Nexiumesomeprazole
According to the FDA label: NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) • Maintenance of healing of EE in adults. ( 1.2 ) • Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.
183,140 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nexium 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.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Chronic Kidney Disease 33,701 reports
A long-term, gradual loss of kidney function over months or years.
Full definition in the glossary →Acute Kidney Injury 17,557 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 14,988 reports
A serious decline in kidney function, where the kidneys can no longer filter waste properly.
Full definition in the glossary →Drug Ineffective 11,362 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 →Gastrooesophageal Reflux Disease 10,991 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 Dose Omission 10,967 reports
A report that a dose of medication was missed or skipped.
Full definition in the glossary →Nausea 10,230 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →End Stage Renal Disease 9,812 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 8,913 reports
Damage to the kidneys. Renal means related to the kidneys. Related to acute kidney injury and renal impairment.
Full definition in the glossary →Pain 8,487 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Malaise 7,889 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Diarrhoea 7,823 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 →Fatigue 7,159 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 6,868 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 6,799 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →
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 | 102,397 |
| Male | 56,303 |
| Unknown | 338 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,669 |
| 18-34 | 4,801 |
| 35-49 | 15,605 |
| 50-64 | 37,018 |
| 65-74 | 23,831 |
| 75+ | 19,022 |
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 Nexium. 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 | 89,364 |
| Non-Serious | 58,158 |
| Hospitalization | 49,464 |
| Death | 14,758 |
| Life-Threatening | 5,432 |
| Disability | 5,069 |
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 Nexium. 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 |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 2,032 |
| 2005 | 2,744 |
| 2006 | 3,528 |
| 2007 | 4,471 |
| 2008 | 5,252 |
| 2009 | 6,616 |
| 2010 | 8,242 |
| 2011 | 13,211 |
| 2012 | 22,369 |
| 2013 | 7,117 |
| 2014 | 7,344 |
| 2015 | 10,486 |
| 2016 | 10,084 |
| 2017 | 8,080 |
| 2018 | 21,308 |
| 2019 | 21,821 |
| 2020 | 7,601 |
| 2021 | 6,010 |
| 2022 | 4,385 |
| 2023 | 3,285 |
| 2024 | 3,030 |
| 2025 | 3,493 |
| 2026 (partial) | 628 |
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 Nexium
In FDA adverse event reports that mention Nexium, these medications appeared most often in the same report.
- Lansoprazole (33,023 reports)
- Pantoprazole (28,874 reports)
- Aspirin (22,008 reports)
- Furosemide (20,204 reports)
- Dexlansoprazole (19,461 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