75/100 · Elevated
Manufactured by Septodont, Inc.
Moderate Safety Concerns with Lidoctaine Hydrochloride and Epinephrine
98,129 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Septodont, Inc.. Based on analysis of 98,129 FDA adverse event reports, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE has a safety score of 75 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 include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, 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.
Lidocaine Hydrochloride And Epinephrine has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 98,129 adverse event reports for this medication, which is primarily manufactured by Septodont, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 73.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A significant number of reports involve serious adverse events such as death, cardiac arrest, and sepsis.
Pain and discomfort are frequently reported, indicating potential issues with efficacy and patient satisfaction. Drug interactions and inappropriate use are common, suggesting a need for strict adherence to guidelines. Serious reactions like pneumonia, sepsis, and renal failure are reported, indicating potential organ toxicity. The high volume of reports suggests a need for ongoing monitoring and patient education.
Patients taking Lidocaine Hydrochloride And Epinephrine 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, warning against the use of this combination without proper medical supervision. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine Hydrochloride And Epinephrine received a safety concern score of 75/100 (elevated concern). This is based on a 73.0% serious event ratio across 46,280 classified reports. The score accounts for 98,129 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: 26,550, Male: 15,487, Unknown: 101. The most frequently reported age groups are age 62 (707 reports), age 66 (691 reports), age 67 (659 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 46,280 classified reports for LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE:
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, warning against the use of this combination without proper medical supervision.
If you are taking Lidocaine Hydrochloride And Epinephrine, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow the prescribed dosage and administration guidelines to avoid potential adverse effects. Healthcare providers should be aware of the potential for serious adverse events and monitor patients closely. 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 for safety concerns, and healthcare providers should be vigilant in managing patient care and reporting adverse events.
The FDA has received approximately 98,129 adverse event reports associated with Lidocaine Hydrochloride And Epinephrine. 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 include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (3,486 reports), Pain (3,065 reports), Fatigue (2,861 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.
Out of 46,280 classified reports, 33,790 (73.0%) were classified as serious and 12,490 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 break down by patient sex as follows: Female: 26,550, Male: 15,487, Unknown: 101. 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 adverse events are: age 62: 707 reports, age 66: 691 reports, age 67: 659 reports, age 64: 656 reports, age 74: 650 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 adverse event reports is Septodont, Inc.. 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 include: Off Label Use, Dyspnoea, Sinusitis, Pneumonia, Diarrhoea. 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 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 has a safety concern score of 75 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. A significant number of reports involve serious adverse events such as death, cardiac arrest, and sepsis.
Key safety signals identified in Lidocaine Hydrochloride And Epinephrine's adverse event data include: Multiple reports of death and severe cardiac events (cardiac arrest, atrial fibrillation) indicate potential cardiovascular risks.. A significant number of reports involve serious infections (pneumonia, sepsis), suggesting possible immunosuppressive effects.. Reports of renal failure and acute kidney injury highlight potential nephrotoxicity.. A high frequency of drug interactions and inappropriate use suggests a need for better patient and provider education.. Severe allergic reactions (anaphylactic reaction, anaphylactic shock) are reported, indicating potential hypersensitivity issues.. 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, warning against the use of this combination without proper medical supervision. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine Hydrochloride And Epinephrine.
Patients should strictly follow the prescribed dosage and administration guidelines to avoid potential adverse effects. Healthcare providers should be aware of the potential for serious adverse events and monitor patients closely.
Lidocaine Hydrochloride And Epinephrine has 98,129 adverse event reports on file with the FDA. Pain and discomfort are frequently reported, indicating potential issues with efficacy and patient satisfaction. The volume of reports for Lidocaine Hydrochloride And Epinephrine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor this drug for safety concerns, and healthcare providers should be vigilant in managing patient care and reporting adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE:
Drugs related to LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE based on therapeutic use, drug class, or shared indications: