🇺🇸 Anthelios 20 in United States

FDA authorised Anthelios 20 on 5 October 2006 · 442 US adverse-event reports

Marketing authorisations

FDA — authorised 5 October 2006

  • Application: NDA021471
  • Marketing authorisation holder: LOREAL USA
  • Local brand name: ANTHELIOS 20
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

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 — 53 reports (11.99%)
  2. Vomiting — 46 reports (10.41%)
  3. Abdominal Distension — 45 reports (10.18%)
  4. Nausea — 45 reports (10.18%)
  5. Abdominal Pain — 44 reports (9.95%)
  6. Ascites — 43 reports (9.73%)
  7. Dry Mouth — 42 reports (9.5%)
  8. Stress — 42 reports (9.5%)
  9. Appendicitis — 41 reports (9.28%)
  10. Condition Aggravated — 41 reports (9.28%)

Source database →

Anthelios 20 in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Anthelios 20 approved in United States?

Yes. FDA authorised it on 5 October 2006; FDA has authorised it.

Who is the marketing authorisation holder for Anthelios 20 in United States?

LOREAL USA holds the US marketing authorisation.