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Byetta

"The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects approximately 24 million pe"...

Byetta

Byetta Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Byetta (exenatide) is an injectable diabetes medicine that helps control blood sugar levels. Exenatide is used to treat type 2 (non-insulin dependent) diabetes. It is administered as a subcutaneous injection. Side effects can include nausea, vomiting, weight loss, heartburn, dizziness, or headache. Other side effects may occur.

There are no adequate and well-controlled studies of Byetta use in pregnant women, but in animal studies, exenatide caused cleft palate, irregular skeletal ossification and an increased number of neonatal deaths. It is not known whether exenatide is excreted in human milk.

Our Byetta 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.

Byetta in Detail - Patient Information: Side Effects

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

Stop using exenatide and call your doctor at once if you have a serious side effect such as:

  • swelling, weight gain, feeling short of breath, urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, diarrhea;
  • dull pain in your middle or lower back;
  • severe pain in your upper stomach spreading to your back, vomiting; or
  • low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery).

Less serious side effects may include:

  • nausea, upset stomach, diarrhea or constipation;
  • weight loss; or
  • loss of appetite.

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 Byetta (Exenatide Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Byetta Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, nervousness, or upset stomach may occur as your body adjusts to the medication. Nausea usually lessens as you continue to use exenatide. Other side effects include decreased appetite or weight loss. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although exenatide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other anti-diabetic medications. Talk with your doctor or pharmacist about all your diabetic medication(s).

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Talk with your doctor or pharmacist about what to do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your doctor may need to adjust your diabetes medication(s).

Stop taking exenatide and tell your doctor right away if any of these very serious side effects occur: signs of pancreatitis (such as persistent nausea/vomiting, loss of appetite, severe stomach/abdominal/back pain), a change in the amount of your urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Byetta (Exenatide Injection)»

What is Prescribing information?

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

Byetta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Hypoglycemia

Table 1 summarizes the incidence and rate of hypoglycemia with BYETTA (exenatide injection) in five placebo-controlled clinical trials.

Table 1: Incidence (%) and Rate of Hypoglycemia When BYETTA (exenatide injection) was Used as Monotherapy or With Concomitant Antidiabetic Therapy in Five Placebo-Controlled Clinical Trials*

  BYETTA
Placebo twice daily 5 mcg twice daily 10 mcg twice daily
Monotherapy (24 Weeks)
N 77 77 78
% Overall 1.3% 5.2% 3.8%
Rate (episodes/patient­year) 0.03 0.21 0.52
% Severe 0.0% 0.0% 0.0%
With Metformin (30 Weeks)
N 113 110 113
% Overall 5.3% 4.5% 5.3%
Rate(episodes/patient­year) 0.12 0.13 0.12
% Severe 0.0% 0.0% 0.0%
With a Sulfonylurea (30 Weeks)
N 123 125 129
% Overall 3.3% 14.4% 35.7%
Rate (episodes/patient­year) 0.07 0.64 1.61
% Severe 0.0% 0.0% 0.0%
With Metformin and a Sulfonylurea (30 Weeks)
N 247 245 241
% Overall 12.6% 19.2% 27.8%
Rate(episodes/patient­year) 0.58 0.78 1.71
% Severe 0.0% 0.4% 0.0%
With a Thiazolidinedione (16 Weeks)
N 112 Dose not studied 121
% Overall 7.1% Dose not studied 10.7%
Rate(episodes/patient-years) 0.56 Dose not studied 0.98
% Severe 0.0% Dose not studied 0.0%
* For the 30-week trials, a hypoglycemia episode was recorded if the patient reported symptoms consistent with hypoglycemia and was recorded as severe if the subject required the assistance of another person to treat the event. For the other trials, a hypoglycemic episode was recorded if a patient reported signs or symptoms of hypoglycemia or had a blood glucose value consistent with hypoglycemia regardless of associated symptoms or treatment and was recorded as severe if the subject required the assistance of another person to treat the event. The requirement for assistance had to be accompanied by a blood glucose measurement of < 50 mg/dL or prompt recovery after administration of oral carbohydrate.
N = The number of Intent-to-Treat subjects in each treatment group.

Immunogenicity

In the 30-week controlled trials of BYETTA (exenatide injection) add-on to metformin and/or sulfonylurea, 38% of patients had low titer antibodies to exenatide at 30 weeks. For this group, the level of glycemic control (hemoglobin A1c [HbA1c]) was generally comparable to that observed in those without antibody titers. An additional 6% of patients had higher titer antibodies at 30 weeks. In about half of this 6% (3% of the total patients given BYETTA (exenatide injection) in the 30-week controlled studies), the glycemic response to BYETTA (exenatide injection) was attenuated; the remainder had a glycemic response comparable to that of patients without antibodies.

In the 16-week trial of BYETTA (exenatide injection) add-on to thiazolidinediones, with or without metformin, 9% of patients had higher titer antibodies at 16 weeks. In the 24-week trial of BYETTA (exenatide injection) used as monotherapy, 3% of patients had higher titer antibodies at 24 weeks. Compared with patients who did not develop antibodies to BYETTA (exenatide injection) , on average the glycemic response in patients with higher titer antibodies was attenuated [see WARNINGS AND PRECAUTIONS].

Other Adverse Reactions

Monotherapy

For the 24-week placebo-controlled study of BYETTA (exenatide injection) used as a monotherapy, Table 2 summarizes adverse reactions (excluding hypoglycemia) occurring with an incidence ≥ 2% and occurring more frequently in BYETTA (exenatide injection) -treated patients compared with placebo-treated patients.

Table 2: Treatment-Emergent Adverse Reactions ≥ 2% Incidence With BYETTA (exenatide injection) Used as Monotherapy (Excluding Hypoglycemia)*

Monotherapy Placebo BID
N = 77
%
All BYETTA (exenatide injection) BID
N = 155
%
Nausea 0 8
Vomiting 0 4
Dyspepsia 0 3
* In a 24-week placebo-controlled trial.
BID = twice daily.

Adverse reactions reported in ≥ 1.0 to < 2.0% of patients receiving BYETTA (exenatide injection) and reported more frequently than with placebo included decreased appetite, diarrhea, and dizziness. The most frequently reported adverse reaction associated with BYETTA (exenatide injection) , nausea, occurred in a dose-dependent fashion.

Two of the 155 patients treated with BYETTA (exenatide injection) withdrew due to adverse reactions of headache and nausea. No placebo-treated patients withdrew due to adverse reactions.

Combination Therapy

Add-on to metformin and/or sulfonylurea

In the three 30-week controlled trials of BYETTA (exenatide injection) add-on to metformin and/or sulfonylurea, adverse reactions (excluding hypoglycemia) with an incidence ≥ 2% and occurring more frequently in BYETTA (exenatide injection) -treated patients compared with placebo-treated patients [see WARNINGS AND PRECAUTIONS] are summarized in Table 3.

Table 3: Treatment-Emergent Adverse Reactions ≥ 2% Incidence and Greater Incidence With BYETTA (exenatide injection) Treatment Used With Metformin and/or a Sulfonylurea (Excluding Hypoglycemia)*

  Placebo BID
N = 483
%
All BYETTA (exenatide injection) BID
N = 963
%
Nausea 18 44
Vomiting 4 13
Diarrhea 6 13
Feeling Jittery 4 9
Dizziness 6 9
Headache 6 9
Dyspepsia 3 6
Asthenia 2 4
Gastroesophageal Reflux Disease 1 3
Hyperhidrosis 1 3
* In three 30-week placebo-controlled clinical trials.
BID = twice daily.

Adverse reactions reported in ≥ 1.0 to < 2.0% of patients receiving BYETTA (exenatide injection) and reported more frequently than with placebo included decreased appetite. Nausea was the most frequently reported adverse reaction and occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased over time in most of the patients who initially experienced nausea. Patients in the long-term uncontrolled open-label extension studies at 52 weeks reported no new types of adverse reactions than those observed in the 30-week controlled trials.

The most common adverse reactions leading to withdrawal for BYETTA (exenatide injection) -treated patients were nausea (3% of patients) and vomiting (1%). For placebo-treated patients, < 1% withdrew due to nausea and none due to vomiting.

Add-on to thiazolidinedione with or without metformin

For the 16-week placebo-controlled study of BYETTA (exenatide injection) add-on to a thiazolidinedione, with or without metformin, Table 4 summarizes the adverse reactions (excluding hypoglycemia) with an incidence of ≥ 2% and occurring more frequently in BYETTA (exenatide injection) -treated patients compared with placebo-treated patients.

Table 4: Treatment-Emergent Adverse Reactions ≥ 2% Incidence With BYETTA (exenatide injection) Used With a Thiazolidinedione, With or Without Metformin (Excluding Hypoglycemia)*

With a TZD or TZD/MET Placebo
N = 112
%
All BYETTA (exenatide injection) BID
N = 121
%
Nausea 15 40
Vomiting 1 13
Dyspepsia 1 7
Diarrhea 3 6
Gastroesophageal Reflux Disease 0 3
* In a 16-week placebo-controlled clinical trial.
BID = twice daily.

Adverse reactions reported in ≥ 1.0 to < 2.0% of patients receiving BYETTA (exenatide injection) and reported more frequently than with placebo included decreased appetite. Chills (n = 4) and injection-site reactions (n = 2) occurred only in BYETTA (exenatide injection) -treated patients. The two patients who reported an injection-site reaction had high titers of antibodies to exenatide. Two serious adverse events (chest pain and chronic hypersensitivity pneumonitis) were reported in the BYETTA (exenatide injection) arm. No serious adverse events were reported in the placebo arm.

The most common adverse reactions leading to withdrawal for BYETTA (exenatide injection) -treated patients were nausea (9%) and vomiting (5%). For placebo-treated patients, < 1% withdrew due to nausea.

Post-Marketing Experience

The following additional adverse reactions have been reported during post-approval use of BYETTA (exenatide injection) . Because these events 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.

Allergy/Hypersensitivity: injection-site reactions, generalized pruritus and/or urticaria, macular or papular rash, angioedema, anaphylactic reaction [see WARNINGS AND PRECAUTIONS].

Drug Interactions: International normalized ratio (INR) increased with concomitant warfarin use sometimes associated with bleeding [see DRUG INTERACTIONS].

Gastrointestinal: nausea, vomiting, and/or diarrhea resulting in dehydration; abdominal distension, abdominal pain, eructation, constipation, flatulence, acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death [see Limitations of Use and WARNINGS AND PRECAUTIONS].

Neurologic: dysgeusia; somnolence

Renal and Urinary Disorders: 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 [see WARNINGS AND PRECAUTIONS].

Skin and Subcutaneous Tissue Disorders: alopecia

Read the entire FDA prescribing information for Byetta (Exenatide Injection) »

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Byetta - User Reviews

Byetta User Reviews

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Here is a collection of user reviews for the medication Byetta sorted by most helpful. Patient Discussions FAQs

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