FDA — authorised 22 March 1996
- Application: NDA020385
- Marketing authorisation holder: PFIZER INC
- Local brand name: NICOTROL
- Indication: SPRAY, METERED — NASAL
- Status: approved
🇺🇸 Nicotrol in United States
FDA authorised Nicotrol on 22 March 1996 · 1,770 US adverse-event reports
Marketing authorisations
FDA — authorised 3 July 1996
- Application: NDA020536
- Marketing authorisation holder: MCNEIL CONS
- Local brand name: NICOTROL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 2 May 1997
- Application: NDA020714
- Marketing authorisation holder: PFIZER
- Local brand name: NICOTROL
- Indication: INHALANT — ORAL
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,770
Most-reported reactions
- Drug Ineffective — 692 reports (39.1%)
- Product Quality Issue — 183 reports (10.34%)
- Cough — 170 reports (9.6%)
- Nausea — 129 reports (7.29%)
- Throat Irritation — 117 reports (6.61%)
- Malaise — 107 reports (6.05%)
- Feeling Abnormal — 97 reports (5.48%)
- Headache — 97 reports (5.48%)
- Dizziness — 91 reports (5.14%)
- Anxiety — 87 reports (4.92%)
Nicotrol 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 Nicotrol approved in United States?
Yes. FDA authorised it on 22 March 1996; FDA authorised it on 3 July 1996; FDA authorised it on 2 May 1997.
Who is the marketing authorisation holder for Nicotrol in United States?
PFIZER INC holds the US marketing authorisation.