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Mycobutin (Rifabutin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mycobutin (Rifabutin) 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 (27)
Death (5)
Disability (3)

Reports by Reaction Type

Pyrexia (7)Mycobacterium Avium Complex Infection (5)Cytomegalovirus Chorioretinitis (5)Immune Reconstitution Syndrome (4)Headache (4)Bone Marrow Disorder (4)Thrombocytopenia (4)Visual Impairment (4)Leukopenia (4)Drug Eruption (3)Malaise (3)Completed Suicide (3)

Possible Mycobutin side effects in 35 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 35 year old male

Reactions: Renal Impairment, Cytomegalovirus Chorioretinitis, Hypoaesthesia, Mycobacterium Avium Complex Infection, Hyperuricaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Chorioretinitis
    Start date: 2010-05-19
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2011-01-20

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2011-03-31

Mycobutin
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2009-11-20
    End date: 2009-12-11

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03
    End date: 2011-03-31

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Infection
    Start date: 2010-01-06
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2010-02-16
    End date: 2010-03-24

Other drugs received by patient: Isentress; Pentamidine Isethionate; Intelence; Semen Coicis; Clindamycin Phosphate; Chlorhexidine Gluconate



Possible Mycobutin side effects in 36 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-23

Patient: 36 year old male

Reactions: Overwork, Psychotic Disorder, Completed Suicide, Insomnia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 750 mg, 1x/day
    Indication: Crohn's Disease

Mycobutin
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Indication: Crohn's Disease



Possible Mycobutin side effects in male

Reported by a consumer/non-health professional from Switzerland on 2012-06-18

Patient: male

Reactions: Mania, Confusional State, Off Label Use, Fatigue, Psychotic Disorder, Completed Suicide

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 750 milligram; strength: 250 mg
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2010-12-01
    End date: 2012-01-30

Mycobutin
    Dosage: 300 milligram;
    Indication: Crohn's Disease
    Start date: 2010-12-01
    End date: 2012-01-30



Possible Mycobutin side effects in 35 year old male

Reported by a physician from Japan on 2012-06-12

Patient: 35 year old male

Reactions: Immune Reconstitution Syndrome, Cytomegalovirus Chorioretinitis, Visual Impairment, Mycobacterium Avium Complex Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Test Positive
    Start date: 2009-11-20
    End date: 2009-12-11

Emtricitabine / Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Darunavir Ethanolate
    Dosage: 800 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03

Atazanavir
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Norvir
    Dosage: 100 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22

Other drugs received by patient: Pentamidine Isethionate; Coix Seed; Clindamycin Phosphate; Intelence; Maskin; Isentress; Vitamin B12



Possible Mycobutin side effects in 73 year old female

Reported by a physician from Japan on 2012-05-31

Patient: 73 year old female, weighing 57.0 kg (125.4 pounds)

Reactions: Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Indication: Tuberculosis
    Start date: 2012-03-16
    End date: 2012-04-06

Mycobutin
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Start date: 2012-04-07

Other drugs received by patient: Levofloxacin; Pyrazinamide; Ethambutol Hydrochloride



Possible Mycobutin side effects in 36 year old male

Reported by a consumer/non-health professional from Germany on 2012-05-30

Patient: 36 year old male

Reactions: Psychotic Disorder, Completed Suicide

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mycobutin
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Indication: Crohn's Disease

Clarithromycin
    Dosage: 750 mg, 1x/day
    Indication: Crohn's Disease



Possible Mycobutin side effects in 14 year old male

Reported by a physician from Germany on 2012-05-11

Patient: 14 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Bone Marrow Disorder, Headache, Pyrexia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: male

Reactions: Weight Decreased, Abdominal Discomfort, Diarrhoea, Appetite Disorder

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in 56 year old female

Reported by a pharmacist from Taiwan, Province of China on 2012-05-03

Patient: 56 year old female

Reactions: Skin Discolouration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin

Other drugs received by patient: Benzbromarone; Isoniazid; Silymarin; Pyrazinamide



Possible Mycobutin side effects in 14 year old male

Reported by a physician from Germany on 2012-04-27

Patient: 14 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Bone Marrow Disorder, Pyrexia, Headache, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin

Other drugs received by patient: Pantoprazole; Amoxicillin



Possible Mycobutin side effects in 14 year old male

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

Patient: 14 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Bone Marrow Disorder, Headache, Pyrexia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in 56 year old female

Reported by a pharmacist from Taiwan, Province of China on 2012-04-24

Patient: 56 year old female

Reactions: Pigmentation Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin

Other drugs received by patient: Isoniazid; Silymarin; Pyrazinamide; Benzbromarone



Possible Mycobutin side effects in 56 year old female

Reported by a pharmacist from Taiwan, Province of China on 2012-04-18

Patient: 56 year old female

Reactions: Pigmentation Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin

Other drugs received by patient: Benzbromarone; Pyrazinamide; Silymarin; Isoniazid



Possible Mycobutin side effects in 73 year old female

Reported by a physician from Japan on 2012-04-18

Patient: 73 year old female

Reactions: Bone Marrow Failure

Drug(s) suspected as cause:
Mycobutin
    Dosage: 100 mg/day
    Start date: 2012-04-07

Mycobutin
    Dosage: 150 mg/day
    Indication: Lymph Node Tuberculosis
    Start date: 2012-03-16
    End date: 2012-04-06

Other drugs received by patient: Ethambutol Hydrochloride; Levofloxacin; Pyrazinamide



Possible Mycobutin side effects in female

Reported by a individual with unspecified qualification from United States on 2012-04-11

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Pain in Extremity, Arthralgia, Yellow Skin, Balance Disorder, Chromaturia, Asthenia

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in 73 year old female

Reported by a physician from Japan on 2012-04-11

Patient: 73 year old female

Reactions: Bone Marrow Failure

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-30

Patient: male

Reactions: Weight Decreased, Abdominal Discomfort, Diarrhoea, Appetite Disorder

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in 35 year old male

Reported by a physician from Japan on 2012-03-26

Patient: 35 year old male

Reactions: Immune Reconstitution Syndrome, Cytomegalovirus Chorioretinitis, Visual Impairment, Mycobacterium Avium Complex Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Darunavir Ethanolate
    Dosage: 800 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03

Atazanavir Sulfate
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Mycobutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Test Positive
    Start date: 2009-11-20
    End date: 2009-12-11

Norvir
    Dosage: 100 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Emtricitabine / Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Other drugs received by patient: Isentress; Clindamycin Phosphate; Maskin; Intelence; Coix Seed; Pentamidine Isethionate; Methycobal



Possible Mycobutin side effects in 35 year old male

Reported by a physician from Japan on 2012-03-01

Patient: 35 year old male

Reactions: Immune Reconstitution Syndrome, Cytomegalovirus Chorioretinitis, Visual Impairment, Mycobacterium Avium Complex Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emtricitabine / Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Atazanavir Sulfate
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Darunavir Ethanolate
    Dosage: 800 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03

Norvir
    Dosage: 100 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22

Mycobutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Test Positive
    Start date: 2009-11-20
    End date: 2009-12-11

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Other drugs received by patient: Clindamycin Phosphate; Isentress; Intelence; Coix Seed; Methycobal; Pentamidine Isethionate; Maskin



Possible Mycobutin side effects in 35 year old male

Reported by a physician from Japan on 2012-01-06

Patient: 35 year old male

Reactions: Immune Reconstitution Syndrome, Cytomegalovirus Chorioretinitis, Visual Impairment, Mycobacterium Avium Complex Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Test Positive
    Start date: 2009-11-20
    End date: 2009-12-11

Darunavir Ethanolate
    Dosage: 800 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03

Atazanavir Sulfate
    Dosage: 300 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Norvir
    Dosage: 100 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Emtricitabine / Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Other drugs received by patient: Coix Seed; Pentamidine Isethionate; Clindamycin Phosphate; Isentress; Intelence; Maskin; Methycobal



Possible Mycobutin side effects in male

Reported by a physician from Japan on 2012-01-04

Patient: male

Reactions: Drug Eruption, Malaise, Pyrexia

Drug(s) suspected as cause:
Clarithromycin
    Start date: 2009-02-21
    End date: 2009-02-23

Mycobutin
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-09
    End date: 2009-02-23

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-09
    End date: 2009-02-20

Other drugs received by patient: Ethambutol Hydrochloride



Possible Mycobutin side effects in 14 year old male

Reported by a physician from Germany on 2011-12-14

Patient: 14 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Bone Marrow Disorder, Headache, Pyrexia, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycobutin



Possible Mycobutin side effects in 91 year old female

Reported by a physician from Japan on 2011-11-23

Patient: 91 year old female, weighing 38.0 kg (83.6 pounds)

Reactions: Glaucoma, Pigmentation Disorder, Uveitis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Mycobutin
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-07-09
    End date: 2010-01-01

Clarithromycin
    Dosage: 400 mg, 2x/day
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-16
    End date: 2010-01-01



Possible Mycobutin side effects in 72 year old female

Reported by a physician from Japan on 2011-11-22

Patient: 72 year old female, weighing 34.0 kg (74.8 pounds)

Reactions: Atypical Mycobacterial Infection, Uveitis

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Mycobutin
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-07-10
    End date: 2010-02-10

Clarithromycin
    Dosage: 400 mg, 2x/day
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2007-10-17
    End date: 2010-04-01



Possible Mycobutin side effects in male

Reported by a physician from Japan on 2011-11-11

Patient: male

Reactions: Drug Eruption, Malaise, Pyrexia

Drug(s) suspected as cause:
Clarithromycin
    Start date: 2009-02-21
    End date: 2009-02-23

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-09
    End date: 2009-02-20

Mycobutin
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-09
    End date: 2009-02-23

Other drugs received by patient: Ethambutol Hydrochloride



Possible Mycobutin side effects in male

Reported by a physician from Japan on 2011-10-25

Patient: male

Reactions: Drug Eruption, Malaise, Pyrexia

Drug(s) suspected as cause:
Clarithromycin
    Start date: 2009-02-21
    End date: 2009-02-23

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-09
    End date: 2009-02-20

Mycobutin
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-02-09
    End date: 2009-02-23

Other drugs received by patient: Ethambutol Hydrochloride



Possible Mycobutin side effects in 72 year old female

Reported by a physician from Japan on 2011-10-10

Patient: 72 year old female, weighing 34.0 kg (74.8 pounds)

Reactions: Atypical Mycobacterial Infection, Uveitis

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Mycobutin
    Dosage: 150 mg, 1x/day
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2009-07-10
    End date: 2010-02-10

Clarithromycin
    Dosage: 400 mg, 2x/day
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2007-10-17
    End date: 2010-04-01

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