Mirapex ER Side Effects

Generic name: pramipexole

Note: This document contains side effect information about pramipexole. Some of the dosage forms listed on this page may not apply to the brand name Mirapex ER.

Some side effects of Mirapex ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pramipexole: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking pramipexole (the active ingredient contained in Mirapex ER) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking pramipexole and call your doctor at once if you have any of these serious side effects:

• extreme drowsiness, falling asleep suddenly, even after feeling alert;

• nausea, sweating, feeling light-headed, fainting;

• hallucinations;

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;

• chest pain, cough with white or pink phlegm (mucus), wheezing;

• feeling short of breath (even with mild exertion), swelling, rapid weight gain;

• feeling weak or tired, loss of appetite, rapid weight loss;

• fast or uneven heartbeats; or

• tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Less serious side effects of pramipexole may include:

• dry mouth, stomach pain, vomiting, constipation;

• headache, dizziness, spinning sensation;

• mild drowsiness;

• swelling in your hands or feet;

• appetite or weight changes;

• blurred vision;

• sleep problems (insomnia), unusual dreams;

• amnesia, forgetfulness, thinking problems; or

• impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pramipexole: oral tablet, oral tablet extended release

General

In general, adverse experiences affecting the body as a whole include asthenia (14%), edema (5%) and malaise (2%). Postmarketing side effects have included chest discomfort, chills, death, drug withdrawal syndrome, face edema, feeling cold, feeling hot, feeling jittery, fever, gait disturbance, impaired healing, influenza-like illness, irritability, localized edema, pitting edema, and thirst.

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 (the active ingredient contained in Mirapex ER) 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 (22% to 24%), constipation (12% to 14%), anorexia (4%), and dysphagia (2%), dry mouth (4% to 5%), vomiting (4%), upper abdominal pain (3% to 4%), and abdominal discomfort (1% to 2%).

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. Postmarketing side effects reported have included angina pectoris, arrhythmia supraventricular, atrial fibrillation, atrioventricular block first degree, atrioventricular block second degree, bradycardia, bundle branch block, cardiac arrest, cardiac failure, cardiac failure congestive, cardiomegaly, coronary artery occlusion, cyanosis, extrasystoles, left ventricular failure, myocardial infarction, nodal arrhythmia, sinus arrhythmia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachycardia, tachycardia, ventricular fibrillation, ventricular extrasystoles, and ventricular hypertrophy.

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%). Laboratory studies have revealed accommodation abnormalities, amaurosis fugax, blepharitis, blepharospasm, cataract, dacryostenosis acquired, diplopia, dry eye, eye hemorrhage, eye irritation, eye pain, eyelid edema, eyelid ptosis, glaucoma, keratitis, macular degeneration, myopia, photophobia, retinal detachment, retinal vascular disorder, scotoma, vision abnormalities, vision blurred, visual acuity reduced, and vitreous floaters.

Dermatologic

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

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 (including visual, auditory, and mixed), increased eating (including binge eating, compulsive eating, and hyperphagia), pathological gambling, depression, anxiety, restlessness, and sleep attacks or sudden onset of sleep.

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) and compulsive shopping 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%. If withdrawal of dopaminergic therapy is suspected as the cause of NMS, dopaminergic therapy should be reinstituted. If a neuroleptic agent is suspected as the cause, the neuroleptic agent should be immediately discontinued and consideration given to dantrolene or bromocriptine administration. Intensive monitoring and supportive care are indicated for all patients with NMS.

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