🇺🇸 PCSK9 inhibitor 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. Atrial Enlargement — 1 report (10%)
  2. Blood Calcium Increased — 1 report (10%)
  3. Cerebral Hyperperfusion Syndrome — 1 report (10%)
  4. Discomfort — 1 report (10%)
  5. Drug Intolerance — 1 report (10%)
  6. Exercise Tolerance Decreased — 1 report (10%)
  7. Left Ventricular Dysfunction — 1 report (10%)
  8. Low Density Lipoprotein Increased — 1 report (10%)
  9. Myalgia — 1 report (10%)
  10. Pain — 1 report (10%)

Source database →

PCSK9 inhibitor 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 PCSK9 inhibitor approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for PCSK9 inhibitor in United States?

The First Affiliated Hospital with Nanjing Medical University is the originator. The local marketing authorisation holder may differ — check the official source linked above.