72/100 · Elevated
Manufactured by Ahold U.S.A., Inc,
Esomeprazole Magnesium Delayed Release Capsules: Common Nausea and Headache with Some Serious Reactions
39,490 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ahold U.S.A., Inc,. Based on analysis of 39,490 FDA adverse event reports, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES 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 ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES include DRUG INEFFECTIVE, NAUSEA, HEADACHE, DIARRHOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES.
Esomeprazole Magnesium Delayed Release Capsules 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 39,490 adverse event reports for this medication, which is primarily manufactured by Ahold U.S.A., Inc,.
The most commonly reported adverse events include Drug Ineffective, Nausea, Headache. Of classified reports, 76.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are nausea and headache, indicating potential gastrointestinal and neurological side effects.
Serious reactions, such as chronic kidney disease and acute kidney injury, are reported but less frequent. There is a notable diversity in reactions, suggesting a wide range of potential side effects. Reports of drug interactions and therapeutic product effect incompleteness are present, indicating potential issues with drug efficacy and interactions.
Patients taking Esomeprazole Magnesium Delayed Release Capsules should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warnings include potential drug interactions and therapeutic product effect incompleteness, which may affect the efficacy of the medication. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Esomeprazole Magnesium Delayed Release Capsules received a safety concern score of 72/100 (elevated concern). This is based on a 76.5% serious event ratio across 13,822 classified reports. The score accounts for 39,490 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: 7,614, Male: 4,795, Unknown: 15. The most frequently reported age groups are age 54 (354 reports), age 65 (277 reports), age 53 (256 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 13,822 classified reports for ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES:
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.
Warnings include potential drug interactions and therapeutic product effect incompleteness, which may affect the efficacy of the medication.
If you are taking Esomeprazole Magnesium Delayed Release Capsules, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, headache, diarrhoea, fatigue. 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 gastrointestinal issues like nausea and headache, and report them to your healthcare provider. Be aware of potential serious reactions such as chronic kidney disease and acute kidney injury, and seek medical attention if they occur. 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 monitors these reports to ensure the drug's safety. Patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 39,490 adverse event reports associated with Esomeprazole Magnesium Delayed Release Capsules. 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 Delayed Release Capsules include Drug Ineffective, Nausea, Headache, Diarrhoea, Fatigue. By volume, the top reported reactions are: Drug Ineffective (1,330 reports), Nausea (1,240 reports), Headache (1,151 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 Delayed Release Capsules.
Out of 13,822 classified reports, 10,577 (76.5%) were classified as serious and 3,245 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 Delayed Release Capsules break down by patient sex as follows: Female: 7,614, Male: 4,795, Unknown: 15. 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 Delayed Release Capsules adverse events are: age 54: 354 reports, age 65: 277 reports, age 53: 256 reports, age 56: 255 reports, age 63: 230 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 Delayed Release Capsules adverse event reports is Ahold U.S.A., 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 Esomeprazole Magnesium Delayed Release Capsules include: Dyspnoea, Pain, Off Label Use, Chronic Kidney Disease, Arthralgia. 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 Delayed Release Capsules 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 Delayed Release Capsules 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 nausea and headache, indicating potential gastrointestinal and neurological side effects.
Key safety signals identified in Esomeprazole Magnesium Delayed Release Capsules's adverse event data include: Chronic kidney disease and acute kidney injury are key safety signals, indicating potential renal toxicity.. Drug interactions and therapeutic product effect incompleteness are significant safety signals, suggesting potential issues with drug efficacy and interactions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Warnings include potential drug interactions and therapeutic product effect incompleteness, which may affect the efficacy of the medication. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Esomeprazole Magnesium Delayed Release Capsules.
Monitor for signs of gastrointestinal issues like nausea and headache, and report them to your healthcare provider. Be aware of potential serious reactions such as chronic kidney disease and acute kidney injury, and seek medical attention if they occur.
Esomeprazole Magnesium Delayed Release Capsules has 39,490 adverse event reports on file with the FDA. Serious reactions, such as chronic kidney disease and acute kidney injury, are reported but less frequent. The volume of reports for Esomeprazole Magnesium Delayed Release Capsules reflects both the drug's usage level and the vigilance of the reporting community.
The FDA monitors these reports to ensure the drug's safety. Patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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