72/100 · Elevated
Manufactured by AbbVie Inc.
Fenofibrate Adverse Events: High Serious Reaction Rate
92,182 FDA adverse event reports analyzed
Last updated: 2026-05-12
FENOFIBRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 92,182 FDA adverse event reports, FENOFIBRATE 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 FENOFIBRATE include NAUSEA, FATIGUE, DIARRHOEA, DRUG INEFFECTIVE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FENOFIBRATE.
Fenofibrate 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 92,182 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 64.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea, fatigue, and diarrhea are the most common adverse reactions.
Serious reactions, including acute kidney injury and renal failure, are frequent. Drug interactions and dose omissions are reported, warranting caution.
Patients taking Fenofibrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fenofibrate can interact with other drugs, and dose omissions are reported, indicating potential for underdosing or overdosing. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fenofibrate received a safety concern score of 72/100 (elevated concern). This is based on a 64.7% serious event ratio across 48,065 classified reports. The score accounts for 92,182 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: Male: 23,048, Female: 21,707, Unknown: 79. The most frequently reported age groups are age 63 (959 reports), age 60 (940 reports), age 65 (914 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 48,065 classified reports for FENOFIBRATE:
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.
Fenofibrate can interact with other drugs, and dose omissions are reported, indicating potential for underdosing or overdosing.
If you are taking Fenofibrate, here are important things to know. The most commonly reported side effects include nausea, fatigue, diarrhoea, drug ineffective, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of kidney injury and adjust dosing as needed. Be cautious with drug interactions and inform healthcare providers of all medications taken. 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 drug interactions.
The FDA has received approximately 92,182 adverse event reports associated with Fenofibrate. 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 Fenofibrate include Nausea, Fatigue, Diarrhoea, Drug Ineffective, Dyspnoea. By volume, the top reported reactions are: Nausea (2,913 reports), Fatigue (2,842 reports), Diarrhoea (2,681 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fenofibrate.
Out of 48,065 classified reports, 31,110 (64.7%) were classified as serious and 16,955 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 Fenofibrate break down by patient sex as follows: Male: 23,048, Female: 21,707, Unknown: 79. 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 Fenofibrate adverse events are: age 63: 959 reports, age 60: 940 reports, age 65: 914 reports, age 66: 911 reports, age 62: 889 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 Fenofibrate adverse event reports is Abbvie 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 Fenofibrate include: Headache, Dizziness, Pain, Asthenia, Fall. 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 Fenofibrate 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.
Fenofibrate 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. Nausea, fatigue, and diarrhea are the most common adverse reactions.
Key safety signals identified in Fenofibrate's adverse event data include: Acute kidney injury and renal failure are key safety signals.. Drug interactions and dose omissions are significant safety concerns.. Serious adverse events account for over 64% of reports.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fenofibrate can interact with other drugs, and dose omissions are reported, indicating potential for underdosing or overdosing. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fenofibrate.
Monitor for signs of kidney injury and adjust dosing as needed. Be cautious with drug interactions and inform healthcare providers of all medications taken.
Fenofibrate has 92,182 adverse event reports on file with the FDA. Serious reactions, including acute kidney injury and renal failure, are frequent. The volume of reports for Fenofibrate 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 drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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