Cycloset Side Effects

Generic name: bromocriptine

Note: This document contains side effect information about bromocriptine. Some of the dosage forms listed on this page may not apply to the brand name Cycloset.

Some side effects of Cycloset may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bromocriptine: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking bromocriptine (the active ingredient contained in Cycloset) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

• vision problems, constant runny nose;

• chest pain, pain when you breathe, fast heart rate, rapid breathing, feeling short of breath (especially when lying down);

• back pain, swelling in your ankles or feet, urinating less than usual or not at all;

• confusion, hallucinations, feeling like you might pass out;

• low blood sugar (headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating);

• muscle movements you cannot control, loss of balance or coordination;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of bromocriptine may include:

• dizziness, spinning sensation, mild drowsiness, feeling tired;

• mild headache, depressed mood, sleep problems (insomnia);

• dry mouth, stuffy nose;

• upset stomach, nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation; or

• cold feeling or numbness in your fingers.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bromocriptine: compounding powder, oral capsule, oral tablet

Gastrointestinal

Gastrointestinal side effects have included nausea (18% to 49%), constipation (3% to 14%), vomiting (2% to 5%), abdominal cramps (5%), indigestion/dyspepsia (4%), anorexia (4%), diarrhea (3%), gastrointestinal bleeding (less than 2%), abdominal discomfort, anorexia, dry mouth, and peptic ulcers have been reported.

Nervous system

Nervous system side effects have included headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), and drowsiness/tiredness (3%). Other side effects occurring less frequently (less than 2%) have included faintness, vertigo, paresthesia, insomnia, decreased sleep requirement, heavy headedness, sluggishness, reduced tolerance to cold, asthenia, tingling of ears, and numbness. A syndrome resembling neuroleptic malignant syndrome has been reported on abrupt withdrawal of bromocriptine (the active ingredient contained in Cycloset)

Cardiovascular

Syncope and symptomatic hypotension (decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively) have been reported in approximately 30% of postpartum patients.

Seizures and/or strokes have been reported with bromocriptine (the active ingredient contained in Cycloset) administration. Many of the patients experiencing seizures and/or strokes reported developing a continuous headache, often progressively severe, hours to days prior to the acute event. In addition, visual disturbances (blurred vision and transient cortical blindness) have been reported to also precede stroke and/or seizure events. If a patient experiences severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, bromocriptine therapy should be discontinued and the patient should be evaluated promptly.

Cardiovascular side effects have included postural/orthostatic hypotension (6%), digital vasospasm (3%), syncope (less than 2%), seizures, stroke, and myocardial infarction. Rare cardiovascular side effects including arrhythmia, pleural and pericardial effusions, constrictive pericarditis, ventricular tachycardia, bradycardia, and vasovagal attack have been reported.

A case of severe dilated cardiomyopathy has been reported in a 31-year-old African American female one month after initiating treatment of a microprolactinoma with bromocriptine 5 mg orally daily. An echocardiogram showed a markedly dilated left ventricle with severe reduction in the left-ventricular ejection fraction. The patient returned to NYHA Class I four weeks after bromocriptine was stopped.

Respiratory

Respiratory side effects have included nasal congestion (3%) and shortness of breath. Pulmonary infiltrates, pleural effusion, and thickening of the pleura have been reported with long-term administration (6 months to 36 months) of bromocriptine (the active ingredient contained in Cycloset) doses ranging from 20 mg to 100 mg daily. Upon termination of bromocriptine therapy, these changes slowly reverted towards normal.

Rare cases of cerebrospinal fluid rhinorrhea have been reported in patients who have received previous transphenoidal surgery and/or pituitary radiation, and who were receiving bromocriptine for tumor recurrence.

Musculoskeletal

Musculoskeletal side effects have included muscle cramps, facial pallor, abnormal involuntary movements, ataxia, edema of the feet and ankles, and erythromelalgia.

Rare musculoskeletal side effects including tingling of fingers, cold feet, numbness, muscle cramps in feet and legs, and exacerbation of Raynaud's Syndrome have been reported during bromocriptine therapy.

Psychiatric

Parkinsonian patients may manifest mild degrees of dementia, therefore, caution should be used when treating such patients.

Bromocriptine (the active ingredient contained in Cycloset) alone or in combination with levodopa, may cause hallucinations (visual or auditory). Hallucinations usually resolve with dosage reduction; occasionally, discontinuation of the drug is required. Rarely, after high doses, hallucinations have persisted for several weeks after discontinuation of the drug.

Psychiatric side effects have included delusional psychosis, paranoia, depression, anxiety, confusion, "on-off" phenomenon, and nightmares. High doses of bromocriptine may be associated with confusion and mental disturbances (hallucinations). Postmarketing reports suggest that patients treated with antiparkinson medications can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and other intense urges. Patients may be unable to control these urges while taking the medications used for the treatment of Parkinson's disease and that increase central dopaminergic tone.

Ocular

Ocular side effects have included visual disturbance and blepharospasm. Secondary deterioration of visual field may develop in patients receiving treatment for hyperprolactinemia due to chiasmal herniation. The visual field defect may improve on reduction of bromocriptine (the active ingredient contained in Cycloset) dosage.

Genitourinary

Genitourinary side effects have included urinary frequency, urinary incontinence, and urinary retention.

Dermatologic

Dermatologic side effects have included mottling of skin and skin rash.

Other

Other side effects have included hair loss, alcohol potentiation, reduced tolerance to cold, tingling of the ears, sign and symptoms of ergotism such as tingling of the fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's syndrome.

Local

Local side effects have included retroperitoneal fibrosis in a few patients receiving long-term therapy (2 to 10 years) with bromocriptine (the active ingredient contained in Cycloset) in doses ranging from 30 to 140 mg daily.

Oncologic

Studies have shown that Parkinson's patients have an approximately 2 to 6 fold higher risk of developing melanoma than the general population. It is not clear whether this increased risk was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease.

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