🇺🇸 Softacort in United States

20 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. Cataract Operation — 2 reports (10%)
  2. Chromaturia — 2 reports (10%)
  3. Conjunctivitis — 2 reports (10%)
  4. Drug Ineffective For Unapproved Indication — 2 reports (10%)
  5. Eye Irritation — 2 reports (10%)
  6. Intraocular Pressure Increased — 2 reports (10%)
  7. Ocular Discomfort — 2 reports (10%)
  8. Product Administered To Patient Of Inappropriate Age — 2 reports (10%)
  9. Product Prescribing Issue — 2 reports (10%)
  10. Vision Blurred — 2 reports (10%)

Source database →

Softacort in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Softacort approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Softacort in United States?

Medical University of Vienna is the originator. The local marketing authorisation holder may differ — check the official source linked above.