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Isoniazid (Isoniazid) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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