Adverse Events During Clinical Trials
Adverse Reactions: Incidence of ≥2% Among EMSAM®-Treated Patients.1
The Most Common Adverse Events Reported with EMSAM in Comparison to Placebo1*†
Body System |
EMSAM (N = 817) |
Placebo (N = 668) |
|
Body as whole |
|
|
Headache |
18 |
17 |
|
Digestive |
Diarrhea |
9 |
7 |
Dyspepsia |
4 |
3 |
|
Nervous |
Insomnia |
12 |
7 |
Dry mouth |
8 |
6 |
|
Respiratory |
Pharyngitis |
3 |
2 |
Sinusitis |
3 |
1 |
|
Skin |
Application site reaction |
24 |
12 |
Rash |
4 |
2 |
*Excludes the following reactions, which had an incidence on placebo treatment greater or equal to EMSAM: infection, nausea, dizziness, pain, abdominal pain, nervousness, back pain, asthenia, anxiety, flu syndrome, accidental injury, somnolence, rhinitis, and palpitations.
- Includes doses of EMSAM from 3 mg to 12 mg per 24 hours in placebo-controlled trials of up to 8 weeks in duration.
Adverse Reactions Leading to Treatment Discontinuation1†
†Among N=817 MDD patients treated with EMSAM at doses of either 3 mg per 24 hours (n=151 patients), 6 mg per 24 hours (n=550 patients) or 6 mg per 24 hours, 9 mg per 24 hours, and 12 mg per 24 hours (n=116 patients) in placebo-controlled trials of up to 8 weeks in duration, 7.1% discontinued treatment due to an adverse reaction as compared with 3.6% of N=668 patients receiving placebo. The only adverse reaction associated with discontinuation, in at least 1% of EMSAM-treated patients at a rate at least twice that of placebo, was application site reaction (2% EMSAM vs. 0% placebo).
ECG: Electrocardiogram.
This is not all the information you need to review before prescribing EMSAM. Please also review the Important Safety Information below and the EMSAM full Prescribing Information including Boxed WARNING.