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adverse reactions
ADVERSE REACTIONS 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 reported by at least 1% of patients receiving pergolide mesylate are included. Percentage of Patients Reporting Events Body System/ Adverse Event* Pergolide Mesylate N = 189 Placebo N = 187 Body as Hyperlink Whole Pain 7.0 2.1 Abdominal pain 5.8 2.1 Injury, accident 5.8 7.0 Headache 5.3 6.4 Asthenia 4.2 4.8 Chest pain 3.7 2.1 Flu syndrome 3.2 2.1 Neck pain 2.7 1.6 Back pain 1.6 2.1 Surgical procedure 1.6 < 1 Chills 1.1 0 Face edema 1.1 0 Infection 1.1 0 Cardiovascular Postural hypotension 9.0 7.0 Vasodilation 3.2 < 1 Palpitation 2.1 < 1 Hypotension 2.1 < 1 Syncope 2.1 1.1 Hypertension 1.6 1.1 Arrhythmia 1.1 < 1 Myocardial infarction 1.1 < 1 Digestive Nausea 24.3 12.8 Constipation 10.6 5.9 Diarrhea 6.4 2.7 Dyspepsia 6.4 2.1 Anorexia 4.8 2.7 Dry Mouth 3.7 < 1 Vomiting 2.7 1.6 Hemic and Lymphatic Anemia 1.1 < 1 Metabolic and Nutritional Peripheral edema 7.4 4.3 Edema 1.6 0 Weight gain 1.6 0 Musculoskeletal Arthralgia 1.6 2.1 Bursitis 1.6 < 1 Myalgia 1.1 < 1 Twitching 1.1 0 Nervous System Dyskinesia 62.4 24.6 Dizziness 19.1 13.9 Hallucinations 13.8 3.2 Dystonia 11.6 8.0 Confusion 11.1 9.6 Somnolence 10.1 3.7 Insomnia 7.9 3.2 Anxiety 6.4 4.3 Tremor 4.2 7.5 Depression 3.2 5.4 Abnormal dreams 2.7 4.3 Personality disorder 2.1 < 1 Psychosis 2.1 0 Abnormal gait 1.6 1.6 Akathisia 1.6 0 Extrapyramidal syndrome 1.6 1.1 Incoordination 1.6 < 1 Paresthesia 1.6 3.2 Akinesia 1.1 1.1 Hypertonia 1.1 0 Neuralgia 1.1 < 1 Speech Disorder 1.1 1.6 Respiratory System Rhinitis 12.2 5.4 Dyspnea 4.8 1.1 Epistaxis 1.6 <1 Hiccup 1.1 0 Skin and Appendages Rash 3.2 2.1 Sweating 2.1 2.7 Special Senses Abnormal vision 5.8 5.4 Diplopia 2.1 0 Taste perversion 1.6 0 Eye disorder 1.1 0 Urogenital System Urinary frequency 2.7 6.4 Urinary tract infection 2.7 3.7 Hematuria 1.1 < 1 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.