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Review Dapsone Safety Reports submitted to FDA

Total Dapsone reports: 8.
Dapsone FDA safety alerts: No.
   Reported hospitalizations: 7.
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FDA Reported Dapsone Side Effects: methaemoglobinaemia, oxygen saturation decreased, blood methaemoglobin present, anaemia, impaired self-care, haemolysis, haemoglobin decreased, dehydration, pyrexia, dyspnoea, diarrhoea.
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Dapsone Side Effects Report #5659516-2
Pharmacist from UNITED STATES reported DAPSONE problem on Mar 07, 2008. Female patient, weighting 104.7 lb, was diagnosed with antifungal prophylaxis and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: fatigue, methaemoglobinaemia. DAPSONE dosage: 50 MG BID PO. Patient recovered.

Dapsone Side Effects Report #5546434-3
DAPSONE problem was reported by a Pharmacist from UNITED STATES on Dec 06, 2007. Male patient, 45 years of age, weighting 141.5 lb, was diagnosed with antifungal prophylaxis and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: methaemoglobinaemia. DAPSONE dosage: 100 MG EVERYDAY PO. Patient was hospitalized. Patient recovered.

Dapsone Side Effects Report #5486902-6
Pharmacist from UNITED STATES reported DAPSONE problem on Oct 12, 2007. Male patient, 42 years of age, was diagnosed with antifungal prophylaxis and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: blood methaemoglobin present, cough, dizziness, dyspnoea, fatigue, oxygen saturation decreased. DAPSONE dosage: 100MG DAILY PO. Patient was hospitalized. Patient recovered.

Dapsone Side Effects Report #5494682-3
DAPSONE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 23, 2007. Female patient, 41 years of age, weighting 138.0 lb, was diagnosed with urticaria and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dyspnoea, incorrect dose administered, pharyngolaryngeal pain, skin discolouration, urticaria. DAPSONE dosage: 50 MG. TWICE DAILY PO. Patient was hospitalized. Patient recovered.

Dapsone Side Effects Report #5419390-6
Health Professional from UNITED STATES reported DAPSONE problem on Aug 16, 2007. Male patient, 41 years of age, weighting 153.2 lb, was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: no therapeutic response, stevens-johnson syndrome, toxic epidermal necrolysis. DAPSONE dosage: unknown. During the same period patient was treated with LEXAPRO. Patient was hospitalized. Patient recovered.

Dapsone Side Effects Report #5427049-4
DAPSONE problem was reported by a Pharmacist from UNITED STATES on Aug 24, 2007. Female patient, 53 years of age, weighting 105.8 lb, was diagnosed with antifungal prophylaxis and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: back pain, blood methaemoglobin present, dyspnoea, dyspnoea exertional, malaise, oxygen saturation decreased. DAPSONE dosage: 100MG PO QD. During the same period patient was treated with PROGRAF, PREDNISONE, CIPRO, ZOLOFT, NORVASC, NEUPOGEN, ZYRTEC. Patient was hospitalized. Patient recovered.

Dapsone Side Effects Report #5398938-4
Pharmacist from UNITED STATES reported DAPSONE problem on July 24, 2007. Male patient, 43 years of age, was diagnosed with antifungal prophylaxis and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal disorder, haemolytic anaemia, infection, methaemoglobinaemia. DAPSONE dosage: 100MG DAILY PO. Patient was hospitalized. Patient recovered.

Dapsone Side Effects Report #5398938-4
DAPSONE problem was reported by a Pharmacist from UNITED STATES on July 24, 2007. Male patient, 43 years of age, was diagnosed with antifungal prophylaxis and was treated with DAPSONE. After drug was administered, patient experienced the following problems/side effects: gastrointestinal disorder, haemolytic anaemia, infection, methaemoglobinaemia. DAPSONE dosage: 100MG DAILY PO. Patient was hospitalized. Patient recovered.


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