Nicorettenicotine polacrilex
According to the FDA label: Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
19,105 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nicorette in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 3,333 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Nicotine Dependence 2,991 reports
Intentional Drug Misuse 2,815 reports
A report that a medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Full definition in the glossary →Nausea 1,642 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Administration Error 1,007 reports
A report that a medication was given or taken incorrectly in some way. This is a usage category.
Full definition in the glossary →Malaise 850 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →- Oral Discomfort 627 reports
Wrong Technique in Product Usage Process 612 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Dizziness 586 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Dyspepsia 573 reports
The medical term for indigestion, meaning discomfort or pain in the upper belly, often after eating.
Full definition in the glossary → See all drugs reporting this event →Macular Degeneration 565 reports
An eye condition that affects central vision, more common with age. It may appear in reports as a condition being treated.
Full definition in the glossary →Headache 546 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Product Quality Issue 530 reports
A report of a possible problem with the medication's quality, such as appearance, packaging, or condition. This is a quality-tracking category.
Full definition in the glossary →- Hiccups 523 reports
Vomiting 513 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 8,873 |
| Male | 6,244 |
| Unknown | 61 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 97 |
| 18-34 | 1,031 |
| 35-49 | 2,196 |
| 50-64 | 3,185 |
| 65-74 | 1,624 |
| 75+ | 505 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Nicorette. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 15,325 |
| Other Serious | 3,158 |
| Hospitalization | 890 |
| Death | 147 |
| Life-Threatening | 104 |
| Disability | 96 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Nicorette. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 113 |
| 2005 | 188 |
| 2006 | 726 |
| 2007 | 1,058 |
| 2008 | 881 |
| 2009 | 940 |
| 2010 | 947 |
| 2011 | 1,180 |
| 2012 | 1,319 |
| 2013 | 1,064 |
| 2014 | 218 |
| 2015 | 1,302 |
| 2016 | 1,236 |
| 2017 | 1,252 |
| 2018 | 1,069 |
| 2019 | 942 |
| 2020 | 883 |
| 2021 | 1,029 |
| 2022 | 775 |
| 2023 | 656 |
| 2024 | 506 |
| 2025 | 605 |
| 2026 (partial) | 216 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Nicorette
In FDA adverse event reports that mention Nicorette, these medications appeared most often in the same report.
- Nicotine Polacrilex Gum (6,132 reports)
- Acetaminophen (736 reports)
- Nicotine Polacrilex Mini (701 reports)
- Nicotine Polarilex (701 reports)
- Alprazolam (679 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026