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In the multi-centerdouble-blindcontrolled clinical trial comparing Casodex 50 mg once daily with flutamide 250 mg three times a dayeach in combination with an LHRH analogthe following adverse reactions with an incidence of 5or greaterregardless of causalityhave been reported.

Other adverse reactionsgreater than or equal to 2but less than 5reported in the Casodex-LHRH analog treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality.

In a periand post-natal development studyfemale rats were dosed from gestation day 16 to lactation day 22 and allowed to litter and rear their offspring to weaningSurvival and weights of offspring during lactation were reduced for litters from maternal rats receiving doses of 250 mg/kg/dayapproximately 2 times the human exposure at the recommended doseMale offspring of rats receiving doses of 10 mg/kg/dayapproximately 0.7 times the human exposure at the recommended doseand abovewere observed to have reduced anogenital distancesmaller secondary sex organscryptorchidism and hypospadias resulting in an inability to mate and impregnate their female partnersFemale offspring of rats receiving doses of 10 mg/kg/dayapproximately 0.7 times the human exposure at the recommended doseand above had reduced pregnancy rates.

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