Pramexol 0.25 Side Effects

The majority of adverse drug reactions usually start early in therapy and most tend to disappear even as therapy is continued. Within the system organ classes, adverse reactions are listed under headings of frequency, using the following categories: very common; common; uncommon; rare; very rare; not known.
Parkinson's disease, most common adverse reactions: The most commonly reported adverse drug reactions in patients with Parkinson's disease were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue. The incidence of somnolence is increased at doses higher than 1.5 mg pramipexole per day. A more frequent adverse drug reaction in combination with levodopa was dyskinesia. Hypotension may occur at the beginning of treatment, especially if Pramipexole is titrated too fast. (See Table 3.)

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Restless Legs Syndrome, most common adverse reactions: The most commonly reported adverse drug reactions in patients with Restless Legs Syndrome treated with Pramipexole were nausea, headache, dizziness and fatigue. Nausea and fatigue were more often reported in female patients treated with Pramexol compared to males. (See Table 4.)

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Description of selected adverse reactions: Somnolence: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes.
Libido disorders: Pramipexole may uncommonly be associated with libido disorders (increased or decreased).
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Pramexol.
Possible independent risk factors for impulse control disorders included dopaminergic treatments and higher doses of dopaminergic treatment, younger age (≤65 years), not being married and self-reported family history of gambling behaviors.
Dopamine agonist withdrawal syndrome: Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including pramipexole. Symptoms include apathy, anxiety, depression, fatigue, sweating and pain.
Cardiac failure: Cardiac failure has been reported in patients with pramipexole.