Table 1:
Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA
in Acute (up to 9 weeks) Child and Adolescent Trials
|
| Adverse Event
(1) |
Percentage of
Patients Reporting Events from BID Trials |
|
STRATTERA
(N=340) |
Placebo
(N=207) |
| Gastrointestinal
Disorders |
|
|
| Abdominal pain upper
|
20 |
16 |
| Constipation |
3 |
1 |
| Dyspepsia |
4 |
2 |
| Vomiting |
11 |
9 |
| Infections |
|
|
| Ear infection |
3 |
1 |
| Influenza |
3 |
1 |
| Investigations
|
|
|
| Weight decreased |
2 |
0 |
| Metabolism and Nutritional
Disorders |
|
|
| Appetite decreased |
14 |
6 |
| Nervous System
Disorders |
|
|
| Dizziness (exc vertigo)
|
6 |
3 |
| Headache |
27 |
25 |
| Somnolence |
7 |
5 |
| Psychiatric
Disorders |
|
|
| Crying |
2 |
1 |
| Irritability |
8 |
5 |
| Mood swings |
2 |
0 |
| Respiratory, Thoracic, and
Mediastinal Disorders |
|
|
| Cough |
11 |
7 |
| Rhinorrhea |
4 |
3 |
| Skin and Subcutaneous
Tissue Disorders |
|
|
| Dermatitis |
4 |
1 |
| 1 Events reported by at least 2% of patients treated with
atomoxetine, and greater than placebo. The following events did not meet this
criterion but were reported by more atomoxetine-treated patients than
placebo-treated patients and are possibly related to atomoxetine treatment:
anorexia, blood pressure increased, early morning awakening, flushing,
mydriasis, sinus tachycardia, tearfulness. The following events were reported
by at least 2% of patients treated with atomoxetine, and equal to or less than
placebo: arthralgia, gastroenteritis viral, insomnia, sore throat, nasal
congestion, nasopharyngitis, pruritus, sinus congestion, upper respiratory
tract infection. |
Table 2:
Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA
in Acute (up to 9 weeks) Child and Adolescent Trials
|
| Adverse Event
|
Percentage of
Patients Reporting Events from BID Trials |
Percentage of
Patients Reporting Events from QD Trials |
|
STRATTERA Placebo
(N=340) |
Placebo
(N=207) |
STRATTERA Placebo
(N=85) |
Placebo
(N=85) |
| Gastrointestinal
Disorders |
|
|
|
|
| Abdominal pain upper
|
20 |
16 |
16 |
9 |
| Constipation |
3 |
1 |
0 |
0 |
| Diarrhea |
3 |
6 |
4 |
1 |
| Dry mouth |
1 |
2 |
4 |
1 |
| Dyspepsia |
4 |
2 |
8 |
0 |
| Nausea |
7 |
8 |
12 |
2 |
| Vomiting |
11 |
9 |
15 |
1 |
| General
Disorders |
|
|
| Fatigue |
4 |
5 |
9 |
1 |
| Psychiatric
Disorders |
|
|
| Mood swings |
2 |
0 |
5 |
2 |
Table 3:
Common Treatment-Emergent Adverse Events Associated with the Use of STRATTERA
in Acute (up to 10 weeks) Adult Trials
|
| Adverse Event
(1) |
Percentage of
Patients Reporting Event |
| System Organ Class/Adverse
Event |
STRATTERA
(N=269) |
Placebo
(N=263) |
| Cardiac
Disorders |
|
|
| Palpitations |
4 |
1 |
| Gastrointestinal
Disorders |
|
|
| Constipation |
10 |
4 |
| Dry mouth |
21 |
6 |
| Dyspepsia |
6 |
4 |
| Flatulence |
2 |
1 |
| Nausea |
12 |
5 |
| General Disorders and
Administration Site Conditions |
|
|
| Fatigue and/or lethargy
|
7 |
4 |
| Pyrexia |
3 |
2 |
| Rigors |
3 |
1 |
| Infections |
|
|
| Sinusitis |
6 |
4 |
| Investigations
|
|
|
| Weight decreased |
2 |
1 |
| Metabolism and Nutritional
Disorders |
|
|
| Appetite decreased |
10 |
3 |
| Musculoskeletal, Connective
Tissue, and Bone Disorders |
|
|
| Myalgia |
3 |
2 |
| Nervous System
Disorders |
|
|
| Dizziness |
6 |
2 |
| Headache |
17 |
17 |
| Insomnia and/or middle
insomnia |
16 |
8 |
| Paraesthesia |
4 |
2 |
| Sinus headache |
3 |
1 |
| Psychiatric
Disorders |
|
|
| Abnormal dreams |
4 |
3 |
| Libido decreased |
6 |
2 |
| Sleep disorder |
4 |
2 |
| Renal and Urinary
Disorders |
|
|
| Urinary hesitation and/or
urinary retention and/or difficulty in micturition |
8 |
0 |
| Reproductive System and
Breast Disorders |
|
|
| Dysmenorrhoea (3) |
7 |
3 |
| Ejaculation failure (2) and/or
ejaculation disorder (2) |
5 |
2 |
| Erectile disturbance
(2) |
7 |
1 |
| Impotence (2) |
3 |
0 |
| Menses delayed (3) |
2 |
1 |
| Menstrual disorder (3)
|
3 |
2 |
| Menstruation irregular
(3) |
2 |
0 |
| Orgasm abnormal |
2 |
1 |
| Prostatitis (2) |
3 |
0 |
| Skin and Subcutaneous
Tissue Disorders |
|
|
| Dermatitis |
2 |
1 |
| Sweating increased |
4 |
1 |
| Vascular
Disorders |
|
|
| Hot flushes |
3 |
1 |
1 Events reported by at least 2% of patients treated with
atomoxetine, and greater than placebo. The following events did not meet this
criterion but were reported by more atomoxetine-treated patients than
placebo-treated patients and are possibly related to atomoxetine treatment:
early morning awakening, peripheral coldness, tachycardia. The following events
were reported by at least 2% of patients treated with atomoxetine, and equal to
or less than placebo: abdominal pain upper, arthralgia, back pain, cough,
diarrhea, influenza, irritability, nasopharyngitis, sore throat, upper
respiratory tract infection, vomiting.
2 Based on total number of males (STRATTERA, n=174; placebo, n=172).
3 Based on total number of females (STRATTERA, n=95; placebo, n=91).
|
| |
Table 4. |
| |
STRATTERA |
Placebo |
| Erectile disturbance (1) |
7% |
1% |
| Impotence (1) |
3% |
0% |
| Orgasm abnormal |
2% |
1% |
| (1) Males
only |
|