Parlodel Side Effects

Generic name: bromocriptine

Generic Name: Bromocriptine

Please note - some side effects for Parlodel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Parlodel - for the consumer

Parlodel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Parlodel:

Cold sensitivity in fingers and toes; constipation; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; indigestion; lightheadedness; loss of appetite; nausea; stomach cramps; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal involuntary movements; bloody or black, tarry stools; chest pain; depression; fainting; hallucinations; one-sided weakness; persistent, watery nasal discharge; progressive, severe headache; shortness of breath; ringing in the ears; seizures; slurred speech or trouble speaking; stomach pain; sudden confusion; sudden daytime sleepiness; sudden loss of coordination; vision changes; vomiting blood or a substance like coffee grounds.

By body system

Gastrointestinal side effects

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 side effects

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.

Cardiovascular side effects

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.

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 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.

Respiratory side effects

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 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 side effects

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.

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

Psychiatric side effects

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).

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

Bromocriptine, 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.

Ocular side effects

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 dosage.

Genitourinary side effects

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

Dermatologic side effects

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

Other side effects

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 side effects

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

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