Permax

Permax Side Effects Center

Last reviewed on RxList 9/25/2018

Permax (pergolide mesylate) is an ergot derivative dopamine receptor agonist is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. Permax is often used in conjunction with other medicines in the treatment of Parkinson's disease. The brand name Permax is discontinued, but generic versions may be available. Common side effects of Permax (pergolide mesylate) include:

• nausea,
• vomiting,
• upset stomach,
• decreased appetite,
• diarrhea,
• constipation,
• dry mouth,
• drowsiness,
• dizziness,
• insomnia,
• agitation,
• anxiety,
• feeling weak,
• sinus congestion,
• back pain, and
• stomach cramps

The starting dose of Permax is 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved. Permax may interact with phenothiazines, haloperidol, thiothixene, metoclopramide, or other drugs that cause drowsiness or dizziness, including antidepressants, alcohol, sedatives, pain relievers, other anxiety medicines, muscle relaxants, and antihistamines. Tell your doctor all medications and supplements you use. Permax is not expected to be harmful to a fetus. Do not take Permax without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Permax (pergolide mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Permax Professional Information

SIDE EFFECTS

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 US 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 month†s 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.

Incidence of Treatment-Emergent Adverse Experiences in the

Placebo-Controlled Clinical Trial Percentage of Patients Reporting Events

Body System/Adverse Event*	Pergolide Mesylate	Placebo
	N= 189	N= 187
Body as a 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
Vasodilatation	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 Svstem
Urinary frequency	2.7		6.4
Urinary tract infection	2.7		3.7
Hematuria	1.1		< 1

 *Events reported by at least 1% of patients receiving pergolide mesylate are included.

Events Observed During the Premarketing Evaluation of Permax (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; infre-quent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in fewer than l/1,000 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 lymphoplastic leukemia, polycythemia, splenomegaly

Metabolic and Nutritional System - Frequent: peripheral edema, weight loss, weight gain; Infrequent: dehydration, hypokalemia, hypoglycemia, iron deficiency anemia, hyperglycemia, gout, hyper-cholesteremia; 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.

Read the entire FDA prescribing information for Permax (Pergolide Mesylate)