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Does Byetta (exenatide) cause side effects?
Incretin mimetics mimic the effects of incretins. Incretins, such as human-glucagon-like peptide-1 (GLP-1), are hormones that are produced and released into the blood by the intestine in response to food.
GLP-1 increases the secretion of insulin from the pancreas, slows absorption of glucose from the gut, and reduces the action of glucagon. (Glucagon is a hormone that increases glucose production by the liver.) All three of these actions reduce levels of glucose in the blood.
In addition, GLP-1 reduces appetite. Byetta is a synthetic (man-made) hormone that resembles and acts like GLP-1. In studies, Byetta-treated patients achieved lower blood glucose levels and experienced weight loss.
Common side effects of Byetta include
- excessively low blood glucose (hypoglycemia),
- nervousness and
- stomach discomfort.
Other important side effects Byetta include
Drug interactions of Byetta include drugs that are taken orally because Byetta slows down the transit of food and drugs through the intestine and, therefore, can reduce the absorption of drugs that are taken orally. To avoid this interaction, administer oral medications one hour before Byetta is administered.
What are the important side effects of Byetta (exenatide)?
The most common side effects of exenatide are:
- nausea (nausea from exenatide is more common with the higher doses and decreases over time.)
- hypoglycemia (excessively low blood glucose),
- nervousness and,
- stomach discomfort.
Other important side effects include:
- decreased appetite,
- acid reflux, and
- increased sweating.
There have been reports of acute pancreatitis associated with the use of exenatide. Patients developing severe, persistent abdominal pain should seek prompt medical attention. If pancreatitis is suspected, exenatide should be discontinued and not started again until pancreatitis has been excluded.
Byetta (exenatide) side effects list for healthcare professionals
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.
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
|Placebo twice daily||5 mcg twice daily||10 mcg twice daily|
|Monotherapy (24 Weeks)|
|With Metformin (30 Weeks)|
|With a Sulfonylurea (30 Weeks)|
|With Metformin and a Sulfonylurea (30 Weeks)|
|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.
- 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.
Other Adverse Reactions
- 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)*
N = 77
|All Byetta (exenatide injection) BID
N = 155
|* 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.
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 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
N = 483
|All Byetta (exenatide injection) BID
N = 963
|Gastroesophageal Reflux Disease||1||3|
|* In three 30-week placebo-controlled clinical
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
|With a TZD or TZD/MET||Placebo
N = 112
|All Byetta (exenatide injection) BID
N = 121
|Gastroesophageal Reflux Disease||0||3|
|* In a 16-week placebo-controlled clinical
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.
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.
- Drug Interactions: International normalized ratio (INR) increased with concomitant warfarin use sometimes associated with bleeding.
- 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.
- 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.
- Skin and Subcutaneous Tissue Disorders: alopecia
What drugs interact with Byetta (exenatide)?
Orally Administered Drugs
- The effect of Byetta (exenatide injection) to slow gastric emptying can reduce the extent and rate of absorption of orally administered drugs.
- Byetta (exenatide injection) should be used with caution in patients receiving oral medications that have narrow therapeutic index or require rapid gastrointestinal absorption.
- For oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before Byetta (exenatide injection) injection.
- If such drugs are to be administered with food, patients should be advised to take them with a meal or snack when Byetta is not administered.
- There are postmarketing reports of increased INR sometimes associated with bleeding, with concomitant use of warfarin and Byetta.
- In a drug interaction study, Byetta (exenatide injection) did not have a significant effect on INR.
- In patients taking warfarin, prothrombin time should be monitored more frequently after initiation or alteration of Byetta (exenatide injection) therapy.
- Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on warfarin.
Byetta (exenatide) is an incretin mimetic that reduces the level of sugar (glucose) in the blood and is used to treat type 2 diabetes. Common side effects of Byetta include nausea, excessively low blood glucose (hypoglycemia), vomiting, diarrhea, headache, nervousness and stomach discomfort. There are no adequate studies of Byetta in pregnant women or nursing mothers.
Related Disease Conditions
Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss of interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Normal Blood Sugar Levels In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes Symptoms in Men
Early symptoms of diabetes are different in men, such as low testosterone. In many cases, prediabetes that will progress to type 2 diabetes if it is not treated early.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Type 1 vs. Type 2 Diabetes: Differences
Diabetes mellitus is a metabolic condition in which a person's blood sugar (glucose) levels are too high. Over 29.1 million children and adults in the US have diabetes. Of that, 8.1 million people have diabetes and don't even know it. Type 1 diabetes (insulin-dependent, juvenile) is caused by a problem with insulin production by the pancreas. Type 2 diabetes (non-insulin dependent) is caused by: Eating a lot of foods and drinking beverages with simple carbohydrates (pizza, white breads, pastas, cereals, pastries, etc.) and simple sugars (donuts, candy, etc.) Consuming too many products with artificial sweeteners (We found out that they are bad for us!) Lack of activity Exercise Stress Genetics While the signs and symptoms of both types of diabetes are the same, which include: Increased urination Increased hunger Increased thirst Unexplained weight loss. However, the treatments are different. Type 1 diabetes is insulin dependent, which means a person with this type of diabetes requires treatment with insulin. People with type 2 diabetes require medication, lifestyle changes like eating a healthy diet, and getting regular exercise.
Pregnancy and Gestational Diabetes
Gestational diabetes is a form of diabetes that can occur during pregnancy. Pregnant women with gestational diabetes have not had the condition prior to becoming pregnant. Usually, gestational diabetes has no symptoms or signs and of gestational diabetes. Gestational diabetes can cause insulin resistance, hypoglycemia, hypoglycemia, and diabetic ketoacidosis. Treatment of gestational diabetes is managing the condition by checking your blood sugar as recommended, diet changes, getting enough exercise, and monitoring your baby's growth.
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Type 2 Diabetes: Diagnosing Diabetes
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Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
Prediabetes is a situation where a person's blood sugar levels are higher than they should be, but aren't high enough to be diagnosed with type 2 diabetes. There are no signs or symptoms of prediabetes. Some of the risk factors for prediabetes are high blood pressure, high cholesterol, heart disease, smoking, family history, poor diet, and lack of activity. Diet changes along with other healthy lifestyle changes are important in treating prediabetes.
Diabetes Treatment: Medication, Diet, and Insulin
The major goal in treating diabetes is controlling elevated blood sugar without causing abnormally low levels of blood sugar. Type 1 diabetes is treated with: insulin, exercise, and a diabetic diet. Type 2 diabetes is first treated with: weight reduction, a diabetic diet, and exercise. When these measures fail to control the elevated blood sugar, oral medications are used. If oral medications are still insufficient, insulin medications are considered.
Diabetes and Safe Medications for Colds and the Flu: OTC Medication Guide
If you have diabetes and catch a cold or the flu, can be more difficult to recover from infections and their complications, for example, pneumonia. Home remedies and over-the-counter (OTC) drugs used for the treatment of the signs and symptoms of colds and the flu may affect blood sugar levels in people with diabetes.Some medications are OK to take if you have diabetes get a cold or the flu include nonsteroidal anti-inflammatory drugs or NSAIDs, like acetaminophen (Tylenol) and ibuprofen (Motrin) to control symptoms of fever and pain. Most cough syrups are safe to take; however, check with your pediatrician to see what medications are safe to give your child if he or she has type 1 or 2 diabetes. If you have diabetes and are sick with a cold or flu, you need to check your blood sugar levels more frequently. Continue taking your regular medications. Eat a diabetic low-glycemic index diet rich in antioxidants. To prevent colds and the flu drink at least eight 8 ounce glasses of water a day. To replenish fluids, drink sports drinks like Gatorade and Pedialyte to replenish electrolytes. Avoid people who are sick, sneezing, coughing, or have other symptoms of a cold or flu.
Types of Diabetes Type 2 Medications
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
Diabetes Foot Problems
Diabetes related foot problems can affect your health with two problems: diabetic neuropathy, where diabetes affects the nerves, and peripheral vascular disease, where diabetes affects the flow of blood. Common foot problems for people with diabetes include athlete's foot, fungal infection of nails, calluses, corns, blisters, bunions, dry skin, foot ulcers, hammertoes, ingrown toenails, and plantar warts.
How to Prevent Diabetes Naturally
Prediabetes is a condition in which a person has early symptoms of diabetes, but has not yet fully developed the condition. If prediabetes is not treated with lifestyle changes, the person could develop type 2 diabetes. Type 2 diabetes and prediabetes can be prevented with lifestyle changes, for example, eating a healthy diet, getting more exercise, reducing stress, quitting smoking, reducing or managing blood pressure and cholesterol, and managing any other health conditions or risk factors that you may have for developing type 2 diabetes.
Diabetes insipidus is a condition in which the patient has frequent urination. Symptoms of diabetes insipidus include irritable, listless, fever, vomiting, or diarrhea due to the loss of large volumes of urine. There are three types of diabetes insipidus, central, nephrogenic, dipsogenic, and gestational. Treatment depends upon the type of diabetes insipidus.
Eye Problems and Diabetes
Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
What Are the Early Signs of Diabetes?
The early signs of diabetes depend on if one has type 1 or type 2 diabetes. Type 1 diabetes usually occurs in children, whereas type 2 diabetes is prevalent in adults.
Diabetes and Kidney Disease
In the United States diabetes is the most common cause of kidney failure. High blood pressure and high levels of blood glucose increase the risk that a person with diabetes will eventually progress to kidney failure. Kidney disease in people with diabetes develops over the course of many years. albumin and eGFR are two key markers for kidney disease in people with diabetes. Controlling high blood pressure, blood pressure medications, a moderate protein diet, and compliant management of blood glucose can slow the progression of kidney disease. For those patients who's kidneys eventually fail, dialysis or kidney transplantation is the only option.
Hypoglycemia Without Diabetes: Causes and Diet
Hypoglycemia (low blood sugar level) is a condition most seen in patients with diabetes, who are on insulin or medications. Hypoglycemia is uncommon to happen in people without diabetes.
Sex, Urinary, and Bladder Problems of Diabetes
Having diabetes can mean early onset and increased severity of bladder symptoms (urinary incontinence and urinary tract infections) and changes in sexual function. Men may have erectile dysfunction; and women may have problems with sexual response and vaginal lubrication. Keep your diabetes under control, and you can lower your risk of sexual and urologic problems.
Is Diabetes Insipidus Life-Threatening?
Diabetes insipidus (DI) is an uncommon disease that manifests as a frequent urge for urination and extreme thirst. It has nothing to do with blood sugar levels. Although in both diabetes mellitus and insipidus, patients experience a large volume of urine production, the cause is completely different.
Can Type 2 Diabetes be Cured?
Type 2 diabetes is a long-term medical condition in which the body is not able to regulate blood sugar (glucose) level because of the inability of the body to properly use insulin. An individual can get type 2 diabetes because of a number of factors that reduce insulin action or quantity in the body. The goals of diabetes management are to eliminate symptoms and prevent the development of complications. Many drugs, both oral and injectable, are available for diabetes management.
Diabetes: Caring for Your Diabetes at Special Times
Taking care of a disease such as diabetes is a life-long process. Learn how to care for yourself or loved one with diabetes in situations such as illness, work, school, travel, or a natural disaster.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
What Are the Early Signs of Type 2 Diabetes?
Type 2 Diabetes is a chronic disease characterized by increased blood sugar (glucose) level. Type 2 Diabetes is caused by either insufficient insulin secretion or resistance to that hormone’s action. Insulin is produced by the pancreas and helps process the glucose in the blood. Thus, with inadequate insulin, the bodies can’t burn all the blood sugar for energy in an efficient way. This means the glucose level in the blood rises, causing a variety of symptoms and when severe may even lead to death.
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.