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: 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 2012-08-15
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 2012-08-14
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 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 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
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 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 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 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 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 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 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 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 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 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 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 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 2012-07-24
Patient: 21 year old male
Reactions: Myalgia, Rhabdomyolysis, Dehydration, Chromaturia, Asthenia
Drug(s) suspected as cause:
Isoniazid
|
