Nicotine polacrilex: adverse event reports filed with FDA

7,798

reports as suspect product

0% of all reports · about 355 a year

392

reports, 12 months to June 2026

321 in the 12 months before

12.9%

marked serious by the reporter

22.1% across the class

0.3%

record death among outcomes, as reported

22 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 polacrilex reports recording the termmedian drug in cholinergic nicotinic agonist

1. Drug ineffectivethe medicine did not work as expected19.4%1,510
2. Nauseafeeling sick11.2%875
3. Intentional drug misuse10.9%847
4. Nicotine dependence10.8%846
5. Macular degenerationa disease of the central retina7.1%551
6. Wrong technique in product usage processthe product was used in the wrong way5.3%417
7. Oral discomfort5.1%396
8. Malaisegeneral feeling of being unwell5%388
9. Dyspepsiaindigestion4.7%364
10. Throat irritationan irritated throat4.1%316
11. Drug administration errora mistake in giving the medicine3.9%304
12. Hiccups3.6%280
13. Headachehead pain3.5%274
14. Vomitingbeing sick3.3%260
15. Dizzinesslight-headedness or unsteadiness3.2%247
16. Off label useused for a purpose or in a way not on the label2.7%211
17. Expired product administeredthe product was used past its expiry date2.7%208
18. Product quality issuea problem with the product itself2.4%185
19. Abdominal discomfortstomach discomfort2.3%182
20. Paraesthesia oral2.3%179
21. Stomatitissore mouth2.2%170
22. Therapeutic product effect incomplete2.1%167
23. Diarrhoealoose or frequent stools2.1%163
24. Incorrect dose administeredthe wrong dose was given1.9%146
25. Dysgeusiaaltered taste1.8%143
26. Painpain, site not specified1.7%136
27. Abdominal pain upperupper stomach pain1.7%134
28. Weight decreasedweight loss1.7%131
29. Blood glucose increasedraised blood sugar reading1.6%124
30. Pyrexiafever1.6%122

Top 30 of 404 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. 91.3% 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 7,798 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nicotine polacrilex 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 polacrilex as a suspect or interacting product; reports listing it only as a concomitant medication (220) 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.