Tolerability profile
REACTINE® is generally well tolerated in adults
The most common adverse reactions in REACTINE® clinical trials were headache and somnolence
The incidence of somnolence associated with REACTINE® was dose related and predominantly mild to moderate
Adverse reactions reported in placebo-controlled REACTINE® trials (maximum dose of 10 mg) at rates of 2% or greater
Adverse experience | REACTINE® (N=3260) | Placebo (N=3061) | Difference of percentage |
|---|---|---|---|
Headache | 7.42 | 8.07 | (0.65)* |
Dry Mouth | 2.09 | 0.82 | 1.27 |
Somnolence | 9.63 | 5.00 | 4.63 |
( )* = Higher frequency in placebo group
Adapted from the REACTINE® Product Monograph. 2023.