72/100 · Elevated
Manufactured by Haleon US Holdings LLC
Nicotine Dependence and Overdose Concerns Highlighted in NICOTINE POLACRILEX Adverse Events
62,946 FDA adverse event reports analyzed
Last updated: 2026-05-12
NICOTINE POLACRILEX is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 62,946 FDA adverse event reports, NICOTINE POLACRILEX has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for NICOTINE POLACRILEX include DRUG INEFFECTIVE, NICOTINE DEPENDENCE, INTENTIONAL DRUG MISUSE, NAUSEA, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NICOTINE POLACRILEX.
Nicotine Polacrilex has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 62,946 adverse event reports for this medication, which is primarily manufactured by Haleon Us Holdings Llc.
The most commonly reported adverse events include Drug Ineffective, Nicotine Dependence, Intentional Drug Misuse. Of classified reports, 36.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reports involve non-serious reactions such as nausea and dizziness, but serious events like overdose and macular degeneration are also reported.
Nicotine dependence and misuse are common, indicating potential addiction risks. Overdose incidents are a significant concern, with 1118 reports, highlighting the need for careful usage. The drug is frequently reported to cause gastrointestinal issues and adverse effects on the respiratory system.
Patients taking Nicotine Polacrilex should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nicotine Polacrilex can cause drug dependence and misuse, and there are warnings about potential drug interactions, especially with other nicotine-containing products. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nicotine Polacrilex received a safety concern score of 72/100 (elevated concern). This is based on a 36.7% serious event ratio across 37,176 classified reports. The score accounts for 62,946 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 18,137, Male: 13,172, Unknown: 138. The most frequently reported age groups are age 60 (531 reports), age 58 (529 reports), age 65 (526 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,176 classified reports for NICOTINE POLACRILEX:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Nicotine Polacrilex can cause drug dependence and misuse, and there are warnings about potential drug interactions, especially with other nicotine-containing products.
If you are taking Nicotine Polacrilex, here are important things to know. The most commonly reported side effects include drug ineffective, nicotine dependence, intentional drug misuse, nausea, malaise. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed usage instructions carefully to avoid overdose and misuse. Report any serious adverse events to your healthcare provider immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors these reports and may take action if serious safety concerns arise. Healthcare providers should be vigilant about patient compliance and potential misuse.
The FDA has received approximately 62,946 adverse event reports associated with Nicotine Polacrilex. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Nicotine Polacrilex include Drug Ineffective, Nicotine Dependence, Intentional Drug Misuse, Nausea, Malaise. By volume, the top reported reactions are: Drug Ineffective (4,911 reports), Nicotine Dependence (4,120 reports), Intentional Drug Misuse (3,480 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nicotine Polacrilex.
Out of 37,176 classified reports, 13,655 (36.7%) were classified as serious and 23,521 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Nicotine Polacrilex break down by patient sex as follows: Female: 18,137, Male: 13,172, Unknown: 138. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Nicotine Polacrilex adverse events are: age 60: 531 reports, age 58: 529 reports, age 65: 526 reports, age 59: 518 reports, age 62: 493 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Nicotine Polacrilex adverse event reports is Haleon Us Holdings Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Nicotine Polacrilex include: Dizziness, Headache, Drug Administration Error, Overdose, Product Quality Issue. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Nicotine Polacrilex to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Nicotine Polacrilex has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of reports involve non-serious reactions such as nausea and dizziness, but serious events like overdose and macular degeneration are also reported.
Key safety signals identified in Nicotine Polacrilex's adverse event data include: Overdose is a notable safety signal, with 1118 reports.. Nicotine dependence and misuse are frequent, suggesting potential addiction risks.. Serious reactions like macular degeneration and death are reported, though less frequently.. Gastrointestinal issues and respiratory symptoms are common, indicating potential side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nicotine Polacrilex can cause drug dependence and misuse, and there are warnings about potential drug interactions, especially with other nicotine-containing products. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nicotine Polacrilex.
Follow the prescribed usage instructions carefully to avoid overdose and misuse. Report any serious adverse events to your healthcare provider immediately.
Nicotine Polacrilex has 62,946 adverse event reports on file with the FDA. Nicotine dependence and misuse are common, indicating potential addiction risks. The volume of reports for Nicotine Polacrilex reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these reports and may take action if serious safety concerns arise. Healthcare providers should be vigilant about patient compliance and potential misuse. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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