Insomniag
 9
 5
 
Agitationh
 4
 2
 
Anxiety
 3
 2
 
Reproductive System and Breast Disorders 
 
Erectile dysfunction
 4
 1
 
Ejaculation delayedc
 2
 1
 
Libido decreasedi
 3
 1
 
Orgasm abnormalj
 2
 <1
Respiratory, Thoracic, and Mediastinal Disorders 
Yawning
 2
 <1
 
Skin and Subcutaneous Tissue Disorders 
Hyperhidrosis
 6
 2

DPNP, another indication, OA, and CLBP — Table 4 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with duloxetine (determined prior to rounding) in the premarketing acute phase of DPNP, another indication, OA, and CLBP placebo-controlled trials and with an incidence greater than placebo.

Table 4: Treatment-Emergent Adverse Reactions: Incidence of 2% or More and Greater than Placebo in DPNP, Another Indication, OA and CLBP Placebo-Controlled Trialsa

a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.

b Incidence of 120 mg/day is significantly greater than the incidence for 60 mg/day.

c Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness and gastrointestinal pain

d Also includes asthenia

e Also includes myalgia and neck pain

f Also includes hypersomnia and sedation

g Also includes hypoaesthesia, hypoaesthesia facial, genital hypoaesthesia and paraesthesia oral

h Also includes initial insomnia, middle insomnia, and early morning awakening.

iAlso includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity

j Also includes ejaculation failure

k Also includes hot flush

l Also includes blood pressure diastolic increased, blood pressure systolic increased, diastolic hypertension, essential hypertension, hypertension, hypertensive crisis, labile hypertension, orthostatic hypertension, secondary hypertension, and systolic hypertension

System Organ Class / Adverse Reaction
 Percentage of Patients Reporting Reaction
 

 Duloxetine 
(N=3303)
&nb