🇺🇸 Systane Complete in United States

738 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. Eye Irritation — 158 reports (21.41%)
  2. Eye Pain — 134 reports (18.16%)
  3. Product Quality Issue — 99 reports (13.41%)
  4. Vision Blurred — 88 reports (11.92%)
  5. Drug Ineffective — 67 reports (9.08%)
  6. Ocular Hyperaemia — 62 reports (8.4%)
  7. Dry Eye — 40 reports (5.42%)
  8. Headache — 34 reports (4.61%)
  9. Eye Pruritus — 30 reports (4.07%)
  10. Eye Swelling — 26 reports (3.52%)

Source database →

Systane Complete 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 Systane Complete approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Systane Complete in United States?

University of Alabama at Birmingham is the originator. The local marketing authorisation holder may differ — check the official source linked above.