Nicorette: adverse event reports filed with FDA

12,495

reports as suspect product

0.1% of all reports · about 555 a year

121

reports, 12 months to June 2026

183 in the 12 months before

18.1%

marked serious by the reporter

22.1% across the class

0.3%

record death among outcomes, as reported

43 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 Nicorette reports recording the termmedian drug in cholinergic nicotinic agonist

1. Intentional drug misuse20.6%2,572
2. Nicotine dependence19.5%2,437
3. Drug ineffectivethe medicine did not work as expected15.6%1,943
4. Nauseafeeling sick7.3%918
5. Drug administration errora mistake in giving the medicine6.8%852
6. Malaisegeneral feeling of being unwell4.5%558
7. Product quality issuea problem with the product itself3.5%441
8. Dizzinesslight-headedness or unsteadiness3.1%382
9. Drug dependencedependence on a medicine2.8%344
10. Vomitingbeing sick2.5%313
11. Oral discomfort2.4%303
12. Dependence2.4%297
13. Hiccups2.3%286
14. Overdosea dose above the recommended amount2.2%280
15. Headachehead pain2.2%277
16. Pharmaceutical product complaint2.1%267
17. Throat irritationan irritated throat2.1%266
18. Dyspepsiaindigestion2.1%260
19. Incorrect drug administration duration1.9%232
20. Hypersensitivityan allergic-type reaction1.6%201
21. Dysgeusiaaltered taste1.5%193
22. Drug abuser1.5%191
23. Abdominal discomfortstomach discomfort1.5%187
24. Wrong technique in product usage processthe product was used in the wrong way1.5%185
25. Abdominal pain upperupper stomach pain1.4%174
26. Feeling abnormalfeeling odd or not right1.3%166
27. Palpitationsawareness of the heartbeat1.3%159
28. Dyspnoeashortness of breath1.2%152
29. Oral pain1.1%143
30. Diarrhoealoose or frequent stools1.1%138

Top 30 of 595 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. 85.9% 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 12,495 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nicorette 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 Nicorette as a suspect or interacting product; reports listing it only as a concomitant medication (743) 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.