Sifrol Adverse Reactions

Tabulated summary of adverse reactions: The following adverse reactions have been reported during use of Sifrol in the clinical trials and in the post-marketing experience. (See Table 3.)

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Description of selected adverse reactions: Sudden onset of sleep and somnolence: Patients treated with pramipexole have reported falling asleep during activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Some of them did not report a warning sign such as somnolence, which is a common occurrence in patients receiving pramipexole, and which, according to the current knowledge of sleep physiology, always proceeds falling asleep. There was no clear relation to the duration of treatment. Some patients were taking other medications with potentially sedative properties. In most cases where information was available, there were no further episodes following reduction of dosage or termination of therapy.
Hypotension: The incidence of hypotension under Sifrol, compared to placebo treatment, was not increased. However, in individual patients, hypotension may occur at the beginning of treatment, especially if Sifrol is titrated too rapidly.
Libido disorders: Sifrol may be associated with disorders of libido (increase or decrease).
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 (see Warnings and Precautions).
Cardiac Failure: In clinical studies and post-marketing experience cardiac failure has been reported in patients with pramipexole. In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole. A causal relationship between pramipexole and cardiac failure has not been demonstrated.