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Mirapex

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Mirapex

Mirapex Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Mirapex (pramipexole) is a dopamine agonist medication used to treat symptoms of Parkinson's disease. Mirapex is also used to treat restless legs syndrome in addition to Parkinson's disease. The most commonly reported side effects are postural hypotension, nausea, constipation, somnolence, and amnesia. It may take a few weeks for full effects of this medication 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mirapex in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Mirapex Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, dizziness, drowsiness, trouble sleeping, constipation, headache, or dry mouth may occur. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., confusion, depression, hallucinations, memory problems), increased difficulty moving/walking, muscle cramps/spasm, restlessness, decreased sexual ability, increased shakiness (tremor)/stiffness.

Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of the ankles/feet, chest pain, compulsive behaviors (e.g., pathological gambling), fever, unusually fast/slow/irregular heartbeat, muscle pain/weakness, unusual tiredness, change in amount of urine, vision changes.

Some people taking pramipexole have reported falling asleep suddenly during their usual daily activities (e.g., talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur any time during treatment with pramipexole, including up to 1 year after starting the medication. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy. You may also develop a sudden drop in blood pressure, which can cause dizziness, nausea, sweating, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Mirapex (Pramipexole)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mirapex FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 event 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 events, this section will, in general, present adverse-event 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 events.

Early Parkinson's Disease

In the three double-blind, placebo-controlled trials of patients with early Parkinson's disease, the most commonly observed adverse events ( > 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 events compared with 11% of 235 patients who received placebo. The adverse events 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]; extrapyramidal syndrome [1.6% on MIRAPEX tablets vs 6.4% 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-event Incidence in Controlled Clinical Studies in Early Parkinson's Disease: Table 4 lists treatment-emergent adverse events 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. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-event incidence rate in the population studied.

Table 4 : Treatment-Emergent Adverse-Event* Incidence in Double-Blind, Placebo-Controlled Trials in Early Parkinson's Disease (Events ≥ 1% of Patients Treated with MIRAPEX tablets and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event MIRAPEX
(N=388)
%
Placebo
(N=235)
%
Body as a Whole
  Asthenia 14 12
  General edema 5 3
  Malaise 2 1
  Reaction unevaluable 2 1
  Fever 1 0
Digestive System
  Nausea 28 18
  Constipation 14 6
  Anorexia 4 2
  Dysphagia 2 0
Metabolic & Nutritional System  
  Peripheral edema 5 4
  Decreased weight 2 0
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
Special Senses
  Vision abnormalities 3 0
Urogenital System
  Impotence 2 1
*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.

Other events reported by 1% or more of patients with early Parkinson's disease and treated with MIRAPEX tablets but reported equally or more frequently in the placebo group were infection, accidental injury, headache, pain, tremor, back pain, syncope, postural hypotension, hypertonia, depression, abdominal pain, anxiety, dyspepsia, flatulence, diarrhea, rash, ataxia, dry mouth, extrapyramidal syndrome, leg cramps, twitching, pharyngitis, sinusitis, sweating, rhinitis, urinary tract infection, vasodilation, flu syndrome, increased saliva, tooth disease, dyspnea, increased cough, gait abnormalities, urinary frequency, vomiting, allergic reaction, hypertension, pruritus, hypokinesia, increased creatine PK, nervousness, dream abnormalities, chest pain, neck pain, paresthesia, tachycardia, vertigo, voice alteration, conjunctivitis, paralysis, accommodation abnormalities, tinnitus, diplopia, and taste perversions.

In a fixed-dose study in early Parkinson's disease, occurrence of the following events 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 events 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 commonly observed adverse events ( > 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 events compared with 16% of 264 patients who received placebo and concomitant levodopa. The events 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]; extrapyramidal syndrome [1.5% on MIRAPEX tablets vs 4.9% on placebo]; dizziness [1.2% on MIRAPEX tablets vs 1.5% on placebo]; confusion [1.2% on MIRAPEX tablets vs 2.3% on placebo]); and cardiovascular system (postural [orthostatic] hypotension [2.3% on MIRAPEX tablets vs 1.1% on placebo]).

Adverse-event Incidence in Controlled Clinical Studies in Advanced Parkinson's Disease: Table 5 lists treatment-emergent adverse events 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. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-events incidence rate in the population studied.

Table 5 : Treatment-Emergent Adverse-Event* Incidence in Double-Blind, Placebo-Controlled Trials in Advanced Parkinson's Disease (Events ≥ 1% of Patients Treated with MIRAPEX tablets and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event MIRAPEX †
(N=260)
%
Placebo†
(N=264)
%
Body as a Whole
  Accidental injury 17 15
  Asthenia 10 8
  General edema 4 3
  Chest pain 3 2
  Malaise 3 2
Cardiovascular System
  Postural hypotension 53 48
Digestive System
  Constipation 10 9
  Dry mouth 7 3
Metabolic & Nutritional System
  Peripheral edema 2 1
  Increased creatine PK 1 0
Musculoskeletal System
  Arthritis 3 1
  Twitching 2 0
  Bursitis 2 0
  Myasthenia 1 0
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
Respiratory System
  Dyspnea 4 3
  Rhinitis 3 1
  Pneumonia 2 0
Skin & Appendages
  Skin disorders 2 1
Special Senses
  Accommodation abnormalities 4 2
  Vision abnormalities 3 1
  Diplopia 1 0
Urogenital System
  Urinary frequency 6 3
  Urinary tract infection 4 3
  Urinary incontinence 2 1
*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.
†Patients received concomitant levodopa.

Other events reported by 1% or more of patients with advanced Parkinson's disease and treated with MIRAPEX tablets but reported equally or more frequently in the placebo group were nausea, pain, infection, headache, depression, tremor, hypokinesia, anorexia, back pain, dyspepsia, flatulence, ataxia, flu syndrome, sinusitis, diarrhea, myalgia, abdominal pain, anxiety, rash, paresthesia, hypertension, increased saliva, tooth disorder, apathy, hypotension, sweating, vasodilation, vomiting, increased cough, nervousness, pruritus, hypesthesia, neck pain, syncope, arthralgia, dysphagia, palpitations, pharyngitis, vertigo, leg cramps, conjunctivitis, and lacrimation disorders.

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 commonly observed adverse events 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 events compared to 5% of 223 patients who received placebo. The adverse event most commonly causing discontinuation of treatment was nausea (1%).

Table 6 lists treatment-emergent events 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.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-event incidence rate in the population studied.

Table 6 : Treatment-Emergent Adverse-Event* Incidence in Double-Blind, Placebo-Controlled Trials in Restless Legs Syndrome (Events ≥ 2% of Patients Treated with MIRAPEX tablets and Numerically More Frequent than in the Placebo Group)

Body System/ Adverse Event 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
General disorders and administration site conditions
  Fatigue 9 7
Infections and infestations
  Influenza 3 1
Nervous system disorders
  Headache 16 15
  Somnolence 6 3
*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.

Other events reported by 2% or more of RLS patients treated with MIRAPEX tablets but reported equally or more frequently in the placebo group, were: vomiting, nasopharyngitis, back pain, pain in extremity, dizziness, and insomnia. Table 7 summarizes data for adverse events that appeared to be dose related in the 12-week fixed dose study.

Table 7 : Dose-Related Adverse Events 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 Event 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
Infections and infestations
  Influenza 1 4 7 1
General disorders and administration site conditions
  Fatigue 3 5 7 5
Psychiatric disorders  
  Insomnia 9 9 13 9
  Abnormal dreams 2 1 8 2
Respiratory, thoracic and mediastinal disorders
  Nasal congestion 0 3 6 1
Musculoskeletal and connective tissue disorders
  Pain in extremity 3 3 7 1

 

General

Adverse Events: Relationship to Age, Gender, and Race

Among the treatment-emergent adverse events 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 events related to race is not possible.

Laboratory Tests

During the development of MIRAPEX tablets, no systematic abnormalities on routine laboratory testing were noted. Therefore, no specific guidance is offered regarding routine monitoring; the practitioner retains responsibility for determining how best to monitor the patient in his or her care.

Other Adverse Events Observed During Phase 2 and 3 Clinical Trials

MIRAPEX tablets have been administered to 1620 Parkinson's disease patients and to 889 RLS patients in Phase 2 and 3 clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing; similar types of events were grouped into a smaller number of standardized categories using MedDRA dictionary terminology. These categories are used in the listing below. Adverse events which are not listed above but occurred on at least two occasions (one occasion if the event was serious) in the 2509 individuals exposed to MIRAPEX tablets are listed below. The reported events below are included without regard to determination of a causal relationship to MIRAPEX tablets.

Blood and lymphatic system disorders: anemia, iron deficiency anemia, leukocytosis, leukopenia, lymphadenitis, lymphadenopathy, thrombocythaemia, thrombocytopenia

Cardiac disorders: 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, ventricular hypertrophy

Congenital, familial and genetic disorders: atrial septal defect, congenital foot malformation, spine malformation

Ear and labyrinth disorders: deafness, ear pain, hearing impaired, hypoacusis, motion sickness, vestibular ataxia

Endocrine disorders: goiter, hyperthyroidism, hypothyroidism

Eye disorders: amaurosis fugax, blepharitis, blepharospasm, cataract, dacryostenosis acquired, 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 blurred, visual acuity reduced, vitreous floaters

Gastrointestinal disorders: abdominal discomfort, abdominal distension, aphthous stomatitis, ascites, cheilitis, colitis, colitis ulcerative, duodenal ulcer, duodenal ulcer hemorrhage, enteritis, eructation, fecal incontinence, gastric ulcer, gastric ulcer hemorrhage, gastritis, gastrointestinal hemorrhage, gastroesophageal reflux disease, gingivitis, haematemesis, haematochezia, hemorrhoids, hiatus hernia, hyperchlorhydria, ileus, inguinal hernia, intestinal obstruction, irritable bowel syndrome, esophageal spasm, esophageal stenosis, esophagitis, pancreatitis, periodontitis, rectal hemorrhage, reflux esophagitis, tongue edema, tongue ulceration, toothache, umbilical hernia

General disorders: chest discomfort, chills, death, drug withdrawal syndrome, face edema, feeling cold, feeling hot, feeling jittery, gait disturbance, impaired healing, influenza-like illness, irritability, localized edema, edema, pitting edema, thirst

Hepatobiliary disorders: biliary colic, cholecystitis, cholecystitis chronic, cholelithiasis

Immune system disorders: drug hypersensitivity

Infections and infestations: abscess, acute tonsillitis, appendicitis, bronchiolitis, bronchitis, bronchopneumonia, cellulitis, cystitis, dental caries, diverticulitis, ear infection, eye infection, folliculitis, fungal infection, furuncle, gangrene, gastroenteritis, gingival infection, herpes simplex, herpes zoster, hordeolum, intervertebral discitis, laryngitis, lobar pneumonia, nail infection, onychomycosis, oral candidiasis, orchitis, osteomyelitis, otitis externa, otitis media, paronychia, pyelonephritis, pyoderma, sepsis, skin infection, tonsillitis, tooth abscess, tooth infection, upper respiratory tract infection, urethritis, vaginal candidiasis, vaginal infection, viral infection, wound infection

Injury, poisoning and procedural complications: accidental falls, drug toxicity epicondylitis, road traffic accident, sunburn, tendon rupture

Metabolism and nutrition disorders: cachexia, decreased appetite, dehydration, diabetes mellitus, fluid retention, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, hypovitaminosis, increased appetite, metabolic alkalosis

Musculoskeletal and connective tissue disorders: bone pain, fasciitis, flank pain, intervertebral disc disorder, intervertebral disc protrusion, joint effusion, joint stiffness, joint swelling, monarthritis, muscle rigidity, muscle spasms, musculoskeletal stiffness, myopathy, myositis, nuchal rigidity, osteoarthritis, osteonecrosis, osteoporosis, polymyalgia, rheumatoid arthritis, shoulder pain, spinal osteoarthritis, tendonitis, tenosynovitis

Neoplasms benign, malignant and unspecified: abdominal neoplasm, adenocarcinoma, adenoma benign, basal cell carcinoma, bladder cancer, breast cancer, breast neoplasm, chronic lymphocytic leukemia, colon cancer, colorectal cancer, endometrial cancer, gallbladder cancer, gastric cancer, gastrointestinal neoplasm, hemangioma, hepatic neoplasm, hepatic neoplasm malignant, lip and/or oral cavity cancer, lung neoplasm malignant, lung cancer metastatic, lymphoma, malignant melanoma, melanocytic naevus, metastases to lung, multiple myeloma, oral neoplasm benign, neoplasm, neoplasm malignant, neoplasm prostate, neoplasm skin, neuroma, ovarian cancer, prostate cancer, prostatic adenoma, pseudo lymphoma, renal neoplasm, skin cancer, skin papilloma, squamous cell carcinoma, thyroid neoplasm, uterine leiomyoma

Nervous system disorders: ageusia, akinesia, anticholinergic syndrome, aphasia, balance disorder, brain edema, carotid artery occlusion, carpal tunnel syndrome, cerebral artery embolism, cerebral hemorrhage, cerebral infarction, cerebral ischemia, chorea, cognitive disorder, coma, convulsion, coordination abnormal, dementia, depressed level of consciousness, disturbance in attention, dizziness postural, dysarthria, dysgraphia, facial palsy, grand mal convulsion, hemiplegia, hyperaesthesia, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, lethargy, loss of consciousness, memory impairment, migraine, muscle contractions involuntary, narcolepsy, neuralgia, neuropathy, nystagmus, parosmia, psychomotor hyperactivity, sciatica, sedation, sensory disturbance, sleep phase rhythm disturbance, sleep talking, stupor, syncope vasovagal, tension headache

Psychiatric disorders: affect lability, aggression, agitation, bradyphrenia, bruxism, suicide, delirium, delusional disorder persecutory type, disorientation, dissociation, emotional distress, euphoric mood, hallucination auditory, hallucination visual, initial insomnia, libido increased, mania, middle insomnia, mood altered, nightmare, obsessive thoughts, obsessive-compulsive disorder, panic reaction, parasomnia, personality disorder, psychotic disorder, restlessness, sleep walking, suicidal ideation

Renal and urinary disorders: chromaturia, dysuria, glycosuria, hematuria, urgency, nephrolithiasis, neurogenic bladder, nocturia, oliguria, pollakiuria, proteinuria, renal artery stenosis, renal colic, renal cyst, renal failure, renal impairment, urinary retention

Reproductive system and breast disorders: amenorrhea, breast pain, dysmenorrhea, epididymitis, gynaecomastia, menopausal symptoms, menorrhagia, metrorrhagia, ovarian cyst, priapism, prostatitis, sexual dysfunction, uterine hemorrhage, vaginal discharge, vaginal hemorrhage

Respiratory, thoracic and mediastinal disorders: apnea, aspiration, asthma, choking, chronic obstructive pulmonary disease, dry throat, dysphonia, dyspnea exertional, epistaxis, haemoptysis, hiccups, hyperventilation, increased bronchial secretion, laryngospasm, nasal dryness, nasal polyps, obstructive airways disorder, pharyngolaryngeal pain, pleurisy, pneumonia aspiration, pneumothorax, postnasal drip, productive cough, pulmonary embolism, pulmonary edema, respiratory alkalosis, respiratory distress, respiratory failure, respiratory tract congestion, rhinitis allergic, rhinorrhea, sinus congestion, sleep apnoea syndrome, sneezing, snoring, tachypnea, wheezing

Skin and subcutaneous tissue disorders: acne, alopecia, cold sweat, dermal cyst, dermatitis, dermatitis bullous, dermatitis contact, dry skin, ecchymosis, eczema, erythema, hyperkeratosis, livedo reticularis, night sweats, periorbital edema, petechiae, photosensitivity allergic reaction, psoriasis, purpura, rash erythematous, rash maculo-papular, rash papular, rosacea, seborrhea, seborrheic dermatitis, skin burning sensation, skin discoloration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, skin irritation, skin nodule, skin odor abnormal, skin ulcer, urticaria

Vascular disorders: aneurysm, angiopathy, arteriosclerosis, circulatory collapse, deep vein thrombosis, embolism, hematoma, hot flush, hypertensive crisis, lymphoedema, pallor, phlebitis, Raynaud's phenomenon, shock, thrombophlebitis, thrombosis, varicose vein

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 events 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: abnormal behavior, abnormal dreams, accidents (including fall), blackouts, compulsive shopping, fatigue, hallucinations (all kinds), headache, hypotension (including postural hypotension), inappropriate antidiuretic hormone secretion (SIADH), increased eating (including binge eating, compulsive eating, and hyperphagia), libido disorders (including increased and decreased libido, and hypersexuality), pathological gambling, pruritus, syncope, vomiting, and weight increase.

Read the entire FDA prescribing information for Mirapex (Pramipexole) »

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Mirapex - User Reviews

Mirapex User Reviews

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Here is a collection of user reviews for the medication Mirapex sorted by most helpful. Patient Discussions FAQs

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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