85/100 · Critical
Manufactured by Encube Ethicals, Inc.
Metronidazole Topical Adverse Events: High Seriousness and Diverse Reactions
91,758 FDA adverse event reports analyzed
Last updated: 2026-05-12
METRONIDAZOLE TOPICAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Encube Ethicals, Inc.. Based on analysis of 91,758 FDA adverse event reports, METRONIDAZOLE TOPICAL has a safety score of 85 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 METRONIDAZOLE TOPICAL include DRUG INEFFECTIVE, NAUSEA, OFF LABEL USE, DIARRHOEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METRONIDAZOLE TOPICAL.
Metronidazole Topical has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 91,758 adverse event reports for this medication, which is primarily manufactured by Encube Ethicals, Inc..
The most commonly reported adverse events include Drug Ineffective, Nausea, Off Label Use. Of classified reports, 87.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (87.3%) indicates significant safety concerns.
A wide range of reactions, including kidney and respiratory issues, suggest diverse potential side effects. Significant reports of drug interactions and hyper-sensitivity reactions highlight the need for caution.
Patients taking Metronidazole Topical should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Metronidazole Topical can interact with other drugs, and patients should be aware of potential drug interactions and hypersensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Metronidazole Topical received a safety concern score of 85/100 (high concern). This is based on a 87.3% serious event ratio across 45,806 classified reports. The score accounts for 91,758 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 25,142, Male: 15,907, Unknown: 136. The most frequently reported age groups are age 65 (757 reports), age 71 (748 reports), age 66 (712 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 45,806 classified reports for METRONIDAZOLE TOPICAL:
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.
Metronidazole Topical can interact with other drugs, and patients should be aware of potential drug interactions and hypersensitivity reactions.
If you are taking Metronidazole Topical, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, off label use, diarrhoea, vomiting. 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 using Metronidazole Topical for any unapproved indications. Be aware of potential serious side effects and report any adverse reactions promptly. 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 closely monitors Metronidazole Topical, and any unusual symptoms should be reported to healthcare providers immediately.
The FDA has received approximately 91,758 adverse event reports associated with Metronidazole Topical. 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 Metronidazole Topical include Drug Ineffective, Nausea, Off Label Use, Diarrhoea, Vomiting. By volume, the top reported reactions are: Drug Ineffective (4,365 reports), Nausea (3,318 reports), Off Label Use (3,130 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Metronidazole Topical.
Out of 45,806 classified reports, 39,972 (87.3%) were classified as serious and 5,834 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 Metronidazole Topical break down by patient sex as follows: Female: 25,142, Male: 15,907, Unknown: 136. 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 Metronidazole Topical adverse events are: age 65: 757 reports, age 71: 748 reports, age 66: 712 reports, age 60: 697 reports, age 69: 687 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 Metronidazole Topical adverse event reports is Encube Ethicals, 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 Metronidazole Topical include: Pyrexia, Headache, Pain, Abdominal Pain, Fatigue. 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 Metronidazole Topical 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.
Metronidazole Topical has a safety concern score of 85 out of 100 (high 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. High percentage of serious adverse events (87.3%) indicates significant safety concerns.
Key safety signals identified in Metronidazole Topical's adverse event data include: Acute kidney injury and chronic kidney disease are reported in a notable number of cases.. Respiratory issues such as dyspnoea and pneumonia are frequent.. Severe reactions like septic shock and toxic encephalopathy are documented.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Metronidazole Topical can interact with other drugs, and patients should be aware of potential drug interactions and hypersensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Metronidazole Topical.
Consult a healthcare provider before using Metronidazole Topical for any unapproved indications. Be aware of potential serious side effects and report any adverse reactions promptly.
Metronidazole Topical has 91,758 adverse event reports on file with the FDA. A wide range of reactions, including kidney and respiratory issues, suggest diverse potential side effects. The volume of reports for Metronidazole Topical reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Metronidazole Topical, and any unusual symptoms should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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