82/100 · Critical
Manufactured by Aurobindo Pharma Limited
Omeprazole Adverse Events: High Serious Reaction Rate
615,788 FDA adverse event reports analyzed
Last updated: 2026-05-12
OMEPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 615,788 FDA adverse event reports, OMEPRAZOLE 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 OMEPRAZOLE include FATIGUE, NAUSEA, DIARRHOEA, DYSPNOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OMEPRAZOLE.
Omeprazole 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 615,788 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Fatigue, Nausea, Diarrhoea. Of classified reports, 74.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, nausea, and diarrhea are the most common adverse reactions.
Serious reactions, including chronic kidney disease and acute kidney injury, are prevalent. Drug interactions and off-label use are reported frequently.
Patients taking Omeprazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Omeprazole may interact with other medications, and its use in unapproved indications is common, warranting caution. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Omeprazole received a safety concern score of 82/100 (high concern). This is based on a 74.2% serious event ratio across 331,730 classified reports. The score accounts for 615,788 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: 180,668, Male: 124,199, Unknown: 439. The most frequently reported age groups are age 65 (6,046 reports), age 70 (5,998 reports), age 68 (5,898 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 331,730 classified reports for OMEPRAZOLE:
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 may interact with other medications, and its use in unapproved indications is common, warranting caution.
If you are taking Omeprazole, here are important things to know. The most commonly reported side effects include fatigue, nausea, diarrhoea, dyspnoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before using Omeprazole for any unapproved indications. Inform your doctor of all medications you are taking to avoid potential drug interactions. 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 Omeprazole for safety, particularly for serious reactions and drug interactions.
The FDA has received approximately 615,788 adverse event reports associated with Omeprazole. 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 include Fatigue, Nausea, Diarrhoea, Dyspnoea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (19,906 reports), Nausea (19,842 reports), Diarrhoea (19,626 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.
Out of 331,730 classified reports, 246,185 (74.2%) were classified as serious and 85,545 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 break down by patient sex as follows: Female: 180,668, Male: 124,199, Unknown: 439. 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 adverse events are: age 65: 6,046 reports, age 70: 5,998 reports, age 68: 5,898 reports, age 66: 5,850 reports, age 71: 5,846 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 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 include: Headache, Pain, Chronic Kidney Disease, Vomiting, Dizziness. 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 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 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. Fatigue, nausea, and diarrhea are the most common adverse reactions.
Key safety signals identified in Omeprazole's adverse event data include: Chronic kidney disease and acute kidney injury are key safety signals.. Multiple serious reactions, including death and sepsis, are reported.. Drug interactions and off-label use are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Omeprazole may interact with other medications, and its use in unapproved indications is common, warranting caution. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Omeprazole.
Consult a healthcare provider before using Omeprazole for any unapproved indications. Inform your doctor of all medications you are taking to avoid potential drug interactions.
Omeprazole has 615,788 adverse event reports on file with the FDA. Serious reactions, including chronic kidney disease and acute kidney injury, are prevalent. The volume of reports for Omeprazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Omeprazole for safety, particularly for serious reactions and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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