N = 400
Abnormal Ejaculation
 11
 2
Anorgasmia
     Male
 4
 1
     Female
 5
 0
Impotence
 2
 2
Libido Decreased
     Male
 8
 5
     Female
 4
 2
Sexual Function Abnormal
     Male
 3
 1
     Female
 2
 0
Fluvoxamine treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae and upon discontinuation of fluvoxamine.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, health care providers should routinely inquire about such possible side effects.
6.5 Weight and Vital Sign Changes    
No statistically significant differences in weight gain or loss were found between patients treated with LUVOX CR Capsules or placebo. Comparisons of immediate-release fluvoxamine maleate tablets or LUVOX CR Capsules versus placebo groups in separate short-term trials on (1) median change from baseline on various vital signs variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various measures of vital signs variables revealed no important differences between fluvoxamine maleate and placebo.
6.6 Laboratory Changes    
Comparisons of immediate-release fluvoxamine maleate tablets or LUVOX CR Capsules versus placebo groups in separate short-term trials on (1) median change from baseline on various serum chemistry, hematology, and urinalysis variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various serum chemistry, hematology, and urinalysis variables revealed no important differences between fluvoxamine maleate and placebo.
6.7 ECG Changes    
Comparisons of immediate-release fluvoxamine maleate tablets or LUVOX CR Capsules and placebo groups in separate pools of short-term OCD and depression trials on (1) mean change from baseline on various ECG variables and on (2) incidence of patients meeting criteria for potentially important changes from baseline on various ECG variables revealed no important differences between fluvoxamine maleate and placebo.
6.8 Other Reactions Observed During the Premarketing eva luation of Fluvoxamine    
During premarketing clinical trials conducted in North America and Europe, multiple doses of LUVOX CR Capsules or immediate-release fluvoxamine maleate tablets were administered for a combined total of 3219 patient exposures in patients suffering OCD or other studied disorders. These exposures include 482 patient exposures with LUVOX CR Capsules and 2737 patient exposures with immediate-release fluvoxamine maleate tablets. Untoward reactions associated with this exposure were record