85/100 · Critical
Manufactured by CVS Pharmacy
High Concern for Renal and Gastrointestinal Issues with Esomeprazole
138,219 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESOMEPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. Based on analysis of 138,219 FDA adverse event reports, ESOMEPRAZOLE 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 ESOMEPRAZOLE include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, NAUSEA, DIARRHOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESOMEPRAZOLE.
Esomeprazole 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 138,219 adverse event reports for this medication, which is primarily manufactured by Cvs Pharmacy.
The most commonly reported adverse events include Chronic Kidney Disease, Acute Kidney Injury, Nausea. Of classified reports, 88.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic and acute kidney disease are among the most frequently reported serious adverse events.
Gastrointestinal issues such as nausea, diarrhea, and abdominal pain are common. Renal impairment and failure are significant safety concerns.
Patients taking Esomeprazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Esomeprazole can cause renal impairment and failure, and patients should be monitored for signs of kidney issues, especially those with pre-existing renal conditions. Drug interactions are also a concern, particularly with other nephrotoxic agents. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Esomeprazole received a safety concern score of 85/100 (high concern). This is based on a 88.5% serious event ratio across 58,870 classified reports. The score accounts for 138,219 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: 29,923, Male: 21,760, Unknown: 76. The most frequently reported age groups are age 65 (1,179 reports), age 63 (1,115 reports), age 66 (1,083 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 58,870 classified reports for ESOMEPRAZOLE:
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.
Esomeprazole can cause renal impairment and failure, and patients should be monitored for signs of kidney issues, especially those with pre-existing renal conditions. Drug interactions are also a concern, particularly with other nephrotoxic agents.
If you are taking Esomeprazole, here are important things to know. The most commonly reported side effects include chronic kidney disease, acute kidney injury, nausea, diarrhoea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any signs of kidney issues, such as changes in urine output or swelling, to their healthcare provider immediately. Follow the prescribed dosage and do not exceed the recommended dose without consulting a 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 has not issued specific warnings for esomeprazole, but healthcare providers should be vigilant about monitoring patients for signs of renal and gastrointestinal issues, especially in elderly patients.
The FDA has received approximately 138,219 adverse event reports associated with Esomeprazole. 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 Esomeprazole include Chronic Kidney Disease, Acute Kidney Injury, Nausea, Diarrhoea, Fatigue. By volume, the top reported reactions are: Chronic Kidney Disease (5,022 reports), Acute Kidney Injury (4,599 reports), Nausea (4,023 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Esomeprazole.
Out of 58,870 classified reports, 52,071 (88.5%) were classified as serious and 6,799 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 Esomeprazole break down by patient sex as follows: Female: 29,923, Male: 21,760, Unknown: 76. 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 Esomeprazole adverse events are: age 65: 1,179 reports, age 63: 1,115 reports, age 66: 1,083 reports, age 70: 1,083 reports, age 75: 1,083 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 Esomeprazole adverse event reports is Cvs Pharmacy. 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 Esomeprazole include: Headache, Dyspnoea, Drug Ineffective, Off Label Use, Pain. 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 Esomeprazole 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.
Esomeprazole 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. Chronic and acute kidney disease are among the most frequently reported serious adverse events.
Key safety signals identified in Esomeprazole's adverse event data include: High frequency of chronic and acute kidney disease reports.. Multiple gastrointestinal issues reported, including nausea and diarrhea.. Renal impairment and failure are notable safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Esomeprazole can cause renal impairment and failure, and patients should be monitored for signs of kidney issues, especially those with pre-existing renal conditions. Drug interactions are also a concern, particularly with other nephrotoxic agents. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Esomeprazole.
Patients should report any signs of kidney issues, such as changes in urine output or swelling, to their healthcare provider immediately. Follow the prescribed dosage and do not exceed the recommended dose without consulting a healthcare provider.
Esomeprazole has 138,219 adverse event reports on file with the FDA. Gastrointestinal issues such as nausea, diarrhea, and abdominal pain are common. The volume of reports for Esomeprazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for esomeprazole, but healthcare providers should be vigilant about monitoring patients for signs of renal and gastrointestinal issues, especially in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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