🇺🇸 Restylane in United States

386 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. Off Label Use — 122 reports (31.61%)
  2. Drug Ineffective — 36 reports (9.33%)
  3. Swelling Face — 35 reports (9.07%)
  4. Product Preparation Error — 34 reports (8.81%)
  5. Swelling — 33 reports (8.55%)
  6. Headache — 26 reports (6.74%)
  7. Injection Site Mass — 26 reports (6.74%)
  8. Erythema — 25 reports (6.48%)
  9. Eyelid Ptosis — 25 reports (6.48%)
  10. Injection Site Swelling — 24 reports (6.22%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Restylane approved in United States?

Yes. FDA has authorised it.

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

Medicis Aesthetics, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.