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Isoniazid (Isoniazid) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Isoniazid 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 (268)
Death (28)
Life Threatening Events (22)

Reports by Reaction Type

Hepatic Function Abnormal (30)Pyrexia (28)Acute Hepatic Failure (26)Liver Disorder (20)Alanine Aminotransferase Increased (18)Hepatitis (17)Jaundice (16)Aspartate Aminotransferase Increased (15)Drug Rash With Eosinophilia and Systemic Symptoms (13)Cough (12)Nausea (12)Paradoxical Drug Reaction (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Isoniazid. For a complete list or a specific selection of reports, please use the links above.

Possible Isoniazid 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 Isoniazid side effects in male

Reported by a physician from Japan on 2012-08-15

Patient: male

Reactions: Liver Disorder

Drug(s) suspected as cause:
Isoniazid
    Indication: Antibiotic Prophylaxis
    Start date: 2012-06-01
    End date: 2012-07-27

Stelara
    Indication: Psoriasis
    Start date: 2012-06-29
    End date: 2012-07-27



Possible Isoniazid side effects in male

Reported by a physician from Japan on 2012-08-15

Patient: male

Reactions: Hepatic Function Abnormal, Rhinorrhoea, Pyrexia

Drug(s) suspected as cause:
Isoniazid
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-04-19
    End date: 2012-06-06

Stelara
    Indication: Psoriasis
    Start date: 2012-05-09
    End date: 2012-06-06

Other drugs received by patient: Olmesartan Medoxomil; Indapamide; Pyridoxal Phosphate; Rasilez



Possible Isoniazid side effects in male

Reported by a physician from Japan on 2012-08-14

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Hepatic Function Abnormal, Chills, Dermatitis Exfoliative, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid
    Indication: Prophylaxis
    Start date: 2011-11-10
    End date: 2011-12-01

Isoniazid
    Start date: 2011-12-13
    End date: 2011-12-18

Stelara
    Indication: Psoriasis
    Start date: 2011-12-02

Other drugs received by patient: Antebate; Epinastine Hydrochloride; Acetaminophen; Pydoxal; Olopatadine HCL; Oxarol; Dovonex



Possible Isoniazid side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-10

Patient: 56 year old male

Reactions: Interstitial Lung Disease, Drug Hypersensitivity

Drug(s) suspected as cause:
Isoniazid
    Dosage: 300 mg;qd, 25 mg;qd 3 days ; 50 mg;qd 3 days ; 100 mg;qd 3 days; 200 mg;qd 5 days
    Indication: Prophylactic Chemotherapy

Isoniazid
    Dosage: 300 mg;qd, 25 mg;qd 3 days ; 50 mg;qd 3 days ; 100 mg;qd 3 days; 200 mg;qd 5 days
    Indication: Prophylactic Chemotherapy

Isoniazid
    Dosage: 300 mg;qd, 25 mg;qd 3 days ; 50 mg;qd 3 days ; 100 mg;qd 3 days; 200 mg;qd 5 days
    Indication: Prophylactic Chemotherapy

Isoniazid
    Dosage: 300 mg;qd, 25 mg;qd 3 days ; 50 mg;qd 3 days ; 100 mg;qd 3 days; 200 mg;qd 5 days
    Indication: Prophylactic Chemotherapy

Other drugs received by patient: Sulufasalzine; Methotrexate



Possible Isoniazid side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-09

Patient: 33 year old female

Reactions: Obstruction, Hepatitis Acute, Jaundice Cholestatic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 25 mg, biw
    Indication: Ankylosing Spondylitis
    Start date: 2012-05-30
    End date: 2012-07-07

Isoniazid
    Dosage: 300 mg, once per day
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-05-09
    End date: 2012-07-11

Other drugs received by patient: Prednisolone; Sulfasalazine; Voltaren; Ultracet; Baclofen



Possible Isoniazid side effects in 3 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-07

Patient: 3 year old male

Reactions: Off Label Use, Arthralgia, Hepatitis

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

Levofloxacin
    Indication: Disseminated Tuberculosis

Levofloxacin
    Indication: Off Label Use

Other drugs received by patient: Methylprednisolone; Ethambutol Hydrochloride; Tacrolimus; Pyrazinamide



Possible Isoniazid side effects in female

Reported by a individual with unspecified qualification from Spain on 2012-08-07

Patient: female

Reactions: Off Label Use, Arthralgia, Drug-Induced Liver Injury

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

Levofloxacin
    Indication: Disseminated Tuberculosis

Levofloxacin
    Indication: Off Label Use

Other drugs received by patient: Pyrazinamide; Sirolimus (Rapamune); Ethambutol Hydrochloride



Possible Isoniazid 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 Isoniazid side effects in 54 year old male

Reported by a physician from Thailand on 2012-08-07

Patient: 54 year old male, weighing 33.9 kg (74.6 pounds)

Reactions: Blood Bilirubin Increased, Colour Blindness

Drug(s) suspected as cause:
Isoniazid
    Start date: 2011-06-27

Isoniazid
    Indication: Pulmonary Tuberculosis
    Start date: 2011-08-22
    End date: 2011-10-02

Moxifloxacin
    Indication: Pulmonary Tuberculosis
    Start date: 2011-08-22
    End date: 2011-10-02

Moxifloxacin
    Start date: 2011-06-27

Rifampicin
    Indication: Pulmonary Tuberculosis
    Start date: 2011-08-22
    End date: 2011-10-02

Rifampicin
    Start date: 2011-06-27



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

Meropenem

Pyrazinamide

Rifampicin



Possible Isoniazid side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 61 year old male

Reactions: Death, Hepatotoxicity, Drug-Induced Liver Injury, Visual Impairment, Liver Function Test Abnormal, Hepatic Failure, Encephalopathy

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isoniazid
    Dosage: 300mg
    Indication: Latent Tuberculosis

Isoniazid



Possible Isoniazid side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 58 year old male, weighing 86.9 kg (191.2 pounds)

Reactions: Nasopharyngitis, Vomiting, Nausea, Chills, Pain, Pyrexia, Tremor, Hepatic Enzyme Increased, Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid
    Dosage: 900 mg weekly po
    Administration route: Oral
    Indication: Latent Tuberculosis
    Start date: 2012-07-11
    End date: 2012-07-25

Priftin
    Dosage: 900 mg weekly po
    Administration route: Oral
    Indication: Latent Tuberculosis
    Start date: 2012-07-11
    End date: 2012-07-25



Possible Isoniazid side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 17 year old female, weighing 54.4 kg (119.7 pounds)

Reactions: Drug Intolerance, Dizziness

Drug(s) suspected as cause:
Isoniazid
    Dosage: 900mg weekly po
    Administration route: Oral

Rifapentine 150mg Sanofi Aventis
    Dosage: 900mg weekly po
    Administration route: Oral
    Indication: Latent Tuberculosis
    Start date: 2012-06-06
    End date: 2012-06-13



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:
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 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:
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 Isoniazid side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 61 year old male

Reactions: Jaundice, Abdominal Pain, Metabolic Acidosis, Hepatic Failure, Encephalopathy, Transaminases Increased, Drug-Induced Liver Injury, Visual Impairment, Blood Bilirubin Abnormal, Depressed Level of Consciousness, Shock, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isoniazid



Possible Isoniazid 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 Isoniazid side effects in female

Reported by a pharmacist from United States on 2012-08-01

Patient: female, weighing 78.9 kg (173.6 pounds)

Reactions: Myalgia, Dyspnoea, Arthralgia, Pyrexia

Drug(s) suspected as cause:
Isoniazid
    Dosage: 900mg weekly po
    Administration route: Oral
    Indication: Latent Tuberculosis
    Start date: 2012-07-23
    End date: 2012-07-23

Priftin
    Dosage: 900mg weekly po
    Administration route: Oral
    Indication: Latent Tuberculosis
    Start date: 2012-07-16
    End date: 2012-07-16

Other drugs received by patient: Promethazine



Possible Isoniazid 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 Isoniazid 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 Isoniazid 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 Isoniazid 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 Isoniazid 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 Isoniazid side effects in 78 year old female

Reported by a physician from Japan on 2012-07-27

Patient: 78 year old female

Reactions: Paradoxical Drug Reaction, Cerebral Infarction, Drug Ineffective

Drug(s) suspected as cause:
Biogenerics Pyrazinamide
    Dosage: 1000 mg, unknown
    Indication: Disseminated Tuberculosis

Ethambutol Hydrochloride
    Dosage: 500 mg, unknown
    Indication: Disseminated Tuberculosis

Isoniazid
    Indication: Meningitis Tuberculous

Isoniazid
    Dosage: 200 mg, unknown
    Indication: Disseminated Tuberculosis

Prednisolone
    Dosage: 40 mg, unknown
    Indication: Disseminated Tuberculosis

Prednisolone
    Indication: Meningitis Tuberculous

Rifampicin
    Dosage: 450 mg, unknown



Possible Isoniazid 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 Isoniazid side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27

Patient: 79 year old female

Reactions: Pancreatitis Acute, Weight Decreased, Vomiting, Blood Potassium Decreased

Drug(s) suspected as cause:
Isoniazid

Other drugs received by patient: Rifampicin; Ethambutol Hydrochloride; Atenolol; Hydrochlorothiazide; Vitamin D; Calcium; Progesterone; Candesartan; Simvastatin; Estrogen NOS; Magnesium Sulfate



Possible Isoniazid 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 Isoniazid side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26

Patient: 21 year old male

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Isoniazid



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:
Isoniazid
    Indication: Tuberculosis

Pyrazinamide
    Indication: Tuberculosis

Rifampicin
    Indication: Tuberculosis

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