🇺🇸 Restasis eye drop in United States

14 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: 23 April 2025 – 23 April 2026
• Total reports: 14

Most-reported reactions

1. Arthralgia — 2 reports (14.29%)
2. Diarrhoea — 2 reports (14.29%)
3. Fatigue — 2 reports (14.29%)
4. Nausea — 2 reports (14.29%)
5. Abdominal Pain — 1 report (7.14%)
6. Alopecia — 1 report (7.14%)
7. Application Site Erythema — 1 report (7.14%)
8. Application Site Inflammation — 1 report (7.14%)
9. Application Site Pruritus — 1 report (7.14%)
10. Application Site Scab — 1 report (7.14%)

Source database →

Frequently asked questions

Is Restasis eye drop approved in United States?

Restasis eye drop does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Restasis eye drop in United States?

Huons Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.