PYRAZINAMIDE

Pyrazinamide Adverse Events Reported to the FDA Over Time

How are Pyrazinamide adverse event reports trending over time?

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

Most Common Pyrazinamide Adverse Events Reported to the FDA

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

Hepatitis	89 (2.42%)
Pyrexia	80 (2.18%)
Acute Hepatic Failure	74 (2.02%)
Jaundice	62 (1.69%)
Alanine Aminotransferase Increased	51 (1.39%)
Immune Reconstitution Syndrome	49 (1.33%)
Vomiting	47 (1.28%)
Aspartate Aminotransferase Increase...	44 (1.2%)
Hepatotoxicity	41 (1.12%)
Paradoxical Drug Reaction	41 (1.12%)
Hepatic Failure	40 (1.09%)
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Nausea	38 (1.04%)
Renal Failure Acute	38 (1.04%)
Drug Rash With Eosinophilia And Sys...	37 (1.01%)
Pulmonary Tuberculosis	37 (1.01%)
Tuberculosis	36 (.98%)
Lymphadenopathy	32 (.87%)
Hepatic Encephalopathy	31 (.84%)
Liver Disorder	31 (.84%)
Condition Aggravated	30 (.82%)
Dyspnoea	29 (.79%)
Sepsis	29 (.79%)
Drug Interaction	28 (.76%)
Disseminated Tuberculosis	27 (.74%)
General Physical Health Deteriorati...	27 (.74%)
Drug Eruption	23 (.63%)
Diarrhoea	22 (.6%)
Fatigue	22 (.6%)
Multi-organ Failure	22 (.6%)
Rash	22 (.6%)
Hepatitis Fulminant	21 (.57%)
Pleural Effusion	21 (.57%)
Renal Failure	21 (.57%)
Weight Decreased	21 (.57%)
Abdominal Pain	20 (.54%)
Blood Bilirubin Increased	19 (.52%)
Pneumonia	19 (.52%)
Rash Maculo-papular	19 (.52%)
Ascites	18 (.49%)
Cough	17 (.46%)
Disease Progression	17 (.46%)
Drug Ineffective	17 (.46%)
Hyponatraemia	17 (.46%)
Liver Transplant	17 (.46%)
Pruritus	17 (.46%)
Confusional State	16 (.44%)
Hepatic Function Abnormal	16 (.44%)
Peritoneal Tuberculosis	16 (.44%)
Anaemia	15 (.41%)
Eosinophilia	15 (.41%)
Skin Lesion	15 (.41%)
Toxic Epidermal Necrolysis	15 (.41%)
Abdominal Pain Upper	14 (.38%)
Arthralgia	14 (.38%)
Convulsion	14 (.38%)
Thrombocytopenia	14 (.38%)
Anorexia	13 (.35%)
Blood Alkaline Phosphatase Increase...	13 (.35%)
Decreased Appetite	13 (.35%)
Headache	13 (.35%)
Septic Shock	13 (.35%)
Dandy-walker Syndrome	12 (.33%)
Death	12 (.33%)
Dehydration	12 (.33%)
Hepatomegaly	12 (.33%)
Oedema Peripheral	12 (.33%)
Pneumonia Aspiration	12 (.33%)
Respiratory Failure	12 (.33%)
Asthenia	11 (.3%)
Blood Creatinine Increased	11 (.3%)
Deep Vein Thrombosis	11 (.3%)
Drug Toxicity	11 (.3%)
Hepatic Enzyme Increased	11 (.3%)
Hepatic Necrosis	11 (.3%)
Loss Of Consciousness	11 (.3%)
Malaise	11 (.3%)
Pain	11 (.3%)
Pancytopenia	11 (.3%)
Renal Impairment	11 (.3%)
Stevens-johnson Syndrome	11 (.3%)
Abdominal Distension	10 (.27%)
Blood Pressure Inadequately Control...	10 (.27%)
Cholestasis	10 (.27%)
Cytolytic Hepatitis	10 (.27%)
Drug Exposure During Pregnancy	10 (.27%)
Drug Resistance	10 (.27%)
Encephalopathy	10 (.27%)
Haemodialysis	10 (.27%)
Haemoptysis	10 (.27%)
Hyperuricaemia	10 (.27%)
Neurotoxicity	10 (.27%)
Neutropenia	10 (.27%)
Oedema	10 (.27%)
Optic Neuritis	10 (.27%)
Blindness	9 (.25%)
Coagulopathy	9 (.25%)
Drug Hypersensitivity	9 (.25%)
Guillain-barre Syndrome	9 (.25%)
Haemoglobin Decreased	9 (.25%)
International Normalised Ratio Incr...	9 (.25%)
Intestinal Obstruction	9 (.25%)

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

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

Hepatic And Hepatobiliary	476 (12.97%)
Epidermal And Dermal Conditions	227 (6.18%)
Mycobacterial Infectious	177 (4.82%)
Hepatobiliary	151 (4.11%)
Gastrointestinal Signs	144 (3.92%)
Therapeutic And Nontherapeutic Effe...	109 (2.97%)
Infections - Pathogen Unspecified	107 (2.91%)
Respiratory	97 (2.64%)
Body Temperature Conditions	83 (2.26%)
Renal Disorders	77 (2.1%)
Neurological	75 (2.04%)
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Hematology Investigations	74 (2.02%)
Spleen, Lymphatic And Reticulendoth...	54 (1.47%)
Encephalopathies	50 (1.36%)
Immunodeficiency Syndromes	49 (1.33%)
Lower Respiratory Tract Disorders	47 (1.28%)
Appetite And General Nutritional	42 (1.14%)
White Blood Cell	41 (1.12%)
Anemias Nonhemolytic And Marrow Dep...	38 (1.04%)
Bacterial Infectious	36 (.98%)
Electrolyte And Fluid Balance Condi...	33 (.9%)
Vision	32 (.87%)
Decreased And Nonspecific Blood Pre...	30 (.82%)
Pleural	30 (.82%)
Deliria	27 (.74%)
Physical Examination Topics	27 (.74%)
Gastrointestinal Motility And Defec...	25 (.68%)
Chemical Injury And Poisoning	24 (.65%)
Nephropathies	24 (.65%)
Enzyme	23 (.63%)
Fungal Infectious	23 (.63%)
Joint	23 (.63%)
Seizures	23 (.63%)
Urinary Tract Signs	23 (.63%)
Central Nervous System Vascular	22 (.6%)
Peripheral Neuropathies	22 (.6%)
Renal And Urinary Tract Investigati...	22 (.6%)
Peritoneal And Retroperitoneal Cond...	21 (.57%)
Viral Infectious	21 (.57%)
Eye	20 (.54%)
Cardiac Arrhythmias	19 (.52%)
Hepatobiliary Therapeutic Procedure...	18 (.49%)
Ocular Infections, Irritations And ...	18 (.49%)
Allergic Conditions	17 (.46%)
Hematological And Lymphoid Tissue T...	17 (.46%)
Increased Intracranial Pressure And...	15 (.41%)
Microbiology And Serology	15 (.41%)
Procedural And Device Related Injur...	15 (.41%)
Purine And Pyrimidine Metabolism	15 (.41%)
Coagulopathies And Bleeding Diathes...	14 (.38%)
Disturbances In Thinking	14 (.38%)
Fatal Outcomes	14 (.38%)
Gastrointestinal Stenosis And Obstr...	14 (.38%)
Glucose Metabolism Disorders	14 (.38%)
Movement Disorders	14 (.38%)
Musculoskeletal And Connective Tiss...	14 (.38%)
Platelet	14 (.38%)
Headaches	13 (.35%)
Muscle	13 (.35%)
Acid-base	12 (.33%)
Immune	12 (.33%)
Medication Errors	12 (.33%)
Neurological Disorders Congenital	12 (.33%)
Pericardial	12 (.33%)
Angiedema And Urticaria	11 (.3%)
Bone, Calcium, Magnesium And Phosph...	11 (.3%)
Cranial Nerve Disorders	11 (.3%)
Embolism And Thrombosis	11 (.3%)
Psychiatric And Behavioural Symptom...	11 (.3%)
Skin Vascular Abnormalities	11 (.3%)
Tissue	11 (.3%)
Immunology And Allergy	10 (.27%)
Upper Respiratory Tract Disorders	10 (.27%)
Anterior Eye Structural Change, Dep...	8 (.22%)
Anxiety Disorders	8 (.22%)
Heart Failures	8 (.22%)
Neuromuscular	8 (.22%)
Ocular Neuromuscular	8 (.22%)
Sleep Disorders	8 (.22%)
Cardiac And Vascular Investigations	7 (.19%)
Exocrine Pancreas Conditions	7 (.19%)
Gallbladder	7 (.19%)
Gastrointestinal Hemorrhages	7 (.19%)
Hematopoietic Neoplasms	7 (.19%)
Oral Soft Tissue Conditions	7 (.19%)
Personality Disorders	7 (.19%)
Pregnancy, Labour, Delivery And Pos...	7 (.19%)
Skin Appendage Conditions	7 (.19%)
Water, Electrolyte And Mineral	7 (.19%)
Gastrointestinal Inflammatory Condi...	6 (.16%)
Gastrointestinal Ulceration And Per...	6 (.16%)
Injuries	6 (.16%)
Metabolic, Nutritional And Blood Ga...	6 (.16%)
Protein And Chemistry Analyses	6 (.16%)
Psychiatric	6 (.16%)
Schizophrenia And Other Psychotic	6 (.16%)
Toxicology And Therapeutic Drug Mon...	6 (.16%)
Vascular Hemorrhagic	6 (.16%)
Abortions And Stillbirth	5 (.14%)
Central Nervous System Infections A...	5 (.14%)
Depressed Mood Disorders	5 (.14%)

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