Pergolide Side Effects

It is possible that some side effects of pergolide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to pergolide: oral tablet

As well as its needed effects, pergolide may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pergolide, check with your doctor immediately:

Rare
  • Chest pain (severe)
  • convulsions (seizures)
  • difficulty in breathing
  • fainting
  • fast heartbeat or irregular pulse
  • headache (severe or continuing)
  • high fever
  • high or low (irregular) blood pressure
  • increased sweating
  • loss of bladder control
  • nausea and vomiting (continuing or severe)
  • nervousness
  • severe muscle stiffness
  • sudden weakness
  • unexplained shortness of breath
  • unusual tiredness or weakness
  • unusually pale skin
  • vision changes, such as blurred vision or temporary blindness

If any of the following side effects occur while taking pergolide, check with your doctor or nurse as soon as possible:

More common
  • Anxiety
  • bloody or cloudy urine
  • confusion
  • difficult or painful urination
  • frequent urge to urinate
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body
Less common
  • Dizziness
  • headache
  • swelling in hands and legs
Rare
  • Abdominal pain or pressure
  • chills
  • cough
  • decreased flow of urine
  • fever
  • pain in side or lower back

Some pergolide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Chest congestion
  • constipation
  • dizziness or lightheadedness, especially when getting up from a lying or sitting position
  • drowsiness
  • heartburn
  • lower back pain
  • muscle pain
  • nausea
  • runny or stuffy nose
  • trouble in sleeping
  • weakness
Less common
  • Diarrhea
  • dryness of mouth
  • loss of appetite
  • swelling of the face
  • vomiting

For Healthcare Professionals

Applies to pergolide: compounding powder, oral tablet

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

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%.

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.

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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