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Review Solifenacin Safety Reports submitted to FDA

Total Solifenacin reports: 4.
Solifenacin FDA safety alerts: No.
   Reported hospitalizations: 1.
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FDA Reported Solifenacin Side Effects: nephritis interstitial, constipation, rash.
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Solifenacin Side Effects Report #5616169-7
Health Professional from UNITED KINGDOM reported SOLIFENACIN problem on Jan 25, 2008. Female patient, 61 years of age, weighting 130.1 lb, was diagnosed with incontinence and was treated with SOLIFENACIN. After drug was administered, patient experienced the following problems/side effects: dysarthria, headache, mental impairment, micturition disorder. SOLIFENACIN dosage: 5 MG, UID/QD, ORAL. During the same period patient was treated with ADCAL, SALAMOL, SERETIDE. Patient recovered.

Solifenacin Side Effects Report #5635866-0
SOLIFENACIN problem was reported by a Health Professional from UNITED KINGDOM on Feb 14, 2008. Male patient, 94 years of age, was treated with SOLIFENACIN. After drug was administered, patient experienced the following problems/side effects: gastrointestinal haemorrhage. SOLIFENACIN dosage: 5 MG, UID/QD, ORAL. During the same period patient was treated with ASPIRIN, ADCAL, AMLODIPINE, CANDESARTAN CILEXETIL, ACETAMINOPHEN. Patient recovered.

Solifenacin Side Effects Report #5487329-3
Health Professional from UNITED KINGDOM reported SOLIFENACIN problem on Oct 01, 2007. Female patient, 64 years of age, was diagnosed with urinary incontinence and was treated with SOLIFENACIN. After drug was administered, patient experienced the following problems/side effects: haemorrhage urinary tract. SOLIFENACIN dosage: 5 MG, UID/QD, ORAL. Patient was hospitalized. Patient recovered.

Solifenacin Side Effects Report #5427698-3
SOLIFENACIN problem was reported by a Health Professional from NETHERLANDS on Aug 14, 2007. Female patient, 76 years of age, was treated with SOLIFENACIN. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial. SOLIFENACIN dosage: 5 MG, UID/QD, ORAL. During the same period patient was treated with DICLOFENAC. Patient recovered.


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