Pramipexole Side Effects

Brand Names: Mirapex, Mirapex ER

Please note - some side effects for Pramipexole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Pramipexole - for the Consumer

Pramipexole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pramipexole:

Abnormal dreams; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; stuffy nose; tiredness; trouble sleeping; upset stomach; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Pramipexole:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; balance problems; change in behavior, mood, or emotions; chest pain; confusion; decreased sexual ability; difficulty walking; fainting; hallucinations; increased urination; memory loss; muscle pain, tenderness, or weakness; new or unusual skin growths; severe or persistent drowsiness or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; swelling of the arms or legs; trouble swallowing; unusual or intense urges (eg, gambling, sexual urges); unusual twitching or muscle movements; vision changes; vivid dreams or daydreams.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Pramipexole Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pramipexole Extended-Release Tablets:

Constipation; cough; dizziness; drowsiness; dry mouth; muscle spasms; nausea; stomach pain or upset; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Pramipexole Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; balance problems; change in behavior, mood, or emotions; chest pain; confusion; decreased sexual ability; difficulty walking; fainting; hallucinations; increased urination; memory loss; muscle pain, tenderness, or weakness; new or unusual skin growths; severe or persistent drowsiness or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; swelling of the arms or legs; trouble swallowing; unusual or intense urges (eg, gambling, sexual urges); unusual twitching or muscle movements; vision changes; vivid dreams or daydreams.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Pramipexole Side Effects - for the Professional

Pramipexole

 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 Pramipexole dihydrochloride tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations.

Approximately 12% of 388 patients with early Parkinson's disease and treated with Pramipexole dihydrochloride 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 Pramipexole dihydrochloride tablets vs 0.4% on placebo]; dizziness [2.1% on Pramipexole dihydrochloride tablets vs 1% on placebo]; somnolence [1.6% on Pramipexole dihydrochloride tablets vs 0% on placebo]; extrapyramidal syndrome [1.6% on Pramipexole dihydrochloride tablets vs 6.4% on placebo]; headache and confusion [1.3% and 1%, respectively, on Pramipexole dihydrochloride tablets vs 0% on placebo]); and gastrointestinal system (nausea [2.1% on Pramipexole dihydrochloride tablets vs 0.4% on placebo]).

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

Table 1 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 Pramipexole dihydrochloride 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 1 Treatment-Emergent Adverse-Event* Incidence in Double-Blind, Placebo-Controlled Trials in Early Parkinson's Disease (Events ≥1% of Patients Treated with Pramipexole Dihydrochloride Tablets and Numerically More Frequent Than in the Placebo Group)

*Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.
Body System/Adverse Event	Pramipexole Dihydrochloride 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

 

Other events reported by 1% or more of patients with early Parkinson's disease and treated with Pramipexole dihydrochloride 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, pruritis, 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 Pramipexole dihydrochloride 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 Pramipexole dihydrochloride 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 Pramipexole dihydrochloride tablets vs 0.4% on placebo]; dyskinesia [1.9% on Pramipexole dihydrochloride tablets vs 0.8% on placebo]; extrapyramidal syndrome [1.5% on Pramipexole dihydrochloride tablets vs 4.9% on placebo]; dizziness [1.2% on Pramipexole dihydrochloride tablets vs 1.5% on placebo]; confusion [1.2% on Pramipexole dihydrochloride tablets vs 2.3% on placebo]); and cardiovascular system (postural [orthostatic] hypotension [2.3% on Pramipexole dihydrochloride tablets vs 1.1% on placebo]).

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

Table 2 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 Pramipexole dihydrochloride tablets and were numerically more frequent than in the placebo group. In these studies, Pramipexole dihydrochloride 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 2 Treatment-Emergent Adverse-Event* Incidence in Double-Blind, Placebo-Controlled Trials in Advanced Parkinson's Disease (Events ≥1% of Patients Treated with Pramipexole Dihydrochloride Tablets and Numerically More Frequent than in the Placebo Group)

* 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.
Body System/ Adverse Event	Pramipexole Dihydrochloride†  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

Other events reported by 1% or more of patients with advanced Parkinson's disease and treated with Pramipexole dihydrochloride 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.

General

Adverse Events; Relationship to Age, Gender, and Race

Among the treatment-emergent adverse events in patients treated with Pramipexole dihydrochloride 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. Less than 4% of patients enrolled were non-Caucasian, therefore, an evaluation of adverse events related to race is not possible.

Other Adverse Events Observed During Phase 2 and 3 Clinical Trials

Pramipexole dihydrochloride tablets have been administered to 1620 Parkinson's disease 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 Pramipexole dihydrochloride tablets are listed below. The reported events below are included without regard to determination of a causal relationship to Pramipexole dihydrochloride 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 leiomyome

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, pollaciuria, 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 apnea 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

Falling Asleep During Activities of Daily Living

Patients treated with Pramipexole dihydrochloride tablets have reported falling asleep while engaged in activities of daily living, including operation of a motor vehicle which sometimes resulted in accidents.

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 Pramipexole dihydrochloride 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 events were grouped into a smaller number of standardized categories using the MedDRA dictionary: abnormal behavior, abnormal dreams, accidents (including fall), blackouts, fatigue, hallucinations (all kinds), headache, hypotension (including postural hypotension), increased eating (including binge eating, compulsive eating, and hyperphagia), libido disorders (including increased and decreased libido, and hypersexuality), pathological gambling, syncope, and weight increase.

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Side Effects by Body System - for Healthcare Professionals

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.

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 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.

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

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%).

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.

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.

Genitourinary

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

Musculoskeletal

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

Ocular

Ocular side effects have included accommodation abnormalities (4%), vision abnormalities (3%), and diplopia (1%).

Dermatologic

Dermatological side effects have included skin disorders (2%).

Respiratory

Respiratory side effects have included dyspnea (4%), rhinitis (3%), pneumonia (2%), and nasopharyngitis.

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.

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) have been reported during postmarketing experience.

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.

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