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Nystatin Safety Reports submitted to FDA

Total Nystatin reports: 9.
Nystatin FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 2.
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Reported Nystatin Side Effects: swelling face, viral infection, sepsis, hypersomnia, diarrhoea, device breakage, oesophagitis, convulsion, condition aggravated, vomiting, pathogen resistance.
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Nystatin Side Effects Report #5249259-1
Consumer or non-health professional from UNITED KINGDOM reported NYSTATIN problem on Feb 08, 2007. Male patient, 81 years of age, weighting 154.3 lb, was diagnosed with oral candidiasis, alpha haemolytic streptococcal infection and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: neutropenia. NYSTATIN dosage: 1 ML, QID, ORAL. During the same period patient was treated with BENZYLPENICILLIN, CLOPIDOGREL, CREON, DONEPEZIL, ESOMEPRAZOLE, QUININE SULPHATE, VENLAFAXINE. Patient was hospitalized. Patient recovered.

Nystatin Side Effects Report #5281934-5
NYSTATIN problem was reported by a Pharmacist from UNITED KINGDOM on Mar 14, 2007. Male patient, child 1 years of age, was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: ageusia. NYSTATIN dosage: unknown. Patient recovered.

Nystatin Side Effects Report #5078500-3
Consumer or non-health professional from UNITED STATES reported NYSTATIN problem on July 24, 2006. Female patient, 38 years of age, weighting 101.0 lb, was diagnosed with gastrointestinal candidiasis and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: dry eye, erythema, eye pain, glossodynia, headache, oral mucosal disorder, swelling face, vision blurred. NYSTATIN dosage: unknown. During the same period patient was treated with VITAMINS. Patient recovered.

Nystatin Side Effects Report #5103612-5
NYSTATIN problem was reported by a Health Professional from UNITED STATES on Sept 11, 2006. Female patient, 90 years of age, weighting 120.0 lb, was diagnosed with oral candidiasis and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: rash maculo-papular, rash pruritic. NYSTATIN dosage: unknown. Patient recovered.

Nystatin Side Effects Report #5107387-5
Consumer or non-health professional from UNITED STATES reported NYSTATIN problem on Aug 25, 2006. Female patient was diagnosed with oral candidiasis and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: feeding disorder neonatal, oral candidiasis, pathogen resistance, vomiting. NYSTATIN dosage: unknown. Patient died.

Nystatin Side Effects Report #5128985-9
NYSTATIN problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 27, 2006. Male patient, 55 years of age, was diagnosed with genital infection fungal and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, convulsion. NYSTATIN dosage: unknown. During the same period patient was treated with PHENOBARBITAL. Patient recovered.

Nystatin Side Effects Report #5131518-4
Health Professional from NETHERLANDS reported NYSTATIN problem on Oct 16, 2006. Male patient was diagnosed with colorectal cancer and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: oesophagitis. NYSTATIN dosage: unknown. During the same period patient was treated with PANTOPRAZOLE, DEXAMETHASONE, MS CONTIN, CETUXIMAB, BEVACIZUMAB, CAPECITABINE, OXALIPLATIN. Patient was hospitalized. Patient recovered.

Nystatin Side Effects Report #5142290-6
NYSTATIN problem was reported by a Pharmacist from UNITED STATES on Oct 11, 2006. Male patient, weighting 11.00 lb, was diagnosed with candidiasis and was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: device breakage, diarrhoea, hypersomnia, sepsis, viral infection. NYSTATIN dosage: 2ML, ORALLY/6 HOURS; 2 DOSES. Patient recovered.

Nystatin Side Effects Report #5417879-7
Consumer or non-health professional from UNITED KINGDOM reported NYSTATIN problem on Aug 06, 2007. Male patient, 77 years of age, was treated with NYSTATIN. After drug was administered, patient experienced the following problems/side effects: swelling face. NYSTATIN dosage: unknown. Patient recovered.


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neutropenia ageusia dry eye, erythema, eye pain, glossodynia, headache, oral mucosal disorder, swelling face, vision blurred, was diagnosed with oral candidiasis, alpha haemolytic streptococcal infection and was diagnosed with gastrointestinal candidiasis and