82/100 · Critical
Manufactured by AstraZeneca Pharmaceuticals LP
High Concern for Renal Issues with Esomeprazole Magnesium
489,170 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESOMEPRAZOLE MAGNESIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 489,170 FDA adverse event reports, ESOMEPRAZOLE MAGNESIUM 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 ESOMEPRAZOLE MAGNESIUM include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, RENAL FAILURE, DRUG INEFFECTIVE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESOMEPRAZOLE MAGNESIUM.
Esomeprazole Magnesium 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 489,170 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Chronic Kidney Disease, Acute Kidney Injury, Renal Failure. Of classified reports, 71.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic and acute kidney disease are the most frequently reported serious adverse events.
A significant number of reports involve renal failure and injury, indicating potential renal toxicity. Gastroesophageal reflux disease and drug ineffectiveness are also commonly reported, suggesting possible efficacy issues.
Patients taking Esomeprazole Magnesium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Esomeprazole magnesium may cause renal impairment and should be used with caution in patients with pre-existing renal conditions. Drug interactions, particularly with other nephrotoxic agents, should be monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Esomeprazole Magnesium received a safety concern score of 82/100 (high concern). This is based on a 71.5% serious event ratio across 228,812 classified reports. The score accounts for 489,170 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: 125,724, Male: 73,456, Unknown: 399. The most frequently reported age groups are age 65 (3,763 reports), age 64 (3,662 reports), age 63 (3,648 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 228,812 classified reports for ESOMEPRAZOLE MAGNESIUM:
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 magnesium may cause renal impairment and should be used with caution in patients with pre-existing renal conditions. Drug interactions, particularly with other nephrotoxic agents, should be monitored.
If you are taking Esomeprazole Magnesium, here are important things to know. The most commonly reported side effects include chronic kidney disease, acute kidney injury, renal failure, drug ineffective, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Regularly monitor renal function, especially in patients with pre-existing renal conditions. Be cautious when combining esomeprazole magnesium with other nephrotoxic drugs. 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 magnesium, but the high incidence of renal issues suggests a need for regular monitoring of renal function in patients taking this medication.
The FDA has received approximately 489,170 adverse event reports associated with Esomeprazole Magnesium. 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 Magnesium include Chronic Kidney Disease, Acute Kidney Injury, Renal Failure, Drug Ineffective, Nausea. By volume, the top reported reactions are: Chronic Kidney Disease (35,562 reports), Acute Kidney Injury (20,318 reports), Renal Failure (16,245 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 Magnesium.
Out of 228,812 classified reports, 163,614 (71.5%) were classified as serious and 65,198 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 Magnesium break down by patient sex as follows: Female: 125,724, Male: 73,456, Unknown: 399. 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 Magnesium adverse events are: age 65: 3,763 reports, age 64: 3,662 reports, age 63: 3,648 reports, age 62: 3,523 reports, age 66: 3,464 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 Magnesium adverse event reports is Astrazeneca Pharmaceuticals Lp. 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 Magnesium include: Gastrooesophageal Reflux Disease, Drug Dose Omission, Diarrhoea, Pain, End Stage Renal Disease. 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 Magnesium 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 Magnesium 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. Chronic and acute kidney disease are the most frequently reported serious adverse events.
Key safety signals identified in Esomeprazole Magnesium's adverse event data include: Chronic kidney disease. Acute kidney injury. Renal failure. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Esomeprazole magnesium may cause renal impairment and should be used with caution in patients with pre-existing renal conditions. Drug interactions, particularly with other nephrotoxic agents, should be monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Esomeprazole Magnesium.
Regularly monitor renal function, especially in patients with pre-existing renal conditions. Be cautious when combining esomeprazole magnesium with other nephrotoxic drugs.
Esomeprazole Magnesium has 489,170 adverse event reports on file with the FDA. A significant number of reports involve renal failure and injury, indicating potential renal toxicity. The volume of reports for Esomeprazole Magnesium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued specific warnings for esomeprazole magnesium, but the high incidence of renal issues suggests a need for regular monitoring of renal function in patients taking this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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