82/100 · Critical
Manufactured by Fresenius Kabi USA, LLC
Lidocaine Hydrochloride and Epinephrine Bitartrate Adverse Events: High Seriousness and Diverse Reactions
104,668 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 104,668 FDA adverse event reports, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE has a safety score of 82 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 HYDROCHLORIDE AND EPINEPHRINE BITARTRATE include DRUG INEFFECTIVE, PAIN, NAUSEA, FATIGUE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE.
Lidocaine Hydrochloride And Epinephrine Bitartrate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 104,668 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Drug Ineffective, Pain, Nausea. Of classified reports, 74.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but the serious event rate is high at 74.4%.
Pain and nausea are the most common reactions, but serious events like death and anaphylactic shock also occur. The reaction diversity is significant, with over 100 distinct reactions reported. The drug is frequently used off-label, which may contribute to adverse events. There is a notable age distribution, with the highest number of reports from individuals aged 60-74.
Patients taking Lidocaine Hydrochloride And Epinephrine Bitartrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and off-label use are common, leading to potential adverse events. Healthcare providers should be cautious and follow approved usage guidelines. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine Hydrochloride And Epinephrine Bitartrate received a safety concern score of 82/100 (high concern). This is based on a 74.4% serious event ratio across 50,510 classified reports. The score accounts for 104,668 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: 28,710, Male: 17,203, Unknown: 121. The most frequently reported age groups are age 62 (777 reports), age 66 (777 reports), age 67 (731 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 50,510 classified reports for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE:
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 off-label use are common, leading to potential adverse events. Healthcare providers should be cautious and follow approved usage guidelines.
If you are taking Lidocaine Hydrochloride And Epinephrine Bitartrate, here are important things to know. The most commonly reported side effects include drug ineffective, pain, nausea, fatigue, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the approved usage guidelines strictly to minimize the risk of adverse events. Report any serious or unusual reactions to the healthcare provider or the FDA. 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 this drug due to the high number of serious adverse events. Patients should report any unusual symptoms to their healthcare provider immediately.
The FDA has received approximately 104,668 adverse event reports associated with Lidocaine Hydrochloride And Epinephrine Bitartrate. 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 Hydrochloride And Epinephrine Bitartrate include Drug Ineffective, Pain, Nausea, Fatigue, Headache. By volume, the top reported reactions are: Drug Ineffective (3,670 reports), Pain (3,236 reports), Nausea (3,052 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 Hydrochloride And Epinephrine Bitartrate.
Out of 50,510 classified reports, 37,601 (74.4%) were classified as serious and 12,909 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 Hydrochloride And Epinephrine Bitartrate break down by patient sex as follows: Female: 28,710, Male: 17,203, Unknown: 121. 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 Hydrochloride And Epinephrine Bitartrate adverse events are: age 62: 777 reports, age 66: 777 reports, age 67: 731 reports, age 64: 710 reports, age 74: 708 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 Hydrochloride And Epinephrine Bitartrate adverse event reports is Fresenius Kabi Usa, 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 Lidocaine Hydrochloride And Epinephrine Bitartrate include: Off Label Use, Dyspnoea, Pneumonia, Diarrhoea, Sinusitis. 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 Hydrochloride And Epinephrine Bitartrate 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 Hydrochloride And Epinephrine Bitartrate has a safety concern score of 82 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. The majority of adverse events are non-serious, but the serious event rate is high at 74.4%.
Key safety signals identified in Lidocaine Hydrochloride And Epinephrine Bitartrate's adverse event data include: High rate of serious events (74.4%). Multiple serious reactions including death, anaphylactic shock, and cardiac arrest. Diverse reactions including local and systemic toxicity, respiratory issues, and neurological effects. Frequent off-label use reported. Significant number of reports related to product quality and use issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and off-label use are common, leading to potential adverse events. Healthcare providers should be cautious and follow approved usage guidelines. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine Hydrochloride And Epinephrine Bitartrate.
Follow the approved usage guidelines strictly to minimize the risk of adverse events. Report any serious or unusual reactions to the healthcare provider or the FDA.
Lidocaine Hydrochloride And Epinephrine Bitartrate has 104,668 adverse event reports on file with the FDA. Pain and nausea are the most common reactions, but serious events like death and anaphylactic shock also occur. The volume of reports for Lidocaine Hydrochloride And Epinephrine Bitartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor this drug due to the high number of serious adverse events. Patients should report any unusual symptoms to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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