ISONIAZID

Isoniazid Adverse Events Reported to the FDA Over Time

How are Isoniazid adverse event reports trending over time?

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

Most Common Isoniazid Adverse Events Reported to the FDA

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

Pyrexia	168 (2.09%)
Jaundice	114 (1.42%)
Hepatitis	107 (1.33%)
Alanine Aminotransferase Increased	100 (1.25%)
Nausea	96 (1.2%)
Vomiting	95 (1.18%)
Liver Disorder	90 (1.12%)
Aspartate Aminotransferase Increase...	86 (1.07%)
Hepatic Function Abnormal	84 (1.05%)
Hepatotoxicity	84 (1.05%)
Drug Interaction	77 (.96%)
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Acute Hepatic Failure	69 (.86%)
Hepatic Failure	65 (.81%)
Rash	59 (.74%)
Fatigue	58 (.72%)
Condition Aggravated	55 (.69%)
Malaise	54 (.67%)
Blood Bilirubin Increased	52 (.65%)
Headache	51 (.64%)
Arthralgia	50 (.62%)
Tuberculosis	50 (.62%)
Pruritus	48 (.6%)
Dyspnoea	47 (.59%)
Abdominal Pain	45 (.56%)
Drug Eruption	45 (.56%)
Drug Rash With Eosinophilia And Sys...	45 (.56%)
Renal Failure Acute	44 (.55%)
Liver Function Test Abnormal	43 (.54%)
Paradoxical Drug Reaction	42 (.52%)
Immune Reconstitution Syndrome	40 (.5%)
Lymphadenopathy	40 (.5%)
Neutropenia	40 (.5%)
Drug Ineffective	39 (.49%)
General Physical Health Deteriorati...	39 (.49%)
Metabolic Acidosis	39 (.49%)
Pneumonia	39 (.49%)
Hepatic Enzyme Increased	38 (.47%)
Anaemia	37 (.46%)
Hepatic Encephalopathy	37 (.46%)
Pleural Effusion	36 (.45%)
Blood Alkaline Phosphatase Increase...	35 (.44%)
Convulsion	35 (.44%)
Pulmonary Tuberculosis	35 (.44%)
Weight Decreased	35 (.44%)
Death	34 (.42%)
Diarrhoea	34 (.42%)
Thrombocytopenia	34 (.42%)
Decreased Appetite	33 (.41%)
Hepatitis Fulminant	33 (.41%)
Abdominal Pain Upper	32 (.4%)
Liver Injury	32 (.4%)
Renal Failure	32 (.4%)
Renal Impairment	31 (.39%)
Asthenia	30 (.37%)
Coagulopathy	30 (.37%)
Cough	30 (.37%)
Encephalopathy	30 (.37%)
Respiratory Failure	29 (.36%)
Blood Creatinine Increased	28 (.35%)
Hepatitis Acute	28 (.35%)
Neuropathy Peripheral	28 (.35%)
Sepsis	28 (.35%)
Transaminases Increased	28 (.35%)
Disseminated Tuberculosis	27 (.34%)
Erythema	27 (.34%)
Gamma-glutamyltransferase Increased	27 (.34%)
Stevens-johnson Syndrome	27 (.34%)
Confusional State	26 (.32%)
Leukopenia	26 (.32%)
Liver Transplant	26 (.32%)
Dehydration	25 (.31%)
Eosinophilia	25 (.31%)
Hepatic Necrosis	25 (.31%)
Interstitial Lung Disease	25 (.31%)
Optic Neuritis	25 (.31%)
Drug Toxicity	24 (.3%)
Rash Maculo-papular	24 (.3%)
Chills	23 (.29%)
Cholestasis	23 (.29%)
Drug Exposure During Pregnancy	23 (.29%)
Loss Of Consciousness	23 (.29%)
Toxic Epidermal Necrolysis	23 (.29%)
Dizziness	22 (.27%)
Oedema Peripheral	22 (.27%)
Pain	22 (.27%)
Pain In Extremity	22 (.27%)
Multi-organ Failure	21 (.26%)
Anorexia	20 (.25%)
Hepatomegaly	20 (.25%)
Myalgia	20 (.25%)
Rash Erythematous	20 (.25%)
Chromaturia	19 (.24%)
Cytolytic Hepatitis	19 (.24%)
Skin Lesion	19 (.24%)
Somnolence	19 (.24%)
Depressed Level Of Consciousness	18 (.22%)
Dermatitis Exfoliative	18 (.22%)
Mental Status Changes	18 (.22%)
Ascites	17 (.21%)
Disease Progression	17 (.21%)
Haemodialysis	17 (.21%)

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

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

Hepatic And Hepatobiliary	879 (10.96%)
Epidermal And Dermal Conditions	502 (6.26%)
Hepatobiliary	406 (5.06%)
Gastrointestinal Signs	330 (4.11%)
Infections - Pathogen Unspecified	203 (2.53%)
Mycobacterial Infectious	202 (2.52%)
Therapeutic And Nontherapeutic Effe...	202 (2.52%)
Neurological	200 (2.49%)
Respiratory	193 (2.41%)
Body Temperature Conditions	171 (2.13%)
Hematology Investigations	160 (2%)
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Renal Disorders	151 (1.88%)
White Blood Cell	109 (1.36%)
Muscle	87 (1.08%)
Anemias Nonhemolytic And Marrow Dep...	84 (1.05%)
Appetite And General Nutritional	77 (.96%)
Lower Respiratory Tract Disorders	77 (.96%)
Enzyme	76 (.95%)
Encephalopathies	70 (.87%)
Joint	69 (.86%)
Chemical Injury And Poisoning	66 (.82%)
Vision	66 (.82%)
Bacterial Infectious	64 (.8%)
Musculoskeletal And Connective Tiss...	64 (.8%)
Seizures	63 (.79%)
Spleen, Lymphatic And Reticulendoth...	63 (.79%)
Urinary Tract Signs	61 (.76%)
Injuries	60 (.75%)
Physical Examination Topics	60 (.75%)
Renal And Urinary Tract Investigati...	60 (.75%)
Viral Infectious	59 (.74%)
Acid-base	57 (.71%)
Headaches	54 (.67%)
Cardiac Arrhythmias	52 (.65%)
Pleural	50 (.62%)
Peripheral Neuropathies	48 (.6%)
Coagulopathies And Bleeding Diathes...	46 (.57%)
Electrolyte And Fluid Balance Condi...	46 (.57%)
Gastrointestinal Motility And Defec...	46 (.57%)
Medication Errors	46 (.57%)
Allergic Conditions	45 (.56%)
Movement Disorders	45 (.56%)
Decreased And Nonspecific Blood Pre...	43 (.54%)
Fatal Outcomes	43 (.54%)
Deliria	42 (.52%)
Cardiac And Vascular Investigations	41 (.51%)
Immunodeficiency Syndromes	40 (.5%)
Fungal Infectious	39 (.49%)
Platelet	37 (.46%)
Microbiology And Serology	36 (.45%)
Eye	35 (.44%)
Nephropathies	35 (.44%)
Cranial Nerve Disorders	34 (.42%)
Suicidal And Self-injurious Behavio...	34 (.42%)
Water, Electrolyte And Mineral	34 (.42%)
Anxiety Disorders	33 (.41%)
Metabolic, Nutritional And Blood Ga...	33 (.41%)
Toxicology And Therapeutic Drug Mon...	33 (.41%)
Immunology And Allergy	31 (.39%)
Ocular Infections, Irritations And ...	31 (.39%)
Psychiatric	31 (.39%)
Peritoneal And Retroperitoneal Cond...	29 (.36%)
Procedural And Device Related Injur...	29 (.36%)
Reproductive Organ And Breast Inves...	29 (.36%)
Hematological And Lymphoid Tissue T...	28 (.35%)
Skin Vascular Abnormalities	28 (.35%)
Hepatobiliary Therapeutic Procedure...	27 (.34%)
Neuromuscular	27 (.34%)
Exocrine Pancreas Conditions	26 (.32%)
Immune	26 (.32%)
Central Nervous System Vascular	25 (.31%)
Disturbances In Thinking	25 (.31%)
Bronchial Disorders	24 (.3%)
Mental Impairment	24 (.3%)
Coronary Artery	23 (.29%)
Protein And Chemistry Analyses	23 (.29%)
Glucose Metabolism Disorders	22 (.27%)
Depressed Mood Disorders	20 (.25%)
Gastrointestinal Hemorrhages	20 (.25%)
Ocular Neuromuscular	20 (.25%)
Angiedema And Urticaria	19 (.24%)
Bone, Calcium, Magnesium And Phosph...	19 (.24%)
Gallbladder	19 (.24%)
Investigations, Imaging And Histopa...	19 (.24%)
Ocular Structural Change, Deposit A...	19 (.24%)
Tissue	19 (.24%)
Sleep Disorders	18 (.22%)
Vascular	18 (.22%)
Eye Disorders Congenital	17 (.21%)
Gastrointestinal Inflammatory Condi...	17 (.21%)
Increased Intracranial Pressure And...	17 (.21%)
Lifestyle Issues	17 (.21%)
Upper Respiratory Tract Disorders	17 (.21%)
Connective Tissue Disorders	16 (.2%)
Gastrointestinal Conditions	16 (.2%)
Pregnancy, Labour, Delivery And Pos...	16 (.2%)
Mood Disorders	15 (.19%)
Neurological Disorders Congenital	15 (.19%)
Pericardial	15 (.19%)
Abortions And Stillbirth	14 (.17%)
Changes In Physical Activity	14 (.17%)

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