Pramipexole (Mirapexin, Sifrol) side effects have been documented since its initial approval in the late 1990s, with common ones like nausea and dizziness identified early in clinical trials, followed by post-marketing additions such as impulse control disorders and fibrosis. No exhaustive public chronological timeline exists, but regulatory labels (FDA, EMA) show progressive updates from trials to ongoing surveillance.singlecare+4
Initial labels focused on frequent reactions from Parkinson's trials: nausea (most common), dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucinations, headache, and fatigue.medicines+2
Orthostatic hypotension, amnesia, and dose-related issues like somnolence appeared in fixed-dose studies around this period.accessdata.fda
Post-approval reports added peripheral edema, hyperalgesia, weight changes, sudden sleep onset, falling asleep without warning, and fibrotic complications (e.g., peritoneal/pleural fibrosis, rhabdomyolysis).accessdata.fda+2
Dopamine agonist withdrawal syndrome (apathy, anxiety, depression, pain) and compulsive behaviors/impulse control loss emerged in updates.singlecare+1
Current SmPCs include augmentation/rebound in RLS, delayed effects like memory impairment and neuroleptic malignant syndrome-like withdrawal, plus less common ones: chest tightness, confusion, cough, double vision, fearfulness, muscle weakness, and skin rash.ema.europa+3
EMA/FDA labels continue refining frequencies, e.g., hallucinations and dyskinesia as ≥5% in advanced Parkinson's.medicines+1
Dopamine Justice Alliance