45/100 · Moderate
Manufactured by TPU Pharma, Inc.
LidoCaine Patch 5% Reports Mostly Mild to Moderate Reactions
18,664 FDA adverse event reports analyzed
Last updated: 2026-05-12
LIDOCAINE PATCH 5% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by TPU Pharma, Inc.. Based on analysis of 18,664 FDA adverse event reports, LIDOCAINE PATCH 5% has a safety score of 45 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 PATCH 5% include PAIN, NAUSEA, FATIGUE, FALL, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LIDOCAINE PATCH 5%.
Lidocaine Patch 5% has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 18,664 adverse event reports for this medication, which is primarily manufactured by Tpu Pharma, Inc..
The most commonly reported adverse events include Pain, Nausea, Fatigue. Of classified reports, 65.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are mild to moderate in severity, with pain being the most common complaint.
Serious reactions, such as pneumonia and death, are less frequent but still notable. Report volume is high, indicating widespread use and potential for increased reporting.
Patients taking Lidocaine Patch 5% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but caution is advised for patients with pre-existing conditions such as kidney or heart disease. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lidocaine Patch 5% received a safety concern score of 45/100 (moderate concern). This is based on a 65.0% serious event ratio across 7,638 classified reports. The score accounts for 18,664 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 5,536, Male: 1,803, Unknown: 14. The most frequently reported age groups are age 64 (136 reports), age 63 (129 reports), age 69 (129 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 7,638 classified reports for LIDOCAINE PATCH 5%:
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.
No specific drug interactions are noted, but caution is advised for patients with pre-existing conditions such as kidney or heart disease.
If you are taking Lidocaine Patch 5%, here are important things to know. The most commonly reported side effects include pain, nausea, fatigue, fall, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any unusual symptoms to their healthcare provider. Follow the prescribed usage instructions to minimize the risk of adverse reactions. 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 Patch 5% and updates the public as new information becomes available.
The FDA has received approximately 18,664 adverse event reports associated with Lidocaine Patch 5%. 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 Patch 5% include Pain, Nausea, Fatigue, Fall, Dyspnoea. By volume, the top reported reactions are: Pain (669 reports), Nausea (585 reports), Fatigue (543 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 Patch 5%.
Out of 7,638 classified reports, 4,965 (65.0%) were classified as serious and 2,673 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 Patch 5% break down by patient sex as follows: Female: 5,536, Male: 1,803, Unknown: 14. 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 Patch 5% adverse events are: age 64: 136 reports, age 63: 129 reports, age 69: 129 reports, age 56: 122 reports, age 60: 122 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 Patch 5% adverse event reports is Tpu Pharma, 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 Patch 5% include: Drug Ineffective, Headache, Diarrhoea, Arthralgia, Dizziness. 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 Patch 5% 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 Patch 5% has a safety concern score of 45 out of 100 (moderate 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 reported reactions are mild to moderate in severity, with pain being the most common complaint.
Key safety signals identified in Lidocaine Patch 5%'s adverse event data include: Pain is the most frequent reaction, reported in over 300 cases.. Serious reactions like pneumonia and death are reported but occur in fewer cases.. A wide range of reactions is observed, indicating potential for diverse side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but caution is advised for patients with pre-existing conditions such as kidney or heart disease. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lidocaine Patch 5%.
Patients should report any unusual symptoms to their healthcare provider. Follow the prescribed usage instructions to minimize the risk of adverse reactions.
Lidocaine Patch 5% has 18,664 adverse event reports on file with the FDA. Serious reactions, such as pneumonia and death, are less frequent but still notable. The volume of reports for Lidocaine Patch 5% reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of LidoCaine Patch 5% and updates the public as new information becomes available. 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 PATCH 5%:
Drugs related to LIDOCAINE PATCH 5% based on therapeutic use, drug class, or shared indications: