OPZELURA SIDE EFFECTS
- Generic Name: ruxolitinib cream
- Brand Name: Opzelura
- Drug Class: DMARDs, JAK Inhibitors, Dermatologics, Other
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 (Trials 1 and 2), 499 subjects 12 years of age and older with atopic dermatitis were treated with OPZELURA twice daily for 8 weeks. In the OPZELURA group, 62% of subjects were females, and 71% of subjects were White, 23% were Black, and 4% were Asian. The adverse reactions reported by ≥ 1% of OPZELURA-treated subjects and at a greater incidence than in the vehicle arm are listed in Table 1.
Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with OPZELURA for Atopic Dermatitis through Week 8 in Trials 1 and 2
| Adverse Reaction | OPZELURA (N=499) n (%) |
Vehicle (N=250) n (%) |
| Subjects with any TEAE* | 132 (27) | 83 (33) |
| Nasopharyngitis | 13 (3) | 2 (1) |
| Bronchitis | 4 (1) | 0 (0) |
| Ear infection | 4 (1) | 0 (0) |
| Eosinophil count increased | 4 (1) | 0 (0) |
| Urticaria | 4 (1) | 0 (0) |
| Diarrhea | 3 (1) | 1 (< 1) |
| Folliculitis | 3 (1) | 0 (0) |
| Tonsillitis | 3 (1) | 0 (0) |
| Rhinorrhea | 3 (1) | 1 (< 1) |
| *TEAE – treatment emergent adverse events | ||
Adverse reactions that occurred in Trials 1 and 2 in < 1% of subjects in the OPZELURA group and none in the vehicle group were: neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, Staphylococcal infection, and acneiform dermatitis.
SRC: NLM .