The most common side effect of FILSUVEZ is application site reactions, such as pain and itchy skin
(n=109) n (%)
(n=114) n (%)
(N=223) N (%)
These side effects were no more common than with placebo gel. Some people experienced allergic reactions or skin reactions to FILSUVEZ, including symptoms such as:
- Red itchy bumps (hives)
- Skin rash
- Redness or itching
If you notice any of these symptoms, stop using FILSUVEZ and contact your doctor immediately.
Serious side effects occurred in 6.4% of patients receiving FILSUVEZ. Among these, only one serious side effect was related to the use of FILSUVEZ, leading to withdrawal from the clinical trial.
No new side effects were seen with long-term use of FILSUVEZ throughout the open-label follow-up study
Patients using FILSUVEZ had a low number of wound infections during the 2-year, open-label follow-up study. When wound infections happened, they were usually mild.†
In the 90-day, double-blind phase 3 study, wound infection occurred in 0.9% of patients treated with FILSUVEZ compared with 3.5% treated with placebo gel. In the 2-year, open-label, follow-up study, wound infection occurred in 4% of patients who continued using FILSUVEZ and 2.9% of patients who switched from placebo gel to FILSUVEZ.
†Wound infection numbers were based on side effects reported and/or use of topical and/or systemic antibiotics related to wound infection.
