🇺🇸 Transdermal nicotine patch in United States

FDA authorised Transdermal nicotine patch on 7 November 1991 · 22 US adverse-event reports

Marketing authorisation

FDA — authorised 7 November 1991

  • Application: NDA020165
  • Marketing authorisation holder: CHATTEM SANOFI
  • Local brand name: NICODERM CQ
  • Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
  • 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. Dizziness — 3 reports (13.64%)
  2. Dyspnoea — 3 reports (13.64%)
  3. Arthralgia — 2 reports (9.09%)
  4. Burning Sensation — 2 reports (9.09%)
  5. Chest Pain — 2 reports (9.09%)
  6. Diarrhoea — 2 reports (9.09%)
  7. Drug Ineffective — 2 reports (9.09%)
  8. Erythema — 2 reports (9.09%)
  9. Increased Appetite — 2 reports (9.09%)
  10. Limb Injury — 2 reports (9.09%)

Source database →

Other Psychiatry / Addiction Medicine approved in United States

Frequently asked questions

Is Transdermal nicotine patch approved in United States?

Yes. FDA authorised it on 7 November 1991.

Who is the marketing authorisation holder for Transdermal nicotine patch in United States?

CHATTEM SANOFI holds the US marketing authorisation.