Pergolide Side Effects

Brand Names: Permax

Please note - some side effects for Pergolide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Pergolide - for the Consumer

Pergolide Mesylate

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 Pergolide Mesylate:

Anxiety; constipation; diarrhea; difficulty sleeping; dizziness; drowsiness; dry mouth; lightheadedness; loss of appetite; nausea; pain; runny nose; stomach pain; stomach upset.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; increased jerking movements; leg or foot swelling; seeing or hearing strange things (hallucinations); severe dizziness or lightheadedness; trouble breathing; unusual weakness; unusually slow, fast, or irregular heartbeat.

Pergolide Side Effects - for the Professional

Pergolide

Commonly Observed

In premarketing clinical trials, the most commonly observed adverse events associated with use of Pergolide mesylate which were not seen at an equivalent incidence among placebo-treated patients were: nervous system complaints, including dyskinesia, hallucinations, somnolence, insomnia; digestive complaints, including nausea, constipation, diarrhea, dyspepsia; and respiratory system complaints, including rhinitis.

Associated with Discontinuation of Treatment

Twenty-seven percent (27%) of approximately 1,200 patients receiving Pergolide mesylate for treatment of Parkinson’s disease in premarketing clinical trials in the U.S. and Canada discontinued treatment due to adverse events. The events most commonly causing discontinuation were related to the nervous system (15.5%), primarily hallucinations (7.8%) and confusion (1.8%).

Fatalities - See WARNINGS.

Incidence in Controlled Clinical Trials

The table that follows enumerates adverse events that occurred at a frequency of 1% or more among patients taking Pergolide mesylate who participated in the premarketing controlled clinical trials comparing Pergolide mesylate with placebo. In a double-blind, controlled study of 6 months’ duration, patients with Parkinson’s disease were continued on l-dopa/carbidopa and were randomly assigned to receive either Pergolide mesylate or placebo as additional therapy.

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

Events Observed During the Premarketing Evaluation of Pergolide Mesylate

This section reports event frequencies evaluated as of October 1988 for adverse events occurring in a group of approximately 1,800 patients who took multiple doses of Pergolide mesylate. The conditions and duration of exposure to Pergolide mesylate varied greatly, involving well-controlled studies as well as experience in open and uncontrolled clinical settings. In the absence of appropriate controls in some of the studies, a causal relationship between these events and treatment with Pergolide mesylate cannot be determined.

The following enumeration by organ system describes events in terms of their relative frequency of reporting in the data base. Events of major clinical importance are also described in the WARNINGS and PRECAUTIONS sections.

The following definitions of frequency are used: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole– Frequent: headache, asthenia, accidental injury, pain, abdominal pain, chest pain, back pain, flu syndrome, neck pain, fever; Infrequent: facial edema, chills, enlarged abdomen, malaise, neoplasm, hernia, pelvic pain, sepsis, cellulitis, moniliasis, abscess, jaw pain, hypothermia; Rare: acute abdominal syndrome, LE syndrome.

Cardiovascular System– Frequent: postural hypotension, syncope, hypertension, palpitations, vasodilatations, congestive heart failure; Infrequent: myocardial infarction, tachycardia, heart arrest, abnormal electrocardiogram, angina pectoris, thrombophlebitis, bradycardia, ventricular extrasystoles, cerebrovascular accident, ventricular tachycardia, cerebral ischemia, atrial fibrillation, varicose vein, pulmonary embolus, AV block, shock; Rare: vasculitis, pulmonary hypertension, pericarditis, migraine, heart block, cerebral hemorrhage.

Digestive System– Frequent: nausea, vomiting, dyspepsia, diarrhea, constipation, dry mouth, dysphagia; Infrequent: flatulence, abnormal liver function tests, increased appetite, salivary gland enlargement, thirst, gastroenteritis, gastritis, periodontal abscess, intestinal obstruction, nausea and vomiting, gingivitis, esophagitis, cholelithiasis, tooth caries, hepatitis, stomach ulcer, melena, hepatomegaly, hematemesis, eructation; Rare: sialadenitis, peptic ulcer, pancreatitis, jaundice, glossitis, fecal incontinence, duodenitis, colitis, cholecystitis, aphthous stomatitis, esophageal ulcer.

Endocrine System– Infrequent: hypothyroidism, adenoma, diabetes mellitus, ADH inappropriate; Rare: endocrine disorder, thyroid adenoma.

Hemic and Lymphatic System– Frequent: anemia; Infrequent: leukopenia, lymphadenopathy, leukocytosis, thrombocytopenia, petechia, megaloblastic anemia, cyanosis; Rare: purpura, lymphocytosis, eosinophilia, thrombocythemia, acute lymphoblastic leukemia, polycythemia, splenomegaly.

Metabolic and Nutritional System– Frequent: peripheral edema, weight loss, weight gain; Infrequent: dehydration, hypokalemia, hypoglycemia, iron deficiency anemia, hyperglycemia, gout, hypercholesteremia; Rare: electrolyte imbalance, cachexia, acidosis, hyperuricemia.

Musculoskeletal System– Frequent: twitching, myalgia, arthralgia; Infrequent: bone pain, tenosynovitis, myositis, bone sarcoma, arthritis; Rare: osteoporosis, muscle atrophy, osteomyelitis.

Nervous System– Frequent: dyskinesia, dizziness, hallucinations, confusion, somnolence, insomnia, dystonia, paresthesia, depression, anxiety, tremor, akinesia, extrapyramidal syndrome, abnormal gait, abnormal dreams, incoordination, psychosis, personality disorder, nervousness, choreoathetosis, amnesia, paranoid reaction, abnormal thinking; Infrequent: akathisia, neuropathy, neuralgia, hypertonia, delusions, convulsion, libido increased, euphoria, emotional lability, libido decreased, vertigo, myoclonus, coma, apathy, paralysis, neurosis, hyperkinesia, ataxia, acute brain syndrome, torticollis, meningitis, manic reaction, hypokinesia, hostility, agitation, hypotonia; Rare: stupor, neuritis, intracranial hypertension, hemiplegia, facial paralysis, brain edema, myelitis, hallucinations and confusion after abrupt discontinuation.

Respiratory System– Frequent: rhinitis, dyspnea, pneumonia, pharyngitis, cough increased; Infrequent: epistaxis, hiccup, sinusitis, bronchitis, voice alteration, hemoptysis, asthma, lung edema, pleural effusion, laryngitis, emphysema, apnea, hyperventilation; Rare: pneumothorax, lung fibrosis, larynx edema, hypoxia, hypoventilation, hemothorax, carcinoma of lung.

Skin and Appendages System– Frequent: sweating, rash; Infrequent: skin discoloration, pruritus, acne, skin ulcer, alopecia, dry skin, skin carcinoma, seborrhea, hirsutism, herpes simplex, eczema, fungal dermatitis, herpes zoster; Rare: vesiculobullous rash, subcutaneous nodule, skin nodule, skin benign neoplasm, lichenoid dermatitis.

Special Senses System– Frequent: abnormal vision, diplopia; Infrequent: otitis media, conjunctivitis, tinnitus, deafness, taste perversion, ear pain, eye pain, glaucoma, eye hemorrhage, photophobia, visual field defect; Rare: blindness, cataract, retinal detachment, retinal vascular disorder.

Urogenital System– Frequent: urinary tract infection, urinary frequency, urinary incontinence, hematuria, dysmenorrhea; Infrequent: dysuria, breast pain, menorrhagia, impotence, cystitis, urinary retention, abortion, vaginal hemorrhage, vaginitis, priapism, kidney calculus, fibrocystic breast, lactation, uterine hemorrhage, urolithiasis, salpingitis, pyuria, metrorrhagia, menopause, kidney failure, breast carcinoma, cervical carcinoma; Rare: amenorrhea, bladder carcinoma, breast engorgement, epididymitis, hypogonadism, leukorrhea, nephrosis, pyelonephritis, urethral pain, uricaciduria, withdrawal bleeding.

Postintroduction Reports - Voluntary reports of adverse events temporally associated with Pergolide that have been received since market introduction and which may have no causal relationship with the drug, include the following: neuroleptic malignant syndrome.

Side Effects by Body System

Gastrointestinal

Gastrointestinal adverse effects are commonly seen during pergolide therapy. Nausea occurs in up to 25% of patients treated and may abate with continued therapy. Also, diarrhea, dyspepsia, abdominal pain, vomiting, and constipation are reported less commonly.

Nervous system

Nervous system adverse effects are also commonly associated with pergolide therapy. Most patients experience an increase in dyskinesias with pergolide. Dizziness and somnolence occurs in approximately 11% of patients treated. Less commonly, insomnia, headache, anxiety, depression, and tremor occur. Hallucinations and confusion have been reported in approximately 14% of patients receiving pergolide and in a few patients following abrupt withdrawal. Two cases of sleep attacks have been reported in patients receiving pergolide. Sleep attacks have also been reported in a number of other patients receiving dopamine agonists.

The incidence of hallucinations appears to be dose-related. Patients experiencing hallucinations during pergolide therapy may benefit from a dose reduction, however, often this is at the expense of control of Parkinson's Disease. In some patients, it is possible to increase the dose beyond the originally toxic dose without reoccurrence of hallucinations after a temporary decrease with resolutions of the side effects. Hallucinations following withdrawal of pergolide have been reported to persist for several weeks.

Cardiovascular

Cardiovascular side effects have included rare reports of pleuritis, pleural effusion, pleural fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves or retroperitoneal fibrosis. The adverse effects reported at an incidence of greater than 1% (n=189) among patients taking pergolide when compared to placebo include: postural hypotension, vasodilation, palpitations, orthostatic hypotension, syncope, hypertension, arrhythmia, and myocardial infarction. Peripheral edema is occasionally reported. Angina has been reported in a few patients.

Symptomatic postural hypotension is most commonly seen during initial therapy. Most patients become tolerant of this effect if begun on low doses and titrated up gradually over a period of three to four weeks.

Patients who experience angina in clinical trials have responded to a decrease in the dose. A possible association between pergolide and the development of ventricular arrhythmias was seen in a few patients during clinical trials. Although this association has not been verified, caution is recommended when high doses of pergolide are used in patients with cardiac disease.

The valvulopathy reported with pergolide has involved aortic, mitral and tricuspid valves. In some cases this side effect resolved with cessation of pergolide therapy. Valve replacement was required in two patients.

In a letter to the Healthcare Professional issued by Eli Lilly and Company last February 10, 2003, it states that of the estimated 500,000 people who have been treated with pergolide since the drug was launched in the United States in 1989, valvulopathy has been reported in less than 0.005%.

Dermatologic

Dermatologic abnormalities reported in patients receiving pergolide occasionally include erythema of the lower extremities, or erythromelalgia. This erythema may be very warm or painful.

Hematologic

Hematologic abnormalities associated with pergolide therapy include anemia. Leukopenia has been reported infrequently.

Respiratory

Respiratory adverse effects occasionally include dyspnea and nasal congestion.

Musculoskeletal

Musculoskeletal adverse effects may rarely include muscle cramps, arthralgia, and myalgias.

Ocular

Ocular adverse effects may include diplopia or vision changes in 2% to 6% of patients treated with pergolide.

Renal

Urinary tract infections, urinary frequency, urinary incontinence, and hematuria are reported in approximately 3% of pergolide-treated patients.

Other

Other adverse effects of pergolide may include flu-like syndrome, and fever.

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