Nicotine: adverse event reports filed with FDA

9,015

reports as suspect product

0% of all reports · about 401 a year

368

reports, 12 months to June 2026

478 in the 12 months before

62.8%

marked serious by the reporter

22.1% across the class

9.6%

record death among outcomes, as reported

865 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Nicotine reports recording the termmedian drug in cholinergic nicotinic agonist

1. Drug ineffectivethe medicine did not work as expected14.9%1,342
2. Product adhesion issue7.9%716
3. Nicotine dependence7.8%704
4. Foetal exposure during pregnancythe unborn baby was exposed to the medicine7.7%692
5. Overdosea dose above the recommended amount7.1%641
6. Nauseafeeling sick7.1%638
7. Treatment noncompliancethe treatment was not taken as directed6.8%617
8. Macular degenerationa disease of the central retina6%543
9. Headachehead pain5.3%475
10. Toxicity to various agentspoisoning or toxic effect of one or more substances4.8%430
11. Malaisegeneral feeling of being unwell4.6%416
12. Product quality issuea problem with the product itself4.2%379
13. Drug dependencedependence on a medicine4.1%367
14. Drug withdrawal syndrome neonatal4%361
15. Off label useused for a purpose or in a way not on the label3.4%310
16. Dizzinesslight-headedness or unsteadiness3.4%309
17. Premature babya baby born early3.4%304
18. Painpain, site not specified3.4%303
19. Dyspnoeashortness of breath3.1%278
20. Constipationconstipation3%269
21. Therapeutic product effect incomplete2.9%259
22. Drug abusemisuse of a medicine2.8%255
23. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.8%253
24. Erythemaskin redness2.8%251
25. Dyspepsiaindigestion2.7%245
26. Pyrexiafever2.7%239
27. Weight decreasedweight loss2.6%231
28. Wrong technique in product usage processthe product was used in the wrong way2.6%230
29. Application site erythemaredness where the product was applied2.5%226
30. Chronic sinusitis2.5%224

Top 30 of 1,079 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the cholinergic nicotinic agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 54,214 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 58.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,015 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nicotine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the cholinergic nicotinic agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Nicotine as a suspect or interacting product; reports listing it only as a concomitant medication (6,400) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.