🇺🇸 Nicotine Replacement Therapy in United States

21 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: 21

Most-reported reactions

1. Contraindicated Product Administered — 4 reports (19.05%)
2. Maternal Exposure During Pregnancy — 4 reports (19.05%)
3. Bipolar I Disorder — 2 reports (9.52%)
4. Diarrhoea — 2 reports (9.52%)
5. Fatigue — 2 reports (9.52%)
6. Heart Rate Irregular — 2 reports (9.52%)
7. Peripheral Swelling — 2 reports (9.52%)
8. Antipsychotic Drug Level Increased — 1 report (4.76%)
9. Attention Deficit/Hyperactivity Disorder — 1 report (4.76%)
10. Basal Ganglia Stroke — 1 report (4.76%)

Source database →

Frequently asked questions

Is Nicotine Replacement Therapy approved in United States?

Nicotine Replacement Therapy does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Nicotine Replacement Therapy in United States?

Ottawa Hospital Research Institute is the originator. The local marketing authorisation holder may differ — check the official source linked above.