Index of reports
> Life Threatening Events (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Isoniazid life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
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 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-02
Patient: 44 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Dehydration, Hepatitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Efavirenz
Dosage: at bed time,last dose:25mar2012. restarted 7jun12
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Isoniazid
Dosage: last dose:26mar2012, administration:every day restarted 7jun12
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-03-02
Truvada
Dosage: 1df=200/300mg, last dose:25mar12. restarted 7jun12
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Other drugs received by patient: Ethambutol Hydrochloride; Streptomycin; Rifampicin
Possible Isoniazid side effects in 57 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-02
Patient: 57 year old male
Reactions: Tubulointerstitial Nephritis, Interstitial Lung Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Isoniazid
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
End date: 2011-05-23
Rifadin
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
End date: 2011-05-23
Levofloxacin
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-06-20
End date: 2011-07-11
Other drugs received by patient: Pyrazinamide; Medicon; Mucodyne; Ethambutol Hydrochloride; Mucosta
Possible Isoniazid side effects in 57 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-18
Patient: 57 year old male
Reactions: Tubulointerstitial Nephritis, Pulmonary Vascular Disorder
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Levofloxacin
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-06-20
End date: 2011-07-11
Isoniazid
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
End date: 2011-05-23
Carbocisteine
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
Mucosta
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
Ethambutol Hydrochloride
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
Rifadin
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
End date: 2011-05-23
Dextromethorphan Hydrobromide
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2011-04-26
End date: 2011-06-07
Other drugs received by patient: Pyrazinamide
Possible Isoniazid side effects in 44 year old female
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: 44 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Dehydration, Hepatitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Efavirenz
Dosage: at bed time,last dose:25mar2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Truvada
Dosage: 1df=200/300mg, last dose:25-mar-2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Isoniazid
Dosage: last dose:26mar2012, administration:every day
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-03-02
Other drugs received by patient: Rifampicin; Streptomycin; Ethambutol Hydrochloride
Possible Isoniazid side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-10
Patient: 56 year old male
Reactions: Lymphopenia, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Hepatitis, Rash Maculo-Papular, Pneumonitis, Eosinophilia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Isoniazid
Indication: Pulmonary Tuberculosis
Ethambutol Hydrochloride
Indication: Pulmonary Tuberculosis
Pyrazinamide
Indication: Pulmonary Tuberculosis
Rifampicin
Indication: Pulmonary Tuberculosis
Possible Isoniazid side effects in 23 year old male
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-05-10
Patient: 23 year old male
Reactions: Lymphopenia, Pyrexia, Rash Maculo-Papular, Hepatitis, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Rifampicin
Indication: Pulmonary Tuberculosis
Pyrazinamide
Indication: Pulmonary Tuberculosis
Isoniazid
Indication: Pulmonary Tuberculosis
Ethambutol Hydrochloride
Indication: Pulmonary Tuberculosis
Possible Isoniazid side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-08
Patient: 44 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Dehydration, Hepatitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Truvada
Dosage: 1df=200/300mg, last dose:25-mar-2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Efavirenz
Dosage: at bed time,last dose:25mar2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Isoniazid
Dosage: last dose:26mar2012, administration:every day
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-03-02
Other drugs received by patient: Streptomycin; Ethambutol Hydrochloride; Rifampicin
Possible Isoniazid side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27
Patient: 44 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Dehydration, Hepatitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Efavirenz
Dosage: at bed time,last dose:25mar2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Truvada
Dosage: 1df=200/300mg, last dose:25-mar-2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Isoniazid
Dosage: last dose:26mar2012, administration:every day
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-03-02
Possible Isoniazid side effects in 46 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-10
Patient: 46 year old male
Reactions: Hepatitis Fulminant, Liver Transplant
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Isoniazid
Administration route: Oral
Epivir
Administration route: Oral
Start date: 2003-07-01
Myambutol
Administration route: Oral
Start date: 2003-07-01
Rifadin
Administration route: Oral
Start date: 2003-07-01
Isoniazid
Administration route: Oral
Start date: 2003-07-01
Zerit
Administration route: Oral
Start date: 2003-07-01
Other drugs received by patient: Omeprazole; Acetaminophen; Bactrim
Possible Isoniazid side effects in 44 year old female
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: 44 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Dehydration, Hepatitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Isoniazid
Dosage: last dose:26mar2012, administration:every day
Administration route: Oral
Indication: Prophylaxis
Start date: 2012-03-02
Efavirenz
Dosage: at bed time,last dose:25mar2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
Truvada
Dosage: 1df=200/300mg, last dose:25-mar-2012.
Administration route: Oral
Indication: HIV Infection
Start date: 2012-03-02
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 31 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-10
Patient: 31 year old female
Reactions: Blood Pressure Increased, Body Temperature Increased, Hypercapnia, Anaemia, Acidosis, Loss of Consciousness, Laziness, Heart Rate Increased, Oxygen Saturation Decreased, Decreased Appetite
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Isoniazid
Dosage: unk
Indication: Mycobacterium Kansasii Infection
Rifampicin
Indication: Mycobacterium Kansasii Infection
Ethambutol Hydrochloride
Indication: Mycobacterium Kansasii Infection
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 46 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-12-28
Patient: 46 year old male
Reactions: Hepatitis Fulminant
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Rifadin
Administration route: Oral
Start date: 2003-07-01
Zerit
Administration route: Oral
Start date: 2003-07-01
Myambutol
Administration route: Oral
Start date: 2003-07-01
Isoniazid
Administration route: Oral
Start date: 2003-07-01
Epivir
Administration route: Oral
Start date: 2003-07-01
Possible Isoniazid side effects in 5 year old female
Reported by a physician from Greece on 2011-12-09
Patient: 5 year old female
Reactions: Grand MAL Convulsion, Acinetobacter Infection, Central Nervous System Infection, Stenotrophomonas Infection, Aspergillosis, Hydrocephalus, Cardiac Arrest, CNS Ventriculitis
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Levetiracetam
Indication: Epilepsy
Ceftazidime
Indication: Stenotrophomonas Infection
Isoniazid
Indication: Tuberculosis of Central Nervous System
Amphotericin B Deoxycholate
Dosage: 5 mg
Indication: CNS Ventriculitis
Ceftazidime
Indication: Acinetobacter Infection
Levetiracetam
Pyrazinamide
Indication: Tuberculosis of Central Nervous System
Levofloxacin
Indication: Tuberculosis of Central Nervous System
Voriconazole
Indication: CNS Ventriculitis
Meropenem
Indication: Inflammation
Colistin
Indication: Acinetobacter Infection
Dexamethasone Tablets Usp, 1.5 MG
Indication: Tuberculosis of Central Nervous System
Rifampin
Indication: Tuberculosis of Central Nervous System
Streptomycin
Indication: Tuberculosis of Central Nervous System
Meropenem
Indication: Acinetobacter Infection
Amphotericin B Deoxycholate
Pyrazinamide
Meropenem
Indication: Stenotrophomonas Infection
Colistin
Indication: Stenotrophomonas Infection
Dexamethasone Tablets Usp, 1.5 MG
Dexamethasone Tablets Usp, 1.5 MG
Amphotericin B
Indication: Aspergillosis
Possible Isoniazid side effects in male
Reported by a consumer/non-health professional from Japan on 2011-11-16
Patient: male
Reactions: Liver Disorder
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Ciprofloxacin HCL
Dosage: 300 mg, bid
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-05
End date: 2010-10-08
Famotidine
Dosage: 20 mg/day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-07
End date: 2010-10-08
Isoniazid
Dosage: 0.25 g, qd
Administration route: Oral
Start date: 2010-10-07
End date: 2010-10-08
Levofloxacin
Dosage: 5 g/day
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-22
End date: 2010-10-27
Aderoxal
Dosage: 0.1 g, tid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-07
End date: 2010-10-08
Isoniazid
Dosage: 250 mg/day
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-06
Rifadin
Dosage: 450 mg/day
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-08
Levofloxacin
Indication: Pyrexia
Ethambutol Hydrochloride
Dosage: 625 mg/day
Administration route: Oral
Indication: Pyrexia
Start date: 2010-10-22
End date: 2010-10-27
Other drugs received by patient: Neoparen NO. 2; Neophagen C; Physio 35; Neoparen NO. 2; Ensure; Neophagen C; Twinpal
Possible Isoniazid side effects in male
Reported by a consumer/non-health professional from Japan on 2011-11-11
Patient: male
Reactions: Liver Disorder
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Aderoxal
Dosage: 0.1 g, tid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-07
End date: 2010-10-08
Rifadin
Dosage: 450 mg/day
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-08
Isoniazid
Dosage: 0.25 g, qd
Administration route: Oral
Start date: 2010-10-07
End date: 2010-10-08
Levofloxacin
Indication: Pyrexia
Famotidine
Dosage: 20 mg/day
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-07
End date: 2010-10-08
Ethambutol Hydrochloride
Dosage: 625 mg/day
Administration route: Oral
Indication: Pyrexia
Start date: 2010-10-22
End date: 2010-10-27
Ciprofloxacin HCL
Dosage: 300 mg, bid
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-05
End date: 2010-10-08
Isoniazid
Dosage: 250 mg/day
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-06
Levofloxacin
Dosage: 5 g/day
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-22
End date: 2010-10-27
Other drugs received by patient: Ensure; Neoparen NO. 2; Physio 35; Neoparen NO. 2; Neophagen C; Neophagen C; Twinpal
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 male
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-31
Patient: male
Reactions: Liver Disorder
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Rifadin
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-08
Ethambutol Hydrochloride
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-22
End date: 2010-10-27
Aderoxal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-07
End date: 2010-10-08
Isoniazid
Administration route: Oral
Start date: 2010-10-07
End date: 2010-10-08
Isoniazid
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-06
Levofloxacin
Administration route: Oral
Indication: Pulmonary Tuberculosis
Start date: 2010-10-22
End date: 2010-10-27
Ciprofloxacin
Indication: Pulmonary Tuberculosis
Start date: 2010-10-05
End date: 2010-10-08
Famotidine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-07
End date: 2010-10-08
Other drugs received by patient: TPN; Ensure; Unknown Medication; Physio; TPN
Possible Isoniazid side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-07
Patient: female, weighing 64.1 kg (141.0 pounds)
Reactions: Unevaluable Event, Hepatic Enzyme Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Rifapentine 300mg (3) Sanofi
Dosage: 900 mg once a week by mouth
Administration route: Oral
Indication: Latent Tuberculosis
Start date: 2011-07-21
End date: 2011-09-01
Isoniazid
Dosage: 900mg once a week by mouth
Administration route: Oral
Indication: Latent Tuberculosis
Start date: 2010-07-21
End date: 2011-09-01
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