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Review Rifabutin Safety Reports submitted to FDA

Total Rifabutin reports: 5.
Rifabutin FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Rifabutin Side Effects: vitritis, uveitis, ocular hyperaemia, endophthalmitis, pyrexia, leukopenia, hyponatraemia, asthenia, anorexia.
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Rifabutin Side Effects Report #5665160-3
Health Professional from UNITED KINGDOM reported RIFABUTIN problem on Mar 03, 2008. Female patient, 38 years of age, weighting 90.39 lb, was diagnosed with mycobacterium avium complex infection and was treated with RIFABUTIN. After drug was administered, patient experienced the following problems/side effects: eye pain, iridocyclitis. RIFABUTIN dosage: unknown. During the same period patient was treated with PROLEUKIN, AMIKACIN, CIPROFLOXACIN, CLARITHROMYCIN, KALETRA, ABACAVIR SULPHATE. Patient was hospitalized. Patient recovered.

Rifabutin Side Effects Report #5633564-0
RIFABUTIN problem was reported by a Consumer or non-health professional from NEW ZEALAND on Feb 11, 2008. Male patient, 59 years of age, was diagnosed with mycobacterium avium complex infection and was treated with RIFABUTIN. After drug was administered, patient experienced the following problems/side effects: osteomalacia, pathological fracture, vitamin d deficiency. RIFABUTIN dosage: unknown. During the same period patient was treated with ZIDOVUDINE, LAMIVUDINE, INDINIVIR SULPHATE, RITONAVIR, CIPROFLOXACIN, ETHAMBUTOL HYDROCHLORIDE. Patient recovered.

Rifabutin Side Effects Report #5532476-0
Consumer or non-health professional from GERMANY reported RIFABUTIN problem on Nov 23, 2007. Female patient, 62 years of age, was diagnosed with helicobacter infection and was treated with RIFABUTIN. After drug was administered, patient experienced the following problems/side effects: ageusia, anosmia, decreased activity, diarrhoea, dizziness, headache, herpes simplex, hypoacusis, nausea. RIFABUTIN dosage: unknown. During the same period patient was treated with CLARITHROMYCIN, OMEPRAZOLE. Patient recovered.

Rifabutin Side Effects Report #5526923-8
RIFABUTIN problem was reported by a Consumer or non-health professional from GERMANY on Nov 16, 2007. Female patient, 62 years of age, was diagnosed with helicobacter infection and was treated with RIFABUTIN. After drug was administered, patient experienced the following problems/side effects: ageusia, anosmia, decreased activity, diarrhoea, dizziness, headache, herpes simplex, hypoacusis, nausea. RIFABUTIN dosage: unknown. During the same period patient was treated with CLARITHROMYCIN, OMEPRAZOLE. Patient recovered.

Rifabutin Side Effects Report #5467348-3
Physician from UNITED KINGDOM reported RIFABUTIN problem on Sept 13, 2007. Male patient, weighting 163.1 lb, was diagnosed with mycobacterium avium complex infection, meningitis tuberculous, hiv test, meningitis streptococcal and was treated with RIFABUTIN. After drug was administered, patient experienced the following problems/side effects: endophthalmitis, ocular hyperaemia, uveitis, vitritis. RIFABUTIN dosage: unknown. During the same period patient was treated with FLUCONAZOLE, ABACAVIR SULPHATE, ISONIAZID, LEVETIRACETAM, PYRIDOXINE, PREDNISOLONE. Patient was hospitalized. Patient recovered.


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eye pain, iridocyclitis, osteomalacia, pathological fracture, vitamin d deficiency, ageusia, anosmia, decreased activity, diarrhoea, dizziness, headache, herpes simplex, hypoacusis, nausea, , was diagnosed with mycobacterium avium complex infection and was diagnosed with mycobacterium avium complex infection and