🇺🇸 Poly-L-Lactic Acid in United States

25 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. Swelling — 5 reports (20%)
  2. Inflammation — 4 reports (16%)
  3. Erythema — 3 reports (12%)
  4. Feeling Hot — 3 reports (12%)
  5. Dyskinesia — 2 reports (8%)
  6. Muscle Tightness — 2 reports (8%)
  7. Pain — 2 reports (8%)
  8. Pyrexia — 2 reports (8%)
  9. Chills — 1 report (4%)
  10. Dehydration — 1 report (4%)

Source database →

Poly-L-Lactic Acid in other countries

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

Frequently asked questions

Is Poly-L-Lactic Acid approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Poly-L-Lactic Acid in United States?

Bausch Health Americas, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.