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Isoniazid (Isoniazid) - Acute Hepatic Failure - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Acute Hepatic Failure (26)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Isoniazid where reactions include acute hepatic failure. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Isoniazid 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

Pyrazinamide

Rifampicin

Meropenem



Possible Isoniazid 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:
Isoniazid
    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

Pyrazinamide
    Administration route: Oral
    Start date: 2011-10-27
    End date: 2011-11-24

Ethambutol Hydrochloride
    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 Isoniazid 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:
Rifampicin
    Dosage: 10 mg/kg/day
    Indication: Pulmonary Tuberculosis

Pyrazinamide
    Dosage: 30 mg/kg/day
    Indication: Pulmonary Tuberculosis

Isoniazid
    Dosage: 5 mg/kg/day
    Indication: Pulmonary Tuberculosis



Possible Isoniazid 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:
Rifampicin
    Indication: Tuberculosis

Pyrazinamide
    Indication: Tuberculosis

Isoniazid
    Indication: Tuberculosis



Possible Isoniazid 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:
Rifampicin

Isoniazid

Pyrazinamide



Possible Isoniazid side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 32 year old female

Reactions: Jaundice, Acute Hepatic Failure, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid

Other drugs received by patient: Ethambutol Hydrochloride; Moxifloxacin; Pyrazinamide; Belatacept; Prednisolone; Rifampicin



Possible Isoniazid side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 17 year old female

Reactions: Jaundice, Acute Hepatic Failure, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid

Other drugs received by patient: Pyrazinamide; Rifampicin



Possible Isoniazid side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16

Patient: 47 year old male

Reactions: Jaundice, Drug Resistance, Disseminated Tuberculosis, Intestinal Obstruction, Hepatitis, Hepatic Encephalopathy, Acute Hepatic Failure, Gastrointestinal Injury

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isoniazid

Other drugs received by patient: Rifampicin; Ethambutol Hydrochloride



Possible Isoniazid side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-11

Patient: 32 year old female

Reactions: Jaundice, Alanine Aminotransferase Increased, Acute Hepatic Failure, Drug Interaction, Kidney Transplant Rejection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid

Other drugs received by patient possibly interacting with the suspect drug:
Rifampicin
    Indication: Sarcoidosis

Immunosuppressive Agents
    Indication: Immunosuppression

Rifampicin

Prednisolone
    Indication: Immunosuppression

Other drugs received by patient: Moxifloxacin; Ethambutol Hydrochloride; Pyrazinamide; Ethambutol Hydrochloride



Possible Isoniazid side effects in 47 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-11

Patient: 47 year old male

Reactions: Jaundice, Hepatic Encephalopathy, Alanine Aminotransferase Increased, Liver Transplant Rejection, Drug Interaction, Acute Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid

Other drugs received by patient possibly interacting with the suspect drug:
Rifampicin
    Indication: Tuberculosis

Prednisolone
    Indication: Immunosuppression

Tacrolimus
    Indication: Immunosuppression

Other drugs received by patient: Rifampicin; Moxifloxacin; Ethambutol Hydrochloride; Ethambutol Hydrochloride



Possible Isoniazid side effects in 45 year old female

Reported by a health professional (non-physician/pharmacist) from India on 2012-05-09

Patient: 45 year old female

Reactions: Jaundice, Hepatic Encephalopathy, Acute Hepatic Failure, Depressed Level of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid
    Indication: Tuberculosis

Ethambutol Hydrochloride
    Indication: Tuberculosis

Rifampicin
    Indication: Tuberculosis

Pyrazinamide



Possible Isoniazid side effects in female

Reported by a physician from United States on 2012-04-18

Patient: female

Reactions: Acute Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid
    Indication: Tuberculosis

Stelara
    Dosage: administered in january
    Indication: Psoriasis

Stelara
    Dosage: administered in december

Other drugs received by patient: Simvastatin



Possible Isoniazid side effects in female

Reported by a physician from United States on 2012-04-13

Patient: female

Reactions: Acute Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Stelara
    Dosage: administered in december

Isoniazid
    Indication: Tuberculosis

Stelara
    Dosage: administered in january
    Indication: Psoriasis

Other drugs received by patient: Simvastatin



Possible Isoniazid side effects in 57 year old female

Reported by a physician from United States on 2012-03-09

Patient: 57 year old female

Reactions: Liver Injury, Hepatitis Acute, Urinary Tract Infection, Encephalopathy, Rash, Hepatic Steatosis, Hepatotoxicity, Acute Hepatic Failure, Hepatic Cirrhosis

Drug(s) suspected as cause:
Isoniazid



Possible Isoniazid side effects in 14 year old male

Reported by a physician from Italy on 2012-02-16

Patient: 14 year old male

Reactions: Acute Hepatic Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rifadin
    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

Ethambutol Hydrochloride
    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

Other drugs received by patient: Acetaminophen; Augmentin '125'; Allopurinol; Prednisone TAB



Possible Isoniazid side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-13

Patient: 38 year old male

Reactions: Acute Hepatic Failure, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid
    Indication: Tuberculosis

Pyrazinamide
    Indication: Tuberculosis

Rifampicin
    Indication: Tuberculosis



Possible Isoniazid side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-19

Patient: 38 year old male

Reactions: Acute Hepatic Failure, Hepatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pyrazinamide
    Indication: Tuberculosis

Rifampicin
    Indication: Tuberculosis

Isoniazid
    Indication: Tuberculosis



Possible Isoniazid side effects in 14 year old male

Reported by a physician from Italy on 2012-01-12

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

Rifadin
    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

Isoniazid
    Administration route: Oral
    Start date: 2011-10-27
    End date: 2011-11-24

Other drugs received by patient: Acetaminophen; Augmentin '125'; Prednisone TAB; Allopurinol



Possible Isoniazid side effects in 14 year old male

Reported by a physician from Italy on 2011-12-29

Patient: 14 year old male

Reactions: Acute Hepatic Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rifadin
    Administration route: Oral
    Start date: 2011-10-27
    End date: 2011-11-24

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

Other drugs received by patient: Allopurinol; Prednisone TAB; Acetaminophen; Augmentin



Possible Isoniazid side effects in 7 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-22

Patient: 7 year old male

Reactions: Unresponsive To Stimuli, Pyrexia, Disorientation, Pericardial Effusion, Abdominal Tenderness, Cachexia, Weight Increased, Miosis, Acute Hepatic Failure, Ocular Icterus, Abdominal Distension, Leukocytosis, Hepatosplenomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pyrazinamide
    Indication: Tuberculosis

Isoniazid
    Indication: Tuberculosis

Ethambutol Hydrochloride
    Indication: Tuberculosis

Rifampicin
    Dosage: unk
    Indication: Tuberculosis

Other drugs received by patient: Ceftriaxone; Fluconazole



Possible Isoniazid side effects in 45 year old female

Reported by a physician from United States on 2011-11-17

Patient: 45 year old female

Reactions: Acute Hepatic Failure, Toxicity To Various Agents, Liver Transplant

Drug(s) suspected as cause:
Isoniazid



Possible Isoniazid side effects in 7 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-14

Patient: 7 year old male

Reactions: Abdominal Pain, Jaundice, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Cachexia, Gamma-Glutamyltransferase Increased, Hepatotoxicity, Aspartate Aminotransferase Increased, Ammonia Increased, Acute Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ethambutol Hydrochloride
    Indication: Tuberculosis

Rifampicin
    Indication: Tuberculosis

Pyrazinamide
    Indication: Tuberculosis

Isoniazid
    Indication: Tuberculosis

Other drugs received by patient: Ceftriaxone; Fluconazole; Pyridoxine HCL; Acetaminophen



Possible Isoniazid side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-11-10

Patient: 19 year old female

Reactions: Hepatic Encephalopathy, Heart Rate Increased, Acute Hepatic Failure, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pyrazinamide
    Dosage: 1500 mg/day
    Indication: Tuberculosis

Isoniazid
    Dosage: 300 mg/day
    Indication: Tuberculosis

Rifampicin
    Dosage: 600 mg/day
    Indication: Tuberculosis

Ethambutol Hydrochloride
    Dosage: 1500 mg/day
    Indication: Tuberculosis



Possible Isoniazid side effects in 7 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: 7 year old male

Reactions: Acute Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pyrazinamide
    Dosage: unk
    Indication: Tuberculosis

Isoniazid
    Dosage: unk
    Indication: Tuberculosis

Ethambutol
    Dosage: unk
    Indication: Tuberculosis

Rifampin
    Dosage: unk
    Indication: Tuberculosis

Other drugs received by patient: Ceftriaxone; Pyridoxine; Fluconazole



Possible Isoniazid side effects in 8 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-10-20

Patient: 8 month old female

Reactions: Blood Bilirubin Increased, Immune Reconstitution Syndrome, Bovine Tuberculosis, Haemorrhage, Coagulopathy, Mental Status Changes, Hepatic Failure, Lymphadenitis, Hepatic Encephalopathy, Liver Function Test Abnormal, Brain Oedema, Hepatic Cirrhosis, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Vaccination Failure, Condition Aggravated, Toxicity To Various Agents, Convulsion, Acute Hepatic Failure, Hepatitis B

Adverse event resulted in: death

Drug(s) suspected as cause:
Lopinavir / Ritonavir

Ritonavir
    Indication: HIV Infection

Ritonavir

Lamivudine
    Indication: HIV Infection

Lamivudine

Zidovudine

Ciprofloxacin
    Indication: Tuberculosis

Zidovudine
    Indication: HIV Infection

Amikacin
    Dosage: usp
    Indication: Tuberculosis

Cotrim
    Indication: Tuberculosis

Tice BCG
    Dosage: liquid intradermal
    Indication: Product Used FOR Unknown Indication

Isoniazid
    Indication: Tuberculosis

Hepatitis B Vaccine
    Dosage: received at 6, 10 and 14 weeks of life
    Indication: Product Used FOR Unknown Indication

Ethambutol Hydrochloride
    Indication: Tuberculosis

Pyrazinamide
    Indication: Tuberculosis

Rifampin
    Indication: Tuberculosis

Lopinavir / Ritonavir
    Indication: HIV Infection



Possible Isoniazid side effects in 8 month old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-10-18

Patient: 8 month old female

Reactions: Blood Bilirubin Increased, Immune Reconstitution Syndrome, Bovine Tuberculosis, Haemorrhage, Coagulopathy, Mental Status Changes, Hepatic Failure, Lymphadenitis, Hepatic Encephalopathy, Liver Function Test Abnormal, Brain Oedema, Hepatic Cirrhosis, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Vaccination Failure, Condition Aggravated, Toxicity To Various Agents, Convulsion, Acute Hepatic Failure, Hepatitis B

Adverse event resulted in: death

Drug(s) suspected as cause:
Norvir
    Indication: HIV Infection

Ethambutol Hydrochloride
    Indication: Tuberculosis

Pyrazinamide
    Indication: Tuberculosis

Norvir

Isoniazid
    Indication: Tuberculosis

Lamivudine

Ciprofloxacin
    Indication: Tuberculosis

Cotrim
    Indication: Tuberculosis

Zidovudine
    Indication: HIV Infection

Zidovudine

Kaletra

Hepatitis B Vaccine
    Dosage: received at 6, 10 and 14 weeks of life
    Indication: Product Used FOR Unknown Indication

Lamivudine
    Indication: HIV Infection

Rifampin
    Indication: Tuberculosis

Tice BCG
    Dosage: liquid intradermal
    Indication: Product Used FOR Unknown Indication

Amikacin
    Dosage: usp
    Indication: Tuberculosis

Kaletra
    Indication: HIV Infection

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