Permax Side Effects
Generic Name: pergolide
Note: This document contains side effect information about pergolide. Some of the dosage forms listed on this page may not apply to the brand name Permax.
Applies to pergolide: compounding powder, oral tablet
Gastrointestinal adverse effects are commonly seen during pergolide (the active ingredient contained in Permax) 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.[Ref]
Nervous system adverse effects are also commonly associated with pergolide (the active ingredient contained in Permax) 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.[Ref]
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.[Ref]
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 (the active ingredient contained in Permax) 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%.[Ref]
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.[Ref]
Dermatologic abnormalities reported in patients receiving pergolide (the active ingredient contained in Permax) occasionally include erythema of the lower extremities, or erythromelalgia. This erythema may be very warm or painful.[Ref]
Hematologic abnormalities associated with pergolide (the active ingredient contained in Permax) therapy include anemia. Leukopenia has been reported infrequently.[Ref]
Musculoskeletal adverse effects may rarely include muscle cramps, arthralgia, and myalgias.[Ref]
Ocular adverse effects may include diplopia or vision changes in 2% to 6% of patients treated with pergolide (the active ingredient contained in Permax) [Ref]
Other adverse effects of pergolide (the active ingredient contained in Permax) may include flu-like syndrome, and fever.[Ref]
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Some side effects may not be reported. You may report them to the FDA.