Table 6 provides the incidence of treatment-emergent adverse reactions in pediatric placebo- controlled trials that occurred in greater than 2% of patients treated with duloxetine and with an incidence greater than placebo.
 

Table 6: Treatment-Emergent Adverse Reactions: Incidence of 2% or More and Greater than Placebo in three 10- week Pediatric Placebo-Controlled Trialsa

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.

bAlso includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain.

cAlso includes asthenia.

dFrequency based on weight measurement meeting potentially clinically significant threshold of ≥3.5% weight loss

(N=467 duloxetine; N=354 Placebo).

eAlso includes hypersomnia and sedation.

fAlso includes initial insomnia, insomnia, middle insomnia, and terminal insomnia.
System Organ Class/Adverse Reaction 
 Percentage of Pediatric Patients Reporting Reaction 
 Duloxetine
(N=476)
 Placebo
(N=362)
 
Gastrointestinal Disorders 
Nausea
 18
 8
 
Abdominal Painb
 13
 10
 
Vomiting
 9
 4
 
Diarrhea
 6
 3
 
Dry Mouth
 2
 1
 
General Disorders and Administration Site Conditions

Fatiguec
 7
 5
 
Investigations
 
 
 
Decreased Weightd
 14
 6
 
Metabilism and Nutrition Disorders
 
Decreased Appetite
 10
 5
 
Nervous System Disorders

Headache
 18
 13
 
Somnolence
 11
 6
 
Dizziness
 8
 4
 
Psychiatric Disorders
 
 
 
Insomniaf
 7
 4
 
Respiratory, Thoracic, and Mediastinal Disorders
 
Oropharyngeal Pain
 4
 2
 
Cough
 3
 1
Other adverse reactions that occurred at an incidence of less than 2% but were reported by more duloxetine treated patients than placebo treated patients and are associated duloxetine treatment: abnormal dreams (including nightmare), anxiety, flushing (including hot flush), hyperhidrosis, palpitations, pulse increased, and tremor.

Discontinuation-emergent symptoms have been reported when stopping duloxetine delayed-release capsules. The most commonly reported symptoms following discontinuation of duloxetine in pediatric clinical trials have included headache, dizziness, insomnia, and abdominal pain [see Warnings and Precautions (5.7) and Adverse Reactions (6.2)].

Growth (Height and Weight) — Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. In studies up to 9 months, duloxetine-treated pediatric patients experienced an increase in height of 1.7 cm on average (2.2 cm i