Nicotine transdermal system patch: adverse event reports filed with FDA

4,462

reports as suspect product

0% of all reports · about 199 a year

105

reports, 12 months to June 2026

35 in the 12 months before

10.2%

marked serious by the reporter

22.1% across the class

0.4%

record death among outcomes, as reported

17 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 transdermal system patch reports recording the termmedian drug in cholinergic nicotinic agonist

1. Product adhesion issue26.7%1,192
2. Product quality issuea problem with the product itself21.1%941
3. Treatment noncompliancethe treatment was not taken as directed19.6%876
4. Nicotine dependence17.9%800
5. Drug ineffectivethe medicine did not work as expected13%580
6. Overdosea dose above the recommended amount7.8%346
7. Wrong technique in product usage processthe product was used in the wrong way6.1%271
8. Nauseafeeling sick5.5%247
9. Drug dose omissiona dose was missed5.2%230
10. Application site pruritusitching where the product was applied4.6%204
11. Underdoseless than the intended dose4.4%197
12. Headachehead pain4.4%196
13. Product use issuea problem in how the product was used4.2%186
14. Application site erythemaredness where the product was applied3.7%163
15. Abnormal dreamsunusual dreams3.6%160
16. Macular degenerationa disease of the central retina3.5%158
17. Malaisegeneral feeling of being unwell3.2%143
18. Expired product administeredthe product was used past its expiry date3.1%139
19. Dizzinesslight-headedness or unsteadiness3.1%137
20. Incorrect dose administeredthe wrong dose was given3%135
21. Application site rash2.6%117
22. Erythemaskin redness2.4%108
23. Incorrect drug administration duration2.4%105
24. Painpain, site not specified2.3%103
25. Anxietyanxiety2.3%101
26. Weight decreasedweight loss2.2%100
27. Off label useused for a purpose or in a way not on the label2.2%96
28. Dyspepsiaindigestion2.1%95
29. Insomniadifficulty sleeping2.1%94
30. Constipationconstipation2.1%92

Top 30 of 268 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. 94.6% 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 4,462 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nicotine transdermal system patch 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 transdermal system patch as a suspect or interacting product; reports listing it only as a concomitant medication (116) 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.