This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pyrazinamide and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (154)
Death (19)
Life Threatening Events (19)
Disability (4)
Reports by Reaction Type
Acute Hepatic Failure (34),
Jaundice (18),
Pyrexia (16),
Hepatitis (16),
Hepatic Encephalopathy (13),
Paradoxical Drug Reaction (11),
Drug Rash With Eosinophilia and Systemic Symptoms (10),
Peritoneal Tuberculosis (9),
Hepatic Function Abnormal (8),
Hepatotoxicity (8),
Alanine Aminotransferase Increased (8),
Ascites (8)
Below are a few examples of reports where side effects / adverse reactions may be related to Pyrazinamide. For a complete list or a specific selection of reports, please use the links above.
Possible Pyrazinamide side effects in male
Reported by a physician from Brazil on 2012-08-24
Patient: male
Reactions: Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Dosage: 1100 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Isoniazid
Dosage: 300 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Lamivudine
Dosage: 300 mg, qd
Indication: HIV Infection
Start date: 2011-02-14
Pyrazinamide
Dosage: 600 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Raltegravir
Dosage: 800 mg, qd
Indication: HIV Infection
Start date: 2011-02-14
Rifampin
Dosage: 600 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Tenofovir Disoproxil Fumarate
Dosage: 300 mg, qd
Indication: HIV Infection
Start date: 2011-02-14
Possible Pyrazinamide side effects in 78 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-17
Patient: 78 year old female, weighing 53.0 kg (116.6 pounds)
Reactions: Rash Papular, Eye Swelling, Neutropenia, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Start date: 2012-04-11
End date: 2012-04-25
Rifampicin
Start date: 2012-04-11
End date: 2012-04-25
Other drugs received by patient: Cholecalciferol; Pyridoxine Hydrochloride; Ethambutol Hydrochloride; Isoniazid; Perindopril Erbumine; Rosuvastatin; Flixotide ^glaxo^
Possible Pyrazinamide side effects in female
Reported by a individual with unspecified qualification from Spain on 2012-08-07
Patient: female
Reactions: Off Label Use, Arthralgia, Hepatitis, Hyperuricaemia
Drug(s) suspected as cause:
Isoniazid
Indication: Pulmonary Tuberculosis
Levofloxacin
Indication: Pulmonary Tuberculosis
Levofloxacin
Indication: Off Label Use
Pyrazinamide
Indication: Pulmonary Tuberculosis
Other drugs received by patient: Mmycophenolate (Mycophenolate Mofetil); Ciclospirin (Ciclosporin); Ethambutol Hydrochloride; Prednisolone
Possible Pyrazinamide side effects in
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-06
Patient:
Reactions: Acute Hepatic Failure, Hepatitis Toxic
Drug(s) suspected as cause:
Isoniazid
Meropenem
Pyrazinamide
Rifampicin
Possible Pyrazinamide side effects in 14 year old male
Reported by a physician from Italy on 2012-08-03
Patient: 14 year old male
Reactions: Acute Hepatic Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Administration route: Oral
Start date: 2011-10-27
End date: 2011-11-24
Isoniazid
Administration route: Oral
Start date: 2011-10-27
End date: 2011-11-24
Pyrazinamide
Administration route: Oral
Start date: 2011-10-27
End date: 2011-11-24
Rifadin
Administration route: Oral
Start date: 2011-10-27
End date: 2011-11-24
Other drugs received by patient: Allopurinol; Augmentin '500'; Prednisone TAB; Acetaminophen
Possible Pyrazinamide side effects in 10 year old female
Reported by a physician from Australia on 2012-08-02
Patient: 10 year old female
Reactions: Neurotoxicity, Grand MAL Convulsion, International Normalised Ratio Increased, Encephalopathy, Acute Hepatic Failure, Status Epilepticus
Drug(s) suspected as cause:
Isoniazid
Dosage: 5 mg/kg/day
Indication: Pulmonary Tuberculosis
Pyrazinamide
Dosage: 30 mg/kg/day
Indication: Pulmonary Tuberculosis
Rifampicin
Dosage: 10 mg/kg/day
Indication: Pulmonary Tuberculosis
Possible Pyrazinamide side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-02
Patient: male
Reactions: Stridor, Breath Sounds Abnormal, Paradoxical Drug Reaction, Tuberculosis, Pyrexia, Cough
Drug(s) suspected as cause:
Isoniazid
Dosage: 12 mg/kg/day
Indication: Pulmonary Tuberculosis
Pyrazinamide
Indication: Pulmonary Tuberculosis
Rifampicin
Indication: Pulmonary Tuberculosis
Possible Pyrazinamide side effects in 23 year old male
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-08-01
Patient: 23 year old male
Reactions: Drug Rash With Eosinophilia and Systemic Symptoms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Dosage: unk
Indication: Pulmonary Tuberculosis
Isoniazid
Dosage: unk
Indication: Pulmonary Tuberculosis
Pyrazinamide
Dosage: unk
Indication: Pulmonary Tuberculosis
Rifampicin
Dosage: unk
Indication: Pulmonary Tuberculosis
Possible Pyrazinamide side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-08-01
Patient: 56 year old male
Reactions: Drug Rash With Eosinophilia and Systemic Symptoms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Dosage: unk
Indication: Pulmonary Tuberculosis
Isoniazid
Dosage: unk
Indication: Pulmonary Tuberculosis
Pyrazinamide
Dosage: unk
Indication: Pulmonary Tuberculosis
Rifampicin
Dosage: unk
Indication: Pulmonary Tuberculosis
Possible Pyrazinamide side effects in 52 year old male
Reported by a consumer/non-health professional from South Africa on 2012-07-31
Patient: 52 year old male, weighing 33.9 kg (74.6 pounds)
Reactions: Colour Blindness
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Dosage: unk
Indication: Pulmonary Tuberculosis
Start date: 2011-06-27
Isoniazid
Dosage: unk
Indication: Pulmonary Tuberculosis
Start date: 2011-06-27
Moxifloxacin
Moxifloxacin
Dosage: unk
Start date: 2011-06-27
Pyrazinamide
Dosage: unk
Indication: Pulmonary Tuberculosis
Start date: 2011-06-27
Rifampicin
Dosage: unk
Indication: Pulmonary Tuberculosis
Start date: 2011-07-27
Possible Pyrazinamide side effects in
Reported by a consumer/non-health professional from France on 2012-07-30
Patient:
Reactions: Drug Eruption, Death, Aspartate Aminotransferase Increased, Anaemia, Neutropenia, Leukopenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Dapsone
Dosage: 100 mg, qd
Indication: Prophylaxis
Start date: 2011-01-15
Epivir
Dosage: 300 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2010-06-30
Isentress
Dosage: 800 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2010-05-30
End date: 2010-08-31
Isoniazid
Dosage: 400 mg, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2010-05-22
End date: 2010-08-10
Kaletra
Dosage: 20
Administration route: Oral
Indication: HIV Infection
Start date: 2010-11-22
Pyrazinamide
Dosage: 2 g, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2010-05-22
End date: 2010-07-26
Rifampin
Dosage: 600 mg, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2010-05-22
End date: 2010-08-10
Viread
Dosage: 300 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2010-05-30
Other drugs received by patient: Bactrim; Leucovorin Calcium; Leucovorin Calcium; Ivermectin; Acyclovir; Ciproflaxacin; Azithromycin; Pyridoxine HCL; Omeprazole
Possible Pyrazinamide side effects in
Reported by a physician from France on 2012-07-30
Patient:
Reactions: Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Dosage: 300 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-14
Ethambutol Hydrochloride
Dosage: 1100 mg, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2011-02-01
Isoniazid
Dosage: 300 mg, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2011-02-01
Pyrazinamide
Dosage: 600 mg, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2011-02-01
Raltegravir
Dosage: 400 mg, bid
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-14
Rifampin
Dosage: 600 mg, qd
Administration route: Oral
Indication: Tuberculosis
Start date: 2011-02-01
Viread
Dosage: 300 mg, qd
Administration route: Oral
Indication: HIV Infection
Start date: 2011-02-14
Possible Pyrazinamide side effects in male
Reported by a physician from Brazil on 2012-07-27
Patient: male
Reactions: Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Dosage: 1100 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Isoniazid
Dosage: 300 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Lamivudine
Dosage: 300 mg, qd
Indication: HIV Infection
Start date: 2011-02-14
Pyrazinamide
Dosage: 600 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Raltegravir
Dosage: 800 mg, qd
Indication: HIV Infection
Start date: 2011-02-14
Rifampin
Dosage: 600 mg, qd
Indication: Tuberculosis
Start date: 2011-02-01
Tenofovir Disoproxil Fumarate
Dosage: 300 mg, qd
Indication: HIV Infection
Start date: 2011-02-14
Possible Pyrazinamide side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-26
Patient: 58 year old female
Reactions: Agitation, Anxiety
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2012-03-07
End date: 2012-03-12
Pyrazinamide
Start date: 2012-03-21
Rifampin and Isoniazid
Start date: 2012-03-16
Rifampin and Isoniazid
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2012-03-07
End date: 2012-03-12
Possible Pyrazinamide side effects in male
Reported by a physician from Brazil on 2012-07-26
Patient: male
Reactions: Nausea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
Drug(s) suspected as cause:
Acetaminophen
Dosage: unk
Indication: Headache
Start date: 2010-12-13
Acyclovir
Dosage: 4000 unk, unk
Indication: Herpes Zoster
Start date: 2010-12-18
End date: 2010-12-25
Azithromycin
Dosage: 1500 unk, unk
Indication: Prophylaxis
Start date: 2010-11-04
Bactrim
Dosage: 400 mg, unk
Indication: Prophylaxis
Start date: 2010-12-13
Efavirenz
Dosage: unk
Indication: HIV Infection
Start date: 2010-11-25
End date: 2011-01-01
Efavirenz
Dosage: unk
Ethambutol Hydrochloride
Dosage: unk
Indication: Tuberculosis
Start date: 2010-10-16
End date: 2010-12-27
Ethambutol Hydrochloride
Dosage: unk
Isoniazid
Dosage: unk
Indication: Tuberculosis
Start date: 2010-10-16
End date: 2011-01-01
Lamivudine
Dosage: 300 mg, qd
Indication: HIV Infection
Start date: 2010-11-25
Prednisone
Dosage: 40 mg, unk
Indication: Meningitis
Start date: 2010-10-16
Pyrazinamide
Dosage: 1200 mg, unk
Indication: Tuberculosis
Start date: 2010-10-16
End date: 2010-12-27
Rifampin
Dosage: 450 mg, qd
Indication: Tuberculosis
Start date: 2010-10-16
End date: 2011-01-01
Rifampin
Dosage: 450 mg, qd
Tenofovir Disoproxil Fumarate
Indication: HIV Infection
Possible Pyrazinamide side effects in 28 year old female
Reported by a health professional (non-physician/pharmacist) from Oman on 2012-07-25
Patient: 28 year old female, weighing 37.0 kg (81.4 pounds)
Reactions: Drug-Induced Liver Injury, Microcytic Anaemia, Blood Glucose Increased
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Dosage: 600 mg, once daily
Indication: Pulmonary Tuberculosis
Ethambutol Hydrochloride
Dosage: 600 mg, once daily
Indication: Extrapulmonary Tuberculosis
INH
Dosage: 300 mg, daily
Indication: Extrapulmonary Tuberculosis
INH
Dosage: 300 mg, daily
Indication: Pulmonary Tuberculosis
Pyrazinamide
Dosage: 1200 mg, once daily
Indication: Pulmonary Tuberculosis
Pyrazinamide
Dosage: 1200 mg, once daily
Indication: Extrapulmonary Tuberculosis
Pyridoxine Hydrochloride INJ
Dosage: 50 mg, once daily
Indication: Extrapulmonary Tuberculosis
Pyridoxine Hydrochloride INJ
Dosage: 50 mg, once daily
Indication: Pulmonary Tuberculosis
Rifampin
Dosage: 300 mg, once daily
Indication: Extrapulmonary Tuberculosis
Rifampin
Dosage: 300 mg, once daily
Indication: Pulmonary Tuberculosis
Other drugs received by patient: Prednisolone; Blood Transfusions (Blood Transfusion, Auxiliary Products); Mycophenolate Mofetil; Tacrolimus
Possible Pyrazinamide side effects in 10 year old
Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-07-24
Patient: 10 year old
Reactions: Acute Hepatic Failure
Drug(s) suspected as cause:
Isoniazid
Indication: Tuberculosis
Pyrazinamide
Indication: Tuberculosis
Rifampicin
Indication: Tuberculosis
Possible Pyrazinamide side effects in 10 year old male
Reported by a physician from India on 2012-07-24
Patient: 10 year old male, weighing 20.0 kg (44.0 pounds)
Reactions: Abdominal Pain, Weight Gain Poor, Drug Resistance, Lymphadenopathy, Drug Ineffective, Pyrexia, Hepatomegaly, Decreased Appetite, Cough
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Indication: Tuberculosis
Isoniazid
Indication: Tuberculosis
Pyrazinamide
Indication: Tuberculosis
Rifampicin
Indication: Tuberculosis
Streptomycin
Indication: Tuberculosis
Possible Pyrazinamide side effects in 35 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19
Patient: 35 year old female
Reactions: Jaundice, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Isoniazid; Rifampicin; Rifampicin
Possible Pyrazinamide side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19
Patient: 40 year old female
Reactions: Jaundice, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Rifampicin; Isoniazid
Possible Pyrazinamide side effects in
Reported by a consumer/non-health professional from Spain on 2012-07-19
Patient:
Reactions: Drug-Induced Liver Injury, Disseminated Tuberculosis, Transaminases Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Ethambutol Hydrochloride
Indication: Disseminated Tuberculosis
Isoniazid
Indication: Disseminated Tuberculosis
Pyrazinamide
Indication: Disseminated Tuberculosis
Rifampicin
Indication: Disseminated Tuberculosis
Other drugs received by patient: Cyclosporine; Mycophenolic Acid
Possible Pyrazinamide side effects in 41 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19
Patient: 41 year old male
Reactions: Jaundice, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Ethambutol Hydrochloride; Isoniazid; Rifabutin
Possible Pyrazinamide side effects in 64 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19
Patient: 64 year old female
Reactions: Jaundice, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Rifampicin; Ethambutol Hydrochloride; Moxifloxacin; Isoniazid
Possible Pyrazinamide side effects in 25 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18
Patient: 25 year old female
Reactions: Jaundice, Hepatic Encephalopathy, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Rifampicin; Azathioprine; Prednisolone; Isoniazid; Cyclosporine
Possible Pyrazinamide side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18
Patient: 20 year old female
Reactions: Jaundice, Hepatic Encephalopathy, Sepsis, Shock Haemorrhagic, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Rifampicin; Ethambutol Hydrochloride; Prednisolone; Tacrolimus; Ofloxacin; Isoniazid
Possible Pyrazinamide side effects in 10 year old male
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-07-18
Patient: 10 year old male
Reactions: Acute Hepatic Failure
Drug(s) suspected as cause:
Isoniazid
Pyrazinamide
Rifampicin
Possible Pyrazinamide side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18
Patient: 40 year old female
Reactions: Jaundice, Hepatic Encephalopathy, Acute Respiratory Distress Syndrome, Acute Hepatic Failure, Hepatitis, Septic Shock, Blood Creatinine Increased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Rifampicin; Isoniazid
Possible Pyrazinamide side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18
Patient: 49 year old female
Reactions: Jaundice, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Possible Pyrazinamide side effects in 20 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18
Patient: 20 year old male
Reactions: Jaundice, Hepatic Encephalopathy, Acute Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pyrazinamide
Other drugs received by patient: Azathioprine; Rifampicin; Isoniazid; Cyclosporine; Streptomycin; Prednisolone; Ethambutol Hydrochloride
Possible Pyrazinamide side effects in 3 year old female
Reported by a physician from India on 2012-07-17
Patient: 3 year old female, weighing 9.5 kg (20.9 pounds)
Reactions: Drug Ineffective, Multiple-Drug Resistance, Osteomyelitis, Injection Site Pain, Psoas Abscess, Spinal Compression Fracture, Extradural Abscess, Impaired Healing, Spinal Deformity, Hepatosplenomegaly
Drug(s) suspected as cause:
Ciprofloxacin
Indication: Tuberculosis
Ethambutol Hydrochloride
Indication: Tuberculosis
Isoniazid
Indication: Tuberculosis
Pyrazinamide
Indication: Tuberculosis
Rifampicin
Indication: Tuberculosis
Streptomycin
Indication: Tuberculosis
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