Nicorette Fruit Chill: adverse event reports filed with FDA

346

reports as suspect product

0% of all reports · about 24 a year

20

reports, 12 months to June 2026

28 in the 12 months before

0.9%

marked serious by the reporter

22.1% across the class

0%

record death among outcomes, as reported

0 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 Fruit Chill reports recording the termmedian drug in cholinergic nicotinic agonist

1. Nicotine dependence20.2%70
2. Drug ineffectivethe medicine did not work as expected15.6%54
3. Malaisegeneral feeling of being unwell9.2%32
4. Drug administration errora mistake in giving the medicine8.4%29
5. Nauseafeeling sick8.4%29
6. Product quality issuea problem with the product itself6.6%23
7. Dizzinesslight-headedness or unsteadiness4.6%16
8. Throat irritationan irritated throat4.6%16
9. Abdominal discomfortstomach discomfort3.2%11
10. Hypersensitivityan allergic-type reaction3.2%11
11. Oral discomfort3.2%11
12. Vomitingbeing sick2.9%10
13. Dysgeusiaaltered taste2.6%9
14. Dyspepsiaindigestion2.6%9
15. Intentional drug misuse2.6%9
16. Product use in unapproved indicationused for a purpose not on the label2.3%8
17. Diarrhoealoose or frequent stools2%7
18. Glossodynia2%7
19. Product use issuea problem in how the product was used2%7
20. Expired product administeredthe product was used past its expiry date1.7%6
21. Oropharyngeal painsore throat1.7%6
22. Wrong technique in product usage processthe product was used in the wrong way1.7%6
23. Blood glucose increasedraised blood sugar reading1.4%5
24. Condition aggravatedthe condition being treated got worse1.4%5
25. Headachehead pain1.4%5
26. Heart rate increaseda fast heart rate reading1.4%5
27. Abdominal pain upperupper stomach pain1.2%4
28. Drug effective for unapproved indication1.2%4
29. Feeling jittery1.2%4
30. Hiccups1.2%4

Top 30 of 92 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. 99.4% 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 346 reports.

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 Fruit Chill as a suspect or interacting product; reports listing it only as a concomitant medication (2) 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.