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

Summary

Common side effects of Mirapex ER include: drowsiness, visual hallucination, constipation, and insomnia. Other side effects include: xerostomia. Continue reading for a comprehensive list of adverse effects.

Applies to pramipexole: oral tablet, oral tablet extended release.

Serious side effects of Mirapex ER

Along with its needed effects, pramipexole (the active ingredient contained in Mirapex ER) 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 suddenly from a sitting/lying position
• drowsiness
• nausea
• seeing, hearing, or feeling things that are not there
• trouble sleeping
• twitching, twisting, or other unusual body movements
• unusual tiredness or weakness

Less common

• Chest tightness
• 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
• swelling of the body
• trouble breathing
• 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
• swelling of the arms or legs

Incidence not known

• Discouragement
• feeling sad or empty
• lack of appetite
• lack of feeling or emotion
• loss of interest or pleasure
• sweating
• trouble concentrating
• uncaring

Other side effects of Mirapex ER

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
• joint pain
• loss of appetite
• runny nose
• skin rash, itching
• weight loss

For Healthcare Professionals

Applies to pramipexole: oral tablet, oral tablet extended release.

General

The most common adverse reactions occurring in early Parkinson's disease when used without levodopa were somnolence, insomnia, nausea, constipation, dizziness, fatigue, asthenia, hallucinations, dry mouth, muscle spasms, and peripheral edema. In advanced Parkinson's disease when used with levodopa, the more common adverse reactions included postural hypotension, dyskinesia, extrapyramidal syndrome, insomnia, abnormal dreams, confusion, asthenia, dystonia, somnolence, hypertonia, dry mouth, amnesia, urinary frequency, dizziness, nausea, constipation, hallucinations, headache, and anorexia.

The most common adverse reactions occurring in patients receiving treatment for Restless Legs Syndrome were nausea, somnolence, fatigue, and headache.^[Ref]

Nervous system

Early Parkinson's disease:

Very common (10% or more): Somnolence (up to 36%), dizziness (up to 25%), dyskinesia (17%)

Common (1% to 10%): Headache, hypesthesia, dystonia, myoclonus, akathisia, tremor, balance disorder, amnesia, abnormal thinking

Frequency not reported: Restlessness

Advanced Parkinson's disease:

Very common (10% or more): Dyskinesia (up to 47%), extrapyramidal syndrome (28%), dizziness (up to 26%),

Common (1% to 10%): Somnolence, dystonia, gait abnormalities, hypertonia, headache

Restless Legs Syndrome:

Very common (10% or more): Augmentation (12%), headache (17%)

Common (1% to 10%): Worsening of Restless Legs Syndrome, somnolence

Uncommon (0.1% to 1%): Dyskinesia

Postmarketing reports: Amnesia, hyperkinesia^[Ref]

In a 26-week clinical trial, worsening of Restless Legs Syndrome (RLS) occurred in 10% of patients suddenly withdrawn from pramipexole 0.75 mg once a day compared to 2% of placebo patients; the RLS symptoms were generally considered mild. Augmentation was reported in 12% and 9% of patients receiving pramipexole 0.75 mg once a day and placebo, respectively. The incidence of augmentation increased with increasing duration of exposure.^[Ref]

Psychiatric

Parkinson's disease:

Very common (10% or more): Hallucinations (17%), insomnia (27%), dream abnormalities (11%), confusion (10%)

Common (1% to 10%): Paranoid reaction, delusions, confusion, sleep attacks, sleep disorder, depression

Uncommon (0.1% to 1%): Hypersexuality, pathological gambling, delirium

Rare (less than 0.1%): Mania

Frequency not reported: Impulse control/compulsive behaviors

Postmarketing reports: New or worsening mental status and behavioral changes, binge eating, compulsive shopping

Restless Legs Syndrome:

Very common (10% or more): Insomnia (up to 13%)

Common (1% to 10%): Abnormal dreams

Uncommon (0.1% to 1%): Hypersexuality, pathological gambling, delirium

Rare (less than 0.1%): Mania

Frequency not reported: Impulse control/compulsive behaviors

Postmarketing reports: New or worsening mental status and behavioral changes, binge eating, compulsive shopping^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (28%), constipation (14%)

Common (1% to 10%): Dysphagia, dry mouth, diarrhea, dyspepsia, vomiting, upper abdominal pain, abdominal discomfort, salivary hypersecretion

Uncommon (0.1% to 1%): Hiccup

Frequency not reported: Hyperphagia

Postmarketing reports: Peritoneal fibrosis^[Ref]

Nausea and vomiting were commonly reported early in therapy and resolved with continued therapy. While there have been postmarketing reports of fibrotic complications including peritoneal fibrosis, pleural fibrosis, and pulmonary fibrosis, the evidence is not sufficient to establish a causal relationship with use of this drug; however a contribution of treatment cannot be completely ruled out.^[Ref]

Cardiovascular

Very common (10% or more): Postural hypotension (up to 53%)

Common (1% to 10%): Chest pain, general edema

Postmarketing reports: Cardia failure, syncope^[Ref]

Cardiovascular side effects have included orthostatic hypotension, with or without symptoms, although the overall incidence was not significantly different from that in placebo-treated patients. In advanced Parkinson's disease trials, postural hypotension was reported in 53% (n=260) of patients receiving immediate-release pramipexole compared with 48% (n=264) of patients receiving placebo. In fixed-dose trials in early Parkinson's disease, orthostatic hypotension was shown to be dose related with a frequency 2-fold greater than placebo for doses greater than 1.5 mg/day. Among patients with advanced Parkinson's disease treated concomitantly with levodopa, orthostatic hypotension was reported much more frequently than in those with early disease and not receiving levodopa.

In a pharmacoepidemiology study, pramipexole use was associated with an increased risk of cardiac failure compared with non-use (observed risk ratio: 1.86; 95% confidence interval, 1.21 to 2.85).^[Ref]

Genitourinary

Common (1% to 10%): Urinary frequency, urinary tract infection, urinary incontinence, impotence^[Ref]

Musculoskeletal

Common (1% to 10%): Arthritis, twitching, bursitis, myasthenia, extremity pain, back pain, muscle spasms, increased creatine phosphokinase

Very rare (less than 0.01%): Rhabdomyolysis

Postmarketing reports: Postural deformity^[Ref]

One case of rhabdomyolysis occurred in a 49- year old male patient with advanced Parkinson's disease receiving pramipexole. His creatinine phosphokinase level was elevated to 10,631 IU/L. His symptoms resolved with discontinuation of the medication.^[Ref]

Ocular

Common (1% to 10%): Vision abnormalities, accommodation abnormalities, diplopia,

Frequency not reported: Blurred vision^[Ref]

Dermatologic

Common (1% to 10%): Skin disorders

Frequency not reported: Pruritus

Postmarketing reports: Skin reactions (including erythema, rash, pruritus, urticaria)^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, rhinitis, pneumonia, nasal congestion, cough

Uncommon (0.1% to 1%): Pneumonia

Postmarketing reports: Pleural fibrosis, pulmonary fibrosis^[Ref]

There have been postmarketing reports of fibrotic complications including peritoneal fibrosis, pleural fibrosis, and pulmonary fibrosis, the evidence is not sufficient to establish a causal relationship with use of this drug; however a contribution of treatment cannot be completely ruled out.^[Ref]

Metabolic

Common (1% to 10%): Decreased weight, increased appetite, anorexia

Postmarketing reports: Increased weight^[Ref]

Other

Very common (10% or more): Asthenia (up to 14%)

Common (1% to 10%): Malaise, fever, vertigo^[Ref]

Endocrine

Frequency not reported: Libido disorders

Postmarketing reports: Inappropriate antidiuretic hormone secretion (SIADH)^[Ref]

Hypersensitivity

Frequency not reported: Rash and other hypersensitivity reactions^[Ref]

Immunologic

Common (1% to 10%): Influenza^[Ref]