🇺🇸 Soothe in United States

457 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

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.

Most-reported reactions

  1. Eye Irritation — 98 reports (21.44%)
  2. Eye Pain — 70 reports (15.32%)
  3. Vision Blurred — 68 reports (14.88%)
  4. Drug Ineffective — 49 reports (10.72%)
  5. Ocular Hyperaemia — 43 reports (9.41%)
  6. Lacrimation Increased — 31 reports (6.78%)
  7. Dry Eye — 28 reports (6.13%)
  8. Headache — 25 reports (5.47%)
  9. Foreign Body Sensation In Eyes — 23 reports (5.03%)
  10. Off Label Use — 22 reports (4.81%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Soothe approved in United States?

Yes. FDA has authorised it.

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

Pharmaceutical Research Network is the originator. The local marketing authorisation holder may differ — check the official source linked above.