BYDUREON

Bydureon Adverse Events Reported to the FDA Over Time

How are Bydureon adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Bydureon, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Bydureon is flagged as the suspect drug causing the adverse event.

Most Common Bydureon Adverse Events Reported to the FDA

What are the most common Bydureon adverse events reported to the FDA?

Blood Glucose Increased	41 (4.58%)
Weight Decreased	25 (2.79%)
Nausea	24 (2.68%)
Injection Site Nodule	23 (2.57%)
Off Label Use	22 (2.46%)
Dizziness	19 (2.12%)
Injection Site Erythema	17 (1.9%)
Urticaria	17 (1.9%)
Injection Site Haemorrhage	16 (1.79%)
Diarrhoea	14 (1.56%)
Injection Site Pain	13 (1.45%)
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Dyspnoea	12 (1.34%)
Glycosylated Haemoglobin Increased	12 (1.34%)
Injection Site Mass	11 (1.23%)
Lip Swelling	11 (1.23%)
Injection Site Pruritus	10 (1.12%)
Malaise	10 (1.12%)
Swelling Face	10 (1.12%)
Vomiting	10 (1.12%)
Myocardial Infarction	9 (1%)
Injection Site Induration	8 (.89%)
Abdominal Pain	7 (.78%)
Blood Glucose Decreased	7 (.78%)
Decreased Appetite	7 (.78%)
Fatigue	7 (.78%)
Headache	7 (.78%)
Pain	7 (.78%)
Pharyngeal Oedema	7 (.78%)
Pruritus	7 (.78%)
Pruritus Generalised	7 (.78%)
Abdominal Pain Upper	6 (.67%)
Angioedema	6 (.67%)
Arrhythmia	6 (.67%)
Atrial Fibrillation	6 (.67%)
Blood Creatinine Increased	6 (.67%)
Cholelithiasis	6 (.67%)
Constipation	6 (.67%)
Hypersensitivity	6 (.67%)
Intentional Drug Misuse	6 (.67%)
Abdominal Discomfort	5 (.56%)
Blood Test Abnormal	5 (.56%)
Feeling Abnormal	5 (.56%)
Injection Site Abscess	5 (.56%)
Injection Site Swelling	5 (.56%)
Injection Site Warmth	5 (.56%)
Loss Of Consciousness	5 (.56%)
Nodule	5 (.56%)
Abdominal Distension	4 (.45%)
Cardiac Flutter	4 (.45%)
Chest Pain	4 (.45%)
Contusion	4 (.45%)
Cough	4 (.45%)
Gallbladder Enlargement	4 (.45%)
Gallbladder Polyp	4 (.45%)
General Physical Health Deteriorati...	4 (.45%)
Heart Rate Increased	4 (.45%)
Hepatic Neoplasm Malignant	4 (.45%)
Influenza	4 (.45%)
Injection Site Rash	4 (.45%)
Lipase Increased	4 (.45%)
Nasopharyngitis	4 (.45%)
Palpitations	4 (.45%)
Rash	4 (.45%)
Road Traffic Accident	4 (.45%)
Urinary Tract Infection	4 (.45%)
Asthenia	3 (.33%)
Back Pain	3 (.33%)
Blood Pressure Increased	3 (.33%)
Cellulitis	3 (.33%)
Cerebrovascular Accident	3 (.33%)
Chest Discomfort	3 (.33%)
Dyspepsia	3 (.33%)
Dysphagia	3 (.33%)
Dysphonia	3 (.33%)
Eye Swelling	3 (.33%)
Feeling Hot	3 (.33%)
Hyperhidrosis	3 (.33%)
Infection	3 (.33%)
Injection Site Haematoma	3 (.33%)
Injection Site Reaction	3 (.33%)
Local Swelling	3 (.33%)
Muscle Spasms	3 (.33%)
Oedema Peripheral	3 (.33%)
Pancreatitis	3 (.33%)
Presyncope	3 (.33%)
Pyrexia	3 (.33%)
Rash Generalised	3 (.33%)
Rash Pruritic	3 (.33%)
Sepsis	3 (.33%)
Swelling	3 (.33%)
Swollen Tongue	3 (.33%)
Visual Acuity Reduced	3 (.33%)
Acarodermatitis	2 (.22%)
Arthralgia	2 (.22%)
Biliary Colic	2 (.22%)
Blister	2 (.22%)
Blood Urea Increased	2 (.22%)
Blood Uric Acid Abnormal	2 (.22%)
Bronchitis	2 (.22%)
Calculus Ureteric	2 (.22%)
Cardiac Arrest	2 (.22%)

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This graph shows the top adverse events submitted to the FDA for Bydureon, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Bydureon is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Bydureon

What are the most common Bydureon adverse events reported to the FDA?

Administration Site Reactions	124 (13.84%)
Gastrointestinal Signs	66 (7.37%)
Metabolic, Nutritional And Blood Ga...	65 (7.25%)
Epidermal And Dermal Conditions	43 (4.8%)
Neurological	35 (3.91%)
Infections - Pathogen Unspecified	29 (3.24%)
Physical Examination Topics	27 (3.01%)
Gastrointestinal Motility And Defec...	25 (2.79%)
Respiratory	24 (2.68%)
Therapeutic Procedures And Supporti...	24 (2.68%)
Angiedema And Urticaria	23 (2.57%)
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Cardiac Arrhythmias	22 (2.46%)
Gallbladder	16 (1.79%)
Injuries	15 (1.67%)
Oral Soft Tissue Conditions	13 (1.45%)
Coronary Artery	10 (1.12%)
Upper Respiratory Tract Disorders	10 (1.12%)
Bacterial Infectious	9 (1%)
Cardiac And Vascular Investigations	9 (1%)
Renal And Urinary Tract Investigati...	9 (1%)
Allergic Conditions	8 (.89%)
Appetite And General Nutritional	8 (.89%)
Headaches	7 (.78%)
Psychiatric	7 (.78%)
Viral Infectious	7 (.78%)
Cardiac Disorder Signs	6 (.67%)
Central Nervous System Vascular	6 (.67%)
Gastrointestinal Hemorrhages	6 (.67%)
Investigations, Imaging And Histopa...	6 (.67%)
Musculoskeletal And Connective Tiss...	6 (.67%)
Product Quality Issues	6 (.67%)
Exocrine Pancreas Conditions	5 (.56%)
Eye	5 (.56%)
Heart Failures	5 (.56%)
Hepatobiliary Neoplasms Malignant A...	5 (.56%)
Muscle	5 (.56%)
Renal Disorders	5 (.56%)
Skin Appendage Conditions	5 (.56%)
Tissue	5 (.56%)
Vision	5 (.56%)
Depressed Mood Disorders	4 (.45%)
Gastrointestinal	4 (.45%)
Gastrointestinal Neoplasms Malignan...	4 (.45%)
Medication Errors	4 (.45%)
Myocardial	4 (.45%)
Urolithiases	4 (.45%)
Body Temperature Conditions	3 (.33%)
Fatal Outcomes	3 (.33%)
Hematology Investigations	3 (.33%)
Tongue Conditions	3 (.33%)
Anal And Rectal Conditions	2 (.22%)
Anemias Nonhemolytic And Marrow Dep...	2 (.22%)
Anxiety Disorders	2 (.22%)
Arteriosclerosis, Stenosis, Vascula...	2 (.22%)
Bile Duct	2 (.22%)
Bone And Joint Injuries	2 (.22%)
Cranial Nerve Disorders	2 (.22%)
Decreased And Nonspecific Blood Pre...	2 (.22%)
Deliria	2 (.22%)
Ectoparasitic	2 (.22%)
Head And Neck Therapeutic Procedure...	2 (.22%)
Hearing	2 (.22%)
Hepatic And Hepatobiliary	2 (.22%)
Hepatobiliary	2 (.22%)
Joint	2 (.22%)
Leukemias	2 (.22%)
Movement Disorders	2 (.22%)
Pulmonary Vascular	2 (.22%)
Reproductive Neoplasms Male Maligna...	2 (.22%)
Therapeutic And Nontherapeutic Effe...	2 (.22%)
Urinary Tract Signs	2 (.22%)
Vascular	2 (.22%)
Vascular Inflammations	2 (.22%)
Abortions And Stillbirth	1 (.11%)
Bone And Joint Therapeutic Procedur...	1 (.11%)
Bone, Calcium, Magnesium And Phosph...	1 (.11%)
Bronchial Disorders	1 (.11%)
Dissociative	1 (.11%)
Electrolyte And Fluid Balance Condi...	1 (.11%)
Embolism And Thrombosis	1 (.11%)
Enzyme	1 (.11%)
Gastrointestinal Conditions	1 (.11%)
Gastrointestinal Inflammatory Condi...	1 (.11%)
Gastrointestinal Stenosis And Obstr...	1 (.11%)
Gastrointestinal Vascular Condition...	1 (.11%)
Glucose Metabolism Disorders	1 (.11%)
Hepatobiliary Therapeutic Procedure...	1 (.11%)
Lifestyle Issues	1 (.11%)
Lower Respiratory Tract Disorders	1 (.11%)
Ocular Hemorrhages And Vascular	1 (.11%)
Ocular Infections, Irritations And ...	1 (.11%)
Pericardial	1 (.11%)
Peripheral Neuropathies	1 (.11%)
Plasma Cell Neoplasms	1 (.11%)
Protein And Chemistry Analyses	1 (.11%)
Seizures	1 (.11%)
Skin And Subcutaneous Tissue	1 (.11%)
Spleen, Lymphatic And Reticulendoth...	1 (.11%)
Suicidal And Self-injurious Behavio...	1 (.11%)
Thyroid Gland	1 (.11%)
Vascular Hemorrhagic	1 (.11%)

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This graph shows the top categories of adverse events submitted to the FDA for Bydureon, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Bydureon is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.