🇺🇸 CLE in United States

10 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 10

Most-reported reactions

1. Drug Exposure During Pregnancy — 1 report (10%)
2. Dysarthria — 1 report (10%)
3. Hepatic Function Abnormal — 1 report (10%)
4. Nausea — 1 report (10%)
5. Pharmaceutical Product Complaint — 1 report (10%)
6. Rash — 1 report (10%)
7. Rash Erythematous — 1 report (10%)
8. Rash Pruritic — 1 report (10%)
9. Surgery — 1 report (10%)
10. Therapy Interrupted — 1 report (10%)

Source database →

Frequently asked questions

Is CLE approved in United States?

CLE does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for CLE in United States?

Impax Laboratories, LLC is the originator. The local marketing authorisation holder may differ — check the official source linked above.