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Mirapex

Last reviewed on RxList: 9/8/2016
Mirapex Side Effects Center

Last reviewed on RxList 7/8/2016

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

Mirapex is taken in tablet form three times per day. 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. 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.

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.

Mirapex 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 (Pramipexole)

Mirapex Professional Information

SIDE EFFECTS

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

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 adversereaction 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 Reaction
MIRAPEX
(N=388) %
Placebo
(N=235) %
Nervous System
  Dizziness 25 24
  Somnolence 22 9
  Insomnia 17 12
  Hallucinations 9 3
  Confusion 4 1
  Amnesia 4 2
  Hypesthesia 3 1
  Dystonia 2 1
  Akathisia 2 0
  Thinking abnormalities 2 0
  Decreased libido 1 0
  Myoclonus 1 0
Digestive System
  Nausea 28 18
  Constipation 14 6
  Anorexia 4 2
  Dysphagia 2 0
Body as a Whole
  Asthenia 14 12
  General edema 5 3
  Malaise 2 1
  Reaction unevaluable 2 1
  Fever 1 0
Metabolic & Nutritional System
  Peripheral edema 5 4
  Decreased weight 2 0
Special Senses
  Vision abnormalities 3 0
Urogenital System
  Impotence 2 1

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 Reaction
MIRAPEX
(N=260) %
Placebo
(N=264) %
Nervous System
  Dyskinesia 47 31
  Extrapyramidal syndrome 28 26
  Insomnia 27 22
  Dizziness 26 25
  Hallucinations 17 4
  Dream abnormalities 11 10
  Confusion 10 7
  Somnolence 9 6
  Dystonia 8 7
  Gait abnormalities 7 5
  Hypertonia 7 6
  Amnesia 6 4
  Akathisia 3 2
  Thinking abnormalities 3 2
  Paranoid reaction 2 0
  Delusions 1 0
  Sleep disorders 1 0
Cardiovascular System
  Postural hypotension 53 48
Body as a Whole
  Accidental injury 17 15
  Asthenia 10 8
  General edema 4 3
  Chest pain 3 2
  Malaise 3 2
Digestive System
  Constipation 10 9
  Dry mouth 7 3
Urogenital System
  Urinary frequency 6 3
  Urinary tract infection 4 3
  Urinary incontinence 2 1
Respiratory System
  Dyspnea 4 3
  Rhinitis 3 1
  Pneumonia 2 0
Special Senses
  Accommodation abnormalities 4 2
  Vision abnormalities 3 1
  Diplopia 1 0
Musculoskeletal System
  Arthritis 3 1
  Twitching 2 0
  Bursitis 2 0
  Myasthenia 1 0
Metabolic & Nutritional System
  Peripheral edema 2 1
  Increased creatine PK 1 0
Skin & Appendages
  Skin disorders 2 1

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 pramipexoletreated 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 Reaction
MIRAPEX 0.125 - 0.75 mg/day
(N=575) %
Placebo
(N=223) %
Gastrointestinal disorders
  Nausea 16 5
  Constipation 4 1
  Diarrhea 3 1
  Dry mouth 3 1
Nervous system disorders
  Headache 16 15
  Somnolence 6 3
General disorders and administration site conditions
  Fatigue 9 7
Infections and infestations
  Influenza 3 1

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 Reaction
MIRAPEX 0.25 mg
(N=88) %
MIRAPEX 0.5 mg
(N=80) %
MIRAPEX 0.75 mg
(N=90) %
Placebo
(N=86) %
Gastrointestinal disorders
  Nausea 11 19 27 5
  Diarrhea 3 1 7 0
  Dyspepsia 3 1 4 7
Psychiatric disorders
  Insomnia 9 9 13 9
  Abnormal dreams 2 1 8 2
General disorders and administration site conditions
  Fatigue 3 5 7 5
Musculoskeletal and connective tissue disorders
  Pain in extremity 3 3 7 1
Infections and infestations
  Influenza 1 4 7 1
Respiratory, thoracic and mediastinal disorders
  Nasal congestion 0 3 6 1

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. 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 (Pramipexole)

Related Resources for Mirapex

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