🇺🇸 Nicotine (4 mg) in United States
18 US adverse-event reports
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: 22 April 2025 – 22 April 2026
- Total reports: 18
Most-reported reactions
- Chest Pain — 2 reports (11.11%)
- Dysphagia — 2 reports (11.11%)
- Dyspnoea — 2 reports (11.11%)
- Heart Rate Increased — 2 reports (11.11%)
- Hypersensitivity — 2 reports (11.11%)
- Incorrect Drug Administration Duration — 2 reports (11.11%)
- Pharyngeal Oedema — 2 reports (11.11%)
- Urticaria — 2 reports (11.11%)
- Accidental Overdose — 1 report (5.56%)
- Arrhythmia — 1 report (5.56%)
Other Smoking Cessation / Addiction Medicine approved in United States
Frequently asked questions
Is Nicotine (4 mg) approved in United States?
Nicotine (4 mg) does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Nicotine (4 mg) in United States?
GlaxoSmithKline is the originator. The local marketing authorisation holder may differ — check the official source linked above.