72/100 · Elevated
Manufactured by ANI Pharmaceuticals, Inc.
Etodolac Adverse Events: High Serious Reaction Rate and Diverse Safety Profile
10,761 FDA adverse event reports analyzed
Last updated: 2026-05-12
ETODOLAC is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 10,761 FDA adverse event reports, ETODOLAC has a safety score of 72 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 ETODOLAC include DRUG INEFFECTIVE, PAIN, NAUSEA, ARTHRALGIA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ETODOLAC.
Etodolac has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 10,761 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Nausea. Of classified reports, 64.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Etodolac reports show a high percentage of serious adverse events, particularly renal and cardiovascular issues.
The drug is associated with a wide range of reactions, indicating a complex safety profile. Pain and gastrointestinal issues are the most commonly reported side effects.
Patients taking Etodolac should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Etodolac is contraindicated in patients with a history of hypersensitivity reactions. It may interact with other NSAIDs and increase the risk of gastrointestinal bleeding. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Etodolac received a safety concern score of 72/100 (elevated concern). This is based on a 64.8% serious event ratio across 5,881 classified reports. The score accounts for 10,761 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: 3,702, Male: 1,943, Unknown: 10. The most frequently reported age groups are age 60 (131 reports), age 54 (115 reports), age 63 (113 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 5,881 classified reports for ETODOLAC:
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.
Etodolac is contraindicated in patients with a history of hypersensitivity reactions. It may interact with other NSAIDs and increase the risk of gastrointestinal bleeding.
If you are taking Etodolac, here are important things to know. The most commonly reported side effects include drug ineffective, pain, nausea, arthralgia, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting etodolac, especially if you have a history of kidney or heart problems. Monitor for signs of serious adverse events such as kidney failure or cardiovascular issues. 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 etodolac for safety, particularly in patients with pre-existing renal or cardiovascular conditions.
The FDA has received approximately 10,761 adverse event reports associated with Etodolac. 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 Etodolac include Drug Ineffective, Pain, Nausea, Arthralgia, Fatigue. By volume, the top reported reactions are: Drug Ineffective (362 reports), Pain (350 reports), Nausea (290 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Etodolac.
Out of 5,881 classified reports, 3,812 (64.8%) were classified as serious and 2,069 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 Etodolac break down by patient sex as follows: Female: 3,702, Male: 1,943, Unknown: 10. 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 Etodolac adverse events are: age 60: 131 reports, age 54: 115 reports, age 63: 113 reports, age 59: 109 reports, age 65: 109 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 Etodolac adverse event reports is Ani 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 Etodolac include: Headache, Diarrhoea, Dyspnoea, Dizziness, Rash. 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 Etodolac 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.
Etodolac has a safety concern score of 72 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. Etodolac reports show a high percentage of serious adverse events, particularly renal and cardiovascular issues.
Key safety signals identified in Etodolac's adverse event data include: Renal failure and chronic kidney disease are among the most serious reported reactions.. Cardiovascular events such as myocardial infarction and pulmonary embolism are also notable.. A diverse range of reactions, including neurological and respiratory issues, further complicates the safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Etodolac is contraindicated in patients with a history of hypersensitivity reactions. It may interact with other NSAIDs and increase the risk of gastrointestinal bleeding. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Etodolac.
Consult a healthcare provider before starting etodolac, especially if you have a history of kidney or heart problems. Monitor for signs of serious adverse events such as kidney failure or cardiovascular issues.
Etodolac has 10,761 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, indicating a complex safety profile. The volume of reports for Etodolac reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor etodolac for safety, particularly in patients with pre-existing renal or cardiovascular conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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