78/100 · Elevated
Manufactured by Shenzhen Finona Information Technology Co., Ltd
Lidocaine Adverse Events: High Serious Event Rate and Diverse Reactions
120,190 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Shenzhen Finona Information Technology Co., Ltd. Based on analysis of 120,190 FDA adverse event reports, LIDOCAINE has a safety score of 78 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 include DRUG INEFFECTIVE, OFF LABEL USE, PAIN, PRODUCT ADHESION ISSUE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE.
Lidocaine has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 120,190 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, Pain. Of classified reports, 65.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Lidocaine reports show a high serious event rate, with over 65% of reactions being serious.
The most common reactions include pain, fatigue, and nausea, indicating potential systemic effects. A diverse range of reactions, from respiratory issues to neurological effects, suggests a broad safety profile. The majority of reports come from older adults, with the highest number of reports from those aged 60-74. Drug ineffectiveness and inappropriate use are frequent, highlighting potential misuse or dosing issues.
Patients taking Lidocaine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lidocaine has warnings for drug interactions, particularly with other local anesthetics and anticholinergics, and should be used with caution in patients with cardiovascular or respiratory conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine received a safety concern score of 78/100 (high concern). This is based on a 65.8% serious event ratio across 55,215 classified reports. The score accounts for 120,190 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 32,647, Male: 17,698, Unknown: 118. The most frequently reported age groups are age 62 (804 reports), age 66 (776 reports), age 67 (757 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,215 classified reports for LIDOCAINE:
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.
Lidocaine has warnings for drug interactions, particularly with other local anesthetics and anticholinergics, and should be used with caution in patients with cardiovascular or respiratory conditions.
If you are taking Lidocaine, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, pain, product adhesion issue, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing and usage instructions carefully to avoid adverse reactions. Report any serious or unusual side effects 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 continues to monitor lidocaine safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should follow prescribed dosing and usage instructions to minimize risks.
The FDA has received approximately 120,190 adverse event reports associated with Lidocaine. 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 include Drug Ineffective, Off Label Use, Pain, Product Adhesion Issue, Fatigue. By volume, the top reported reactions are: Drug Ineffective (4,180 reports), Off Label Use (3,932 reports), Pain (3,538 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.
Out of 55,215 classified reports, 36,354 (65.8%) were classified as serious and 18,861 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 break down by patient sex as follows: Female: 32,647, Male: 17,698, Unknown: 118. 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 adverse events are: age 62: 804 reports, age 66: 776 reports, age 67: 757 reports, age 64: 756 reports, age 60: 728 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 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 include: Nausea, Product Quality Issue, Headache, Sinusitis, Dyspnoea. 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 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 has a safety concern score of 78 out of 100 (high 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. Lidocaine reports show a high serious event rate, with over 65% of reactions being serious.
Key safety signals identified in Lidocaine's adverse event data include: High serious event rate (65.8%). Diverse reactions including respiratory, neurological, and gastrointestinal issues. Frequent drug ineffectiveness and off-label use reports. Significant number of reports related to product quality and administration issues. Multiple reports of death and severe infections. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lidocaine has warnings for drug interactions, particularly with other local anesthetics and anticholinergics, and should be used with caution in patients with cardiovascular or respiratory conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine.
Follow prescribed dosing and usage instructions carefully to avoid adverse reactions. Report any serious or unusual side effects to your healthcare provider immediately.
Lidocaine has 120,190 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and nausea, indicating potential systemic effects. The volume of reports for Lidocaine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor lidocaine safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should follow prescribed dosing and usage instructions to minimize risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Shenzhen Finona Information Technology Co., Ltd and compare their safety profiles:
View all Shenzhen Finona Information Technology Co., Ltd drugs →
The following drugs share commonly reported adverse reactions with LIDOCAINE:
Drugs related to LIDOCAINE based on therapeutic use, drug class, or shared indications: