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 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 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 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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