🇺🇸 Ferric Hydroxide Polymaltose in United States

140 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. Off Label Use — 29 reports (20.71%)
  2. Hair Follicle Tumour Benign — 22 reports (15.71%)
  3. Product Use In Unapproved Indication — 21 reports (15%)
  4. Anaemia — 14 reports (10%)
  5. Pyrexia — 13 reports (9.29%)
  6. Maternal Exposure During Pregnancy — 9 reports (6.43%)
  7. Arthralgia — 8 reports (5.71%)
  8. Clear Cell Renal Cell Carcinoma — 8 reports (5.71%)
  9. Lymphoproliferative Disorder — 8 reports (5.71%)
  10. Pneumonia — 8 reports (5.71%)

Source database →

Ferric Hydroxide Polymaltose 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 Ferric Hydroxide Polymaltose approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Ferric Hydroxide Polymaltose in United States?

South Valley University is the originator. The local marketing authorisation holder may differ — check the official source linked above.