85/100 · Critical
Manufactured by Aurobindo Pharma Limited
High Safety Concerns with Omeprazole Magnesium, Particularly for Chronic Kidney Disease and Acute Kidney Injury
841,693 FDA adverse event reports analyzed
Last updated: 2026-05-12
OMEPRAZOLE MAGNESIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 841,693 FDA adverse event reports, OMEPRAZOLE MAGNESIUM 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 OMEPRAZOLE MAGNESIUM include CHRONIC KIDNEY DISEASE, NAUSEA, FATIGUE, DIARRHOEA, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OMEPRAZOLE MAGNESIUM.
Omeprazole Magnesium 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 841,693 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Chronic Kidney Disease, Nausea, Fatigue. Of classified reports, 72.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic kidney disease and acute kidney injury are among the most frequent and serious adverse reactions.
A significant number of reports indicate drug ineffectiveness and renal failure. The drug is frequently reported to cause falls and dizziness, posing a risk of injury.
Patients taking Omeprazole Magnesium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Omeprazole magnesium can cause serious renal issues and should be used with caution in patients with pre-existing kidney conditions. It may also interact with other medications, leading to adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Omeprazole Magnesium received a safety concern score of 85/100 (high concern). This is based on a 72.2% serious event ratio across 433,042 classified reports. The score accounts for 841,693 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: 234,910, Male: 155,911, Unknown: 569. The most frequently reported age groups are age 65 (7,376 reports), age 70 (7,177 reports), age 66 (7,125 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 433,042 classified reports for OMEPRAZOLE 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.
Omeprazole magnesium can cause serious renal issues and should be used with caution in patients with pre-existing kidney conditions. It may also interact with other medications, leading to adverse effects.
If you are taking Omeprazole Magnesium, here are important things to know. The most commonly reported side effects include chronic kidney disease, nausea, fatigue, diarrhoea, acute kidney injury. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should avoid driving or operating heavy machinery if experiencing dizziness or falls. Regularly monitor kidney function, especially in elderly patients or those with pre-existing kidney conditions. 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 closely monitors Omeprazole magnesium due to its high safety concerns, particularly for renal function. Healthcare providers should regularly monitor patients for signs of kidney damage and adjust dosages as necessary.
The FDA has received approximately 841,693 adverse event reports associated with Omeprazole 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 Omeprazole Magnesium include Chronic Kidney Disease, Nausea, Fatigue, Diarrhoea, Acute Kidney Injury. By volume, the top reported reactions are: Chronic Kidney Disease (36,720 reports), Nausea (26,060 reports), Fatigue (25,232 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Omeprazole Magnesium.
Out of 433,042 classified reports, 312,595 (72.2%) were classified as serious and 120,447 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 Omeprazole Magnesium break down by patient sex as follows: Female: 234,910, Male: 155,911, Unknown: 569. 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 Omeprazole Magnesium adverse events are: age 65: 7,376 reports, age 70: 7,177 reports, age 66: 7,125 reports, age 68: 7,106 reports, age 64: 7,101 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 Omeprazole Magnesium adverse event reports is Aurobindo Pharma Limited. 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 Omeprazole Magnesium include: Drug Ineffective, Dyspnoea, Pain, Headache, Renal Failure. 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 Omeprazole 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.
Omeprazole Magnesium 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 kidney disease and acute kidney injury are among the most frequent and serious adverse reactions.
Key safety signals identified in Omeprazole Magnesium's adverse event data include: Chronic kidney disease. Acute kidney injury. Drug ineffectiveness. Renal failure. Falls and dizziness. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Omeprazole magnesium can cause serious renal issues and should be used with caution in patients with pre-existing kidney conditions. It may also interact with other medications, leading to adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Omeprazole Magnesium.
Patients should avoid driving or operating heavy machinery if experiencing dizziness or falls. Regularly monitor kidney function, especially in elderly patients or those with pre-existing kidney conditions.
Omeprazole Magnesium has 841,693 adverse event reports on file with the FDA. A significant number of reports indicate drug ineffectiveness and renal failure. The volume of reports for Omeprazole Magnesium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Omeprazole magnesium due to its high safety concerns, particularly for renal function. Healthcare providers should regularly monitor patients for signs of kidney damage and adjust dosages as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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