Esomeprazole sodium: adverse event reports filed with FDA

634

reports as suspect product

0% of all reports · about 37 a year

47

reports, 12 months to June 2026

73 in the 12 months before

97.6%

marked serious by the reporter

86.4% across the class

11.5%

record death among outcomes, as reported

73 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 sodium reports recording the termmedian drug in proton pump inhibitor

1. Nauseafeeling sick22.4%142
2. Headachehead pain18.6%118
3. Diarrhoealoose or frequent stools18%114
4. Fatiguetiredness17.7%112
5. Pruritusitching17%108
6. Abdominal pain upperupper stomach pain15%95
7. Arthritis15%95
8. Neuropathy peripheralnerve damage in hands or feet11.8%75
9. Off label useused for a purpose or in a way not on the label11.8%75
10. Dyspnoeashortness of breath11.4%72
11. Chest painchest pain11%70
12. Myalgiamuscle pain11%70
13. Falla fall10.9%69
14. Blood glucose increasedraised blood sugar reading10.6%67
15. Astheniaweakness or lack of energy10.3%65
16. Palpitationsawareness of the heartbeat10.3%65
17. Vomitingbeing sick9.8%62
18. Painpain, site not specified9.5%60
19. Insomniadifficulty sleeping9.3%59
20. Pericardial effusionfluid around the heart9.1%58
21. Pyrexiafever9%57
22. Malaisegeneral feeling of being unwell8.8%56
23. Abdominal painstomach or belly pain8.7%55
24. Blood pressure increaseda raised blood pressure reading8.7%55
25. Pulmonary oedemafluid in the lungs8.7%55
26. Weight decreasedweight loss8.7%55
27. Cardiac failure congestivecongestive heart failure8.5%54
28. Eye haemorrhage8.5%54
29. Malnutrition8.5%54
30. Multi-organ disorder8.5%54

Top 30 of 416 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. 7.3% 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 634 reports.

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 sodium as a suspect or interacting product; reports listing it only as a concomitant medication (1,797) 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.