🇺🇸 Edetate Calcium Disodium in United States

FDA authorised Edetate Calcium Disodium on 3 May 2023 · 300 US adverse-event reports

Marketing authorisation

FDA — authorised 3 May 2023

  • Application: ANDA216435
  • Marketing authorisation holder: CASPER PHARMA LLC
  • Local brand name: EDETATE CALCIUM DISODIUM
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

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. Airway Remodelling — 30 reports (10%)
  2. Asthma — 30 reports (10%)
  3. Atopy — 30 reports (10%)
  4. Blood Immunoglobulin E Increased — 30 reports (10%)
  5. Central Nervous System Mass — 30 reports (10%)
  6. Chronic Sinusitis — 30 reports (10%)
  7. Confusional State — 30 reports (10%)
  8. Eosinophil Count Decreased — 30 reports (10%)
  9. Eosinophil Count Increased — 30 reports (10%)
  10. Eosinophilic Granulomatosis With Polyangiitis — 30 reports (10%)

Source database →

Frequently asked questions

Is Edetate Calcium Disodium approved in United States?

Yes. FDA authorised it on 3 May 2023.

Who is the marketing authorisation holder for Edetate Calcium Disodium in United States?

CASPER PHARMA LLC holds the US marketing authorisation.