Pramipexole Side Effects

Brand Names: Mirapex

Please note - some side effects for Pramipexole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pramipexole - for the Consumer

Pramipexole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pramipexole:

Abnormal dreams; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; stuffy nose; tiredness; trouble sleeping; upset stomach; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; change in behavior, mood, or emotions; chest pain; confusion; decreased sexual ability; difficulty walking; fainting; hallucinations; increased urination; memory loss; muscle pain, tenderness, or weakness; new or unusual skin growths; severe or persistent drowsiness or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; swelling of the arms or legs; trouble swallowing; unusual or intense urges (eg, gambling, sexual urges); unusual twitching or muscle movements; vision changes; vivid dreams or daydreams.

Side Effects by Body System

General

In general, adverse experiences affecting the body as a whole include asthenia (14%), edema (5%) and malaise (2%).

Nervous system

Nervous system side effects have been reported frequently during clinical trials and were cited as the primary reason for discontinuation of therapy. Dizziness (25%), somnolence (6% to 22%), insomnia (17%), and hallucinations (9%) have been reported in patients on pramipexole monotherapy. Dyskinesia and extrapyramidal syndrome were most often observed in patients with advanced Parkinson's disease treated concomitantly with levodopa, occurring in 47% and 28% of these patients, respectively. Confusion (4%), amnesia (4%), hypesthesia (3%), dystonia (2%), akathisia (2%), thinking abnormalities (2%), decreased libido (1%), myoclonus (1%), sudden sleep attacks, and headache have also been reported. Syncope and libido disorders (including increased libido and hypersexuality) have been reported during postmarketing experience.

The risk for developing hallucinations appears to be greater in elderly patients over 65 years of age.

Gastrointestinal

Gastrointestinal side effects have been reported frequently. These have included nausea (16% to 28%), constipation (14%), anorexia (4%), and dysphagia (2%), diarrhea, and dry mouth.

Taking pramipexole with food may lessen the nausea.

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension, with or without symptoms, in pramipexole-treated patients during clinical trials, although the overall incidence was not significantly different from that in placebo-treated patients. Nevertheless, orthostatic hypotension is considered a side effect of dopaminergic therapy in general, especially during the early stages of treatment.

In clinical trials, orthostatic hypotension was reported much more frequently among patients with advanced Parkinson's disease treated concomitantly with levodopa than those with early disease and not receiving levodopa.

Genitourinary

Genitourinary side effects have included urinary frequency (6%), urinary tract infection (4%), urinary incontinence (2%), and impotence (2%).

Musculoskeletal

Musculoskeletal side effects have been reported rarely. An isolated case of rhabdomyolysis has been reported in a patient with advanced Parkinson's disease.

Ocular

Ocular side effects have included accommodation abnormalities (4%), vision abnormalities (3%), and diplopia (1%).

Dermatologic

Dermatological side effects have included skin disorders (2%).

Respiratory

Respiratory side effects have included dyspnea (4%), rhinitis (3%), pneumonia (2%), and nasopharyngitis.

Psychiatric

Psychiatric side effects including at least one case of mania have been reported. Abnormal behavior, abnormal dreams, hallucinations (all kinds), increased eating (including binge eating, compulsive eating, and hyperphagia), and pathological gambling have been reported during postmarketing experience.

A 41-year-old female with a history of bipolar II disorder experienced mania coincident with pramipexole therapy. Pramipexole was added to her regimen of valproic acid 750 mg twice daily. The starting dose of 0.125 mg was titrated over a 3-week period to 1.5 mg a day, to which there was a partial response. As the dosage was increased to 2 mg, the patient developed mania characterized by symptoms of euphoria, paranoia, irritability, decreased requirement of sleep, poor judgment, increased libido, and excessive spending of money. The manic symptoms lasted 2 months, but subsided within a week of pramipexole discontinuation.

Metabolic

Metabolic side effects including increased weight have been reported during postmarketing experience.

Other

Other side effects have been reported. Abrupt discontinuation or rapid tapering of dopaminergic therapy has resulted in acute worsening of Parkinsonism or, less frequently, in a syndrome resembling the neuroleptic malignant syndrome. Fatigue has been reported. Blackouts and accidents (including falls) have been reported during postmarketing experience.

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome (NMS). NMS is associated with a case fatality rate of about 20%.

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