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Byetta (Exenatide Injection) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 /



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



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