
APPLICATION SITE ERYTHEMA438 reports
APPLICATION SITE PRURITUS438 reports
INSOMNIA438 reports
FATIGUE425 reports
GAIT DISTURBANCE423 reports
OVERDOSE407 reports
PNEUMONIA371 reports
DEVICE ADHESION ISSUE365 reports
ANXIETY347 reports
ON AND OFF PHENOMENON339 reports
ASTHENIA336 reports
MALAISE331 reports
RESTLESS LEGS SYNDROME327 reports
VOMITING321 reports
CONFUSIONAL STATE298 reports
WEIGHT DECREASED291 reports
CONDITION AGGRAVATED290 reports
PRODUCT DOSE OMISSION ISSUE289 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS289 reports
URINARY TRACT INFECTION288 reports
CONSTIPATION283 reports
PAIN283 reports
DYSPHAGIA277 reports
DYSPNOEA261 reports
BALANCE DISORDER253 reports
HEADACHE242 reports
MUSCLE RIGIDITY240 reports
FEELING ABNORMAL238 reports
MOBILITY DECREASED234 reports
GENERAL PHYSICAL HEALTH DETERIORATION226 reports
MEMORY IMPAIRMENT224 reports
LOSS OF CONSCIOUSNESS222 reports
APPLICATION SITE REACTION219 reports
DEPRESSION216 reports
MUSCULOSKELETAL STIFFNESS205 reports
DEVICE ISSUE201 reports
HALLUCINATION, VISUAL201 reports
THERAPY INTERRUPTED199 reports
APPLICATION SITE RASH197 reports
FREEZING PHENOMENON194 reports
PRURITUS194 reports
HYPERHIDROSIS185 reports
RASH184 reports
MUSCLE SPASMS183 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE181 reports
INTENTIONAL PRODUCT MISUSE179 reports
PAIN IN EXTREMITY175 reports
PYREXIA174 reports
HOSPITALISATION172 reports
INCORRECT DOSE ADMINISTERED172 reports
SPEECH DISORDER172 reports
DIARRHOEA166 reports
BRADYKINESIA165 reports
UNEVALUABLE EVENT165 reports
HYPOTENSION161 reports
DECREASED APPETITE158 reports
DRUG INTERACTION154 reports
STOMA SITE DISCHARGE151 reports
DELUSION147 reports
PRODUCT QUALITY ISSUE147 reports
COUGH146 reports
PNEUMONIA ASPIRATION144 reports
ERYTHEMA143 reports
SYNCOPE141 reports
SLEEP DISORDER140 reports
PRODUCT USE ISSUE137 reports
HYPERTENSION135 reports
WEIGHT INCREASED135 reports
PRODUCT AVAILABILITY ISSUE133 reports
DEMENTIA132 reports
AGITATION130 reports
PHARMACEUTICAL PRODUCT COMPLAINT130 reports
DELIRIUM128 reports
THERAPEUTIC RESPONSE SHORTENED125 reports
MUSCULAR WEAKNESS124 reports
PERIPHERAL SWELLING123 reports
DEPRESSED MOOD121 reports
DEVICE DISLOCATION121 reports
DYSTONIA121 reports
MOVEMENT DISORDER121 reports
MYOCARDIAL INFARCTION120 reports
COGNITIVE DISORDER119 reports
APPLICATION SITE IRRITATION118 reports
SEIZURE117 reports
ARTHRALGIA115 reports
BACK PAIN114 reports
COVID 19112 reports
RESTLESSNESS111 reports

Report Outcomes

Out of 13,764 classified reports for ROTIGOTINE:

Serious 62.7%Non-Serious 37.3%

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

Male6,097 (50.3%)
Female6,009 (49.5%)
Unknown26 (0.2%)

Reports by Age

Age 79315 reports
Age 77298 reports
Age 72297 reports
Age 71293 reports
Age 74286 reports
Age 76285 reports
Age 73279 reports
Age 78279 reports
Age 70278 reports
Age 75271 reports
Age 80253 reports
Age 69235 reports
Age 68234 reports
Age 67230 reports
Age 81217 reports
Age 65213 reports
Age 66192 reports
Age 63182 reports
Age 82177 reports
Age 83168 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 ROTIGOTINE?

This profile reflects 28,260 FDA FAERS reports that mention ROTIGOTINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROTIGOTINE?

Frequently reported terms in FAERS include PRODUCT ADHESION ISSUE, DRUG INEFFECTIVE, FALL, DEATH, OFF LABEL USE, PARKINSON^S DISEASE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROTIGOTINE?

Labeling and FAERS entries often list UCB, Inc. in connection with ROTIGOTINE. 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.