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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