Note: This document contains side effect information about exenatide. Some dosage forms listed on this page may not apply to the brand name Bydureon.

Summary

Common side effects of Bydureon include: diarrhea, nausea, and vomiting. Other side effects include: dizziness, dyspepsia, fidgeting, and headache. Continue reading for a comprehensive list of adverse effects.

Applies to exenatide: subcutaneous solution, subcutaneous suspension extended release.

Serious side effects of Bydureon

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

• Agitation
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bloated or feeling of fullness
• chest tightness
• chills
• confusion
• constipation
• cough
• dark urine
• decreased awareness or responsiveness
• decreased urination or urine output
• depression
• difficulty with swallowing
• dizziness
• dry mouth
• fainting
• fast heartbeat
• fever
• headache
• hives or welts, itching, or skin rash
• hostility
• increase in heart rate
• indigestion
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lightheadedness
• loss of appetite
• loss of consciousness
• muscle twitching
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid breathing
• rapid weight gain
• seizures
• severe sleepiness
• sunken eyes
• swelling of the face, ankles, or hands
• thirst
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• wrinkled skin
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking exenatide:

Symptoms of overdose

• Anxiety
• blurred vision
• cold sweats
• cool, pale skin
• increased hunger
• nervousness
• nightmares
• severe vomiting
• shakiness
• slurred speech

Other side effects of Bydureon

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:

More common

• Belching
• diarrhea
• feeling jittery
• heartburn
• stomach discomfort or upset

Less common

• Decreased appetite
• increased sweating
• lack or loss of strength

Incidence not known

• Change in taste
• excess air or gas in the stomach or bowels
• hair loss, thinning of hair
• loss of taste
• passing gas
• pressure in the stomach
• rash with flat lesions or small raised lesions on the skin
• redness of the skin
• sleepiness or unusual drowsiness
• swelling of the stomach area

For Healthcare Professionals

Applies to exenatide: subcutaneous powder for injection extended release, subcutaneous solution, subcutaneous suspension extended release.

General

The most commonly reported side effects have included nausea, vomiting, diarrhea, injection site pruritus, and injection site nodules.^[Ref]

Hypersensitivity

Postmarketing reports: Generalized pruritus and/or urticaria, macular or papular rash, angioedema, anaphylactic reaction^[Ref]

Immunologic

Very common (10% or more): Anti-exenatide (the active ingredient contained in Bydureon) antibodies (up to 90%)^[Ref]

Metabolic

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)^[Ref]

Renal

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^[Ref]

Local

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^[Ref]

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%).^[Ref]

Gastrointestinal

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^[Ref]

In clinical trials with the extended-release auto-injector, acute pancreatitis occurred in 0.4% of patients.^[Ref]

Cardiovascular

Very common (10% or more): Increased heart rate (up to 15%)

Common (1% to 10%): Hypertension^[Ref]

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.^[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis

Rare (less than 0.1%) Alopecia^[Ref]

Genitourinary

Common (1% to 10%): Erectile dysfunction^[Ref]

Musculoskeletal

Common (1% to 10%): Joint pain, back pain, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, diabetic neuropathy

Uncommon (0.1% to 1%): Dysgeusia

Rare (less than 0.1%): Somnolence^[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, anxiety^[Ref]

Respiratory

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^[Ref]

Other

Common (1% to 10%): Fatigue, asthenia, feeling jittery^[Ref]

Hematologic

Rare (less than 0.1%): Increased INR with concomitant warfarin therapy, sometimes associated with bleeding

Postmarketing reports: Drug-induced thrombocytopenia^[Ref]