ETHAMBUTOL

Ethambutol Adverse Events Reported to the FDA Over Time

How are Ethambutol adverse event reports trending over time?

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

Most Common Ethambutol Adverse Events Reported to the FDA

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

Pyrexia	122 (2.49%)
Immune Reconstitution Syndrome	86 (1.76%)
Drug Rash With Eosinophilia And Sys...	59 (1.21%)
Drug Interaction	55 (1.12%)
Vomiting	55 (1.12%)
Hepatitis	50 (1.02%)
Nausea	50 (1.02%)
Renal Failure Acute	44 (.9%)
Lymphadenopathy	43 (.88%)
Blindness	40 (.82%)
Eosinophilia	40 (.82%)
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Dyspnoea	39 (.8%)
Tuberculosis	39 (.8%)
Condition Aggravated	38 (.78%)
Optic Neuritis	38 (.78%)
Thrombocytopenia	37 (.76%)
Confusional State	36 (.74%)
Neutropenia	36 (.74%)
Paradoxical Drug Reaction	36 (.74%)
Liver Disorder	35 (.72%)
Anaemia	33 (.67%)
Hepatotoxicity	33 (.67%)
Jaundice	33 (.67%)
Rash Maculo-papular	33 (.67%)
Alanine Aminotransferase Increased	32 (.65%)
Hepatitis Fulminant	32 (.65%)
Acute Hepatic Failure	31 (.63%)
Drug Ineffective	31 (.63%)
Rash	31 (.63%)
General Physical Health Deteriorati...	30 (.61%)
Asthenia	29 (.59%)
Abdominal Pain	28 (.57%)
Hepatic Failure	28 (.57%)
Hepatic Function Abnormal	28 (.57%)
Pneumonia	28 (.57%)
Visual Acuity Reduced	28 (.57%)
Neuropathy Peripheral	27 (.55%)
Drug Eruption	26 (.53%)
Cytolytic Hepatitis	25 (.51%)
Renal Failure	25 (.51%)
Arthralgia	24 (.49%)
Vision Blurred	24 (.49%)
Disseminated Tuberculosis	23 (.47%)
Headache	23 (.47%)
Malaise	23 (.47%)
Pruritus	23 (.47%)
Pulmonary Tuberculosis	23 (.47%)
Toxic Epidermal Necrolysis	23 (.47%)
Cholestasis	22 (.45%)
Colour Blindness	22 (.45%)
Optic Neuropathy	22 (.45%)
Aspartate Aminotransferase Increase...	21 (.43%)
Hepatic Encephalopathy	21 (.43%)
Diarrhoea	20 (.41%)
Pancytopenia	20 (.41%)
Decreased Appetite	19 (.39%)
Drug Exposure During Pregnancy	19 (.39%)
Fatigue	19 (.39%)
Multi-organ Failure	19 (.39%)
Erythema	18 (.37%)
Hepatic Enzyme Increased	18 (.37%)
Hepatomegaly	18 (.37%)
Peritoneal Tuberculosis	18 (.37%)
Respiratory Failure	18 (.37%)
Visual Field Defect	18 (.37%)
Convulsion	17 (.35%)
Haemodialysis	17 (.35%)
Impaired Gastric Emptying	17 (.35%)
Loss Of Consciousness	17 (.35%)
Death	16 (.33%)
Histiocytosis Haematophagic	16 (.33%)
Liver Function Test Abnormal	16 (.33%)
Mycobacterium Avium Complex Infecti...	16 (.33%)
Skin Lesion	16 (.33%)
Stevens-johnson Syndrome	16 (.33%)
Blood Alkaline Phosphatase Increase...	15 (.31%)
Depressed Level Of Consciousness	15 (.31%)
Hyponatraemia	15 (.31%)
Anorexia	14 (.29%)
Ascites	14 (.29%)
Metabolic Acidosis	14 (.29%)
Pleural Effusion	14 (.29%)
Acute Myocardial Infarction	13 (.27%)
Atypical Mycobacterial Infection	13 (.27%)
Deep Vein Thrombosis	13 (.27%)
Interstitial Lung Disease	13 (.27%)
Pain	13 (.27%)
Renal Impairment	13 (.27%)
Skin Exfoliation	13 (.27%)
Toxic Skin Eruption	13 (.27%)
Uveitis	13 (.27%)
Weight Decreased	13 (.27%)
Cataract	12 (.25%)
Cough	12 (.25%)
Dandy-walker Syndrome	12 (.25%)
Drug Resistance	12 (.25%)
Leukopenia	12 (.25%)
Proteinuria	12 (.25%)
Rash Erythematous	12 (.25%)
Rash Generalised	12 (.25%)
Transaminases Increased	12 (.25%)

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

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

Hepatic And Hepatobiliary	400 (8.18%)
Epidermal And Dermal Conditions	353 (7.22%)
Mycobacterial Infectious	193 (3.95%)
Gastrointestinal Signs	169 (3.46%)
Vision	162 (3.31%)
Therapeutic And Nontherapeutic Effe...	150 (3.07%)
Neurological	133 (2.72%)
Body Temperature Conditions	130 (2.66%)
Respiratory	126 (2.58%)
Hepatobiliary	124 (2.54%)
White Blood Cell	118 (2.41%)
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Renal Disorders	114 (2.33%)
Infections - Pathogen Unspecified	104 (2.13%)
Immunodeficiency Syndromes	86 (1.76%)
Hematology Investigations	80 (1.64%)
Anemias Nonhemolytic And Marrow Dep...	72 (1.47%)
Spleen, Lymphatic And Reticulendoth...	65 (1.33%)
Appetite And General Nutritional	47 (.96%)
Lower Respiratory Tract Disorders	44 (.9%)
Cardiac Arrhythmias	41 (.84%)
Deliria	41 (.84%)
Bacterial Infectious	40 (.82%)
Gastrointestinal Motility And Defec...	40 (.82%)
Platelet	40 (.82%)
Cranial Nerve Disorders	39 (.8%)
Encephalopathies	36 (.74%)
Peripheral Neuropathies	36 (.74%)
Electrolyte And Fluid Balance Condi...	34 (.7%)
Joint	34 (.7%)
Urinary Tract Signs	34 (.7%)
Chemical Injury And Poisoning	33 (.67%)
Acid-base	31 (.63%)
Decreased And Nonspecific Blood Pre...	30 (.61%)
Muscle	29 (.59%)
Cardiac And Vascular Disorders Cong...	28 (.57%)
Nephropathies	28 (.57%)
Physical Examination Topics	28 (.57%)
Fungal Infectious	27 (.55%)
Renal And Urinary Tract Investigati...	27 (.55%)
Viral Infectious	27 (.55%)
Enzyme	26 (.53%)
Glucose Metabolism Disorders	26 (.53%)
Coronary Artery	25 (.51%)
Central Nervous System Vascular	24 (.49%)
Disturbances In Thinking	24 (.49%)
Ocular Infections, Irritations And ...	24 (.49%)
Eye	23 (.47%)
Eye Disorders Congenital	23 (.47%)
Headaches	23 (.47%)
Hematological And Lymphoid Tissue T...	23 (.47%)
Ocular Structural Change, Deposit A...	23 (.47%)
Fatal Outcomes	22 (.45%)
Allergic Conditions	20 (.41%)
Cardiac And Vascular Investigations	20 (.41%)
Movement Disorders	20 (.41%)
Peritoneal And Retroperitoneal Cond...	20 (.41%)
Seizures	20 (.41%)
Neurological Disorders Of The Eye	19 (.39%)
Procedural And Device Related Injur...	19 (.39%)
Skin Vascular Abnormalities	19 (.39%)
Anterior Eye Structural Change, Dep...	18 (.37%)
Embolism And Thrombosis	18 (.37%)
Increased Intracranial Pressure And...	18 (.37%)
Metabolic, Nutritional And Blood Ga...	18 (.37%)
Musculoskeletal And Connective Tiss...	18 (.37%)
Pleural	18 (.37%)
Hematopoietic Neoplasms	17 (.35%)
Anxiety Disorders	16 (.33%)
Gastrointestinal Hemorrhages	16 (.33%)
Lifestyle Issues	15 (.31%)
Oral Soft Tissue Conditions	15 (.31%)
Immunology And Allergy	14 (.29%)
Hearing	13 (.27%)
Immune	13 (.27%)
Neurological Disorders Congenital	13 (.27%)
Toxicology And Therapeutic Drug Mon...	13 (.27%)
Medication Errors	12 (.25%)
Microbiology And Serology	12 (.25%)
Pregnancy, Labour, Delivery And Pos...	12 (.25%)
Exocrine Pancreas Conditions	11 (.22%)
Gastrointestinal	11 (.22%)
Gastrointestinal Ulceration And Per...	11 (.22%)
Ocular Neuromuscular	11 (.22%)
Tissue	11 (.22%)
Angiedema And Urticaria	10 (.2%)
Injuries	10 (.2%)
Mental Impairment	10 (.2%)
Musculoskeletal And Connective Tiss...	10 (.2%)
Purine And Pyrimidine Metabolism	10 (.2%)
Vascular Hypertensive	10 (.2%)
Water, Electrolyte And Mineral	10 (.2%)
Ear And Labyrinthine Disorders Cong...	9 (.18%)
Protein And Chemistry Analyses	9 (.18%)
Schizophrenia And Other Psychotic	9 (.18%)
Skin Appendage Conditions	9 (.18%)
Gastrointestinal Inflammatory Condi...	8 (.16%)
Hemolyses And Related Conditions	8 (.16%)
Hepatobiliary Therapeutic Procedure...	8 (.16%)
Renal And Urinary Tract Disorders C...	8 (.16%)
Sleep Disorders	8 (.16%)
Vascular	8 (.16%)

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