This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Nicotine Polacrilex

cholinergic nicotinic agonist

Last updated: June 17, 2026

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Nicotine Polacrilex is a medication, a cholinergic nicotinic agonist. According to the FDA-approved label, reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking. FAERS contains 37,784 submissions naming this drug from 2004 through 2026; the top three reactions cited are drug ineffective, nicotine dependence, and intentional drug misuse.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Nicotine Polacrilex. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Nicotine Polacrilex. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 37,784 FAERS submissions that named Nicotine Polacrilex. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Nicotine Polacrilex. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Nicotine Polacrilex. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have a sodium-restricted diet heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. Stop use and ask doctor if mouth problems occur persistent indigestion or severe sore throat occurs irregular heartbeat or palpitations occur you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash) Keep out of reach of children an...

FDA label effective date: 2024-07-04

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.