73/100 · Elevated
Manufactured by Fresenius Kabi USA, LLC
Moderate Safety Concerns with Lidocaine Hydrochloride
116,938 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 116,938 FDA adverse event reports, LIDOCAINE HYDROCHLORIDE has a safety score of 73 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 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.
Lidocaine Hydrochloride has a safety concern score of 73 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 116,938 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, 73.9% 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 serious reactions such as death, cardiac arrest, and sepsis are reported.
Pain and nausea are the most common reactions, indicating potential side effects during administration. There is a notable number of drug interactions and overdose reports, suggesting caution is needed.
Patients taking Lidocaine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lidocaine Hydrochloride can cause drug interactions and overdose, which can lead to serious adverse events. Healthcare providers should be cautious when co-administering with other drugs and monitor patients closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine Hydrochloride received a safety concern score of 73/100 (elevated concern). This is based on a 73.9% serious event ratio across 56,775 classified reports. The score accounts for 116,938 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: 32,341, Male: 19,255, Unknown: 177. The most frequently reported age groups are age 62 (892 reports), age 66 (891 reports), age 67 (824 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 56,775 classified reports for LIDOCAINE HYDROCHLORIDE:
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 Hydrochloride can cause drug interactions and overdose, which can lead to serious adverse events. Healthcare providers should be cautious when co-administering with other drugs and monitor patients closely.
If you are taking Lidocaine Hydrochloride, 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 prescribed dosage and administration instructions carefully to avoid overdose and other adverse reactions. Inform your healthcare provider about any other medications you are taking to avoid potential drug interactions. 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 monitors lidocaine hydrochloride for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 116,938 adverse event reports associated with Lidocaine Hydrochloride. 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 include Drug Ineffective, Pain, Nausea, Fatigue, Headache. By volume, the top reported reactions are: Drug Ineffective (4,170 reports), Pain (3,541 reports), Nausea (3,513 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.
Out of 56,775 classified reports, 41,968 (73.9%) were classified as serious and 14,807 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 break down by patient sex as follows: Female: 32,341, Male: 19,255, Unknown: 177. 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 adverse events are: age 62: 892 reports, age 66: 891 reports, age 67: 824 reports, age 64: 795 reports, age 60: 782 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 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 include: Off Label Use, Dyspnoea, Diarrhoea, Pneumonia, Vomiting. 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 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 has a safety concern score of 73 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 adverse events are non-serious, but serious reactions such as death, cardiac arrest, and sepsis are reported.
Key safety signals identified in Lidocaine Hydrochloride's adverse event data include: Death and serious adverse events like cardiac arrest and sepsis are reported.. Drug interactions and overdose are significant safety signals.. Pain and nausea are the most frequent reactions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lidocaine Hydrochloride can cause drug interactions and overdose, which can lead to serious adverse events. Healthcare providers should be cautious when co-administering with other drugs and monitor patients closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine Hydrochloride.
Follow the prescribed dosage and administration instructions carefully to avoid overdose and other adverse reactions. Inform your healthcare provider about any other medications you are taking to avoid potential drug interactions.
Lidocaine Hydrochloride has 116,938 adverse event reports on file with the FDA. Pain and nausea are the most common reactions, indicating potential side effects during administration. The volume of reports for Lidocaine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA monitors lidocaine hydrochloride for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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