🇺🇸 Extended-Release Niacin in United States

10 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. Coagulopathy — 1 report (10%)
  2. Derealisation — 1 report (10%)
  3. Drug Dispensing Error — 1 report (10%)
  4. Erythema — 1 report (10%)
  5. Feeling Hot — 1 report (10%)
  6. Flushing — 1 report (10%)
  7. Heart Rate Increased — 1 report (10%)
  8. Liver Injury — 1 report (10%)
  9. Paraesthesia — 1 report (10%)
  10. Pruritus — 1 report (10%)

Source database →

Extended-Release Niacin 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 Extended-Release Niacin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Extended-Release Niacin in United States?

Henry Ford Health System is the originator. The local marketing authorisation holder may differ — check the official source linked above.