70/100 · Elevated
Manufactured by Ahold U.S.A., Inc,
Esomeprazole Magnesium Capsule, Delayed Release: Common Mild Reactions with Some Serious Adverse Events
39,490 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE 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 CAPSULE, DELAYED RELEASE has a safety score of 70 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 CAPSULE, DELAYED RELEASE 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 CAPSULE, DELAYED RELEASE.
Esomeprazole Magnesium Capsule, Delayed Release has a safety concern score of 70 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 majority of reported reactions are mild to moderate in nature, but serious adverse events, particularly respiratory and renal issues, are concerning.
Nausea, headache, and diarrhea are the most frequently reported reactions, indicating a common gastrointestinal side effect profile. There is a notable presence of serious adverse events, particularly involving the respiratory and renal systems, which warrant further investigation. The drug is often used off-label, which may contribute to the reported adverse events, including chronic kidney disease and acute kidney injury.
Patients taking Esomeprazole Magnesium Capsule, Delayed Release should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Esomeprazole magnesium capsule, delayed release, may interact with other medications, and patients should be monitored for potential drug interactions, especially with those affecting renal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Esomeprazole Magnesium Capsule, Delayed Release received a safety concern score of 70/100 (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 CAPSULE, DELAYED RELEASE:
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 capsule, delayed release, may interact with other medications, and patients should be monitored for potential drug interactions, especially with those affecting renal function.
If you are taking Esomeprazole Magnesium Capsule, Delayed Release, 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. Patients should report any new or worsening symptoms to their healthcare provider, especially if they experience respiratory or renal issues. Follow the prescribed dosage and do not use the drug for off-label indications without consulting a healthcare professional. 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 esomeprazole magnesium capsule, delayed release, and regulatory actions may be taken based on ongoing safety data.
The FDA has received approximately 39,490 adverse event reports associated with Esomeprazole Magnesium Capsule, Delayed Release. 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 Capsule, Delayed Release 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 Capsule, Delayed Release.
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 Capsule, Delayed Release 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 Capsule, Delayed Release 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 Capsule, Delayed Release 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 Capsule, Delayed Release 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 Capsule, Delayed Release 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 Capsule, Delayed Release has a safety concern score of 70 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 majority of reported reactions are mild to moderate in nature, but serious adverse events, particularly respiratory and renal issues, are concerning.
Key safety signals identified in Esomeprazole Magnesium Capsule, Delayed Release's adverse event data include: Chronic kidney disease and acute kidney injury are reported as serious adverse events, indicating potential renal toxicity.. Respiratory issues such as pneumonia and wheezing are also common, suggesting possible respiratory side effects.. Drug interactions are reported, indicating the need for caution when used with other medications.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Esomeprazole magnesium capsule, delayed release, may interact with other medications, and patients should be monitored for potential drug interactions, especially with those affecting renal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Esomeprazole Magnesium Capsule, Delayed Release.
Patients should report any new or worsening symptoms to their healthcare provider, especially if they experience respiratory or renal issues. Follow the prescribed dosage and do not use the drug for off-label indications without consulting a healthcare professional.
Esomeprazole Magnesium Capsule, Delayed Release has 39,490 adverse event reports on file with the FDA. Nausea, headache, and diarrhea are the most frequently reported reactions, indicating a common gastrointestinal side effect profile. The volume of reports for Esomeprazole Magnesium Capsule, Delayed Release reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of esomeprazole magnesium capsule, delayed release, and regulatory actions may be taken based on ongoing safety data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Ahold U.S.A., Inc, and compare their safety profiles:
The following drugs share commonly reported adverse reactions with ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE:
Drugs related to ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE based on therapeutic use, drug class, or shared indications: