Omeprazole magnesium: adverse event reports filed with FDA

4,120

reports as suspect product

0% of all reports · about 195 a year

175

reports, 12 months to June 2026

99 in the 12 months before

74.9%

marked serious by the reporter

86.4% across the class

9.5%

record death among outcomes, as reported

391 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 Omeprazole magnesium reports recording the termmedian drug in proton pump inhibitor

1. Chronic kidney diseaselong-term kidney disease43.9%1,809
2. Acute kidney injurysudden loss of kidney function22.3%919
3. End stage renal diseasekidney failure needing dialysis or transplant15.6%644
4. Renal failurekidney failure12.4%510
5. Renal injury9.3%385
6. Gastrooesophageal reflux diseaseacid reflux7.7%317
7. Drug ineffectivethe medicine did not work as expected6.1%252
8. Tubulointerstitial nephritis4.9%200
9. Painpain, site not specified3.5%144
10. Constipationconstipation3.1%127
11. Diarrhoealoose or frequent stools3%125
12. Nauseafeeling sick2.9%118
13. Falla fall2.8%117
14. Toxicity to various agentspoisoning or toxic effect of one or more substances2.8%114
15. Drug interactionan interaction between medicines2.7%112
16. Deaththe patient died; cause not stated by this term2.7%111
17. Dyspnoeashortness of breath2.7%110
18. Hypotensionlow blood pressure2.6%108
19. Cognitive disorderproblems with thinking or memory2.5%103
20. Renal impairmentreduced kidney function2.4%98
21. Balance disorderproblems with balance2.4%97
22. Orthostatic hypotension2.4%97
23. Mobility decreasedreduced ability to move about2.1%88
24. Off label useused for a purpose or in a way not on the label2%84
25. Sedationdrowsiness from a medicine2%84
26. Blood calcium decreased1.9%80
27. Depressed level of consciousness1.9%80
28. Creatinine renal clearance decreased1.9%79
29. Sedation complication1.9%78
30. Abdominal pain upperupper stomach pain1.9%77

Top 30 of 605 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. 84.2% 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 4,120 reports.

Drugs most often listed in the same reports

Other products listed in reports where Omeprazole magnesium 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 Omeprazole magnesium as a suspect or interacting product; reports listing it only as a concomitant medication (1,211) 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.