72/100 · Elevated
Manufactured by Cosette Pharmaceuticals, Inc.
Olmesartan Medoxomil: Common Gastrointestinal and Hypotensive Reactions
74,967 FDA adverse event reports analyzed
Last updated: 2026-05-12
OLMESARTAN MEDOXOMIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cosette Pharmaceuticals, Inc.. Based on analysis of 74,967 FDA adverse event reports, OLMESARTAN MEDOXOMIL 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 OLMESARTAN MEDOXOMIL include SPRUE-LIKE ENTEROPATHY, DIARRHOEA, WEIGHT DECREASED, GASTROOESOPHAGEAL REFLUX DISEASE, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OLMESARTAN MEDOXOMIL.
Olmesartan Medoxomil 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 74,967 adverse event reports for this medication, which is primarily manufactured by Cosette Pharmaceuticals, Inc..
The most commonly reported adverse events include Sprue-Like Enteropathy, Diarrhoea, Weight Decreased. Of classified reports, 65.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are gastrointestinal issues like diarrhea and nausea, and hypotension.
Serious adverse events, such as acute kidney injury and chronic kidney disease, are reported but less frequent. Weight changes, both increased and decreased, are notable side effects. Drug ineffectiveness and drug interaction reports are significant concerns. Hypertension and blood pressure changes are frequently reported, indicating potential cardiovascular effects.
Patients taking Olmesartan Medoxomil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Olmesartan Medoxomil can cause hypotension and should be used with caution in patients with a history of hypotension or other cardiovascular conditions. Drug interactions are also a concern, and patients should inform their healthcare providers of al This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Olmesartan Medoxomil received a safety concern score of 72/100 (elevated concern). This is based on a 65.6% serious event ratio across 35,039 classified reports. The score accounts for 74,967 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: 16,552, Male: 10,785, Unknown: 83. The most frequently reported age groups are age 70 (588 reports), age 65 (567 reports), age 75 (561 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,039 classified reports for OLMESARTAN MEDOXOMIL:
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.
Olmesartan Medoxomil can cause hypotension and should be used with caution in patients with a history of hypotension or other cardiovascular conditions. Drug interactions are also a concern, and patients should inform their healthcare providers of al
If you are taking Olmesartan Medoxomil, here are important things to know. The most commonly reported side effects include sprue-like enteropathy, diarrhoea, weight decreased, gastrooesophageal reflux disease, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about all medications and supplements you are taking to avoid potential drug interactions. Monitor your blood pressure regularly and report any significant changes to your healthcare provider. 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 the safety of Olmesartan Medoxomil, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should follow their prescribed dosing and consult their healthcare provider if they exp
The FDA has received approximately 74,967 adverse event reports associated with Olmesartan Medoxomil. 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 Olmesartan Medoxomil include Sprue-Like Enteropathy, Diarrhoea, Weight Decreased, Gastrooesophageal Reflux Disease, Dizziness. By volume, the top reported reactions are: Sprue-Like Enteropathy (3,449 reports), Diarrhoea (2,421 reports), Weight Decreased (2,200 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Olmesartan Medoxomil.
Out of 35,039 classified reports, 22,983 (65.6%) were classified as serious and 12,056 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 Olmesartan Medoxomil break down by patient sex as follows: Female: 16,552, Male: 10,785, Unknown: 83. 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 Olmesartan Medoxomil adverse events are: age 70: 588 reports, age 65: 567 reports, age 75: 561 reports, age 71: 552 reports, age 60: 545 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 Olmesartan Medoxomil adverse event reports is Cosette 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 Olmesartan Medoxomil include: Nausea, Acute Kidney Injury, Drug Ineffective, Fatigue, 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 Olmesartan Medoxomil 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.
Olmesartan Medoxomil 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. The most common reactions are gastrointestinal issues like diarrhea and nausea, and hypotension.
Key safety signals identified in Olmesartan Medoxomil's adverse event data include: Acute kidney injury and chronic kidney disease are key safety signals.. Hypotension and related cardiovascular events are significant.. Gastrointestinal issues like diarrhea and nausea are common.. Drug ineffectiveness and interaction reports are frequent.. Serious adverse events, though less common, include death and myocardial infarction.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Olmesartan Medoxomil can cause hypotension and should be used with caution in patients with a history of hypotension or other cardiovascular conditions. Drug interactions are also a concern, and patients should inform their healthcare providers of al Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Olmesartan Medoxomil.
Inform your healthcare provider about all medications and supplements you are taking to avoid potential drug interactions. Monitor your blood pressure regularly and report any significant changes to your healthcare provider.
Olmesartan Medoxomil has 74,967 adverse event reports on file with the FDA. Serious adverse events, such as acute kidney injury and chronic kidney disease, are reported but less frequent. The volume of reports for Olmesartan Medoxomil reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Olmesartan Medoxomil, and healthcare providers should report any adverse events to the FDA's MedWatch program. Patients should follow their prescribed dosing and consult their healthcare provider if they exp For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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