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Review Daktarin Safety Reports submitted to FDA

Total Daktarin reports: 7.
Daktarin FDA safety alerts: No.
   Reported hospitalizations: 5.
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FDA Reported Daktarin Side Effects: dyspnoea, international normalised ratio increased, haematuria, haematoma, oedema mouth, foaming at mouth, ventricular extrasystoles, intraventricular haemorrhage, hypocalcaemia, hyperkalaemia, electroencephalogram abnormal.
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Daktarin Side Effects Report #5597413-1
Physician from UNITED KINGDOM reported DAKTARIN problem on Jan 08, 2008. Female patient, weighting 162.5 lb, was diagnosed with oral candidiasis, thrombosis, polycythaemia, diabetes mellitus and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: blood urine present, computerised tomogram abnormal, haemorrhage, international normalised ratio increased. DAKTARIN dosage: unknown. During the same period patient was treated with WARFARIN, LANSOPRAZOLE, METFORMIN, REPAGLINIDE. Patient was hospitalized. Patient recovered.

Daktarin Side Effects Report #5598453-9
DAKTARIN problem was reported by a Health Professional from FRANCE on Jan 14, 2008. Female patient, 92 years of age, was diagnosed with fungal infection and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: haematoma. DAKTARIN dosage: unknown. During the same period patient was treated with PREVISCAN, TRIATEC, CORDARONE, TIAPRIDAL, TRANXENE, ARICEPT, NEULEPTIL. Patient was hospitalized. Patient recovered.

Daktarin Side Effects Report #5600877-8
Physician from NETHERLANDS reported DAKTARIN problem on Jan 16, 2008. Male patient, weighting 154.3 lb, was diagnosed with oral candidiasis and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: dermatomyositis. DAKTARIN dosage: unknown. During the same period patient was treated with TRISPORAL, FLAGYL. Patient was hospitalized. Patient recovered.

Daktarin Side Effects Report #5525464-1
DAKTARIN problem was reported by a Consumer or non-health professional from NETHERLANDS on Nov 15, 2007. Female patient, weighting 7.94 lb, was diagnosed with oral candidiasis and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: somnolence. DAKTARIN dosage: unknown. Patient recovered.

Daktarin Side Effects Report #5490796-2
Consumer or non-health professional from BRAZIL reported DAKTARIN problem on Oct 11, 2007. Female patient, child 3 years of age, was diagnosed with accidental exposure and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: accidental exposure, vomiting. DAKTARIN dosage: unknown. Patient recovered.

Daktarin Side Effects Report #5383892-1
DAKTARIN problem was reported by a Consumer or non-health professional from BRAZIL on July 02, 2007. Male patient, weighting 8.82 lb, was diagnosed with oral candidiasis and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: foaming at mouth. DAKTARIN dosage: unknown. During the same period patient was treated with DAKTARIN GEL. Patient recovered.

Daktarin Side Effects Report #5383892-1
Consumer or non-health professional from BRAZIL reported DAKTARIN problem on July 02, 2007. Male patient, weighting 8.82 lb, was diagnosed with oral candidiasis and was treated with DAKTARIN. After drug was administered, patient experienced the following problems/side effects: foaming at mouth. DAKTARIN dosage: unknown. During the same period patient was treated with DAKTARIN GEL. Patient recovered.


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blood urine present, computerised tomogram abnormal, haemorrhage, international normalised ratio increased, , was diagnosed with oral candidiasis, thrombosis, polycythaemia, diabetes mellitus and was diagnosed with fungal infection and