Drugs › Cholinergic nicotinic agonist
Brand name · Nicotine polacrilex
Equate Nicotine: adverse event reports filed with FDA
1,691 reports list it as a suspect or interacting product, 2013–2025. Class: Cholinergic nicotinic agonist.
- 1,691
- reports as suspect product
- 0% of all reports · about 127 a year
- 0
- reports, 12 months to June 2026
- 7 in the 12 months before
- 1.3%
- marked serious by the reporter
- 22.1% across the class
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
1,691 adverse event reports received by FDA list the brand name Equate Nicotine (nicotine polacrilex) as a suspect or interacting product, from March 2013 to May 2025. A further 0 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 0 reports listed it, against 7 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 127 reports a year and 0% of the 20,646,523 reports in the database, and 3.1% of the reports for the cholinergic nicotinic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are application site erythema (14.5%), drug ineffective (14.3%) and application site pruritus (13.7%). A report can list several reactions, so shares add to more than 100%; 131 different terms appear across these reports. Application site erythema is recorded in 14.5% of these reports, a larger share than in the median cholinergic nicotinic agonist drug (3.1%).
1.3% of the reports are marked serious by the reporter (22.1% across the class); 0% record death among the outcomes and 0.2% record hospitalisation, as reported. 99.8% of the reports came from consumers, and the largest patient age group is 45 to 64 (14.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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
Reactions recorded in the reports
share of Equate Nicotine reports recording the termmedian drug in cholinergic nicotinic agonist
- Application site erythemaredness where the product was applied14.5%246
- Drug ineffectivethe medicine did not work as expected14.3%242
- Application site pruritusitching where the product was applied13.7%231
- Application site rash12.3%208
- Rashskin rash9.8%165
- Application site pain8.1%137
- Nauseafeeling sick7.1%120
- Dizzinesslight-headedness or unsteadiness5%84
- Product complaint4.6%77
- Pruritusitching4.4%74
- Application site reactiona reaction where the product was applied4%67
- Application site swelling3.7%63
- Product quality issuea problem with the product itself3.6%61
- Erythemaskin redness3.3%56
- Vomitingbeing sick3.3%56
- Headachehead pain3%50
- Hypersensitivityan allergic-type reaction3%50
- Malaisegeneral feeling of being unwell2.8%48
- Nicotine dependence2.7%46
- Urticariahives2.4%40
- Application site burn2.1%36
- Application site urticaria2.1%35
- Wrong technique in product usage processthe product was used in the wrong way1.8%31
- Abnormal dreamsunusual dreams1.7%28
- Expired product administeredthe product was used past its expiry date1.5%25
- Burning sensationa burning feeling1.4%24
- Palpitationsawareness of the heartbeat1.2%21
- Skin irritationirritated skin1.2%21
Top 30 of 131 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Smoking cessation therapy | 882 | 52.2% |
| Ex-tobacco user | 192 | 11.4% |
| Drug withdrawal maintenance therapy | 8 | 0.5% |
| Tobacco user | 3 | 0.2% |
| Nicotine dependence | 2 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,691 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Equate Nicotine reports |
|---|---|---|
| Nicoderm Cq | 39 | 2.3% |
| Nicorette | 13 | 0.8% |
Other products listed in reports where Equate Nicotine 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
| Measure | Equate Nicotine | Cholinergic nicotinic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 1,691 | 54,214 | 20,646,523 |
| Share of that pool | — | 3.1% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 1.3% | 22.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 19 | 91 |
| Hospitalisation recorded, per 1,000 reports | 2 | 60 | 213 |
| Consumer-filed share | 99.8% | 88% | 45.8% |
| Top term, share of reports | Application site erythema 14.5% | median 3.1% | 0.1% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Nicoderm Cq | brand | 15,396 | 173 | 10.8% |
| Nicorette | brand | 12,495 | 121 | 18.1% |
| Nicotine | generic | 9,015 | 368 | 62.8% |
| Nicotine polacrilex | generic | 7,798 | 392 | 12.9% |
| Nicotine transdermal system patch | generic | 4,462 | 105 | 10.2% |
| Nicotrol | brand | 2,281 | 6 | 32.4% |
| Nicotine transdermal system | generic | 1,076 | 165 | 13.7% |
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.
Questions about Equate Nicotine reports
How many adverse event reports has FDA received for Equate Nicotine?
1,691 reports list Equate Nicotine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 0 list it only as a concomitant medication.
What reactions are recorded in Equate Nicotine reports?
application site erythema (14.5%), drug ineffective (14.3%), application site pruritus (13.7%), application site rash (12.3%) and rash (9.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Equate Nicotine was responsible.
How serious are the reports?
1.3% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 0.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (99.8%), not given (0.1%) and other health professional (0.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Equate Nicotine rising?
0 reports in the 12 months to June 2026, against 7 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Equate Nicotine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Equate Nicotine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Equate Nicotine as a suspect or interacting product; reports listing it only as a concomitant medication (0) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.