72/100 · Elevated
Manufactured by Shenzhen Finona Information Technology Co., Ltd
Lidocaine 4% Adverse Events: Mostly Non-Serious, but Serious Reactions Notable
109,615 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE 4% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Shenzhen Finona Information Technology Co., Ltd. Based on analysis of 109,615 FDA adverse event reports, LIDOCAINE 4% 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 LIDOCAINE 4% include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT ADHESION ISSUE, PAIN, PRODUCT QUALITY ISSUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE 4%.
Lidocaine 4% 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 109,615 adverse event reports for this medication, which is primarily manufactured by Shenzhen Finona Information Technology Co., Ltd.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Product Adhesion Issue. Of classified reports, 67.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are non-serious, but serious adverse events, including death and pneumonia, are not uncommon.
Pain and fatigue are the most frequently reported symptoms, indicating potential issues with efficacy and patient comfort. There is a significant number of drug ineffective and product quality issues reported, suggesting potential problems with the drug's formulation or labeling. Serious reactions account for 67% of all reported outcomes, highlighting the need for careful monitoring and patient education. The high volume of reports related to drug ineffectiveness and product quality issues suggests a need for improved product standards and patient education.
Patients taking Lidocaine 4% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and inappropriate use are common, with warnings against off-label use and proper administration techniques. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine 4% received a safety concern score of 72/100 (elevated concern). This is based on a 67.0% serious event ratio across 51,643 classified reports. The score accounts for 109,615 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: 30,272, Male: 16,847, Unknown: 113. The most frequently reported age groups are age 62 (780 reports), age 66 (743 reports), age 64 (733 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 51,643 classified reports for LIDOCAINE 4%:
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.
Drug interactions and inappropriate use are common, with warnings against off-label use and proper administration techniques.
If you are taking Lidocaine 4%, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, product adhesion issue, pain, product quality issue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and administration instructions to avoid potential side effects. Report any adverse reactions to healthcare providers promptly to ensure proper monitoring and management. 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.
Regulatory oversight is ongoing, with a focus on improving product quality and addressing misuse through better patient education and guidelines.
The FDA has received approximately 109,615 adverse event reports associated with Lidocaine 4%. 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 Lidocaine 4% include Drug Ineffective, Off Label Use, Product Adhesion Issue, Pain, Product Quality Issue. By volume, the top reported reactions are: Drug Ineffective (4,004 reports), Off Label Use (3,870 reports), Product Adhesion Issue (3,421 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lidocaine 4%.
Out of 51,643 classified reports, 34,624 (67.0%) were classified as serious and 17,019 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 Lidocaine 4% break down by patient sex as follows: Female: 30,272, Male: 16,847, Unknown: 113. 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 Lidocaine 4% adverse events are: age 62: 780 reports, age 66: 743 reports, age 64: 733 reports, age 67: 715 reports, age 74: 700 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 Lidocaine 4% adverse event reports is Shenzhen Finona Information Technology Co., Ltd. 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 Lidocaine 4% include: Fatigue, Nausea, Headache, Dyspnoea, Pneumonia. 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 Lidocaine 4% 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.
Lidocaine 4% 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 reported reactions are non-serious, but serious adverse events, including death and pneumonia, are not uncommon.
Key safety signals identified in Lidocaine 4%'s adverse event data include: High frequency of drug ineffectiveness and product quality issues. Significant number of serious adverse events, including death and pneumonia. Common reactions include pain, fatigue, and nausea, indicating potential side effects. A high percentage of reports are related to off-label use, suggesting potential misuse. Multiple reports of drug interactions and inappropriate use, indicating a need for better guidance. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and inappropriate use are common, with warnings against off-label use and proper administration techniques. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine 4%.
Always follow the prescribed dosage and administration instructions to avoid potential side effects. Report any adverse reactions to healthcare providers promptly to ensure proper monitoring and management.
Lidocaine 4% has 109,615 adverse event reports on file with the FDA. Pain and fatigue are the most frequently reported symptoms, indicating potential issues with efficacy and patient comfort. The volume of reports for Lidocaine 4% reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on improving product quality and addressing misuse through better patient education and guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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