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Mirapex ER

Last reviewed on RxList: 1/26/2016
Mirapex ER Side Effects Center

Last reviewed on RxList 01/27/2017

Mirapex ER (pramipexole dihydrochloride) is a dopamine agonist used alone or with other medications to treat Parkinson's disease. Mirapex ER is also used to treat restless legs syndrome (RLS). Common side effects of Mirapex ER include:

  • drowsiness,
  • nausea,
  • stomach pain,
  • vomiting,
  • constipation,
  • headache,
  • dry mouth,
  • dizziness,
  • spinning sensation,
  • swelling in your hands or feet,
  • appetite or weight changes,
  • blurred vision,
  • sleep problems (insomnia),
  • unusual dreams,
  • amnesia,
  • forgetfulness,
  • thinking problems,
  • impotence,
  • loss of interest in sex, or
  • trouble having an orgasm.

Tell your doctor if you have unlikely but serious side effects of Mirapex ER including:

The recommended dose of Mirapex ER is one extended-release tablet taken orally once daily, with or without food. Mirapex ER may interact with cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxants, anti-seizure medications, antidepressants, anti-anxiety medications, alcohol, or other medications that can make you drowsy. Tell your doctor all medications and supplements you take. Do not drive, use machinery, or do any activity that requires alertness while taking Mirapex ER. Talk to your doctor if you become pregnant or plan to become pregnant while taking Mirapex ER. During pregnancy, this medication should be used only when clearly needed. Consult your doctor before using Mirapex ER if you are breastfeeding.

Our Mirapex ER (Pramipexole Dihydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Mirapex ER Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Mirapex ER (Pramipexole Dihydrochloride Extended-Release Tablets)

Mirapex ER Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
  • Symptomatic Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
  • Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Hallucinations and Psychotic-like Behavior [see WARNINGS AND PRECAUTIONS]
  • Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Rhabdomyolysis [see WARNINGS AND PRECAUTIONS]
  • Retinal Pathology [see WARNINGS AND PRECAUTIONS]
  • Events Reported with Dopaminergic Therapy [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.

During the premarketing development of MIRAPEX ER tablets, patients with early Parkinson's disease were treated with MIRAPEX ER tablets, placebo, or immediate-release pramipexole tablets. In addition, a randomized, double-blind, parallel group trial was conducted in 156 early Parkinson's disease patients (Hoehn & Yahr Stages I-III) to assess overnight switching of immediate-release pramipexole tablets to MIRAPEX ER tablets. In this latter study, concomitant treatment with stable doses of levodopa, monoamine oxidase B inhibitor (MAOB-I) drugs, anticholinergics, or amantadine, individually or in combination, was allowed. In a third trial, advanced Parkinson's disease patients received MIRAPEX ER tablets, placebo, or immediate-release pramipexole tablets as adjunctive therapy to levodopa.

Early Parkinson's Disease

The most common adverse reactions ( ≥ 5% and more frequent than placebo) after 33 weeks of treatment with MIRAPEX ER tablets in the trial of early Parkinson's disease patients were somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema.

Twenty four of 223 (11%) patients treated with MIRAPEX ER tablets for 33 weeks discontinued treatment due to adverse reactions compared to 4 of 103 (4%) patients who received placebo and approximately 20 of 213 (9%) patients who received immediate-release pramipexole tablets. The adverse reaction most commonly causing discontinuation of treatment with MIRAPEX ER tablets was nausea (2%).

Table 1 lists adverse reactions that occurred with a frequency of at least 2% with MIRAPEX ER and were more frequent than with placebo during 33 weeks of treatment in a double-blind, placebo-controlled study in early Parkinson's disease. In this study, patients did not receive concomitant levodopa; however, levodopa was permitted as rescue medication.

Table 1 : Adverse-Reactions in a 33-Week Double-Blind, Placebo-Controlled Trial with MIRAPEX ER in Early Parkinson's Disease

Body System/Adverse Reaction Placebo
(n=103) %
MIRAPEX ER
(n=223) %
Immediate-Release Pramipexole
(n=213) %
Nervous system disorders
  Somnolence 15 36 33
  Dizziness 7 12 12
  Tremor 1 3 3
  Balance disorder 1 2 0
Gastrointestinal disorders
  Nausea 9 22 24
  Constipation 2 14 12
  Dry mouth 1 5 4
  Vomiting 0 4 4
  Upper abdominal pain 1 3 4
  Dyspepsia 2 3 3
  Abdominal discomfort 0 2 1
Psychiatric disorders
  Hallucinations, including visual, auditory and mixed 1 5 6
  Insomnia 3 4 4
  Sleep attacks or sudden onset of sleep 1 3 6
  Sleep disorder 1 2 3
  Depression 0 2 0
General disorders and administration site conditions
  Fatigue 4 6 6
  Peripheral edema 4 5 8
  Asthenia 2 3 1
Musculoskeletal and connective tissue disorders
  Muscle spasms 3 5 3
Injury, poisoning and procedural complications
  Fall 1 4 4
Ear and labyrinth disorders
  Vertigo 1 4 2
Respiratory, thoracic and mediastinal disorders
  Cough 1 3 3
Metabolism and nutrition disorders
  Increased appetite 1 3 2
Vascular disorders
  Orthostatic hypotension 1 3 0

Because this study used a flexible dose titration design, it was not possible to assess the effects of dose on the incidence of adverse reactions.

Adverse reactions can initially occur in either the titration or maintenance phase. Some adverse reactions developed in MIRAPEX ER-treated patients during the titration phase and SHUVLVWHG .7 days) into the maintenance phase (i.e., MIRAPEX ER % -SODFHER WUHDWPHQW GLIIHUHQFH . SHUVLVWHQW DGYHUVH reactions were somnolence, nausea, constipation, fatigue, and dry mouth.

A double-blind, randomized, parallel group trial evaluated the tolerability of an overnight switch from immediate-release pramipexole tablets to MIRAPEX ER tablets at the same daily dose in 156 early Parkinson's disease patients with or without levodopa. One of 104 patients switched from immediate-release pramipexole tablets to MIRAPEX ER tablets discontinued due to adverse reactions (vertigo and nausea).

Advanced Parkinson's Disease

The most common adverse reactions . DQG JUHDWHU IUHTXHQF\ WKDQ LQ SODFHER GXULQJ ZHHNV RI WUHDWPHQW with MIRAPEX ER tablets in the trial of advanced Parkinson's disease patients with concomitant levodopa were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.

Eight of 164 (5%) patients treated with MIRAPEX ER tablets for 18 weeks discontinued treatment due to adverse reactions compared to 7 of 178 (4%) patients who received placebo and 8 of 175 (5%) patients who received immediate-release pramipexole tablets. The most common adverse reactions leading to discontinuation of treatment with MIRAPEX ER tablets were nausea (1%) and hallucination (1%).

Table 2 lists adverse reactions that occurred with a frequency of at least 2% with MIRAPEX ER and were more frequent than with placebo during 18 weeks of treatment in patients with advanced Parkinson's disease treated with MIRAPEX ER tablets. In this study, MIRAPEX ER tablets, immediate-release pramipexole tablets, or placebo was administered to patients who were also receiving concomitant levodopa.

Table 2 : Adverse-Reactions in an 18-Week Double-Blind, Placebo-Controlled Trial with MIRAPEX ER in Advanced Parkinson's Disease

Body System/Adverse Reaction Placebo
n=178 %
MIRAPEX ER
n=164 %
Immediate-Release Pramipexole
n=175 %
Nervous system disorders
  Dyskinesia 8 17 18
  Headache 3 7 4
  Dizziness (postural) 1 2 3
Gastrointestinal disorders
  Nausea 10 11 11
  Constipation 5 7 6
  Salivary hypersecretion 0 2 0
  Diarrhea 1 2 1
Psychiatric disorders
  Hallucinations, including visual, auditory and mixed 2 9 7
  Insomnia 2 4 4
Metabolism and nutrition disorders
  Anorexia 2 5 1
Musculoskeletal and connective tissue disorders
  Back pain 1 2 3

Because this flexible dose study used a titration design, it was not possible to assess the effects of dose on the incidence of adverse reactions.

Adverse reactions can initially occur in either the titration or maintenance phase. Some adverse reactions developed in MIRAPEX ER-treated patients during the titration phase and pHUVLVWHG . GD\V LQWR WKH maintenance phase (i.e., MIRAPEX ER % -SODFHER WUHDWPHQW GLIIHUHQFH. SHUVLVWHQW DGYHUVH reactions were dyskinesia and insomnia.

Laboratory Tests

During the development of MIRAPEX ER tablets, no systematic abnormalities on routine laboratory testing were noted.

Other adverse reactions observed during clinical trials of MIRAPEX immediate-release or MIRAPEX ER in early and advanced Parkinson's disease

Other adverse reactions in clinical studies involving MIRAPEX immediate-release or MIRAPEX ER tablets include abnormal dreams, akathisia, amnesia, decreased libido, decreased weight, dyspnea, pneumonia, and vision abnormalities.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of MIRAPEX immediate-release or MIRAPEX ER tablets, primarily in Parkinson's disease patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to pramipexole tablets. Similar types of reactions were grouped into a smaller number of standardized categories using the MedDRA terminology: cardiac failure, inappropriate antidiuretic hormone secretion (SIADH), skin reactions (including erythema, rash, pruritus, urticaria), syncope, vomiting, and weight increase.

Read the entire FDA prescribing information for Mirapex ER (Pramipexole Dihydrochloride Extended-Release Tablets)

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Read the Mirapex ER User Reviews »

© Mirapex ER Patient Information is supplied by Cerner Multum, Inc. and Mirapex ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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