65/100 · Elevated
Manufactured by Alembic Pharmaceuticals Inc.
Moderate Safety Concerns with Lidocaine and Prilocaine Use
2,864 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE AND PRILOCAINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 2,864 FDA adverse event reports, LIDOCAINE AND PRILOCAINE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for LIDOCAINE AND PRILOCAINE include FATIGUE, NAUSEA, DIARRHOEA, OFF LABEL USE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE AND PRILOCAINE.
Lidocaine And Prilocaine has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 2,864 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 58.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fever and respiratory issues are common, indicating potential allergic reactions.
Death and serious infections are reported, highlighting severe risks. Pain and gastrointestinal issues are frequent, suggesting possible side effects. Drug dose errors and inappropriate use are significant, indicating potential misuse.
Patients taking Lidocaine And Prilocaine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not explicitly mentioned, but patients should be cautious of potential interactions with other anesthetics or medications affecting the cardiovascular or respiratory systems. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine And Prilocaine received a safety concern score of 65/100 (elevated concern). This is based on a 58.6% serious event ratio across 1,205 classified reports. The score accounts for 2,864 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: 582, Male: 364, Unknown: 1. The most frequently reported age groups are age 65 (23 reports), age 62 (17 reports), age 59 (15 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,205 classified reports for LIDOCAINE AND PRILOCAINE:
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 are not explicitly mentioned, but patients should be cautious of potential interactions with other anesthetics or medications affecting the cardiovascular or respiratory systems.
If you are taking Lidocaine And Prilocaine, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, off label use, vomiting. 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. Report any adverse reactions 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 the safety of lidocaine and prilocaine, and healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 2,864 adverse event reports associated with Lidocaine And Prilocaine. 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 And Prilocaine include Fatigue, Nausea, Diarrhoea, Off Label Use, Vomiting. By volume, the top reported reactions are: Fatigue (143 reports), Nausea (113 reports), Diarrhoea (95 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 And Prilocaine.
Out of 1,205 classified reports, 706 (58.6%) were classified as serious and 499 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 And Prilocaine break down by patient sex as follows: Female: 582, Male: 364, Unknown: 1. 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 And Prilocaine adverse events are: age 65: 23 reports, age 62: 17 reports, age 59: 15 reports, age 63: 15 reports, age 70: 15 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 And Prilocaine adverse event reports is Alembic Pharmaceuticals 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 And Prilocaine include: Pyrexia, Death, Dyspnoea, Product Dose Omission Issue, Pain. 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 And Prilocaine 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 And Prilocaine has a safety concern score of 65 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. Fever and respiratory issues are common, indicating potential allergic reactions.
Key safety signals identified in Lidocaine And Prilocaine's adverse event data include: Fever (67 reports) and pneumonia (54 reports) suggest allergic reactions or infections.. Death (62 reports) and serious infections (27 reports) indicate severe risks.. Pain (60 reports) and gastrointestinal issues (26 reports) are common side effects.. Drug dose omission (61 reports) and inappropriate use (23 reports) indicate misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not explicitly mentioned, but patients should be cautious of potential interactions with other anesthetics or medications affecting the cardiovascular or respiratory systems. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine And Prilocaine.
Always follow the prescribed dosage and administration instructions. Report any adverse reactions to your healthcare provider immediately.
Lidocaine And Prilocaine has 2,864 adverse event reports on file with the FDA. Death and serious infections are reported, highlighting severe risks. The volume of reports for Lidocaine And Prilocaine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of lidocaine and prilocaine, and 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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