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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.
Common side effects of Cycloset include: symptomatic hypotension. See below for a comprehensive list of adverse effects.
Applies to bromocriptine: oral capsule, oral tablet
Along with its needed effects, bromocriptine (the active ingredient contained in Cycloset) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking bromocriptine:
Less common—reported more often in patients with Parkinson's disease
Rare—reported more often in patients taking large doses
Incidence not known
Some side effects of bromocriptine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to bromocriptine: compounding powder, oral capsule, oral tablet
The incidence of adverse reactions with this drug are high, but generally mild to moderate in degree. The most commonly reported adverse reactions have included nausea, headache, dizziness, vomiting, and fatigue.
Very common (10% or more): Nausea (up to 49%), constipation (12.5%)
Common (1% to 10%): Dyspepsia, vomiting, abdominal cramps, diarrhea
Frequency not reported: Severe gastrointestinal bleeding from peptic ulcers (including fatalities), dry mouth
Postmarketing reports: Retroperitoneal fibrosis, gastrointestinal ulcer
Retroperitoneal fibrosis has been reported in a few patients receiving this drug in doses ranging from 30 to 140 mg/day for 2 to 10 years.
Symptomatic hypotension has been reported in patients receiving this drug for any indication. 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. Rare cases of serious adverse events including hypertension, myocardial infarction, seizures, and strokes, have been reported in postpartum women. Patients experiencing seizures and/or strokes have 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.
Type 2 diabetes mellitus trials: Syncope was reported in 1.5% of patients; the cause of syncope was not known in all cases. In a 52-week safety trial in which all serious adverse events and cardiovascular endpoints were adjudicated, serious adverse events occurred in 8.5% of drug treated patients compared with 9.6% of placebo patients. The composite cardiovascular endpoint occurred in 31 (1.5%) drug-treated patients and 30 (3%) placebo patients.
Fibrotic complications including cases of retroperitoneal fibrosis, pulmonary fibrosis, pleural effusion, pleural thickening, pericarditis, and pericardial effusions have been reported during postmarketing period. These reports have been more commonly received in patients on long-term and high-dose treatment.
Common (1% to 10%): Syncope, hypotension, orthostatic hypotension, cold-sensitive digital vasospasm
Rare (0.01% to 0.1%): Hypertension
Frequency not reported: Myocardial infarction, arrhythmia, ventricular tachycardia, bradycardia, ankle and feet edema, signs and symptoms of ergotism (e.g., tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's syndrome)
Postmarketing reports: Cardiac valvulopathy, pericarditis, pericardial effusions, constrictive pericarditis, cardiac valve fibrosis
Frequency not reported: Insomnia, paranoia, depression, anxiety, nervousness, nightmares, "on-off" phenomenon
Postmarketing reports: Hallucinations, mental confusion, psychomotor agitation/excitation, increased libido, hypersexuality, pathological gambling, increased sexual urges, intense urges to spend money uncontrollably, other intense urges
This drug, 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.
A few cases of cerebrospinal fluid rhinorrhea have been reported in patients with large prolactinomas who have received previous transsphenoidal surgery, pituitary radiation, or both. It may also occur in previously untreated patients whose tumor extends into the sphenoid sinus.
Very common (10% or more): Headache (up to 19%), Dizziness (up to 17%)
Common (1% to 10%): Somnolence, lightheadedness, dyskinesia, ataxia
Frequency not reported: Cerebrospinal fluid rhinorrhea, paresthesia, vasovagal attack, seizures
Postmarketing reports: Stroke, neuroleptic-like malignant syndrome upon cessation in patients with Parkinson's disease, sudden sleep onset
Very common (10% or more): Rhinitis (up to 13.8%), sinusitis (10%)
Common (1% to 10%): Nasal congestion
Frequency not reported: Shortness of breath, nasal stuffiness
Postmarketing reports: Pulmonary fibrosis, pleural effusion, pleural thickening, pleural fibrosis, pleurisy, dyspnea
Fibrotic complications including cases of retroperitoneal fibrosis, pulmonary fibrosis, pleural effusion, pleural thickening, pericarditis, and pericardial effusions have been reported during postmarketing approval use of this drug. These reports have been more commonly received in patients on long-term and high-dose treatment.
Common (1% to 10%): Amblyopia
Frequency not reported: Blepharospasm
Postmarketing reports: Visual disturbance, vision blurred
Frequency not reported: Muscle cramps
Postmarketing reports: Leg cramps
Frequency not reported: Urinary frequency, urinary incontinence, urinary retention
Frequency not reported: Hair loss, erythromelalgia, mottling of skin, skin rash
Postmarketing reports: Allergic skin reactions
Very common (10% or more): Asthenia (up to 18.9%), fatigue (up to 13.9%)
Frequency not reported: Vertigo, sluggishness, lassitude, alcohol potentiation
Postmarketing reports: Tinnitus
Postmarketing reports: Allergic skin reactions
Frequency not reported: Growth hormone-secreting tumor expansion in patients with acromegaly
Common (1% to 10%): Infection, flu syndrome
Common (1% to 10%): Anorexia, hypoglycemia
In the monotherapy trial in patients with type 2 diabetes mellitus, hypoglycemia was reported in 2 patients (3.7%). In the add-on to sulfonylurea trials, hypoglycemia was reported in 8.6% of patients.
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