Omeprazole
According to the FDA label: 1. INDICATIONS AND USAGE Omeprazole delayed-release capsules, USP, are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to…
339,247 adverse event reports submitted to the FDA (1989–2026)
Top Reported Adverse Events
The most frequently reported events in association with Omeprazole in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Fatigue 20,360 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 20,317 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 20,125 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 16,699 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 16,027 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Headache 14,980 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Chronic Kidney Disease 14,100 reports
A long-term, gradual loss of kidney function over months or years.
Full definition in the glossary →Pain 14,086 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Vomiting 13,570 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Dizziness 13,401 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 13,011 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Acute Kidney Injury 12,099 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →Malaise 11,146 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Arthralgia 10,909 reports
Asthenia 10,878 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 184,289 |
| Male | 126,516 |
| Unknown | 440 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 6,537 |
| 18-34 | 13,447 |
| 35-49 | 28,641 |
| 50-64 | 68,980 |
| 65-74 | 59,197 |
| 75+ | 55,654 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Omeprazole. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 156,898 |
| Hospitalization | 124,660 |
| Non-Serious | 87,778 |
| Death | 31,023 |
| Life-Threatening | 17,101 |
| Disability | 12,018 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Omeprazole. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1989 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 2,482 |
| 2005 | 3,085 |
| 2006 | 3,080 |
| 2007 | 3,243 |
| 2008 | 4,328 |
| 2009 | 5,458 |
| 2010 | 7,434 |
| 2011 | 9,828 |
| 2012 | 12,812 |
| 2013 | 12,142 |
| 2014 | 14,807 |
| 2015 | 21,188 |
| 2016 | 23,501 |
| 2017 | 22,181 |
| 2018 | 28,691 |
| 2019 | 32,201 |
| 2020 | 25,692 |
| 2021 | 22,367 |
| 2022 | 21,233 |
| 2023 | 20,116 |
| 2024 | 19,394 |
| 2025 | 19,655 |
| 2026 (partial) | 4,321 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Omeprazole
In FDA adverse event reports that mention Omeprazole, these medications appeared most often in the same report.
- Aspirin (50,464 reports)
- Furosemide (45,111 reports)
- Ergocalciferol (39,691 reports)
- Gabapentin (37,968 reports)
- Acetaminophen (37,132 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026