🇺🇸 Nicotine replacement in United States
30 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: 30
Most-reported reactions
- Contraindicated Product Administered — 5 reports (16.67%)
- Hypoglycaemia — 4 reports (13.33%)
- Maternal Exposure During Pregnancy — 4 reports (13.33%)
- Ventricular Tachyarrhythmia — 4 reports (13.33%)
- Fatigue — 3 reports (10%)
- Bipolar I Disorder — 2 reports (6.67%)
- Diarrhoea — 2 reports (6.67%)
- Dizziness — 2 reports (6.67%)
- Electrocardiogram Qt Prolonged — 2 reports (6.67%)
- Heart Rate Irregular — 2 reports (6.67%)
Other Smoking Cessation / Addiction Medicine approved in United States
Frequently asked questions
Is Nicotine replacement approved in United States?
Nicotine replacement does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Nicotine replacement in United States?
Instituto Fernandes Figueira is the originator. The local marketing authorisation holder may differ — check the official source linked above.