82/100 · Critical
Manufactured by Sanofi-Aventis U.S. LLC
High Serious Adverse Reactions Associated with Irbesartan Use
85,150 FDA adverse event reports analyzed
Last updated: 2026-05-12
IRBESARTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sanofi-Aventis U.S. LLC. Based on analysis of 85,150 FDA adverse event reports, IRBESARTAN has a safety score of 82 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 IRBESARTAN include FATIGUE, NAUSEA, DIARRHOEA, DRUG INEFFECTIVE, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IRBESARTAN.
Irbesartan has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 85,150 adverse event reports for this medication, which is primarily manufactured by Sanofi-Aventis U.S. Llc.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 78.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse reactions such as acute kidney injury and renal failure are common, indicating potential renal toxicity.
Falls and dizziness are frequent, suggesting a risk of falls and accidents in elderly patients. Drug interactions and ineffective drug performance are reported, indicating potential issues with drug efficacy and compatibility.
Patients taking Irbesartan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Irbesartan can cause dizziness and falls, especially in elderly patients, and may interact with other drugs, leading to reduced efficacy or adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Irbesartan received a safety concern score of 82/100 (high concern). This is based on a 78.1% serious event ratio across 43,001 classified reports. The score accounts for 85,150 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: 22,580, Male: 16,927, Unknown: 39. The most frequently reported age groups are age 72 (1,100 reports), age 73 (1,025 reports), age 67 (1,008 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 43,001 classified reports for IRBESARTAN:
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.
Irbesartan can cause dizziness and falls, especially in elderly patients, and may interact with other drugs, leading to reduced efficacy or adverse effects.
If you are taking Irbesartan, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, drug ineffective, acute kidney injury. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of renal impairment, especially in elderly patients. Be cautious of potential drug interactions and monitor for adverse effects. 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 has not issued specific warnings for Irbesartan, but healthcare providers should monitor patients for signs of renal impairment and adjust dosages accordingly.
The FDA has received approximately 85,150 adverse event reports associated with Irbesartan. 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 Irbesartan include Fatigue, Nausea, Diarrhoea, Drug Ineffective, Acute Kidney Injury. By volume, the top reported reactions are: Fatigue (2,461 reports), Nausea (2,423 reports), Diarrhoea (2,261 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Irbesartan.
Out of 43,001 classified reports, 33,589 (78.1%) were classified as serious and 9,412 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 Irbesartan break down by patient sex as follows: Female: 22,580, Male: 16,927, Unknown: 39. 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 Irbesartan adverse events are: age 72: 1,100 reports, age 73: 1,025 reports, age 67: 1,008 reports, age 70: 988 reports, age 71: 972 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 Irbesartan adverse event reports is Sanofi-Aventis U.S. Llc. 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 Irbesartan include: Dizziness, Dyspnoea, Fall, Headache, Asthenia. 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 Irbesartan 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.
Irbesartan has a safety concern score of 82 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. Serious adverse reactions such as acute kidney injury and renal failure are common, indicating potential renal toxicity.
Key safety signals identified in Irbesartan's adverse event data include: Acute kidney injury and renal failure. Falls and dizziness. Drug interactions and ineffective drug performance. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Irbesartan can cause dizziness and falls, especially in elderly patients, and may interact with other drugs, leading to reduced efficacy or adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Irbesartan.
Monitor patients for signs of renal impairment, especially in elderly patients. Be cautious of potential drug interactions and monitor for adverse effects.
Irbesartan has 85,150 adverse event reports on file with the FDA. Falls and dizziness are frequent, suggesting a risk of falls and accidents in elderly patients. The volume of reports for Irbesartan reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for Irbesartan, but healthcare providers should monitor patients for signs of renal impairment and adjust dosages accordingly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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