ETODOLAC

Etodolac Adverse Events Reported to the FDA Over Time

How are Etodolac adverse event reports trending over time?

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

Most Common Etodolac Adverse Events Reported to the FDA

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

Dyspnoea	48 (1.81%)
Gastrointestinal Haemorrhage	38 (1.44%)
Pyrexia	35 (1.32%)
Renal Failure Acute	34 (1.28%)
Dizziness	33 (1.25%)
Diarrhoea	30 (1.13%)
Nausea	30 (1.13%)
Anaemia	29 (1.1%)
Haemoglobin Decreased	26 (.98%)
Aspartate Aminotransferase Increase...	25 (.94%)
Gastric Ulcer	25 (.94%)
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Abdominal Pain Upper	24 (.91%)
Malaise	23 (.87%)
Oedema Peripheral	23 (.87%)
Alanine Aminotransferase Increased	22 (.83%)
Chest Pain	21 (.79%)
Drug Ineffective	21 (.79%)
Urticaria	21 (.79%)
Asthenia	20 (.76%)
Pruritus	20 (.76%)
Rash	20 (.76%)
Fatigue	18 (.68%)
Blood Lactate Dehydrogenase Increas...	17 (.64%)
Condition Aggravated	17 (.64%)
Pneumonia	17 (.64%)
Blood Alkaline Phosphatase Increase...	16 (.6%)
Drug Eruption	16 (.6%)
Interstitial Lung Disease	16 (.6%)
Melaena	16 (.6%)
Rectal Haemorrhage	16 (.6%)
Duodenal Ulcer	15 (.57%)
Liver Function Test Abnormal	15 (.57%)
White Blood Cell Count Decreased	15 (.57%)
Death	14 (.53%)
Gamma-glutamyltransferase Increased	14 (.53%)
Gastric Haemorrhage	14 (.53%)
Haematemesis	14 (.53%)
Headache	14 (.53%)
Liver Disorder	14 (.53%)
Cardiac Arrest	13 (.49%)
Erythema	13 (.49%)
Vomiting	13 (.49%)
Cellulitis	12 (.45%)
Cholelithiasis	12 (.45%)
Insomnia	12 (.45%)
Pleural Effusion	12 (.45%)
Drug Interaction	11 (.42%)
Haematocrit Decreased	11 (.42%)
Hepatic Function Abnormal	11 (.42%)
Pain	11 (.42%)
Pain In Extremity	11 (.42%)
Urinary Tract Infection	11 (.42%)
White Blood Cell Count Increased	11 (.42%)
Blood Creatinine Increased	10 (.38%)
C-reactive Protein Increased	10 (.38%)
Completed Suicide	10 (.38%)
Fall	10 (.38%)
Gastritis	10 (.38%)
Loss Of Consciousness	10 (.38%)
Rash Pruritic	10 (.38%)
Renal Failure	10 (.38%)
Stomatitis	10 (.38%)
Agranulocytosis	9 (.34%)
Back Pain	9 (.34%)
Blood Pressure Decreased	9 (.34%)
Cough	9 (.34%)
Face Oedema	9 (.34%)
Haemorrhage	9 (.34%)
Hyperkalaemia	9 (.34%)
Hypotension	9 (.34%)
Pancytopenia	9 (.34%)
Platelet Count Decreased	9 (.34%)
Rhabdomyolysis	9 (.34%)
Sepsis	9 (.34%)
Abdominal Pain	8 (.3%)
Bradycardia	8 (.3%)
Constipation	8 (.3%)
Dyspepsia	8 (.3%)
Erythema Multiforme	8 (.3%)
Faeces Discoloured	8 (.3%)
Gastric Ulcer Perforation	8 (.3%)
Jaundice	8 (.3%)
Neoplasm Malignant	8 (.3%)
Pancreatitis	8 (.3%)
Peripheral Embolism	8 (.3%)
Red Blood Cell Count Decreased	8 (.3%)
Renal Impairment	8 (.3%)
Swelling Face	8 (.3%)
Arthralgia	7 (.26%)
Asthma	7 (.26%)
Cardio-respiratory Arrest	7 (.26%)
Chills	7 (.26%)
Cholecystitis	7 (.26%)
Colitis Microscopic	7 (.26%)
Diabetes Mellitus	7 (.26%)
Disease Progression	7 (.26%)
Drug Hypersensitivity	7 (.26%)
Duodenal Ulcer Perforation	7 (.26%)
Hypokalaemia	7 (.26%)
International Normalised Ratio Incr...	7 (.26%)
Neutropenia	7 (.26%)

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

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

Epidermal And Dermal Conditions	160 (6.04%)
Gastrointestinal Signs	116 (4.38%)
Hematology Investigations	116 (4.38%)
Gastrointestinal Hemorrhages	111 (4.19%)
Respiratory	102 (3.85%)
Neurological	97 (3.66%)
Gastrointestinal Ulceration And Per...	92 (3.47%)
Hepatobiliary	89 (3.36%)
Infections - Pathogen Unspecified	83 (3.13%)
Renal Disorders	58 (2.19%)
Hepatic And Hepatobiliary	56 (2.11%)
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Anemias Nonhemolytic And Marrow Dep...	46 (1.74%)
Gastrointestinal Motility And Defec...	44 (1.66%)
Enzyme	40 (1.51%)
Therapeutic And Nontherapeutic Effe...	40 (1.51%)
Cardiac Arrhythmias	36 (1.36%)
Body Temperature Conditions	35 (1.32%)
Electrolyte And Fluid Balance Condi...	35 (1.32%)
Gastrointestinal Inflammatory Condi...	31 (1.17%)
Joint	30 (1.13%)
Bacterial Infectious	29 (1.1%)
Cardiac And Vascular Investigations	27 (1.02%)
Lower Respiratory Tract Disorders	27 (1.02%)
Medication Errors	27 (1.02%)
Musculoskeletal And Connective Tiss...	27 (1.02%)
Angiedema And Urticaria	26 (.98%)
White Blood Cell	26 (.98%)
Pleural	22 (.83%)
Renal And Urinary Tract Investigati...	22 (.83%)
Muscle	21 (.79%)
Injuries	20 (.76%)
Physical Examination Topics	20 (.76%)
Gallbladder	19 (.72%)
Decreased And Nonspecific Blood Pre...	18 (.68%)
Oral Soft Tissue Conditions	17 (.64%)
Protein And Chemistry Analyses	17 (.64%)
Suicidal And Self-injurious Behavio...	17 (.64%)
Allergic Conditions	16 (.6%)
Miscellaneous And Site Unspecified ...	16 (.6%)
Gastrointestinal Conditions	15 (.57%)
Headaches	15 (.57%)
Chemical Injury And Poisoning	14 (.53%)
Embolism And Thrombosis	14 (.53%)
Fatal Outcomes	14 (.53%)
Coronary Artery	13 (.49%)
Sleep Disorders	13 (.49%)
Bronchial Disorders	12 (.45%)
Fungal Infectious	12 (.45%)
Skin Appendage Conditions	12 (.45%)
Cardiac Disorder Signs	11 (.42%)
Lifestyle Issues	11 (.42%)
Urinary Tract Signs	11 (.42%)
Mood Disorders	10 (.38%)
Tissue	10 (.38%)
Vision	10 (.38%)
Water, Electrolyte And Mineral	10 (.38%)
Acid-base	9 (.34%)
Appetite And General Nutritional	9 (.34%)
Bile Duct	9 (.34%)
Central Nervous System Vascular	9 (.34%)
Glucose Metabolism Disorders	9 (.34%)
Mental Impairment	9 (.34%)
Procedural And Device Related Injur...	9 (.34%)
Vascular Hemorrhagic	9 (.34%)
Viral Infectious	9 (.34%)
Coagulopathies And Bleeding Diathes...	8 (.3%)
Disturbances In Thinking	8 (.3%)
Exocrine Pancreas Conditions	8 (.3%)
Inner Ear And Viiith Cranial Nerve	8 (.3%)
Musculoskeletal And Connective Tiss...	8 (.3%)
Product Quality Issues	8 (.3%)
Psychiatric	8 (.3%)
Metabolic, Nutritional And Blood Ga...	7 (.26%)
Microbiology And Serology	7 (.26%)
Movement Disorders	7 (.26%)
Peritoneal And Retroperitoneal Cond...	7 (.26%)
Upper Respiratory Tract Disorders	7 (.26%)
Adrenal Gland	6 (.23%)
Anxiety Disorders	6 (.23%)
Deliria	6 (.23%)
Gastrointestinal Neoplasms Malignan...	6 (.23%)
Heart Failures	6 (.23%)
Nephropathies	6 (.23%)
Platelet	6 (.23%)
Vascular	6 (.23%)
Cardiac And Vascular Disorders Cong...	5 (.19%)
Chlamydial Infectious	5 (.19%)
Cranial Nerve Disorders	5 (.19%)
Diverticular	5 (.19%)
Hematological And Lymphoid Tissue T...	5 (.19%)
Respiratory And Mediastinal Neoplas...	5 (.19%)
Gastrointestinal	4 (.15%)
Gastrointestinal Therapeutic Proced...	4 (.15%)
Seizures	4 (.15%)
Thoracic Disorders	4 (.15%)
Abdominal Hernias And Other Abdomin...	3 (.11%)
Changes In Physical Activity	3 (.11%)
Eye	3 (.11%)
Investigations, Imaging And Histopa...	3 (.11%)
Lipid Analyses	3 (.11%)
Metastases	3 (.11%)

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