Prevacid: adverse event reports filed with FDA

40,151

reports as suspect product

0.2% of all reports · about 1,785 a year

273

reports, 12 months to June 2026

217 in the 12 months before

95.8%

marked serious by the reporter

86.4% across the class

12.9%

record death among outcomes, as reported

5,173 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 Prevacid reports recording the termmedian drug in proton pump inhibitor

1. Chronic kidney diseaselong-term kidney disease76.5%30,723
2. Acute kidney injurysudden loss of kidney function37.1%14,895
3. Renal failurekidney failure28.6%11,475
4. End stage renal diseasekidney failure needing dialysis or transplant23.1%9,271
5. Renal injury22.5%9,026
6. Tubulointerstitial nephritis8.9%3,557
7. Deaththe patient died; cause not stated by this term5.5%2,191
8. Gastrooesophageal reflux diseaseacid reflux4.9%1,987
9. Nephrogenic anaemia4.9%1,957
10. Hyperchlorhydria4.6%1,844
11. Renal impairmentreduced kidney function4.3%1,745
12. Rebound acid hypersecretion3.9%1,565
13. Rebound effect3.6%1,430
14. Nephropathy2.9%1,173
15. Dialysisdialysis2.6%1,061
16. Painpain, site not specified2.2%902
17. Renal haemangioma2%786
18. Hyperparathyroidism secondary1.9%766
19. Proteinuriaprotein in the urine1.6%625
20. Drug dependencedependence on a medicine1.5%613
21. Drug ineffectivethe medicine did not work as expected1.5%607
22. Hypertensive nephropathy1.4%572
23. Nephrolithiasiskidney stones1.4%560
24. Diabetic nephropathy1.4%550
25. Dyspepsiaindigestion1.3%510
26. Renal disorder1.2%495
27. Condition aggravatedthe condition being treated got worse1.2%491
28. Drug hypersensitivityan allergic-type reaction to a medicine1.2%490
29. Chronic kidney disease-mineral and bone disorder1.2%488
30. Depressionlow mood1.2%488

Top 30 of 1,231 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. 97.3% 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 40,151 reports.

Drugs most often listed in the same reports

Other products listed in reports where Prevacid 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 Prevacid as a suspect or interacting product; reports listing it only as a concomitant medication (33,350) 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.