Bydureon BCise Side Effects

Generic name: exenatide

Medically reviewed by Drugs.com. Last updated on Jun 16, 2024.

Note: This document provides detailed information about Bydureon BCise Side Effects associated with exenatide. Some dosage forms listed on this page may not apply specifically to the brand name Bydureon BCise.

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

Precautions

Never share medicine pens or single-dose trays with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles, pens, or single-dose trays can result in transmission of infection.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Tell your doctor if you are also using insulin. You should not use prandial insulin (eg, Apidra®, Lantus®) while you are using this medicine. Using these medicines together may cause unwanted effects.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are using exenatide (the active ingredient contained in Bydureon BCise) unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, diabetic patients may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur during pregnancy in patients with diabetes.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

This medicine may increase the risk of having thyroid tumors. Tell your doctor right away if you have a lump or swelling in your neck or throat and if you use Bydureon® or Bydureon® BCise®. Also tell your doctor if you have trouble swallowing or breathing, or if your voice gets hoarse.

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may lower the number of platelets in your blood, causing your body to not form blood clots. This may lead to serious bleeding and death. Call your doctor right away if you have unusual bleeding or bruising. Your blood platelet count may continue to be low for about 10 weeks after stopping this medicine.

Call your doctor right away if you notice any of these side effects at the injection site, including depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or peeling of the skin.

This medicine does not cause hypoglycemia (low blood sugar). However, low blood sugar can occur when you use exenatide with other medicines, such as insulin or sulfonylureas, that can lower blood sugar. Low blood sugar also can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting.

Symptoms of low blood sugar include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms including seizures or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include: blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination (frequency and amount), ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Bydureon BCise

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:

Serious side effects of Bydureon BCise

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:

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

For healthcare professionals

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

General adverse events

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 BCise) 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]

See also:

Frequently asked questions

• How long does it take for Bydureon Bcise to take effect?
• How and where is the Bydureon injection given?
• How do you use the Bydureon Bcise autoinjector?
• How long can Bydureon be unrefrigerated?
• How do you use the Bydureon pen?
• How does Bydureon work?

Further information

Bydureon BCise side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer