65/100 · Elevated
Manufactured by Resilia Pharmaceuticals, Inc.
Econazole Nitrate Adverse Events: Moderate Safety Concerns
2,049 FDA adverse event reports analyzed
Last updated: 2026-05-12
ECONAZOLE NITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Resilia Pharmaceuticals, Inc.. Based on analysis of 2,049 FDA adverse event reports, ECONAZOLE NITRATE 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 ECONAZOLE NITRATE include DRUG INEFFECTIVE, FATIGUE, DYSPNOEA, PAIN, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ECONAZOLE NITRATE.
Econazole Nitrate 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 2,049 adverse event reports for this medication, which is primarily manufactured by Resilia Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Dyspnoea. Of classified reports, 65.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and dyspnoea are common, with a significant number of serious adverse events reported.
Drug ineffectiveness and drug interactions are notable concerns. Renal failure and acute kidney injury are serious adverse events that require monitoring. A diverse range of reactions indicates potential for multiple side effects.
Patients taking Econazole Nitrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and ineffectiveness are common, and patients should be monitored for potential interactions with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Econazole Nitrate received a safety concern score of 65/100 (elevated concern). This is based on a 65.4% serious event ratio across 884 classified reports. The score accounts for 2,049 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: 428, Male: 385, Unknown: 1. The most frequently reported age groups are age 72 (21 reports), age 62 (18 reports), age 82 (17 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 884 classified reports for ECONAZOLE NITRATE:
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 ineffectiveness are common, and patients should be monitored for potential interactions with other medications.
If you are taking Econazole Nitrate, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, dyspnoea, pain, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider of all medications they are taking to avoid potential drug interactions. Regular follow-ups are recommended to monitor for any adverse reactions or ineffectiveness. 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring drug efficacy.
The FDA has received approximately 2,049 adverse event reports associated with Econazole Nitrate. 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 Econazole Nitrate include Drug Ineffective, Fatigue, Dyspnoea, Pain, Nausea. By volume, the top reported reactions are: Drug Ineffective (58 reports), Fatigue (54 reports), Dyspnoea (46 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Econazole Nitrate.
Out of 884 classified reports, 578 (65.4%) were classified as serious and 306 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 Econazole Nitrate break down by patient sex as follows: Female: 428, Male: 385, 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 Econazole Nitrate adverse events are: age 72: 21 reports, age 62: 18 reports, age 82: 17 reports, age 86: 17 reports, age 35: 16 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 Econazole Nitrate adverse event reports is Resilia 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 Econazole Nitrate include: Rash, Diarrhoea, Dizziness, Renal Failure, Headache. 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 Econazole Nitrate 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.
Econazole Nitrate 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. Fatigue and dyspnoea are common, with a significant number of serious adverse events reported.
Key safety signals identified in Econazole Nitrate's adverse event data include: High frequency of serious adverse events (578 out of 884, 65.4%). Multiple organ systems affected, including respiratory, renal, and cardiovascular. Drug ineffectiveness and drug interactions are frequently reported. A wide range of reactions, including neurological and gastrointestinal symptoms. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and ineffectiveness are common, and patients should be monitored for potential interactions with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Econazole Nitrate.
Patients should inform their healthcare provider of all medications they are taking to avoid potential drug interactions. Regular follow-ups are recommended to monitor for any adverse reactions or ineffectiveness.
Econazole Nitrate has 2,049 adverse event reports on file with the FDA. Drug ineffectiveness and drug interactions are notable concerns. The volume of reports for Econazole Nitrate reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring drug efficacy. 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 ECONAZOLE NITRATE:
Drugs related to ECONAZOLE NITRATE based on therapeutic use, drug class, or shared indications: