Table 2: Treatment-Emergent Adverse Reactions: Incidence of 5% or More and Greater than Placebo in Placebo-Controlled Trials of Approved Indicationsa

aThe 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 Also includes asthenia.

c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.

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

e Also includes hypersomnia and sedation.

f Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and gastrointestinal pain.

 Percentage of Patients Reporting Reaction
 
Adverse Reaction
 Duloxetine
(N=8100)
 Placebo
(N=5655)
 
  Nauseac 
 23
 8
 
  Headache
 14
 12
 
  Dry mouth
 13
 5
 
  Somnolencee
 10
 3
 
  Fatigueb,c 
 9
 5
 
  Insomniad
 9
 5
 
  Constipationc
 9
 4
 
  Dizzinessc
 9
 5
 
  Diarrhea
 9
 6
 
  Decreased appetitec
 7
 2
 
  Hyperhidrosisc
 6
 1
 
  Abdominal painf
 5
 4
6.5 Adverse Reactions Occurring at an Incidence of 2% or More Among Duloxetine-Treated Patients in Adult Placebo-Controlled Trials
 
Pooled MDD and GAD Trials — Table 3 gives the incidence of treatment-emergent adverse reactions in MDD and GAD placebo-controlled trials for approved indications that occurred in 2% or more of patients treated with duloxetine and with an incidence greater than placebo.
 

Table 3: Treatment-Emergent Adverse Reactions: Incidence of 2% or More and Greater than Placebo in MDD and GAD Placebo-Controlled Trialsa,b

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.

bFor GAD, there were no adverse events that were significantly different between treatments in adults ≥65 years that were also not significant in the adults <65 years.

cEvents for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.

dAlso includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain

e Also includes asthenia

f Also includes hypersomnia and sedation

g Also includes initial insomnia, middle insomnia, and early morning awakening

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

i Also includes loss of libido
j Also includes anorgasmia

System Organ Class / Adverse Reaction
 Percentage of Patients Reporting Reaction

 Duloxetine 
(N=4797)
 Placebo
(N