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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

As well as its needed effects, pramipexole may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pramipexole, check with your doctor immediately:

More common
  • Dizziness, lightheadedness, or fainting, especially when standing up suddenly from a sitting/lying position
  • drowsiness
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • nausea
  • trouble 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
  • swelling of the body
  • tightness in the chest
  • troubled 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

Some pramipexole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

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

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]

Common (1% to 10%): Arthritis, twitching, bursitis, myasthenia, extremity pain, back pain, muscle spasms, increased creatine phosphokinase
Very rare (less than 0.01%): Rhabdomyolysis[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[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]

References

1. "Product Information. Mirapex (pramipexole)." Boehringer Ingelheim, Ridgefield, CT.

2. "Product Information. Mirapex ER (pramipexole)." Boehringer Ingelheim, Ridgefield, CT.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

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