Ropinirole: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Ropinirole. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Nausea60%
Dizziness40%
Somnolence40%
Dyskinesia34%
Headache17%
Syncope12%
Vomiting12%
Fatigue11%
Viral infection11%
Dyspepsia10%
Falls10%
Hallucinations10%
Upper respiratory tract infection9%
Nasopharyngitis9%
Pain8%
Leg edema7%
Increased drug level7%
Arthralgia7%
Increased sweating6%
Asthenia6%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Parkinson’s Disease Ropinirole Hydrochloride Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole Hydrochloride Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials ). Restless Legs Syndrome Ropinirole Hydrochloride Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.

Source: FDA labeling via NIH DailyMed (set c1c74e92…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.