Pramipexole Side Effects

It is possible that some side effects of pramipexole may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to pramipexole: oral tablet, oral tablet extended release

Along with its needed effects, pramipexole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pramipexole:

More common
  • Dizziness, lightheadedness, or fainting, especially when standing up
  • drowsiness
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • nausea
  • trouble with sleeping
  • twitching, twisting, or other unusual body movements
  • unusual tiredness or weakness
Less common
  • Confusion
  • cough
  • difficulty with swallowing
  • double vision or other changes in vision
  • falling asleep without warning
  • fearfulness, suspiciousness, or other mental changes
  • fever
  • frequent urination
  • memory loss
  • muscle or joint pain
  • muscle weakness
  • restlessness or need to keep moving
  • shortness of breath
  • swelling of the body
  • tightness in the chest
  • troubled breathing
  • wheezing
  • writhing, twisting, or other unusual body movements
Rare
  • Abnormal thinking
  • anxiety
  • bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • dizziness
  • frequent urge to urinate
  • loss of bladder control
  • mood or mental changes
  • swelling of the arms or legs

Some side effects of pramipexole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • dryness of the mouth
  • headache
  • heartburn, indigestion, or acid stomach
Less common
  • Abnormal dreams
  • decreased sexual drive or ability
  • general feeling of discomfort or illness
  • increased cough
  • increased sweating
  • itching
  • joint pain
  • loss of appetite
  • runny nose
  • skin problems, such as rash or itching
  • weight loss

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 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.

Endocrine

Postmarketing reports: Inappropriate antidiuretic hormone secretion (SIADH)

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