82/100 · Critical
Manufactured by HyVee Inc
Esomeprazole Magnesium Dihydrate Adverse Events: High Serious Reaction Rate
39,585 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESOMEPRAZOLE MAGNESIUM DIHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by HyVee Inc. Based on analysis of 39,585 FDA adverse event reports, ESOMEPRAZOLE MAGNESIUM DIHYDRATE 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 DIHYDRATE 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 DIHYDRATE.
Esomeprazole Magnesium Dihydrate 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 39,585 adverse event reports for this medication, which is primarily manufactured by Hyvee Inc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Headache. Of classified reports, 76.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but the serious reaction rate is high at 76.6%.
Nausea, headache, and diarrhea are the most common reactions, indicating gastrointestinal side effects. There is a notable increase in chronic kidney disease and acute kidney injury reports, suggesting potential renal risks. Drug interactions and therapeutic product effects are frequently reported, indicating potential interactions with other medications.
Patients taking Esomeprazole Magnesium Dihydrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Esomeprazole Magnesium Dihydrate may interact with other medications, and patients should be monitored for potential renal issues, particularly chronic and acute kidney disease. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Esomeprazole Magnesium Dihydrate received a safety concern score of 82/100 (high concern). This is based on a 76.6% serious event ratio across 13,884 classified reports. The score accounts for 39,585 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: 7,652, Male: 4,813, Unknown: 15. The most frequently reported age groups are age 54 (354 reports), age 65 (281 reports), age 53 (257 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 13,884 classified reports for ESOMEPRAZOLE MAGNESIUM DIHYDRATE:
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 Dihydrate may interact with other medications, and patients should be monitored for potential renal issues, particularly chronic and acute kidney disease.
If you are taking Esomeprazole Magnesium Dihydrate, 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. Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. Monitor for signs of kidney issues, such as changes in urine output or swelling, and report any concerns immediately. 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 Dihydrate, and healthcare providers should be aware of the potential for serious adverse events and renal complications.
The FDA has received approximately 39,585 adverse event reports associated with Esomeprazole Magnesium Dihydrate. 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 Dihydrate include Drug Ineffective, Nausea, Headache, Diarrhoea, Fatigue. By volume, the top reported reactions are: Drug Ineffective (1,331 reports), Nausea (1,244 reports), Headache (1,154 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 Dihydrate.
Out of 13,884 classified reports, 10,638 (76.6%) were classified as serious and 3,246 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 Dihydrate break down by patient sex as follows: Female: 7,652, Male: 4,813, 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 Dihydrate adverse events are: age 54: 354 reports, age 65: 281 reports, age 53: 257 reports, age 56: 255 reports, age 63: 231 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 Dihydrate adverse event reports is Hyvee 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 Dihydrate 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 Dihydrate 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 Dihydrate 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. The majority of adverse events are non-serious, but the serious reaction rate is high at 76.6%.
Key safety signals identified in Esomeprazole Magnesium Dihydrate's adverse event data include: High rate of serious reactions (76.6%). Frequent reports of chronic and acute kidney issues. Multiple gastrointestinal side effects reported. Common drug interactions and therapeutic product effects. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Esomeprazole Magnesium Dihydrate may interact with other medications, and patients should be monitored for potential renal issues, particularly chronic and acute kidney disease. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Esomeprazole Magnesium Dihydrate.
Inform your healthcare provider about all medications you are taking to avoid potential drug interactions. Monitor for signs of kidney issues, such as changes in urine output or swelling, and report any concerns immediately.
Esomeprazole Magnesium Dihydrate has 39,585 adverse event reports on file with the FDA. Nausea, headache, and diarrhea are the most common reactions, indicating gastrointestinal side effects. The volume of reports for Esomeprazole Magnesium Dihydrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Esomeprazole Magnesium Dihydrate, and healthcare providers should be aware of the potential for serious adverse events and renal complications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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