Prilosec Otcomeprazole
According to the FDA label: Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
30,578 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Prilosec Otc 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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Chronic Kidney Disease 18,101 reports
A long-term, gradual loss of kidney function over months or years.
Full definition in the glossary →Acute Kidney Injury 9,428 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 →Renal Failure 7,621 reports
A serious decline in kidney function, where the kidneys can no longer filter waste properly.
Full definition in the glossary →End Stage Renal Disease 5,800 reports
The final stage of chronic kidney disease, where the kidneys can no longer function well enough to sustain the body without dialysis or a transplant. Renal means related to the kidneys.
Full definition in the glossary →Renal Injury 5,351 reports
Damage to the kidneys. Renal means related to the kidneys. Related to acute kidney injury and renal impairment.
Full definition in the glossary →- Tubulointerstitial Nephritis 2,341 reports
- Hyperchlorhydria 2,165 reports
Pain 2,107 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →- Rebound Effect 2,006 reports
Gastrooesophageal Reflux Disease 1,948 reports
A condition, often called acid reflux or GERD, where stomach acid flows back into the food pipe, causing heartburn. Also spelled gastroesophageal in American English.
Full definition in the glossary → See all drugs reporting this event →Drug Dependence 1,678 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Drug Ineffective 1,643 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 →- Nephrogenic Anaemia 1,508 reports
Death 1,328 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →- Rebound Acid Hypersecretion 1,291 reports
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 | 12,788 |
| Male | 8,559 |
| Unknown | 41 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 106 |
| 18-34 | 481 |
| 35-49 | 1,773 |
| 50-64 | 3,938 |
| 65-74 | 2,135 |
| 75+ | 1,488 |
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 Prilosec Otc. 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 | 22,511 |
| Non-Serious | 6,912 |
| Hospitalization | 3,446 |
| Death | 2,645 |
| Disability | 579 |
| Life-Threatening | 266 |
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 Prilosec Otc. 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 |
|---|---|
| 2004 | 37 |
| 2005 | 55 |
| 2006 | 65 |
| 2007 | 87 |
| 2008 | 229 |
| 2009 | 603 |
| 2010 | 438 |
| 2011 | 692 |
| 2012 | 1,229 |
| 2013 | 623 |
| 2014 | 570 |
| 2015 | 682 |
| 2016 | 634 |
| 2017 | 538 |
| 2018 | 9,084 |
| 2019 | 8,419 |
| 2020 | 2,576 |
| 2021 | 1,907 |
| 2022 | 660 |
| 2023 | 373 |
| 2024 | 389 |
| 2025 | 555 |
| 2026 (partial) | 133 |
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 Prilosec Otc
In FDA adverse event reports that mention Prilosec Otc, these medications appeared most often in the same report.
- Dexlansoprazole (11,367 reports)
- Lisinopril (4,400 reports)
- Aspirin (4,071 reports)
- Furosemide (3,854 reports)
- Rabeprazole (3,548 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