Esomeprazole: adverse event reports filed with FDA

17,193

reports as suspect product

0.1% of all reports · about 767 a year

1,293

reports, 12 months to June 2026

1,553 in the 12 months before

96.8%

marked serious by the reporter

86.4% across the class

9.6%

record death among outcomes, as reported

1,655 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Esomeprazole reports recording the termmedian drug in proton pump inhibitor

1. Chronic kidney diseaselong-term kidney disease24.1%4,144
2. Acute kidney injurysudden loss of kidney function16.5%2,835
3. Headachehead pain7.7%1,328
4. Renal failurekidney failure7.1%1,215
5. Fatiguetiredness6.5%1,111
6. Nauseafeeling sick6.4%1,103
7. Dyspnoeashortness of breath6.2%1,060
8. Diarrhoealoose or frequent stools6.1%1,044
9. Off label useused for a purpose or in a way not on the label5.9%1,008
10. Renal injury5.8%1,001
11. End stage renal diseasekidney failure needing dialysis or transplant5.6%971
12. Pyrexiafever5.5%941
13. Vomitingbeing sick5.4%922
14. Drug ineffectivethe medicine did not work as expected5.2%889
15. Malaisegeneral feeling of being unwell5.1%880
16. Painpain, site not specified5.1%872
17. Arthralgiajoint pain4.7%802
18. Drug interactionan interaction between medicines4.6%798
19. Pruritusitching4.6%795
20. Gastrooesophageal reflux diseaseacid reflux4.6%784
21. Dizzinesslight-headedness or unsteadiness4.4%762
22. Abdominal pain upperupper stomach pain4.3%742
23. Tinnitusringing in the ears3.9%665
24. Anxietyanxiety3.8%648
25. Palpitationsawareness of the heartbeat3.6%623
26. Falla fall3.6%621
27. Tubulointerstitial nephritis3.5%595
28. Insomniadifficulty sleeping3.5%594
29. Tachycardiafast heart rate3.4%589
30. Coughcough3.4%577

Top 30 of 1,966 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 22 drugs in the proton pump inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 484,090 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 33% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 17,193 reports.

Drugs most often listed in the same reports

Other products listed in reports where Esomeprazole is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the proton pump inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Esomeprazole as a suspect or interacting product; reports listing it only as a concomitant medication (31,013) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.