Index of reports
> Cases with Off Label Use (138)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Byetta (Exenatide Injection) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 138 Next >>
Possible Byetta side effects in 69 year old male
Reported by a consumer/non-health professional from Australia on 2012-08-27
Patient: 69 year old male, weighing 117.0 kg (257.4 pounds)
Reactions: Vomiting, Chest Discomfort, Nausea, International Normalised Ratio Increased, Hypotension, Drug Intolerance, Hypoglycaemia, Musculoskeletal Chest Pain, Off Label Use, Dehydration, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Crestor; Felodipine; Warfarin Sodium; Monodur; Uremide; Gliclazide; Metformin HCL; Aspirin; Micardis; Progout; Novo MIX 30; Lantus; Linagliptin
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male
Reactions: Pancreatitis Acute, Off Label Use, Hospitalisation, Pancreatic Carcinoma
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: unk, unknown
Start date: 2006-01-10
Byetta
Dosage: 10 ug, bid
End date: 2007-02-16
Other drugs received by patient: Lisinopril; Lofibra; Flomax; Toprol-XL; Humalog; Vytorin; Cilostazol; Actos; Latanoprost; Lantus; Avodart; Creon; Prevacid
Possible Byetta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: female, weighing 70.3 kg (154.6 pounds)
Reactions: Weight Decreased, Intentional Drug Misuse, Headache, Constipation, Hunger, Off Label Use, Weight Increased, Abdominal Discomfort, Fatigue, Dyspepsia, Nervousness, Blood Glucose Increased, Drug Effect Decreased, Insulin C-Peptide Decreased, Nausea, Blood Glucose Decreased, Impaired Insulin Secretion
Drug(s) suspected as cause:
Byetta
Dosage: 5 ug, bid
Indication: Insulin-Requiring Type 2 Diabetes Mellitus
Start date: 2008-07-01
Byetta
Dosage: 10 ug, bid
End date: 2012-04-01
Other drugs received by patient: Humalog; Victoza; Lantus; Novolog; Novolog MIX 70 / 30
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: male
Reactions: Off Label Use, Renal Failure, Limb Injury, Cardiac Failure, Myocardial Infarction, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Metformin Hydrochloride; Lantus; Bumex; Metoprolol Tartrate; Novolog; Glyburide; Spironolactone
Possible Byetta side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-07-10
Patient: female
Reactions: Intentional Drug Misuse, Laryngeal Oedema, Hypoaesthesia, Erythema, Off Label Use, Injection Site Erythema, Hypoaesthesia Oral, Oedema Peripheral, Rash Erythematous, Feeling Abnormal
Drug(s) suspected as cause:
Byetta
Dosage: 5 ug, unknown
Start date: 2011-12-03
Byetta
Dosage: 5 ug, unknown
Indication: Obesity
End date: 2011-11-24
Possible Byetta side effects in 69 year old male
Reported by a consumer/non-health professional from Australia on 2012-07-06
Patient: 69 year old male, weighing 117.0 kg (257.4 pounds)
Reactions: Vomiting, Chest Discomfort, Nausea, Hypoglycaemia, Drug Intolerance, International Normalised Ratio Increased, Musculoskeletal Chest Pain, Off Label Use, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Linagliptin; Micardis; Warfarin Sodium; Novolog; Progout; Metformin HCL; Gliclazide; Aspirin; Crestor; Monodur; Uremide; Lantus; Felodipine
Possible Byetta side effects in male
Reported by a physician from Netherlands on 2012-07-03
Patient: male, weighing 100.0 kg (220.0 pounds)
Reactions: Off Label Use, Weight Decreased, Lung Neoplasm Malignant
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Metformin HCL; Ascal; Levemir; Lipitor; Levemir; Novorapid
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: male
Reactions: Off Label Use, Palpitations, Diarrhoea, Flatulence, Faecal Incontinence, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: 10 ug, bid
Indication: Type 2 Diabetes Mellitus
Start date: 2008-01-01
Byetta
Dosage: 10 ug, bid
Other drugs received by patient: Metformin HCL; Lantus; Metoprolol Succinate; Novolog; Water Pills; Lovastatin; Aspirin; Metformin HCL
Possible Byetta side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: female
Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Blood Glucose Decreased, Dysarthria, Transient Ischaemic Attack, Blood Glucose Increased
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Lantus; Pradaxa; Novolog; Metformin HCL
Possible Byetta side effects in 66 year old male
Reported by a consumer/non-health professional from Colombia on 2012-06-20
Patient: 66 year old male
Reactions: Off Label Use, Cardio-Respiratory Arrest, Adverse Drug Reaction, Nodule
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: 5 ug, bid
Start date: 2012-06-02
Byetta
Dosage: 10 ug, unk
Indication: Type 2 Diabetes Mellitus
Start date: 2012-03-01
Other drugs received by patient: Enalapril Maleate; Calcium with Vitamin D; Levemir; Metoprolol; Atorvastatin; Clopidogrel; Novorapid; Ranitidine
Possible Byetta side effects in male
Reported by a consumer/non-health professional from France on 2012-06-19
Patient: male
Reactions: Pancreatitis Acute, Off Label Use, Ventricular Fibrillation, Septic Shock, Renal Failure Chronic, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Metformin HCL; Glimepiride; Novolog MIX 70 / 30; Ezetimibe; Ramipril; Befizal
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: male
Reactions: Pancreatitis Acute, Off Label Use, Hospitalisation, Pancreatic Carcinoma
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Humalog; Actos; Flomax; Avodart; Lantus; Toprol-XL
Possible Byetta side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: Off Label Use, Underdose, Blood Glucose Increased
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Insulin; Drug Used IN Diabetes
Possible Byetta side effects in 54 year old female
Reported by a consumer/non-health professional from Colombia on 2012-05-29
Patient: 54 year old female
Reactions: Vomiting, Nausea, Headache, Tremor, Off Label Use, Diarrhoea, Depressed Mood, Blood Glucose Increased
Drug(s) suspected as cause:
Byetta
Dosage: 10 ug, bid
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-10
End date: 2012-02-23
Byetta
Dosage: 5 ug, qd
Start date: 2012-02-24
Other drugs received by patient: Acetaminophen; Ferrous Sulfate TAB; Atorvastatin Calcium; Lantus; Carbamazepine; Losartan Potassium; Apidra; Ranitidine
Possible Byetta side effects in 66 year old male
Reported by a consumer/non-health professional from Colombia on 2012-05-29
Patient: 66 year old male
Reactions: Off Label Use, Cardio-Respiratory Arrest
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Novorapid; Enalapril Maleate; Metoprolol Tartrate; Ranitidine; Levemir; Clopidogrel; Atorvastatin Calcium; Calcium with Vitamin D
Possible Byetta side effects in 49 year old female
Reported by a consumer/non-health professional from Australia on 2012-05-21
Patient: 49 year old female
Reactions: Off Label Use, Ketoacidosis, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Insulin
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: male, weighing 102.5 kg (225.5 pounds)
Reactions: Off Label Use, Pancreatic Carcinoma Recurrent, Adenocarcinoma Pancreas, Malignant Ascites, Jaundice Cholestatic
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Actos; Metformin HCL; Calcium Carbonate; Fosinopril Sodium; Vytorin
Possible Byetta side effects in 64 year old female
Reported by a physician from France on 2012-05-09
Patient: 64 year old female, weighing 111.3 kg (244.9 pounds)
Reactions: Pancreatitis Acute, Off Label Use, Diabetes Mellitus Inadequate Control
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Levothyroxine Sodium; Zolpidem; Atenolol; Glucophage; Plavix; Xalatan; Valsartan and Hydrochlorothiazide; Humalog; Escitalopram; Pravastatin
Possible Byetta side effects in 71 year old male
Reported by a physician from Sweden on 2012-04-30
Patient: 71 year old male
Reactions: Off Label Use, Atrioventricular Block, Bradycardia, Hyperhidrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Metformin HCL; Sulfuric Acid; Insulin Glargine
Possible Byetta side effects in male
Reported by a consumer/non-health professional from Australia on 2012-04-30
Patient: male
Reactions: Chest Discomfort, Vomiting, Nausea, Drug Intolerance, Hypoglycaemia, International Normalised Ratio Increased, Off Label Use, Chest Pain, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Felodipine; Linagliptin; Metformin HCL; Aspirin; Progout; Micardis; Uremide; Crestor; Warfarin Sodium; Lantus; Gliclazide; Monodur
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: male, weighing 112.2 kg (246.8 pounds)
Reactions: Off Label Use, Adverse Drug Reaction, General Physical Health Deterioration, Arrhythmia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Dosage: 2 mg, weekly (1/w)
Indication: Insulin-Requiring Type 2 Diabetes Mellitus
Byetta
Dosage: 5 ug, bid
Indication: Insulin-Requiring Type 2 Diabetes Mellitus
Byetta
Dosage: 10 ug, bid
Other drugs received by patient: Furosemide; Novolog; Fenofibrate; Lisinopril / USA /; Clonidine; Metoprolol Tartrate; Amlodipine; Tamsulosin HCL; Aspirin / USA /; Crestor
Possible Byetta side effects in 58 year old female
Reported by a consumer/non-health professional from Turkey on 2012-04-26
Patient: 58 year old female, weighing 107.0 kg (235.4 pounds)
Reactions: Off Label Use, Pneumonia, Blood Glucose Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Lantus
Possible Byetta side effects in male
Reported by a consumer/non-health professional from Japan on 2012-04-20
Patient: male
Reactions: Off Label Use, Abdominal Discomfort, Nausea, Liver Function Test Abnormal, Diabetes Mellitus Inadequate Control, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: 10 ug, unk
End date: 2012-03-01
Byetta
Dosage: 5 ug, unk
Start date: 2012-03-01
Byetta
Indication: Diabetes Mellitus
Byetta
Dosage: 10 ug, unk
Other drugs received by patient: Metformin Hydrochloride; Amaryl; Amaryl; Metformin Hydrochloride
Possible Byetta side effects in 54 year old female
Reported by a consumer/non-health professional from Colombia on 2012-04-18
Patient: 54 year old female
Reactions: Vomiting, Nausea, Headache, Tremor, Off Label Use, Diarrhoea, Bronchitis, Depressed Mood, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: 10 ug, bid
Indication: Type 2 Diabetes Mellitus
Start date: 2012-02-10
End date: 2012-02-23
Byetta
Dosage: 5 ug, qd
Start date: 2012-02-24
Other drugs received by patient: Carbamazepine; Acetaminophen; Ferrous Sulfate TAB; Apidra; Lantus; Atorvastatin; Ranitidine; Losartan Potassium
Possible Byetta side effects in female
Reported by a physician from United States on 2012-04-13
Patient: female, weighing 67.1 kg (147.7 pounds)
Reactions: Weight Decreased, Hypersensitivity, Exophthalmos, Adrenocortical Insufficiency Acute, Nausea, Supraventricular Tachycardia, Thyrotoxic Crisis, Arrhythmia, Off Label Use, Sensation of Foreign Body, Palpitations, Thyroid Disorder, Hyperthyroidism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: 10 ug, bid
Byetta
Dosage: 5 ug, bid
Indication: Type 2 Diabetes Mellitus
Other drugs received by patient: Synthroid; Amaryl; Synthroid; Humalog; Beta Blocking Agents; Metformin HCL
Possible Byetta side effects in 57 year old male
Reported by a consumer/non-health professional from Brazil on 2012-04-11
Patient: 57 year old male
Reactions: Off Label Use, Incorrect Storage of Drug, Cerebrovascular Accident, Learning Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Lipitor; Somalgin; Ciprofibrate; Aldactone; Levemir; Clopidogrel; Apidra
Possible Byetta side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-28
Patient: male
Reactions: Jaundice, Pancreatitis Acute, Aortic Aneurysm, Pyrexia, Cyst, Pseudocyst, Multi-Organ Failure, Off Label Use, Renal Failure, Pancreatitis Necrotising, Pancreatitis Chronic, Pneumonia Staphylococcal, Acute Respiratory Failure
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Lasix; Aspirin; Xanax; Metoprolol Succinate; Tramadol Hydrochloride and Acetaminophen; Celebrex; Zetia; Cardura; Omeprazole; Minoxidil; Tricor; Amlodipine Besylate and Benazepril HCL; Allopurinol; Humalog MIX 50
Possible Byetta side effects in male
Reported by a physician from United States on 2012-03-23
Patient: male, weighing 108.8 kg (239.4 pounds)
Reactions: Weight Decreased, Off Label Use, Blood Glucose Decreased, Vomiting, Nausea, Coronary Artery Occlusion, Dizziness, Blood Pressure Decreased, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Byetta
Dosage: 10 ug, bid
Start date: 2010-02-01
Byetta
Dosage: 5 ug, bid
Indication: Type 2 Diabetes Mellitus
Start date: 2007-03-19
End date: 2010-02-01
Byetta
Dosage: 5 ug, bid
End date: 2011-09-01
Other drugs received by patient: Cozaar; Neurotin / 00949202 /; Tylenol Arthritis; Multi-Vitamins; Flomax; Gemfibrozil; Pravastatin; Ultram; Pristiq; Nasonex; Advair Diskus 100 / 50; Lasix; Lortab; Valium; Lasix; Symbicort; Darvocet; Allopurinol; Neurotin / 00949202 /; Flexeril; Novolog; Potassium; Prevacid; Vitamin D2; Toprol-XL; Bumex; Aspirin; Valium; Ritalin-SR; Vytorin
Possible Byetta side effects in 56 year old female
Reported by a consumer/non-health professional from Brazil on 2012-03-13
Patient: 56 year old female
Reactions: Blood Pressure Increased, Off Label Use, Speech Disorder, Malaise, Hypoglycaemia, Dizziness, Hypoaesthesia, Hyperhidrosis
Drug(s) suspected as cause:
Byetta
Other drugs received by patient: Atorvastatin; Pristiq; Propranolol; AD-TIL; Ranitidine HCL; Nexus; Synthroid; Colecalciferol
Possible Byetta side effects in female
Reported by a consumer/non-health professional from Israel on 2012-03-13
Patient: female, weighing 106.0 kg (233.2 pounds)
Reactions: Off Label Use, Weight Decreased, Dyspnoea, Oropharyngeal Swelling, Nausea, Dizziness
Drug(s) suspected as cause:
Byetta
Dosage: 5 ug, qd
Indication: Osteoporosis
Start date: 2012-02-01
End date: 2012-02-12
Byetta
Dosage: 5 ug, bid
Start date: 2012-02-13
End date: 2012-02-18
Other drugs received by patient: Omepradex; Plavix; Glucophage; Lyrica; Ramipril; Cardiloc; Amaryl; Lipitor / 01326102 /; Cartia / ISR /
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