EUCRISA SIDE EFFECTS
- Generic Name: crisaborole
- Brand Name: Eucrisa Ointment
- Drug Class: PDE-4 Inhibitors, Topical
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 1012 subjects 2 to 79 years of age with mild to moderate atopic dermatitis were treated with EUCRISA twice daily for 4 weeks. The adverse reaction reported by ≥1% of EUCRISA-treated subjects is listed in Table 1.
Table 1: Adverse Reaction Occurring in ≥1% of Subjects in Atopic Dermatitis Trials through Week 4
| Adverse Reaction | EUCRISA N=1012 n (%) |
Vehicle N=499 n (%) |
| Application site paina | 45 (4) | 6 (1) |
| a Refers to skin sensations such as burning or stinging. | ||
Less common (<1%) adverse reactions in subjects treated with EUCRISA included contact urticaria.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of EUCRISA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Skin and Subcutaneous: allergic contact dermatitis.
SRC: NLM .