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Review Norset Safety Reports submitted to FDA

Total Norset reports: 2.
Norset FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Norset Side Effects: pyrexia, gastrointestinal pain, dysphagia, dermatitis bullous, stevens-johnson syndrome.
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Norset Side Effects Report #5422155-2
Health Professional from FRANCE reported NORSET problem on Aug 17, 2007. Male patient, 57 years of age, was diagnosed with ill-defined disorder and was treated with NORSET. After drug was administered, patient experienced the following problems/side effects: dysphagia, gastrointestinal pain, pyrexia, stevens-johnson syndrome. NORSET dosage: unknown. During the same period patient was treated with COVERSYL, SERESTA, TEGRETOL, MEDIATENSYL, CELECTOL, ORDIK, KARDEGIC. Patient was hospitalized. Patient recovered.

Norset Side Effects Report #5430587-1
NORSET problem was reported by a Health Professional from FRANCE on Aug 17, 2007. Male patient, 57 years of age, was diagnosed with ill-defined disorder and was treated with NORSET. After drug was administered, patient experienced the following problems/side effects: dermatitis bullous, dysphagia, gastrointestinal pain, pyrexia. NORSET dosage: unknown. During the same period patient was treated with PERINDOPRIL ERBUMINE, SERESTA, TEGRETOL, MEDIATENSYL, CELECTOL, ORDIK, KARDEGIC. Patient was hospitalized. Patient recovered.


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dysphagia, gastrointestinal pain, pyrexia, stevens-johnson syndrome, dermatitis bullous, dysphagia, gastrointestinal pain, pyrexia, , was diagnosed with ill-defined disorder and was diagnosed with ill-defined disorder and