Fatigued
 11
 5
 
Infections and Infestations 
 
 
 
Nasopharyngitis
 4
 4
 
Upper Respiratory Tract Infection
 3
 3
 
Influenza
 2
 0
 
Metabolism and Nutrition Disorders
 
Decreased Appetiteb
 8
 1
 
Musculoskeletal and Connective Tissue

Musculoskeletal Paine
 3
 3
 
Muscle Spasms
 2
 2
 
Nervous System Disorders  

Headache 
 13
 8
 
Somnolenceb,f 
 11
 3
 
Dizziness
 9
 5
 
Paraesthesiag
 2
 2
 
Tremorb
 2
 <1
 
Psychiatric Disorders

Insomniab,h 
 10
 5
 
Agitationi
 3
 1
 
Reproductive System and Breast Disorders

Erectile dysfunctionb
 4
 <1
 
Ejaculation Disorderj
 2
 <1
 
Respiratory, Thoracic, and Mediastinal Disorders
 
Cough
 2
 2
 
Skin and Subcutaneous Tissue Disorders
 
Hyperhidrosis
 6
 1
 
Vascular Disorders

 
Flushingk
 3
 1
 
Blood pressure increasedl 
 2
 1
 
6.6 Effects on Male and Female Sexual Function in Adults
 
Changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetes, but they may also be a consequence of pharmacologic treatment. Because adverse sexual reactions are presumed to be voluntarily underreported, the Arizona Sexual Experience Scale (ASEX), a validated measure designed to identify sexual side effects, was used prospectively in 4 MDD placebo-controlled trials. In these trials, as shown in Table 5 below, patients treated with duloxetine experienced significantly more sexual dysfunction, as measured by the total score on the ASEX, than did patients treated with placebo. Gender analysis showed that this difference occurred only in males. Males treated with duloxetine experienced more difficulty with ability to reach orgasm (ASEX Item 4) than males treated with placebo. Females did not experience more sexual dysfunction on duloxetine than on placebo as measured by ASEX total score. Negative numbers signify an improvement from a baseline level of dysfunction, which is commonly seen in depressed patients. Physicians should routinely inquire about possible sexual side effects.

Table 5: Mean Change in ASEX Scores by Gender in MDDPlacebo-Controlled Trials

a n=Number of patients with non-missing change score for ASEX total

b p=0.013 versus placebo

c p<0.001 ve