Mirapex ER Side Effects

Generic Name: pramipexole

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

Not all side effects for Mirapex ER may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to pramipexole: oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by pramipexole (the active ingredient contained in Mirapex ER). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking pramipexole:

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 of the side effects that can occur with pramipexole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.[Ref]

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.[Ref]

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

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%).[Ref]

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.[Ref]

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.[Ref]

Genitourinary

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

Musculoskeletal

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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Endocrine

Postmarketing reports: Inappropriate antidiuretic hormone secretion (SIADH)

References

1. "Product Information. Mirapex (pramipexole)." Pharmacia and Upjohn, Kalamazoo, MI.

2. Ondo WG, Dat Vuong K, Khan H, Atassi F, Kwak C, Jankovic J "Daytime sleepiness and other sleep disorders in Parkinson's disease." Neurology 57 (2001): 1392-6

3. "Pramipexole (Mirapex) for restless legs syndrome." Med Lett Drugs Ther 49 (2007): 26-8

4. Hobson DE, Lang AE, Martin WR, Razmy A, Rivest J, Fleming J "Excessive daytime sleepiness and sudden-onset sleep in Parkinson disease: a survey by the Canadian Movement Disorders Group." JAMA 287 (2002): 455-63

5. Avorn J, Schneeweiss S, Sudarsky LR, et al. "Sudden uncontrollable somnolence and medication use in Parkinson disease." Arch Neurol 62 (2005): 1242-8

6. Winkelman JW, Sethi KD, Kushida CA, et al. "Efficacy and safety of pramipexole in restless legs syndrome." Neurology 67 (2006): 1034-9

7. Iwasaki S, Hamaguchi K, Iwasaki A, Takakusagi M, Narabayashi Y "Hypotensive effect of long-term levodopa in patients with Parkinson's disease." Eur Neurol 30 (1990): 194-9

8. Hoehn MM "Levodopa-induced postural hypotension. Treatment with fludrocortisone." Arch Neurol 32 (1975): 50-1

9. Sharma V, Smith A "A case of mania following the use of pramipexole." Am J Psychiatry 164 (2007): 351

10. Sechi GP, Tanda F, Mutani R "Fatal hyperpyrexia after withdrawal of levodopa." Neurology 34 (1984): 249-51

11. Gibb WR, Griffith DN "Levodopa withdrawal syndrome identical to neuroleptic malignant syndrome." Postgrad Med J 62 (1986): 59-60

12. Rainer C, Scheinost NA, Lefeber EJ "Neuroleptic malignant syndrome. When levodopa withdrawal is the cause." Postgrad Med 89 (1991): 175-8,

13. Figa-Talamanca L, Gualandi C, Di Meo L, Di Battista G, Neri G, Lo Russo F "Hyperthermia after discontinuance of levodopa and bromocriptine therapy: impaired dopamine receptors a possible cause." Neurology 35 (1985): 258-61

14. Turjanski N, Fernandez W, Lees AJ "The effects of acute levodopa withdrawal on motor performance and dopaminergic receptor sensitivity in patients with Parkinson's disease." J Neurol Neurosurg Psychiatry 56 (1993): 771-5

15. Genis D "Neuroleptic malignant syndrome: impaired dopaminergic systems?" Neurology 35 (1985): 1806

16. Friedman JH, Feinberg SS, Feldman RG "A neuroleptic malignantlike syndrome due to levodopa therapy withdrawal." JAMA 254 (1985): 2792-5

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