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Note: This document contains side effect information about exenatide. Some of the dosage forms listed on this page may not apply to the brand name Bydureon.
Common side effects of Bydureon include: diarrhea, nausea, and vomiting. Other side effects include: dizziness, dyspepsia, fidgeting, and headache. See below for a comprehensive list of adverse effects.
Applies to exenatide: subcutaneous powder for suspension extended release, subcutaneous solution, subcutaneous suspension extended release
Subcutaneous route (Powder for Suspension, Extended Release; Suspension, Extended Release)
Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether exenatide extended-release causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.Exenatide extended-release is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of exenatide extended-release and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with exenatide extended-release
Along with its needed effects, exenatide (the active ingredient contained in Bydureon) 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 exenatide:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking exenatide:
Symptoms of overdose
Some side effects of exenatide 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:
Incidence not known
Applies to exenatide: subcutaneous powder for injection extended release, subcutaneous solution, subcutaneous suspension extended release
The most commonly reported side effects have included nausea, vomiting, diarrhea, injection site pruritus, and injection site nodules.
Postmarketing reports: Generalized pruritus and/or urticaria, macular or papular rash, angioedema, anaphylactic reaction
Very common (10% or more): Anti-exenatide (the active ingredient contained in Bydureon) antibodies (up to 90%)
Very common (10% or more): Hypoglycemia (up to 19%)
Common (1% to 10%): Decreased appetite, rapid weight loss (greater than 3.3 lbs/1.5 kg a week), anorexia, hypokalemia
Rare (less than 0.1%): Dehydration (associated with nausea, vomiting and/or diarrhea)
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure or acute renal failure (sometimes requiring hemodialysis), kidney transplant and kidney transplant dysfunction
Very common (10% or more): Injection-site reactions (up to 17.1%)
Common (1% to 10%): Injection-site pain, injection site pruritus, injection site erythema
During clinical trials for the exenatide auto-injector (Bydureon BCISE[R]), injection site nodule was the most commonly reported adverse reaction reported in 10.5% of patients (n=526). Injection site pruritus and injection site erythema were reported in 3.2% and 2.3% of patients, respectively. Injection site nodule was reported as the reason for discontinuation in 0.5% of patients.
Clinical trials comparing immediate-release (Byetta[R]) and extended-release (Bydureon[R]) exenatide have shown that injection-site reactions occurred more frequently in patients treated with extended-release (17.1% vs 12.7%).
Very common (10% or more): Nausea (up to 34%), diarrhea (up to 13%), vomiting (up to 19%)
Uncommon (0.1% to 1%): Intestinal obstruction
Common (1% to 10%): Dyspepsia, constipation, gastroesophageal reflux disease, abdominal distension, abdominal pain, upper abdominal pain, abdominal discomfort, toothache, viral gastroenteritis, gastroenteritis
Very rare (less than 0.01%): Ileus, ischemic colitis, gut ischemia
Postmarketing reports: Eructation, flatulence, acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death
In clinical trials with the extended-release auto-injector, acute pancreatitis occurred in 0.4% of patients.
Very common (10% or more): Increased heart rate (up to 15%)
Common (1% to 10%): Hypertension
Increases in heart rate of up to 4.5 beats per minute have been observed; long-term effects of increases in heart rate have not been established.
Common (1% to 10%): Hyperhidrosis
Rare (less than 0.1%) Alopecia
Common (1% to 10%): Erectile dysfunction
Common (1% to 10%): Joint pain, back pain, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms
Common (1% to 10%): Headache, dizziness, diabetic neuropathy
Uncommon (0.1% to 1%): Dysgeusia
Rare (less than 0.1%): Somnolence
Common (1% to 10%): Depression, insomnia, anxiety
Very common (10% or more): Nasopharyngitis (up to 19%), upper respiratory tract infection (up to 17%)
Common (1% to 10%): Sinusitis, influenza, cough, oropharyngeal pain
Common (1% to 10%): Fatigue, asthenia, feeling jittery
Rare (less than 0.1%): Increased INR with concomitant warfarin therapy, sometimes associated with bleeding