ACCOLATE

Accolate Adverse Events Reported to the FDA Over Time

How are Accolate adverse event reports trending over time?

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

Most Common Accolate Adverse Events Reported to the FDA

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

Asthma	51 (4.43%)
Dyspnoea	44 (3.83%)
Drug Dose Omission	42 (3.65%)
Malaise	40 (3.48%)
Chronic Obstructive Pulmonary Disea...	25 (2.17%)
Fall	18 (1.57%)
Drug Ineffective	17 (1.48%)
Nausea	15 (1.3%)
Loss Of Consciousness	14 (1.22%)
Pain	14 (1.22%)
Diabetes Mellitus	13 (1.13%)
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Back Pain	12 (1.04%)
Headache	11 (.96%)
Pneumonia	11 (.96%)
Arthritis	10 (.87%)
Cough	10 (.87%)
Emphysema	10 (.87%)
Incorrect Dose Administered	10 (.87%)
Bronchitis	9 (.78%)
Coronary Arterial Stent Insertion	9 (.78%)
Gastrooesophageal Reflux Disease	9 (.78%)
Multiple Allergies	9 (.78%)
Respiratory Disorder	9 (.78%)
Hepatitis	8 (.7%)
Intentional Drug Misuse	8 (.7%)
Blindness	7 (.61%)
Weight Decreased	7 (.61%)
Wheezing	7 (.61%)
Cardiac Failure Congestive	6 (.52%)
Death	6 (.52%)
Depression	6 (.52%)
Drug Hypersensitivity	6 (.52%)
Dysphonia	6 (.52%)
Fatigue	6 (.52%)
Feeling Abnormal	6 (.52%)
Heart Rate Irregular	6 (.52%)
Heart Valve Calcification	6 (.52%)
Heart Valve Incompetence	6 (.52%)
Jaundice	6 (.52%)
Labile Blood Pressure	6 (.52%)
Nasopharyngitis	6 (.52%)
Nerve Compression	6 (.52%)
Pyrexia	6 (.52%)
Radiotherapy	6 (.52%)
Road Traffic Accident	6 (.52%)
Syncope	6 (.52%)
Urine Odour Abnormal	6 (.52%)
Arthralgia	5 (.43%)
Confusional State	5 (.43%)
Diverticulitis	5 (.43%)
Dizziness	5 (.43%)
Dysgeusia	5 (.43%)
Dyspepsia	5 (.43%)
Insomnia	5 (.43%)
Liver Transplant	5 (.43%)
Lung Disorder	5 (.43%)
Muscular Weakness	5 (.43%)
Myocardial Infarction	5 (.43%)
Renal Impairment	5 (.43%)
Rhinorrhoea	5 (.43%)
Spinal Fracture	5 (.43%)
Spondylitis	5 (.43%)
Upper Limb Fracture	5 (.43%)
Abdominal Pain Upper	4 (.35%)
Anxiety	4 (.35%)
Back Disorder	4 (.35%)
Bladder Disorder	4 (.35%)
Blood Bilirubin Increased	4 (.35%)
Blood Pressure Increased	4 (.35%)
Chest Pain	4 (.35%)
Contusion	4 (.35%)
Convulsion	4 (.35%)
Hand Fracture	4 (.35%)
Hepatic Cirrhosis	4 (.35%)
Hepatic Enzyme Increased	4 (.35%)
Joint Injury	4 (.35%)
Lung Neoplasm Malignant	4 (.35%)
Macular Degeneration	4 (.35%)
Muscle Spasms	4 (.35%)
Neoplasm Malignant	4 (.35%)
Off Label Use	4 (.35%)
Pneumonia Primary Atypical	4 (.35%)
Sinusitis	4 (.35%)
Spinal Deformity	4 (.35%)
Stomatitis	4 (.35%)
Urinary Tract Infection	4 (.35%)
Vomiting	4 (.35%)
White Blood Cell Count Increased	4 (.35%)
Abdominal Pain	3 (.26%)
Acute Hepatic Failure	3 (.26%)
Alanine Aminotransferase Increased	3 (.26%)
Ankle Fracture	3 (.26%)
Aspartate Aminotransferase Increase...	3 (.26%)
Cerebrovascular Accident	3 (.26%)
Cheilitis	3 (.26%)
Chest Discomfort	3 (.26%)
Chest X-ray Abnormal	3 (.26%)
Decreased Appetite	3 (.26%)
Diarrhoea	3 (.26%)
Gait Disturbance	3 (.26%)
Gastric Disorder	3 (.26%)

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This graph shows the top adverse events submitted to the FDA for Accolate, 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 Accolate 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 Accolate

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

Respiratory	95 (8.26%)
Bronchial Disorders	85 (7.39%)
Medication Errors	62 (5.39%)
Infections - Pathogen Unspecified	53 (4.61%)
Neurological	40 (3.48%)
Hepatic And Hepatobiliary	39 (3.39%)
Gastrointestinal Signs	38 (3.3%)
Injuries	36 (3.13%)
Bone And Joint Injuries	27 (2.35%)
Joint	27 (2.35%)
Therapeutic And Nontherapeutic Effe...	26 (2.26%)
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Allergic Conditions	24 (2.09%)
Musculoskeletal And Connective Tiss...	24 (2.09%)
Hepatobiliary	19 (1.65%)
Glucose Metabolism Disorders	16 (1.39%)
Headaches	15 (1.3%)
Lower Respiratory Tract Disorders	15 (1.3%)
Therapeutic Procedures And Supporti...	15 (1.3%)
Urinary Tract Signs	14 (1.22%)
Gastrointestinal Motility And Defec...	13 (1.13%)
Renal Disorders	13 (1.13%)
Cardiac And Vascular Investigations	12 (1.04%)
Cardiac Valve	12 (1.04%)
Hematology Investigations	10 (.87%)
Muscle	10 (.87%)
Peripheral Neuropathies	9 (.78%)
Physical Examination Topics	9 (.78%)
Psychiatric	9 (.78%)
Vascular Therapeutic Procedures	9 (.78%)
Decreased And Nonspecific Blood Pre...	8 (.7%)
Bone And Joint Therapeutic Procedur...	7 (.61%)
Fatal Outcomes	7 (.61%)
Heart Failures	7 (.61%)
Mental Impairment	7 (.61%)
Miscellaneous And Site Unspecified ...	7 (.61%)
Oral Soft Tissue Conditions	7 (.61%)
Sleep Disorders	7 (.61%)
Vision	7 (.61%)
Anxiety Disorders	6 (.52%)
Body Temperature Conditions	6 (.52%)
Central Nervous System Vascular	6 (.52%)
Coronary Artery	6 (.52%)
Depressed Mood Disorders	6 (.52%)
Epidermal And Dermal Conditions	6 (.52%)
Hearing	6 (.52%)
Hepatobiliary Therapeutic Procedure...	6 (.52%)
Deliria	5 (.43%)
Musculoskeletal And Connective Tiss...	5 (.43%)
Upper Respiratory Tract Disorders	5 (.43%)
Viral Infectious	5 (.43%)
Angiedema And Urticaria	4 (.35%)
Appetite And General Nutritional	4 (.35%)
Bladder And Bladder Neck Disorders	4 (.35%)
Gallbladder	4 (.35%)
Gastrointestinal Conditions	4 (.35%)
Metabolic, Nutritional And Blood Ga...	4 (.35%)
Ocular Structural Change, Deposit A...	4 (.35%)
Respiratory And Mediastinal Neoplas...	4 (.35%)
Seizures	4 (.35%)
Suicidal And Self-injurious Behavio...	4 (.35%)
Bacterial Infectious	3 (.26%)
Cardiac Disorder Signs	3 (.26%)
Dental And Gingival Conditions	3 (.26%)
Gastrointestinal Vascular Condition...	3 (.26%)
Investigations, Imaging And Histopa...	3 (.26%)
Lipid Metabolism	3 (.26%)
Movement Disorders	3 (.26%)
Procedural And Device Related Injur...	3 (.26%)
Respiratory And Pulmonary Investiga...	3 (.26%)
Skin Appendage Conditions	3 (.26%)
Vascular Hypertensive	3 (.26%)
Anal And Rectal Conditions	2 (.17%)
Bile Duct	2 (.17%)
Demyelinating	2 (.17%)
Embolism And Thrombosis	2 (.17%)
Food Intolerance Syndromes	2 (.17%)
Fungal Infectious	2 (.17%)
Gastrointestinal Hemorrhages	2 (.17%)
Gastrointestinal Neoplasms Malignan...	2 (.17%)
Immune	2 (.17%)
Immunodeficiency Syndromes	2 (.17%)
Immunology And Allergy	2 (.17%)
Lipid Analyses	2 (.17%)
Mood Disorders	2 (.17%)
Neurological, Special Senses And Ps...	2 (.17%)
Ocular Sensory Symptoms	2 (.17%)
Peritoneal And Retroperitoneal Cond...	2 (.17%)
Product Quality Issues	2 (.17%)
Renal And Urinary Tract Investigati...	2 (.17%)
Spleen, Lymphatic And Reticulendoth...	2 (.17%)
Vascular Hemorrhagic	2 (.17%)
Water, Electrolyte And Mineral	2 (.17%)
Abortions And Stillbirth	1 (.09%)
Bone Disorders	1 (.09%)
Breast Neoplasms Malignant And Unsp...	1 (.09%)
Cardiac And Vascular Disorders Cong...	1 (.09%)
Cardiac Arrhythmias	1 (.09%)
Changes In Physical Activity	1 (.09%)
Chemical Injury And Poisoning	1 (.09%)
Coagulopathies And Bleeding Diathes...	1 (.09%)
Disturbances In Thinking	1 (.09%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Accolate, 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 Accolate 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.