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Pyrazinamide (Pyrazinamide) - Side Effect Reports to FDA

 
 



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 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

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 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 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 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 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 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 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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