🇺🇸 Kybella in United States

1,925 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. Drug Ineffective — 321 reports (16.68%)
  2. Injection Site Swelling — 303 reports (15.74%)
  3. Off Label Use — 282 reports (14.65%)
  4. Swelling — 253 reports (13.14%)
  5. Injection Site Pain — 191 reports (9.92%)
  6. Facial Paresis — 130 reports (6.75%)
  7. Injection Site Nodule — 121 reports (6.29%)
  8. Nerve Injury — 113 reports (5.87%)
  9. Hypoaesthesia — 110 reports (5.71%)
  10. Injection Site Mass — 101 reports (5.25%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Kybella approved in United States?

Yes. FDA has authorised it.

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

Massachusetts General Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.