Reported Reactions

Drugs › Proton pump inhibitor

Brand name · Omeprazole and sodium bicarbonate

Zegerid: adverse event reports filed with FDA

1,117 reports list it as a suspect or interacting product, 2005–2025. Class: Proton pump inhibitor. Also reported as Zegerid /00661201/.

1,117
reports as suspect product
0% of all reports · about 53 a year
0
reports, 12 months to June 2026
2 in the 12 months before
88%
marked serious by the reporter
86.4% across the class
10%
record death among outcomes, as reported
112 reports · not verified by FDA

Between July 2005 and February 2025, 1,117 adverse event reports received by FDA list the brand name Zegerid (omeprazole and sodium bicarbonate) as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,335) are left out of every figure here.

In the 12 months to June 2026, 0 reports listed it, against 2 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 53 reports a year and 0% of the 20,646,523 reports in the database, and 0.2% of the reports for the proton pump inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded chronic kidney disease (71.4%), acute kidney injury (40.2%) and renal failure (37.7%). A report can list several reactions, so shares add to more than 100%; 227 different terms appear across these reports. Chronic kidney disease is recorded in 71.4% of these reports, a larger share than in the median proton pump inhibitor drug (31.6%).

88% of the reports are marked serious by the reporter (86.4% across the class); 10% record death among the outcomes and 11.4% record hospitalisation, as reported. 29.5% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (26.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

047Jul 2021: 6Aug 2021: 6Sep 2021: 0Oct 2021: 5Nov 2021: 1Dec 2021: 32022Jan 2022: 3Feb 2022: 2Mar 2022: 5Apr 2022: 0May 2022: 6Jun 2022: 2Jul 2022: 2Aug 2022: 0Sep 2022: 7Oct 2022: 0Nov 2022: 1Dec 2022: 22023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 1Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 12024Jan 2024: 1Feb 2024: 2Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 2Jul 2024: 0Aug 2024: 1Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 1Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0

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

02174332005: 620052006: 72007: 52008: 1420082009: 112010: 162011: 1320112012: 142013: 132014: 1020142015: 282016: 312017: 7520172018: 2492019: 4332020: 7020202021: 832022: 302023: 220232024: 62025: 1

Reactions recorded in the reports

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

  1. Chronic kidney diseaselong-term kidney disease71.4%798
  2. Acute kidney injurysudden loss of kidney function40.2%449
  3. Renal failurekidney failure37.7%421
  4. End stage renal diseasekidney failure needing dialysis or transplant20.1%225
  5. Renal injury18.9%211
  6. Nephrogenic anaemia5.8%65
  7. Rebound acid hypersecretion5.7%64
  8. Renal impairmentreduced kidney function5.6%63
  9. Deaththe patient died; cause not stated by this term3.4%38
  10. Drug ineffectivethe medicine did not work as expected2.9%32
  11. Hyperparathyroidism secondary2.9%32
  12. Nephrolithiasiskidney stones2.2%25
  13. Depressionlow mood2.1%24
  14. Hypertensive nephropathy2.1%23
  15. Dialysisdialysis1.8%20
  16. Hypertensionhigh blood pressure1.6%18
  17. Chronic kidney disease-mineral and bone disorder1.4%16
  18. Haematuriablood in the urine1.4%16
  19. Anxietyanxiety1.3%14
  20. Nocturia1.3%14
  21. Pollakiuriapassing urine more often1.3%14
  22. Proteinuriaprotein in the urine1.3%14
  23. Dizzinesslight-headedness or unsteadiness1.2%13

Top 30 of 227 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

Death10%112
Life-threatening0.9%10
Hospitalisation (initial or prolonged)11.4%127
Disability1.3%15
Congenital anomaly0%0
Other serious85.1%951
Not serious12%134

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

Patient age

Under 20.1%1
2 to 110.3%3
12 to 170%0
18 to 447.2%80
45 to 6426.1%292
65 to 749.4%105
75 and over4.8%54
Age not given52.1%582

Patient sex

Female44.9%502
Male29%324
Not given26.1%291

Who reported

Physician4.1%46
Pharmacist0.6%7
Other health professional10.8%121
Lawyer29.5%329
Consumer or non-health professional25%279
Not given30%335

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Gastrooesophageal reflux disease49644.4%
Dyspepsia353.1%
Gastric ph decreased171.5%
Gastrointestinal disorder111%
Gastric ulcer40.4%
Abdominal pain upper20.2%

The indication field is filled in by the reporter and is often blank; shares are of all 1,117 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Zegerid reports
Nexium67760.6%
Prilosec60153.8%
Prevacid59553.3%
Pantoprazole sodium54348.6%
Nexium 24HR40035.8%
Prevacid 24 HR35631.9%
Prilosec OTC32829.4%
Dexilant32529.1%
Omeprazole29626.5%
Pantoprazole21619.3%

Other products listed in reports where Zegerid 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

MeasureZegeridProton pump inhibitorAll reports
Reports as suspect product1,117484,09020,646,523
Share of that pool—0.2%0%
Reports, latest 12 months0—1,332,454
Marked serious88%86.4%57.4%
Death recorded among outcomes, per 1,000 reports10010591
Hospitalisation recorded, per 1,000 reports114199213
Consumer-filed share25%26.2%45.8%
Top term, share of reportsChronic kidney disease 71.4%median 31.6%0.4%

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

DrugName typeReportsLatest 12 monthsMarked serious
Nexiumbrand85,36757668.6%
Omeprazolegeneric61,1762,50689.4%
Pantoprazolegeneric44,9802,71095.2%
Pantoprazole sodiumgeneric44,0981,62990.9%
Prilosecbrand42,34311588.3%
Prevacidbrand40,15127395.8%
Nexium 24HRbrand27,75330085.1%
Lansoprazolegeneric26,5701,74994.8%
Prilosec OTCbrand24,54911978.4%
Dexilantbrand23,62123391.5%
Prevacid 24 HRbrand20,1361392.6%
Esomeprazolegeneric17,1931,29396.8%
Aciphexbrand7,246392.1%
Esomeprazole magnesiumgeneric5,01436882.5%
Omeprazole magnesiumgeneric4,12017574.9%

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.

Questions about Zegerid reports

How many adverse event reports has FDA received for Zegerid?

1,117 reports list Zegerid as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 1,335 list it only as a concomitant medication.

What reactions are recorded in Zegerid reports?

chronic kidney disease (71.4%), acute kidney injury (40.2%), renal failure (37.7%), end stage renal disease (20.1%) and renal injury (18.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Zegerid was responsible.

How serious are the reports?

88% are marked serious by the reporter. Among the outcomes recorded, 10% of reports include death and 11.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

not given (30%), lawyer (29.5%) and consumer or non-health professional (25%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Zegerid rising?

0 reports in the 12 months to June 2026, against 2 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Zegerid was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Zegerid?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

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 Zegerid as a suspect or interacting product; reports listing it only as a concomitant medication (1,335) 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.