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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