Exenatide Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 6, 2022.
Applies to exenatide: subcutaneous solution, subcutaneous suspension extended release.
Subcutaneous route (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
Serious side effects of Exenatide
Along with its needed effects, exenatide 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
- 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
- dark urine
- decreased awareness or responsiveness
- decreased urination or urine output
- difficulty with swallowing
- dry mouth
- fast heartbeat
- hives or welts, itching, or skin rash
- increase in heart rate
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- loss of consciousness
- muscle twitching
- 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
- severe sleepiness
- sunken eyes
- swelling of the face, ankles, or hands
- unusual bleeding or bruising
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- 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
- blurred vision
- cold sweats
- cool, pale skin
- increased hunger
- severe vomiting
- slurred speech
Other side effects of Exenatide
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:
- feeling jittery
- stomach discomfort or upset
- 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.
The most commonly reported side effects have included nausea, vomiting, diarrhea, injection site pruritus, and injection site nodules.[Ref]
Very common (10% or more): Anti-exenatide antibodies (up to 90%)[Ref]
Very common (10% or more): Hypoglycemia (up to 19%)
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]
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]
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
In clinical trials with the extended-release auto-injector, acute pancreatitis occurred in 0.4% of patients.[Ref]
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]
Common (1% to 10%): Hyperhidrosis
Rare (less than 0.1%) Alopecia[Ref]
Common (1% to 10%): Joint pain, back pain, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms[Ref]
Common (1% to 10%): Headache, dizziness, diabetic neuropathy
Uncommon (0.1% to 1%): Dysgeusia
Rare (less than 0.1%): Somnolence[Ref]
Common (1% to 10%): Depression, insomnia, anxiety[Ref]
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]
Common (1% to 10%): Fatigue, asthenia, feeling jittery[Ref]
Rare (less than 0.1%): Increased INR with concomitant warfarin therapy, sometimes associated with bleeding
Frequently asked questions
- How long does it take for Bydureon Bcise to take effect?
- How long can Bydureon be unrefrigerated?
- How does Bydureon work?
- How do you use the Bydureon Bcise autoinjector?
- How do you use the Bydureon pen?
More about exenatide
- Check interactions
- Compare alternatives
- Reviews (416)
- Dosage information
- During pregnancy
- Drug class: incretin mimetics
- Exenatide drug information
- Exenatide extended release
- Exenatide (Advanced Reading)
- Exenatide Injection (Byetta)
Related treatment guides
1. Product Information. Byetta (exenatide). Amylin Pharmaceuticals Inc. 2005.
2. Cerner Multum, Inc. Australian Product Information.
3. Product Information. Bydureon BCise (exenatide). Astra-Zeneca Pharmaceuticals. 2017.
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.