Summary
Commonly reported side effects of ropinirole include: syncope, dizziness, drowsiness, dyskinesia, fatigue, nausea, orthostatic hypotension, viral infection, decreased blood pressure, decreased pulse, and increased pulse. Other side effects include: asthenia, confusion, lower extremity edema, hallucination, hypotension, systolic hypertension, vertigo, and diaphoresis. Continue reading for a comprehensive list of adverse effects.
Applies to ropinirole: oral extended-release tablets, oral immediate-release tablets.
Side effects include:
Patients with early parkinson disease receiving immediate-release tablets (without levodopa): Nausea, somnolence, dizziness, syncope, asthenic condition, viral infection, leg edema, vomiting, dyspepsia.
Patients with early parkinson disease receiving extended-release tablets: Nausea, somnolence, sudden onset of sleep, hypertension, headache, abdominal pain/discomfort, dizziness, constipation.
Patients with advanced parkinson disease receiving immediate-release tablets (with concomitant levodopa): Dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, headache.
Patients with advanced parkinson disease receiving extended-release tablets: Nausea, dyskinesia, dizziness, hallucinations.
Patients with RLS receiving immediate-release tablets: Nausea, somnolence, vomiting, dizziness, fatigue.
For Healthcare Professionals
Applies to ropinirole: oral kit, oral tablet, oral tablet extended release.
Gastrointestinal
Parkinson's disease:
Very common (10% or more): Nausea (up to 60%), vomiting (up to 12%)
Common (1% to 10%): Dry mouth, abdominal pain, anorexia, dyspepsia, flatulence, constipation, diarrhea, dysphagia, increased saliva, heartburn
Restless Leg Syndrome:
Very common (10% or more): Nausea (up to 40%), vomiting (up to 12.9%)
Common (1% to 10%): Diarrhea, dyspepsia, dry mouth, abdominal pain upper
Uncommon (0.1% to 1%):[Ref]
Nervous system
Parkinson's disease
Very common (10% or more): Dizziness (40%), somnolence (40%), dyskinesia (34%), headache (17%)
Common (1% to 10%): Hyperkinesia, hypesthesia, hypokinesia, paresis, paresthesia, tremor
Uncommon (0.1% to 1%): Sudden onset of sleep, excessive daytime somnolence
Restless Leg Syndrome:
Very common (10% or more): Headache (up to 22.3%), somnolence (12%), dizziness (up to 12.9%)
Common (1% to 10%): Paresthesia, migraine, paradoxical augmentation and rebound of restless leg syndrome[Ref]
Psychiatric
Parkinson's disease
Very common (10% or more): Hallucination (10%)
Common (1% to 10%): Amnesia, impaired concentration, confusion, amnesia, anxiety, abnormal dreaming, nervousness
Uncommon (0.1% to 1%): Psychotic reactions other than hallucinations, included delirium, delusions, paranoia
Frequency not reported: Aggression
Postmarketing reports: Impulse control disorders included pathological gambling and hypersexuality and increased libido
Restless Leg Syndrome:
Common (1% to 10%): Nervousness
Postmarketing reports: Impulse control disorders included pathological gambling and hypersexuality and increased libido[Ref]
Cardiovascular
Parkinson's disease:
Very common (10% or more): Syncope (up to 12%)
Common (1% to 10%): Hypertension, hypotension, orthostatic symptoms, chest pain, dependent edema, leg edema, flushing, extrasystoles, atrial fibrillation, palpitation, tachycardia, peripheral ischemia
Restless Leg Syndrome:
Common (1% to 10%): Syncope
Uncommon (0.1% to 1%): Orthostatic hypotension, peripheral edema
Frequency not reported: Hypotension[Ref]
Immunologic
Common (1% to 10%): Influenza, viral infection[Ref]
General
The most commonly reported adverse reaction reported in patients with early Parkinson's disease included nausea, somnolence, dizziness, syncope, asthenic conditions, viral infection, leg edema, vomiting, and dyspepsia. Among patients with advance Parkinson's disease, the more commonly reported adverse reactions included dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache.
The most commonly reported adverse reactions in patients with restless legs syndrome included nausea, vomiting, somnolence, dizziness, and a asthenic condition.[Ref]
Respiratory
Parkinson's disease
Common (1% to 10%): Yawning, upper respiratory tract infection, dyspnea, bronchitis, pharyngitis, rhinitis, sinusitis
Restless Leg Syndrome:
Very common (10% or more): Upper respiratory infection (10.7%)
Common (1% to 10%): Nasopharyngitis, cough, nasal congestion, rhinitis, sinusitis[Ref]
Ocular
Parkinson's disease:
Common (1% to 10%): Eye abnormality, abnormal vision, xerophthalmia, diplopia[Ref]
Metabolic
Parkinson's disease
Common (1% to 10%): Decreased weight[Ref]
Genitourinary
Common (1% to 10%): Impotence, urinary tract infection, pyuria, urinary incontinence, urinary tract infection[Ref]
Other
Parkinson's disease
Very common (10% or more): Asthenic condition (16%)
Common (1% to 10%): Pain, vertigo
Restless Leg Syndrome:
Very common (10% or more): Fatigue (10.4%)
Common (1% to 10%): Asthenic condition, vertigo
Postmarketing reports:[Ref]
Asthenic conditions include asthenia, fatigue, and/or malaise[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia, arthritis, extremity pain, back pain, injury, myalgia[Ref]
Dermatologic
Common (1% to 10%): Increased sweating[Ref]
Hematologic
Parkinson's disease
Common (1% to 10%): Anemia[Ref]
Hepatic
Parkinson's disease
Common (1% to 10%): Increased alkaline phosphatase
Frequency not reported: Increased liver enzymes[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions including urticarial, angioedema, rash, pruritus[Ref]
