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Cycloset

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Cycloset

Cycloset Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cycloset (bromocriptine mesylate) is a dopamine receptor agonist used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Cycloset is not for treating type 1 diabetes. Common side effects include dizziness, spinning sensation, mild drowsiness, feeling weak or tired, headache, depressed mood, insomnia, nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation, or cold feeling or numbness in your fingers.

The recommended dose of Cycloset is 1.6 mg to 4.8 mg administered once daily within two hours after waking. Cycloset may interact with antidepressants, sedatives, narcotics, medicines to treat psychiatric disorders, antibiotics, antifungal medications, anti-malaria drugs, asthma or allergy medications, cancer medicines, medicines used to prevent organ transplant rejection, cholesterol-lowering drugs, oral diabetes medications, heart or blood pressure medications, heart rhythm medications, HIV/AIDS medications, seizure medications, erectile dysfunction medicines, or stomach acid reducers. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cycloset is not expected to harm a fetus. However, a pituitary tumor in the mother can expand during pregnancy. High blood pressure can also occur during pregnancy and this drug could be dangerous if taken by a pregnant woman with high blood pressure. Consult your doctor. This drug lowers the hormone needed to produce breast milk. Do not breastfeed while taking Cycloset.

Our Cycloset (bromocriptine mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cycloset in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using 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 may include:

  • dizziness, mild drowsiness, feeling weak or tired;
  • mild headache;
  • stuffy nose;
  • upset stomach, nausea, vomiting, 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cycloset (Bromocriptine Mesylate Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cycloset FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

In the pooled CYCLOSET (bromocriptine mesylate tablets) phase 3 clinical trials (CYCLOSET (bromocriptine mesylate tablets) N = 2298; placebo N = 1266), adverse events leading to discontinuation occurred in 539 (24%) CYCLOSET (bromocriptine mesylate tablets) -treated patients and 118 (9%) placebo-treated patients. This between-group difference was driven mostly by gastrointestinal adverse events, particularly nausea.

The CYCLOSET (bromocriptine mesylate tablets) safety trial was a 52-week, placebo-controlled study that included patients treated only with diet therapy or with other anti-diabetic medications. A total of 3,070 patients were randomized to CYCLOSET (bromocriptine mesylate tablets) (titrated to 1.6 to 4.8 mg daily, as tolerated) or placebo. The study population had a mean baseline age of 60 years (range 27-80) and 33% were 65 years of age or older. Approximately 43% of the patients were female, 68% were Caucasian, 17% were Black, 13% were Hispanic, and 1% were Asian. The mean baseline body mass index was 32 kg/m². The mean duration of diabetes at baseline was 8 years and the mean baseline HbA1c was 7.0% with a mean baseline fasting plasma glucose of 142 mg/dL. At baseline, 12% of patients were treated with diet only, 40% were treated with one oral anti-diabetic agent, 33% were treated with two oral anti-diabetic agents, and 16% were treated with insulin alone or insulin in combination with an oral anti-diabetic agent. At baseline, 76% of patients reported a history of hypercholesterolemia, 75% reported a history of hypertension, 11% reported a history of revascularization surgery, 10% reported a history of myocardial infarction, 10% reported a history of angina, and 5% reported a history of stroke. Forty-seven percent of the CYCLOSET (bromocriptine mesylate tablets) -treated patients and 32% of the placebo-treated patients prematurely discontinued treatment. Adverse events leading to discontinuation of study drug occurred among 24% of the CYCLOSET (bromocriptine mesylate tablets) -treated patients and 11% of the placebo-treated patients. This between-group difference was driven mostly by gastrointestinal adverse events, particularly nausea.

Table 1 summarizes the adverse events reported in ≥ 5% of patients treated with CYCLOSET (bromocriptine mesylate tablets) in the phase 3 clinical trials regardless of investigator assessment of causality. The most commonly reported adverse events (nausea, fatigue, vomiting, headache, dizziness) lasted a median of 14 days and were more likely to occur during the initial titration of CYCLOSET (bromocriptine mesylate tablets) . None of the reports of nausea or vomiting were described as serious. There were no differences in the pattern of common adverse events across race groups or age groups ( < 65 years old vs. > 65 years old). In the 52-week CYCLOSET (bromocriptine mesylate tablets) safety trial, 11.5% of CYCLOSET (bromocriptine mesylate tablets) -treated women compared to 3.6% of placebo-treated women reported vomiting. In this same trial, 5.4% of CYCLOSET (bromocriptine mesylate tablets) -treated men compared to 2.8% of placebo-treated men reported vomiting.

Table 1 : Adverse Events Reported in Phase 3 Clinical Trials of CYCLOSET (bromocriptine mesylate tablets) ( ≥ 5% of Patients and Numerically More Frequent in CYCLOSET (bromocriptine mesylate tablets) -Treated Patients than in Placebo-Treated Patients, Regardless of Investigator Assessment of Causality†)

Monotherapy CYCLOSET 1.6 mg - 4.8 mg
N (%)
Placebo
N (%)
N = 159 N = 80 N = 79
Nausea 26 (32.5) 6 (7.6)
Rhinitis 11 (13.8) 3 (3.8)
Headache 10 (12.5) 7 (8.9)
Asthenia 10 (12.5) 5 (6.3)
Dizziness 10 (12.5) 6 (7.6)
Constipation 9 (11.3) 3 (3.8)
Sinusitis 8 (10.0) 2 (2.5)
Diarrhea 7 (8.8) 4 (5.1)
Amblyopia 6 (7.5) 1 (1.3)
Dyspepsia 6 (7.5) 2 (2.5)
Vomiting 5 (6.3) 1 (1.3)
Infection 5 (6.3) 4 (5.1)
Anorexia 4 (5.0) 1 (1.3)
Adjunct to Sulfonylurea (2 pooled 24 week studies)
N = 494 N = 244 N = 250
Nausea 62 (25.4) 12 (4.8)
Asthenia 46 (18.9) 20 (8.0)
Headache 41 (16.8) 40 (16.0)
Flu syndrome 23 (9.4) 19 (7.6)
Constipation 24 (9.8) 11 (4.4)
Cold 20 (8.2) 20 (8.0)
Dizziness 29 (11.9) 14 (5.6)
Rhinitis 26 (10.7) 12 (4.8)
Sinusitis 18 (7.4) 16 (6.4)
Somnolence 16 (6.6) 5 (2.0)
Vomiting 13 (5.3) 8 (3.2)
Amblyopia 13 (5.3) 6 (2.4)
52-Week Safety Trial‡
N=3070 N = 2054 N = 1016
Nausea 661 (32.2) 77 (7.6)
Dizziness 303 (14.8) 93 (9.2)
Fatigue 285 (13.9) 68 (6.7)
Headache 235 (11.4) 84 (8.3)
Vomiting 167 (8.1) 32 (3.1)
Diarrhea 167 (8.1) 81 (8.0)
Constipation 119 (5.8) 52 (5.1)
†All randomized subjects receiving at least one dose of study drug
‡ The Safety Trial enrolled patients treated with diet or no more than 2 anti-diabetic medications (metformin, insulin secretagogues such as a sulfonylurea, thiazolidinediones, alpha glucosidase inhibitors, and/or Insulin)

Hypoglycemia

In the monotherapy trial, hypoglycemia was reported in 2 CYCLOSET (bromocriptine mesylate tablets) -treated patients (3.7%) and 1 placebo-treated patient (1.3%). In the add-on to sulfonylurea trials, the incidence of hypoglycemia was 8.6% among the CYCLOSET (bromocriptine mesylate tablets) -treated patients and 5.2% among the placebo-treated patients. In the CYCLOSET (bromocriptine mesylate tablets) safety trial, hypoglycemia was defined as any of the following: 1) symptoms suggestive of hypoglycemia that promptly resolved with appropriate intervention, 2) symptoms with a measured glucose < 60 mg/dL or 3) measured glucose below 49 mg/dL regardless of symptoms. In the 52-week safety trial, the incidence of hypoglycemia was 6.9% among the CYCLOSET (bromocriptine mesylate tablets) -treated patients and 5.3% among the placebo-treated patients. In the safety trial, severe hypoglycemia was defined as an inability to self-treat neurological symptoms consistent with hypoglycemia that occurred in the setting of a measured blood glucose < 50 mg/dl (or evidence of prompt resolution of these symptoms with administration of oral carbohydrates, subcutaneous glucagon, or intravenous glucose if blood glucose was not measured). In this trial, severe hypoglycemia was reported among 0.5% of CYCLOSET (bromocriptine mesylate tablets) -treated patients and 1% of placebo-treated patients.

Syncope

In combined phase 2 and 3 clinical trials, syncope was reported in 1.4% of the 2,500 CYCLOSET (bromocriptine mesylate tablets) -treated patients and 0.6% of the 1,454 placebo-treated patients. Among the 3,070 patients studied in the 52-week safety trial, 33 CYCLOSET (bromocriptine mesylate tablets) -treated patients (1.6%) and 7 placebo-treated patients (0.7%) reported an adverse event of syncope. The cause of syncope is not known in all cases [See WARNINGS AND PRECAUTIONS]. In this trial, electrocardiograms were not available at the time of these events, but an assessment of routine electrocardiograms obtained during the course of the trial did not identify arrhythmias or QTc interval prolongation among the CYCLOSET (bromocriptine mesylate tablets) -treated patients reporting syncope.

Central Nervous System

In the 52-week safety trial, somnolence and hypoesthesia were the only adverse events within the nervous system organ class that were reported at a rate of < 5% and ≥ 1% and that occurred at a numerically greater frequency among CYCLOSET (bromocriptine mesylate tablets) -treated patients (CYCLOSET (bromocriptine mesylate tablets) 4.3% vs. Placebo 1.3% for somnolence; CYCLOSET (bromocriptine mesylate tablets) 1.4% vs. Placebo 1.1% for hypoesthesia).

Serious Adverse Events and Cardiovascular Safety

The primary endpoint of the 52-week safety trial was the occurrence of all serious adverse events. A secondary endpoint was the occurrence of the composite of myocardial infarction, stroke, coronary revascularization, hospitalization for angina, and hospitalization for congestive heart failure.

All serious adverse events and cardiovascular endpoints were adjudicated by an independent event adjudication committee. Serious adverse events occurred in 176/2054 (8.5%) CYCLOSET (bromocriptine mesylate tablets) -treated patients and 98/1016 (9.6%) placebo-treated patients. The hazard ratio comparing CYCLOSET (bromocriptine mesylate tablets) to placebo for the time to first occurrence of a serious adverse event was 1.02 (upper bound of one-sided 96% confidence interval, 1.27). None of the serious adverse events grouped by System-Organ-Class occurred more than 0.3 percentage points higher with CYCLOSET (bromocriptine mesylate tablets) than with placebo. The composite cardiovascular endpoint occurred in 31 (1.5%) CYCLOSET (bromocriptine mesylate tablets) -treated patients and 30 (3.0%) placebo-treated patients. The hazard ratio comparing CYCLOSET (bromocriptine mesylate tablets) to placebo for the timeto-first occurrence of the prespecified composite cardiovascular endpoint was 0.58 (two-sided 95% confidence interval, 0.35 - 0.96). Therefore, the incidence of this composite endpoint was not increased with CYCLOSET (bromocriptine mesylate tablets) relative to placebo.

Postmarketing Experience

The active agent in CYCLOSET (bromocriptine mesylate) has been used in other formulations and often multiple times per day to treat hyperprolactinemia, acromegaly, and Parkinson's disease. The following adverse reactions have been identified during postapproval use of bromocriptine mesylate for these indications, generally at doses higher than those approved for the treatment of type 2 diabetes. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hallucinations

Hallucinations and mental confusion including delusions have been reported with bromocriptine. To date, there have been no reported cases of hallucinations or delusions among CYCLOSET (bromocriptine mesylate tablets) -treated patients (n= 2500) in combined Phase 2 and 3 clinical trials of CYCLOSET (bromocriptine mesylate tablets) .

Fibrotic - Related Complications

Fibrotic complications, including cases of retroperitoneal fibrosis, pulmonary fibrosis, pleural effusion, pleural thickening, pericarditis and pericardial effusions have been reported. These complications do not always resolve when bromocriptine is discontinued. Among several studies investigating a possible relation between bromocriptine exposure and cardiac valvulopathy, some events of cardiac valvulopathy have been reported, but no definitive association between bromocriptine mesylate use and clinically significant (moderate to severe) cardiac valvulopathy could be concluded.

To date, there have been no reported cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis or pericardial effusions among the CYCLOSET (bromocriptine mesylate tablets) -treated patients (n=2500) in combined Phase 2 and 3 controlled clinical trials of CYCLOSET (bromocriptine mesylate tablets) . There was one unconfirmed case (0.04% event rate) of an adverse event of pulmonary fibrosis classified as non-serious in a CYCLOSET (bromocriptine mesylate tablets) -treated patient.

No cases of cardiac valvulopathy have been reported in any of the clinical studies to date with CYCLOSET (bromocriptine mesylate tablets) .

Psychotic and Psychiatric Disorders

Psychotic disorders have been reported with bromocriptine. Additionally, pathological gambling has been reported with bromocriptine used to treat patients with Parkinson's disease. To date, there have been no reported cases of psychoses or pathological gambling among the CYCLOSET (bromocriptine mesylate tablets) -treated patients (N=2500) in combined Phase 2 and 3 controlled clinical trials of CYCLOSET (bromocriptine mesylate tablets) .

Stroke

The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn based on postmarketing reports of stroke. Causality of bromocriptine use and the occurrence of stroke in this patient population has not been proven. Based on the CYCLOSET (bromocriptine mesylate tablets) clinical trials, there is no evidence of increased risk for stroke when CYCLOSET (bromocriptine mesylate tablets) is used to treat type 2 diabetes.

Neuroleptic - like malignant syndrome

A neuroleptic-like malignant syndrome (manifested by high fever and increase in creatinine phosphokinase) has been reported upon cessation of bromocriptine treatment in patients with advanced Parkinson's disease or patients with secondary Parkinsonism. To date, there have been no reported cases of neuroleptic-like malignant syndrome in combined Phase 2 and 3 controlled clinical trials of CYCLOSET (bromocriptine mesylate tablets) , including the Safety Trial (N=2500). In the CYCLOSET (bromocriptine mesylate tablets) Safety Trial, there were no reports of neuroleptic-like malignant syndrome during the 30 days of follow-up after cessation of CYCLOSET (bromocriptine mesylate tablets) (N = 2054).

Read the entire FDA prescribing information for Cycloset (Bromocriptine Mesylate Tablets) »

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