🇺🇸 lidocaine spray in United States

FDA authorised lidocaine spray on 7 October 2008 · 20 US adverse-event reports

Marketing authorisations

FDA — authorised 7 October 2008

  • Application: NDA022221
  • Marketing authorisation holder: THEA PHARMA
  • Local brand name: AKTEN
  • Indication: GEL — OPHTHALMIC
  • Status: approved

Read official source →

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. Death — 3 reports (15%)
  2. Dizziness — 3 reports (15%)
  3. Drug Abuse — 2 reports (10%)
  4. Drug Ineffective — 2 reports (10%)
  5. Headache — 2 reports (10%)
  6. Insomnia — 2 reports (10%)
  7. Pyrexia — 2 reports (10%)
  8. Sunburn — 2 reports (10%)
  9. Acute Kidney Injury — 1 report (5%)
  10. Adjustment Disorder With Depressed Mood — 1 report (5%)

Source database →

lidocaine spray 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 lidocaine spray approved in United States?

Yes. FDA authorised it on 7 October 2008; FDA has authorised it.

Who is the marketing authorisation holder for lidocaine spray in United States?

THEA PHARMA holds the US marketing authorisation.