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Index of reports
> Cases with Off Label Use (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Bydureon (Exenatide) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Bydureon side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: 61 year old male
Reactions: Off Label Use, Gastritis Bacterial, Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Benicar; Glucophage; Amaryl; Levemir
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-16
Patient: female, weighing 119.3 kg (262.4 pounds)
Reactions: Injection Site Mass, Weight Decreased, Off Label Use, Injection Site Haematoma, International Normalised Ratio Increased, International Normalised Ratio Decreased, Pulmonary Thrombosis, Joint Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Diovan HCT; Pristiq; Vytorin; Lantus; Xopenex HFA; Pulmicort; Actos; Metformin Hydrochloride; Lantus
Possible Bydureon side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: male
Reactions: Off Label Use, Angioedema, Hypersensitivity, Urticaria, Rash Pruritic
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Lorazepam; Lantus; Januvia; Glipizide
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient: female, weighing 74.8 kg (164.6 pounds)
Reactions: Pruritus Generalised, LIP Swelling, Off Label Use, Hypersensitivity, Swelling Face, Urticaria, Injection Site Nodule
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Vitamin D; Aspirin; Prandin / USA /; Lantus; Januvia; Metformin HCL
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from Finland on 2012-06-19
Patient: female
Reactions: Off Label Use, Acute Myeloid Leukaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Metoprolol Succinate; Lantus; Warfarin Sodium; Teveten; Levothyroxine Sodium; Hexal; Digoxin
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female, weighing 82.5 kg (181.6 pounds)
Reactions: Pruritus, Hypersensitivity, Nausea, Urticaria, Skin Burning Sensation, Off Label Use, Diarrhoea, Oedema Peripheral, Blood Glucose Increased, Injection Site Nodule
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Lantus; Lantus; Lantus; Metformin HCL
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female, weighing 74.8 kg (164.6 pounds)
Reactions: Off Label Use, LIP Swelling, Pruritus Generalised, Hypersensitivity, Swelling Face, Urticaria, Injection Site Nodule
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Prandin / USA /; Metformin HCL; Lantus; Januvia
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Blood Urine Present, Injection Site Haemorrhage, Haemorrhage, Injection Site Pain, Off Label Use, Dysuria, Blood Glucose Increased, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Insulin; Novolog; Kombiglyze XR
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female
Reactions: Off Label Use, Goitre, Injection Site Nodule
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Levemir
Possible Bydureon side effects in 66 year old female
Reported by a physician from Germany on 2012-05-22
Patient: 66 year old female
Reactions: Off Label Use, Salivary Gland Resection, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Levemir; Novorapid; Torsemide; Omeprazole; Enalapril Maleate; Simvastatin; Bisoprolol Fumarate; Metformin HCL; Levothyroxine Sodium; Levemir; Aspirin
Possible Bydureon side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: female, weighing 97.5 kg (214.5 pounds)
Reactions: Off Label Use, Drug Effect Decreased, Cystitis, Blood Glucose Increased
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Lantus; Novolog
Possible Bydureon side effects in 66 year old female
Reported by a consumer/non-health professional from Germany on 2012-04-30
Patient: 66 year old female
Reactions: Off Label Use, Salivary Gland Resection, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Levemir; Levemir
Possible Bydureon side effects in male
Reported by a physician from United Kingdom on 2012-04-30
Patient: male, weighing 98.0 kg (215.5 pounds)
Reactions: Off Label Use, Malaise, Injection Site Haematoma, Blood Glucose Increased, Injection Site Nodule
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Metformin HCL; Drug Used IN Diabetes; Humulin M3
Possible Bydureon 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 Bydureon side effects in 66 year old male
Reported by a physician from Germany on 2012-04-11
Patient: 66 year old male, weighing 100.0 kg (220.0 pounds)
Reactions: Off Label Use, Rash Generalised
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Liprolog; Metformin HCL; Aspirin; Exforge HCT; Simvastatin
Possible Bydureon side effects in 51 year old female
Reported by a consumer/non-health professional from Germany on 2012-03-16
Patient: 51 year old female
Reactions: Off Label Use, Myocardial Infarction, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Novorapid; Lantus
Possible Bydureon side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2012-02-28
Patient: male, weighing 124.0 kg (272.8 pounds)
Reactions: Off Label Use, Weight Decreased, Blood Glucose Increased
Drug(s) suspected as cause:
Bydureon
Dosage: 2 mg, weekly (1/w)
Start date: 2011-11-25
End date: 2011-12-25
Exenatide
Dosage: unk, unknown
Exenatide
Dosage: unk, unknown
Other drugs received by patient: Levemir; Novorapid
Possible Bydureon side effects in 51 year old male
Reported by a consumer/non-health professional from Germany on 2012-02-16
Patient: 51 year old male
Reactions: Off Label Use, Amylase Increased, Lipase Increased, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Metformin HCL; Bisoprolol Fumarate; Enalapril; Liprolog
Possible Bydureon side effects in male
Reported by a consumer/non-health professional from Ireland on 2012-02-15
Patient: male
Reactions: Dysgeusia, Off Label Use, Injection Site Haemorrhage, Laceration, Cerebrovascular Accident, Incorrect Storage of Drug, Venous Injury
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Lantus; Lantus; Novorapid; Caprin; Novorapid
Possible Bydureon side effects in male
Reported by a consumer/non-health professional from Germany on 2012-02-14
Patient: male
Reactions: Off Label Use, Malaise, Chest Pain, Dizziness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Marcumar; Gabapentin; Metformin HCL; Novorapid; Torsemide; Ramipril; Carvedilol; Repaglinide; Acetyldigoxin; Allopurinol; Spironolactone
Possible Bydureon side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-02-08
Patient: male
Reactions: Off Label Use, Injection Site Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Levemir (Insulin Determir); Metformin HCL; Apidra
Possible Bydureon side effects in male
Reported by a consumer/non-health professional from Germany on 2012-02-07
Patient: male
Reactions: Off Label Use, Hospitalisation, Injection Site Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bydureon
Other drugs received by patient: Levemir; Metformin HCL; Apidra
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