ROPARK XL (Requip XL)2 mg – 50 tablet

Data inclusive of trials in early Parkinson disease (PD) without levodopa and restless legs syndrome (RLS). Extended-release data from trials in early PD without levodopa. As reported with immediate-release formulation, unless otherwise noted.

>10%:

Cardiovascular: Hypotension (RLS: ≤25%; PD: 2%), orthostatic hypotension (RLS: ≤25%; PD: 6%; extended release: 14%), hypertension (PD: 5%; extended release: 3% to 15%), syncope (PD: ≤12%; RLS: 1% to 2%; sometimes associated with bradycardia)

Central nervous system: Drowsiness (PD: ≤40%; extended release: 8% to 15%; RLS: 12%), dizziness (PD: 40%; extended release: 6% to 10%; RLS: 11%), headache (PD, extended release: 5% to 15%)

Gastrointestinal: Nausea (PD: 60%; RLS: 40%; extended release: 10% to 33%), vomiting (PD: 12%; extended release: 10%; RLS: 11%)

Infection: Viral infection (PD: 11%)

Neuromuscular & skeletal: Asthenia (PD: 16%; RLS: 9%), back pain (PD, extended release: 5% to 15%)

1% to 10%:

Cardiovascular: Lower extremity edema (PD: 7%), dependent edema (PD: 6%), chest pain (PD: 4%), flushing (PD: 3%), palpitations (PD: 3%), peripheral ischemia (PD: 3%), atrial fibrillation (PD: 2%), extrasystoles (PD: 2%), peripheral edema (RLS: 2%), tachycardia (PD: 2%)

Central nervous system: Pain (PD: 8%), confusion (PD: 5%), hallucination (PD: 5%), narcolepsy (PD, extended release: 5% to 10%), hypoesthesia (PD: 4%), amnesia (PD: 3%), paresthesia (RLS: 3%), yawning (PD: 3%), lack of concentration (PD: 2%), vertigo (2%)

Dermatologic: Diaphoresis (PD: 6%), hyperhidrosis (RLS: 3%)

Gastrointestinal: Dyspepsia (PD: 10%; RLS: 4%), abdominal pain (PD: 6% to 7%; includes immediate release and extended release), constipation (PD, extended release: 5%), diarrhea (RLS: 5%), xerostomia (PD: 5%; RLS: 3%), anorexia (PD: 4%), flatulence (PD: 3%), upper abdominal pain (RLS: 3%)

Genitourinary: Urinary tract infection (PD: 5%), impotence (PD: 3%)

Hepatic: Increased serum alkaline phosphatase (PD: 3%)

Infection: Influenza (RLS: 3%)

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (PD, extended release: 10%), arthralgia (RLS: 4%), limb pain (RLS: 3%), muscle cramps (RLS: 3%), hyperkinetic muscle activity (PD: 2%)

Ophthalmic: Visual disturbance (PD: 6%), eye disease (PD: 3%), xerophthalmia (PD: 2%)

Respiratory: Nasopharyngitis (RLS: 9%), pharyngitis (PD: 6%), rhinitis (PD: 4%), sinusitis (PD: 4%), bronchitis (PD: 3%), cough (RLS: 3%), dyspnea (PD: 3%), nasal congestion (RLS: 2%)

<1%: Pleural effusion

Postmarketing: Aggressive behavior, agitation, behavioral problems, delirium, delusion, disorientation, heart valve disease, impulse control disorder (Bastiaens 2013; Corvol 2018), interstitial pulmonary disease, mental status changes, paranoid ideation, pleuropulmonary fibrosis, psychiatric disturbance, psychosis