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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.

In Summary

Common side effects of Cycloset include: symptomatic hypotension. See below for a comprehensive list of adverse effects.

For the Consumer

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:

More Common

  • Dizziness or lightheadedness, especially when getting up from a lying or sitting position
  • nausea

Less common—reported more often in patients with Parkinson's disease

  • Confusion
  • 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

Rare—reported more often in patients taking large doses

  • Increased frequency of urination
  • loss of appetite, continuing
  • lower back pain
  • runny nose, continuing
  • stomach pain, continuing or severe
  • weakness

Rare

  • Black, tarry stools
  • bloody vomit
  • blurred vision
  • fainting
  • fast heartbeat
  • increased sweating
  • nausea
  • nervousness
  • seizures
  • severe chest pain
  • sudden weakness
  • temporary blindness
  • unusual headache
  • vomiting, continuing or severe

Incidence Not Known

  • Agitation
  • anxiety
  • blue or pale skin
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • difficulty in breathing
  • difficulty in speaking
  • double vision
  • false beliefs that cannot be changed by facts
  • fever
  • headache
  • high fever
  • high or low blood pressure
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • increased frequency of urination
  • loss of bladder control
  • lower back pain
  • severe muscle stiffness
  • slow speech
  • troubled or quick, shallow breathing
  • unusual tiredness or weakness
  • unusually pale skin

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:

Less Common

  • Constipation
  • diarrhea
  • drowsiness or tiredness
  • dry mouth
  • leg cramps at night
  • loss of appetite
  • mental depression
  • stomach pain
  • stuffy nose
  • tingling or pain in the fingers and toes when exposed to cold temperatures
  • vomiting

For Healthcare Professionals

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

General

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.[Ref]

Gastrointestinal

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[Ref]

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.[Ref]

Cardiovascular

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.[Ref]

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[Ref]

Psychiatric

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[Ref]

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.[Ref]

Nervous system

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.[Ref]

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[Ref]

Respiratory

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[Ref]

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.[Ref]

Ocular

Common (1% to 10%): Amblyopia

Frequency not reported: Blepharospasm

Postmarketing reports: Visual disturbance, vision blurred[Ref]

Musculoskeletal

Frequency not reported: Muscle cramps

Postmarketing reports: Leg cramps[Ref]

Genitourinary

Frequency not reported: Urinary frequency, urinary incontinence, urinary retention[Ref]

Dermatologic

Frequency not reported: Hair loss, erythromelalgia, mottling of skin, skin rash

Postmarketing reports: Allergic skin reactions[Ref]

Other

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[Ref]

Hypersensitivity

Postmarketing reports: Allergic skin reactions

Endocrine

Frequency not reported: Growth hormone-secreting tumor expansion in patients with acromegaly

Immunologic

Common (1% to 10%): Infection, flu syndrome

Metabolic

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.

References

1. "Product Information. Cycloset (bromocriptine)." Valeant Pharmaceuticals, Costa Mesa, CA.

2. "Product Information. Parlodel (bromocriptine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

3. Champagne SP, Coste E, Peyriere H, Nigond J, Mania E, Pons M, HillaireBuys D, Balmes P, Blayac JP, Davy JM "Chronic constrictive pericarditis induced by long-term bromocriptine therapy: Report of two cases." Ann Pharmacother 33 (1999): 1050-4

4. Kaushik P, Vatsavai SR, Banda VR, Sanghi PK, Ahmad M, Kaushik R "Acute onset of severe dilated cardiomyopathy during bromocriptine therapy." Ann Pharmacother 38 (2004): 1219-21

5. Larrazet F, Spaulding C, Lobreau HJ, Weber S, Guerin F "Possible bromocriptine-induced myocardial infarction." Ann Intern Med 118 (1993): 199-200

6. Boyd A "Bromocriptine and psychosis: a literature review." Psychiatr Q 66 (1995): 87-95

7. Dorevitch A, Aronzon R, Stark M "Psychotic exacerbation attributed to low-dose bromocriptine treatment of galactorrhea and hyperprolactinemia." Acta Obstet Gynecol Scand 70 (1991): 375-6

8. Peter SA, Autz A, Jean-Simon ML "Bromocriptine-induced schizophrenia." J Natl Med Assoc 85 (1993): 700-1

9. Bende M, Bergman B, Sjogren C "Nasal mucosal congestion after treatment with bromocriptine." Laryngoscope 103 (1993): 1142-4

10. Couldwell WT, Weiss MH "Visual loss associated with bromocriptine." Lancet 340 (1992): 1210-411

11. Leiguarda R, Merello M, Sabe L, Starkstein S "Bromocriptine-induced dystonia in patients with aphasia and hemiparesis." Neurology 43 (1993): 2319-22

12. Fabre N, Montastruc JL, Rascol O "Alopecia: an adverse effect of bromocriptine." Clin Neuropharmacol 16 (1993): 266-8

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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