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Rifater (Rifampin / Isoniazid / Pyrazinamide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rifater 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 (24)
Death (4)
Disability (2)

Reports by Reaction Type

Cytolytic Hepatitis (9)Cholestasis (8)Drug Rash With Eosinophilia and Systemic Symptoms (7)Eosinophilia (5)Pyrexia (3)Hepatomegaly (3)Rash (3)Renal Failure (3)Hyperbilirubinaemia (2)Mouth Ulceration (2)Periarthritis (2)Transaminases Increased (2)

Possible Rifater side effects in 44 year old female

Reported by a pharmacist from Taiwan, Province of China on 2012-06-21

Patient: 44 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2012-02-13
    End date: 2012-02-20

Ethambutol Hydrochloride
    Administration route: Oral
    Indication: Tuberculosis

Rifampin and Isoniazid
    Administration route: Oral
    Indication: Tuberculosis

Pyrazinamide
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2012-03-03
    End date: 2012-04-04

Isoniazid / Pyridoxine
    Administration route: Oral
    Indication: Tuberculosis



Possible Rifater side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-14

Patient: male

Reactions: Hepatomegaly, Cytolytic Hepatitis, Cholestasis

Drug(s) suspected as cause:
Remicade
    Dosage: 300 mg, once/single
    Start date: 2011-07-27

Rifater
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-04-01

Myambutol
    Dosage: 1200 mg, qd
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-04-15

Acetaminophen
    Dosage: 1 df, tid
    Indication: Arthralgia
    End date: 2011-09-08

Voltaren
    Dosage: 75 mg, qd
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01
    End date: 2011-07-27

Rifampin and Isoniazid
    Dosage: 2 df, qd
    Start date: 2011-04-15
    End date: 2011-07-27

Lansoprazole
    Dosage: 15 mg, qd
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01
    End date: 2011-09-08

Rifampin and Isoniazid
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-15

Remicade
    Dosage: 5 mg/kg, every 15 days
    Indication: Ankylosing Spondylitis



Possible Rifater side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-14

Patient: male

Reactions: Hepatomegaly, Cytolytic Hepatitis, Cholestasis

Drug(s) suspected as cause:
Myambutol
    Dosage: 1200 mg, qd
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-04-15

Remicade
    Dosage: 5 mg/kg, every 15 days
    Indication: Ankylosing Spondylitis

Voltaren
    Dosage: 75 mg, qd
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01
    End date: 2011-07-27

Rifampin and Isoniazid
    Dosage: 2 df, qd
    Start date: 2011-04-15
    End date: 2011-07-27

Rifampin and Isoniazid
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-15

Remicade
    Dosage: 300 mg, once/single
    Start date: 2011-07-27

Lansoprazole
    Dosage: 15 mg, qd
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01
    End date: 2011-09-08

Rifater
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-04-01

Acetaminophen
    Dosage: 1 df, tid
    Indication: Arthralgia
    End date: 2011-09-08



Possible Rifater side effects in 44 year old female

Reported by a pharmacist from Taiwan, Province of China on 2012-06-14

Patient: 44 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2012-02-13
    End date: 2012-02-20

Isoniazid / Pyridoxine
    Administration route: Oral
    Indication: Tuberculosis

Pyrazinamide
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2012-03-03
    End date: 2012-04-04

Ethambutol Hydrochloride
    Administration route: Oral
    Indication: Tuberculosis

Rifampin and Isoniazid
    Administration route: Oral
    Indication: Tuberculosis



Possible Rifater side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-11

Patient: male

Reactions: Hepatomegaly, Cytolytic Hepatitis, Cholestasis

Drug(s) suspected as cause:
Myambutol
    Dosage: 1200 mg, qd
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-04-15

Voltaren
    Dosage: 75 mg, qd
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01
    End date: 2011-07-27

Rifampin and Isoniazid
    Dosage: 2 df, qd
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-15

Remicade
    Dosage: 5 mg/kg, every 15 days
    Indication: Ankylosing Spondylitis

Remicade
    Dosage: 300 mg, once/single
    Start date: 2011-07-27

Lansoprazole
    Dosage: 15 mg, qd
    Indication: Ankylosing Spondylitis
    Start date: 2008-01-01
    End date: 2011-09-08

Rifampin and Isoniazid
    Dosage: 2 df, qd
    Start date: 2011-04-15
    End date: 2011-07-27

Acetaminophen
    Dosage: 1 df, tid
    Indication: Arthralgia
    End date: 2011-09-08

Rifater
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2011-02-15
    End date: 2011-04-01



Possible Rifater side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-31

Patient: 74 year old male

Reactions: Renal Failure, Drug Rash With Eosinophilia and Systemic Symptoms, Toxic Skin Eruption, Mixed Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater

Other drugs received by patient: Nexium; Allopurinol; Kardegic / FRA /; Myambutol; Esomeprazole Magnesium; Desloratadine; Hydrocortisone; Colchicine



Possible Rifater side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-21

Patient: 65 year old female

Reactions: Rash Pustular, Stomatitis, Mouth Ulceration, Cytolytic Hepatitis, Rash, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater

Other drugs received by patient: ALL Other Therapeutic Products



Possible Rifater side effects in male

Reported by a physician from France on 2012-04-26

Patient: male

Reactions: Mononucleosis Syndrome, Rash Erythematous, Lymphopenia, Oedema, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myambutol
    Indication: Pulmonary Tuberculosis
    Start date: 2010-08-02
    End date: 2010-09-16

Myambutol
    Start date: 2010-09-29
    End date: 2011-04-22

Rifadin
    Indication: Pulmonary Tuberculosis
    Start date: 2010-09-29
    End date: 2011-04-22

Rifater
    Indication: Pulmonary Tuberculosis
    Start date: 2010-08-02

Mabthera
    Indication: non-Hodgkin's Lymphoma
    Start date: 2010-07-19
    End date: 2010-11-19

Allopurinol
    Administration route: Oral
    Indication: Hyperuricaemia
    Start date: 2010-08-16

Other drugs received by patient: Citalopram Hydrobromide; Oxazepam; Zolpidem Tartrate; Movicol



Possible Rifater side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-24

Patient: 64 year old female

Reactions: Cholestasis

Adverse event resulted in: death

Drug(s) suspected as cause:
Clavulanate Potassium
    Dosage: unk
    End date: 2010-10-14

Ambisome
    Dosage: 3 mg/kg, unk
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2010-09-28
    End date: 2010-10-25

Rifater
    Dosage: unk
    Administration route: Oral
    Indication: Tuberculosis
    End date: 2010-10-02

Vfend
    Dosage: unk
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2010-10-04
    End date: 2010-10-14



Possible Rifater side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-19

Patient: 74 year old male

Reactions: Renal Failure, Cytolytic Hepatitis, Cholestasis, Drug Rash With Eosinophilia and Systemic Symptoms, Mixed Liver Injury, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater

Other drugs received by patient: Allopurinol; Nexium; Myambutol; Esomeprazole Magnesium; Kardegic / FRA /; Desloratadine; Hydrocortisone



Possible Rifater side effects in 81 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-22

Patient: 81 year old female

Reactions: Neutropenia

Drug(s) suspected as cause:
Rifater



Possible Rifater side effects in 71 year old female

Reported by a physician from United Kingdom on 2012-03-09

Patient: 71 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Myopathy Toxic, Muscular Weakness

Drug(s) suspected as cause:
Rifater

Other drugs received by patient: Augmentin '125'; Albuterol; Simvastatin; Pyridoxine HCL; Ethambutol Hydrochloride; Acetaminophen; Sando K; Ipratropium Bromide; Clarithromycin; Piperacillin and Tazobactam



Possible Rifater side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-27

Patient: 65 year old female

Reactions: Rash Pustular, Stomatitis, Mouth Ulceration, Cytolytic Hepatitis, Rash, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater

Other drugs received by patient: ALL Other Therapeutic Products



Possible Rifater side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-19

Patient: 54 year old male

Reactions: Periarthritis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Rifater
    Dosage: dose:6 unit(s)
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2011-04-06
    End date: 2011-06-06

Rifampin and Isoniazid
    Dosage: dose:3 unit(s)
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2011-06-06

Other drugs received by patient: Myambutol



Possible Rifater side effects in 53 year old female

Reported by a physician from France on 2012-01-17

Patient: 53 year old female

Reactions: Abdominal Pain, Cytolytic Hepatitis

Drug(s) suspected as cause:
Rifater
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2011-09-16
    End date: 2011-10-18

Myambutol
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2011-09-16

Myambutol
    Start date: 2011-10-28



Possible Rifater side effects in 64 year old female

Reported by a physician from France on 2012-01-13

Patient: 64 year old female

Reactions: Cholestasis, Granulomatous Liver Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Amoxicillin and Clavulanate Potassium
    Indication: Product Used FOR Unknown Indication
    End date: 2010-10-14

Ambisome
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-28
    End date: 2010-10-25

Vfend
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-04
    End date: 2010-10-14

Rifater
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2010-01-01
    End date: 2010-10-02

Other drugs received by patient: Myambutol; Chemotherapy



Possible Rifater side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-12

Patient: 64 year old female

Reactions: Hepatitis Cholestatic, Cholestasis, Granulomatous Liver Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Rifater
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2010-10-02

Vfend
    Dosage: unk
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2010-10-04
    End date: 2010-10-14

Amoxicillin and Clavulanate Potassium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    End date: 2010-10-14

Ambisome
    Dosage: 3 mg/kg, uid/qd
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2010-09-28
    End date: 2010-10-25

Other drugs received by patient: Myambutol



Possible Rifater side effects in 64 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-11

Patient: 64 year old female

Reactions: Cholestasis

Adverse event resulted in: death

Drug(s) suspected as cause:
Vfend
    Dosage: unk
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2010-10-04
    End date: 2010-10-14

Amoxicillin and Clavulanate Potassium
    Dosage: unk
    End date: 2010-10-14

Ambisome
    Dosage: 3 mg/kg, unk
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2010-09-28
    End date: 2010-10-25

Rifater
    Dosage: unk
    Administration route: Oral
    Indication: Tuberculosis
    End date: 2010-10-02



Possible Rifater side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-03

Patient: 74 year old male, weighing 47.0 kg (103.4 pounds)

Reactions: Hyperbilirubinaemia, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vfend
    Dosage: 200 mg, 2x/day
    Indication: Aspergillosis
    Start date: 2011-07-02

Rifater
    Dosage: 4 tablets once daily
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2011-06-26
    End date: 2011-07-05



Possible Rifater side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-30

Patient: 54 year old male

Reactions: Periarthritis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Rifampin and Isoniazid
    Dosage: dose:3 unit(s)
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2011-06-06

Rifater
    Dosage: dose:6 unit(s)
    Administration route: Oral
    Indication: Pulmonary Tuberculosis
    Start date: 2011-04-06
    End date: 2011-06-06

Other drugs received by patient: Myambutol



Possible Rifater side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-25

Patient: 74 year old male

Reactions: Hyperbilirubinaemia, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater
    Dosage: 4 tablets once daily
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2011-06-26
    End date: 2011-07-05

Vfend
    Dosage: 200 mg, 2x/day
    Indication: Aspergillosis
    Start date: 2011-07-02



Possible Rifater side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-04

Patient: 68 year old female

Reactions: Pruritus, Rectal Haemorrhage, Cytolytic Hepatitis, Ischaemic Stroke, Pulmonary Embolism, Prothrombin Time Prolonged, Drug Rash With Eosinophilia and Systemic Symptoms, Haematemesis, Eosinophilia, Cholelithiasis, Haemoglobin Decreased, Face Oedema, Renal Failure, Skin Lesion, Cytomegalovirus Infection, Lipase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Myambutol
    Administration route: Oral
    Start date: 2010-11-20
    End date: 2011-01-02

Myambutol
    Administration route: Oral
    Start date: 2011-01-02
    End date: 2011-01-14

Rifater
    Administration route: Oral
    Start date: 2010-11-20
    End date: 2011-01-02

Other drugs received by patient: Colchicine; Allopurinol; Rocephin; Omeprazole; Amiloride HCL and Hydrochlorothiazide; Flagyl; Effexor



Possible Rifater side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-18

Patient: 69 year old male

Reactions: Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rifater



Possible Rifater side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-10

Patient: 48 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Jaundice, Vomiting, Cytolytic Hepatitis, Rash, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Oral Candidiasis, Oral Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Allopurinol
    Dosage: dose:1 unit(s)
    Administration route: Oral
    Start date: 2011-05-20
    End date: 2011-07-04

Rifater
    Dosage: dose:6 unit(s)
    Administration route: Oral
    Indication: Tuberculous Pleurisy
    Start date: 2011-05-20
    End date: 2011-07-04

Myambutol
    Dosage: dose:4 unit(s)
    Administration route: Oral
    Indication: Tuberculous Pleurisy
    Start date: 2011-05-20
    End date: 2011-07-04

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