Mirapex

Last updated on RxList: 7/21/2021
Mirapex Side Effects Center

What Is Mirapex?

Mirapex (pramipexole) is a dopamine agonist medication used to treat symptoms of Parkinson's disease, and restless legs syndrome.

What Are Side Effects of Mirapex?

Common side effects of Mirapex include:

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

Tell your doctor if you experience serious side effects of Mirapex including extreme drowsiness, falling asleep suddenly, even after feeling alert; nausea, sweating, feeling light-headed, fainting; hallucinations; muscle spasms, muscle pain or tenderness, muscle weakness with fever or flu symptoms and dark colored urine; increased urination, chest pain, cough with white or pink phlegm (mucus), wheezing; shortness of breath (even with mild exertion), swelling, rapid weight gain; weakness, tiredness, 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. It may take a few weeks for full effects of Mirapex to be noticed.

Dosage for Mirapex

Mirapex is taken in tablet form three times per day.

What Drugs, Substances, or Supplements Interact with Mirapex?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can worsen the sleepiness caused by pramipexole. This list is not complete and there may be other drugs that can interact with pramipexole. Alcohol can also increase the side effects.

Mirapex During Pregnancy and Breastfeeding

During pregnancy, this medication should be used only when clearly needed. Although very unlikely, if you suddenly stop taking this drug, withdrawal reactions may occur, including fever and confusion.

Additional Information

Our Mirapex 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.

QUESTION

What kind of disorder is restless leg syndrome (RLS)? See Answer
Mirapex Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • hallucinations (seeing or hearing things that are not real);
  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • tremors, twitching or uncontrollable muscle movements;
  • unexplained muscle pain, tenderness, or weakness;
  • vision problems; or
  • posture changes you cannot control, such as involuntary bending forward of your neck, bending forward at the waist, or tilting sideways when you sit, stand, or walk.

Side effects such as confusion or hallucinations may be more likely in older adults.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common side effects may include:

  • muscle spasm or muscle weakness;
  • drowsiness, dizziness, weakness;
  • confusion, memory problems;
  • dry mouth;
  • nausea, constipation;
  • increased urination; or
  • sleep problems (insomnia), unusual dreams.

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 (Pramipexole)

SLIDESHOW

Sleep Disorders: Insomnia, Sleep Apnea, and More See Slideshow
Mirapex 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].
  • Postural Deformity [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 and may not reflect the rates observed in clinical practice.

Parkinson's Disease

During the premarketing development of pramipexole, patients with either early or advanced Parkinson's disease were enrolled in clinical trials. Apart from the severity and duration of their disease, the two populations differed in their use of concomitant levodopa therapy. Patients with early disease did not receive concomitant levodopa therapy during treatment with pramipexole; those with advanced Parkinson's disease all received concomitant levodopa treatment. Because these two populations may have differential risks for various adverse reactions, this section will, in general, present adverse-reaction data for these two populations separately.

Because the controlled trials performed during premarketing development all used a titration design, with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse reactions.

Early Parkinson's Disease

In the three double-blind, placebo-controlled trials of patients with early Parkinson's disease, the most common adverse reactions (>5%) that were numerically more frequent in the group treated with MIRAPEX tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations.

Approximately 12% of 388 patients with early Parkinson's disease and treated with MIRAPEX tablets who participated in the double-blind, placebo-controlled trials discontinued treatment due to adverse reactions compared with 11% of 235 patients who received placebo. The adverse reactions most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [3.1% on MIRAPEX tablets vs 0.4% on placebo]; dizziness [2.1% on MIRAPEX tablets vs 1% on placebo]; somnolence [1.6% on MIRAPEX tablets vs 0% on placebo]; headache and confusion [1.3% and 1.0%, respectively, on MIRAPEX tablets vs 0% on placebo]) and gastrointestinal system (nausea [2.1% on MIRAPEX tablets vs 0.4% on placebo]).

Adverse-reaction Incidence in Controlled Clinical Studies in Early Parkinson's Disease

Table 4 lists adverse reactions that occurred in the double-blind, placebo-controlled studies in early Parkinson's disease that were reported by ≥1% of patients treated with MIRAPEX tablets and were numerically more frequent than in the placebo group. In these studies, patients did not receive concomitant levodopa.

Table 4 Adverse-Reactions in Pooled Double-Blind, Placebo-Controlled Trials with MIRAPEX in Early Parkinson's Disease

Body System/Adverse ReactionMIRAPEX
(N=388)
%
Placebo
(N=235)
%
Nervous System
  Dizziness2524
  Somnolence229
  Insomnia1712
  Hallucinations93
  Confusion41
  Amnesia42
  Hypesthesia31
  Dystonia21
  Akathisia20
  Thinking abnormalities20
  Decreased libido10
  Myoclonus10
Digestive System
  Nausea2818
  Constipation146
  Anorexia42
  Dysphagia20
Body as a Whole
  Asthenia1412
  General edema53
  Malaise21
  Reaction unevaluable21
  Fever10
Metabolic & Nutritional System
  Peripheral edema54
  Decreased weight20
Special Senses
  Vision abnormalities30
Urogenital System
  Impotence21

In a fixed-dose study in early Parkinson's disease, occurrence of the following reactions increased in frequency as the dose increased over the range from 1.5 mg/day to 6 mg/day: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these reactions was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence with pramipexole at a dose of 1.5 mg/day was comparable to that reported for placebo.

Advanced Parkinson's Disease

In the four double-blind, placebo-controlled trials of patients with advanced Parkinson's disease, the most common adverse reactions (>5%) that were numerically more frequent in the group treated with MIRAPEX tablets and concomitant levodopa were postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency.

Approximately 12% of 260 patients with advanced Parkinson's disease who received MIRAPEX tablets and concomitant levodopa in the double-blind, placebo-controlled trials discontinued treatment due to adverse reactions compared with 16% of 264 patients who received placebo and concomitant levodopa. The reactions most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [2.7% on MIRAPEX tablets vs 0.4% on placebo]; dyskinesia [1.9% on MIRAPEX tablets vs 0.8% on placebo]) and cardiovascular system (postural [orthostatic] hypotension [2.3% on MIRAPEX tablets vs 1.1% on placebo]).

Adverse-reaction Incidence in Controlled Clinical Studies in Advanced Parkinson's Disease

Table 5 lists adverse reactions that occurred in the double-blind, placebo-controlled studies in advanced Parkinson's disease that were reported by ≥1% of patients treated with MIRAPEX tablets and were numerically more frequent than in the placebo group. In these studies, MIRAPEX tablets or placebo was administered to patients who were also receiving concomitant levodopa.

Table 5 Adverse-Reactions in Pooled Double-Blind, Placebo-Controlled Trials with MIRAPEX in Advanced Parkinson's Disease

Body System/Adverse ReactionMIRAPEX
(N=260)
%
Placebo
(N=264)
%
Nervous System
  Dyskinesia4731
  Extrapyramidal syndrome2826
  Insomnia2722
  Dizziness2625
  Hallucinations174
  Dream abnormalities1110
  Confusion107
  Somnolence96
  Dystonia87
  Gait abnormalities75
  Hypertonia76
  Amnesia64
  Akathisia32
  Thinking abnormalities32
  Paranoid reaction20
  Delusions10
  Sleep disorders10
Cardiovascular System
  Postural hypotension5348
Body as a Whole
  Accidental injury1715
  Asthenia108
  General edema43
  Chest pain32
  Malaise32
Digestive System
  Constipation109
  Dry mouth73
Urogenital System
  Urinary frequency63
  Urinary tract infection43
  Urinary incontinence21
Respiratory System
  Dyspnea43
  Rhinitis31
  Pneumonia20
Special Senses
  Accommodation abnormalities42
  Vision abnormalities31
  Diplopia10
Musculoskeletal System
  Arthritis31
  Twitching20
  Bursitis20
  Myasthenia10
Metabolic & Nutritional System
  Peripheral edema21
   Increased creatine PK10
Skin & Appendages
  Skin disorders21

Restless Legs Syndrome

MIRAPEX tablets for treatment of RLS have been evaluated for safety in 889 patients, including 427 treated for over six months and 75 for over one year.

The overall safety assessment focuses on the results of three double-blind, placebo-controlled trials, in which 575 patients with RLS were treated with MIRAPEX tablets for up to 12 weeks. The most common adverse reactions with MIRAPEX tablets in the treatment of RLS (observed in >5% of pramipexole-treated patients and at a rate at least twice that observed in placebo-treated patients) were nausea and somnolence. Occurrences of nausea and somnolence in clinical trials were generally mild and transient.

Approximately 7% of 575 patients treated with MIRAPEX tablets during the double-blind periods of three placebo-controlled trials discontinued treatment due to adverse reactions compared to 5% of 223 patients who received placebo. The adverse reaction most commonly causing discontinuation of treatment was nausea (1%).

Table 6 lists reactions that occurred in three double-blind, placebo-controlled studies in RLS patients that were reported by ≥2% of patients treated with MIRAPEX tablets and were numerically more frequent than in the placebo group.

Table 6 Adverse-Reactions in Pooled Double-Blind, Placebo-Controlled Trials with MIRAPEX in Restless Legs Syndrome

Body System/Adverse ReactionMIRAPEX
0.125 – 0.75 mg/day
(N=575)
%
Placebo
(N=223)
%
Gastrointestinal disorders
  Nausea165
  Constipation41
  Diarrhea31
  Dry mouth31
Nervous system disorders
  Headache1615
  Somnolence63
General disorders and administration site conditions
  Fatigue97
Infections and infestations
  Influenza31

Table 7 summarizes data for adverse reactions that appeared to be dose related in the 12-week fixed dose study.

Table 7 Dose-Related Adverse Reactions in a 12-Week Double-Blind, Placebo-Controlled Fixed Dose Study in Restless Legs Syndrome (Occurring in ≥5% of all Patients in the Treatment Phase)

Body System/Adverse ReactionMIRAPEX
0.25 mg
(N=88)
%
MIRAPEX
0.5 mg
(N=80)
%
MIRAPEX
0.75 mg
(N=90)
%
Placebo
(N=86)
%
Gastrointestinal disorders
  Nausea1119275
  Diarrhea3170
  Dyspepsia3147
Psychiatric disorders
  Insomnia99139
  Abnormal dreams2182
General disorders and administration site conditions
  Fatigue3575
Musculoskeletal and connective tissue disorders
  Pain in extremity3371
Infections and infestations
  Influenza1471
Respiratory, thoracic and mediastinal disorders
  Nasal congestion0361

Adverse Reactions

Relationship to Age, Gender, and Race

Among the adverse reactions in patients treated with MIRAPEX tablets, hallucination appeared to exhibit a positive relationship to age in patients with Parkinson’s disease. Although no gender-related differences were observed in Parkinson’s disease patients, nausea and fatigue, both generally transient, were more frequently reported by female than male RLS patients. Less than 4% of patients enrolled were non-Caucasian: therefore, an evaluation of adverse reactions related to race is not possible.

Laboratory Tests

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

Post Marketing Experience

In addition to the adverse events reported during clinical trials, the following adverse reactions have been identified during post-approval use of MIRAPEX 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.

Cardiac Disorders: cardiac failure

Gastrointestinal Disorders: vomiting

Metabolism and Nutrition Disorders: syndrome of inappropriate antidiuretic hormone secretion (SIADH), weight increase

Musculoskeletal and Connective Tissue Disorders: postural deformity [see WARNINGS AND PRECAUTIONS]

Nervous System Disorders: syncope

Skin and Subcutaneous Tissue Disorders: skin reactions (including erythema, rash, pruritus, urticaria)

Read the entire FDA prescribing information for Mirapex (Pramipexole)

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

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