🇺🇸 Polyene Phosphatidyl choline in United States

13 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. Pyrexia — 3 reports (23.08%)
  2. Nausea — 2 reports (15.38%)
  3. Abdominal Distension — 1 report (7.69%)
  4. Agranulocytosis — 1 report (7.69%)
  5. Alanine Aminotransferase Increased — 1 report (7.69%)
  6. Ammonia Increased — 1 report (7.69%)
  7. Ascites — 1 report (7.69%)
  8. Aspartate Aminotransferase Increased — 1 report (7.69%)
  9. Blood Creatinine Increased — 1 report (7.69%)
  10. Blood Potassium Decreased — 1 report (7.69%)

Source database →

Polyene Phosphatidyl choline 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 Polyene Phosphatidyl choline approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Polyene Phosphatidyl choline in United States?

Zhejiang Hisun Pharmaceutical Co. Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.