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Permax

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Permax

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Side Effects
Interactions

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:

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 Permax (pergolide mesylate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthines ) or metoclopramide, ordinarily should not be administered concurrently with Permax (pergolide mesylate) (a dopamine agonist); these agents may diminish the effectiveness of Permax. Because pergolide mesylate is approximately 90% bound to plasma proteins, caution should be exercised if pergolide mesylate is coadministered with other drugs known to affect protein binding.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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