Sifrol Side Effects

Infections and infestations: Pneumonia.
Endocrine disorders: Inappropriate antidiuretic hormone secretion.
Psychiatric disorders: Abnormal behavior (reflecting symptoms of impulse control disorders and compulsions) such as binge eating, compulsive shopping, hyper sexuality and pathological gambling. Abnormal dreams. Confusion. Delusion. Hallucinations. Hyperphagia. Insomnia. Libido disorders. Paranoia. Restlessness.
Nervous system disorders: Amnesia. Dizziness. Dyskinesia. Headache. Hyperkinesia. Somnolence. Sudden onset of sleep. Syncope.
Eye disorders: Visual impairment including diplopia, vision blurred and visual acuity reduced.
Cardiac disorders: Cardiac failure.
Vascular disorders: Hypotension.
Respiratory, thoracic and mediastinal disorders: Dyspnoea. Hiccups. Gastrointestinal disorders: Constipation. Nausea. Vomiting.
Skin and subcutaneous tissue disorders: Hypersensitivity. Pruritus. Rash.
General disorders and administration site conditions: Fatigue. Peripheral oedema.
Investigations: Weight decrease including decreased appetite. Weight increase.
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.
SIFROL may be associated with disorders of libido (increase or decrease).
Patients treated with pramipexole dihydrochloride monohydrate tablets 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 dihydrochloride monohydrate tablets at doses above 1.5 mg/day, 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 medication with potentially sedative properties. In most cases where information was available, there were no further episodes following reduction of dosage or termination of therapy.
Patients treated with dopamine agonists for Parkinson's disease, including SIFROL, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.
In clinical studies and post-marketing experience cardiac failure has been reported in patients with pramipexole dihydrochloride monohydrate. In a pharmacoepidemiological study pramipexole dihydrochloride monohydrate use was associated with an increased risk of cardiac failure compared with non-use of pramipexole dihydrochloride monohydrate. A causal relationship between pramipexole dihydrochloride monohydrate and cardiac failure has not been demonstrated.