Drug · FAERS side-effect profile with label screen

Omepraole and Bicarbonate side effects: what 315 FDA adverse event reports show

Omepraole, Sodium Bicarbonate · 8 reaction terms · 635 drug–reaction co-reports · data 2026-09-14

Drug class

Proton Pump Inhibitor

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Omepraole, Sodium Bicarbonate (Zegerid Otc)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

315 reports · 89% serious · 26 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

• treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect.

FDA label, Indications and Usage

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 8 strongest signals

No label text to screen 8

What the badges mean

Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
End stage renal disease	63	227.7 182.5–284.2ROR 284.2 · χ² 13,959 / p <1e-300	212.4 EB05 171.9 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 147.8 · ♀ 34% (drug 57%)	no trial data cached
Chronic kidney disease	215	186.7 173.0–201.4ROR 581.8 · χ² 39,548 / p <1e-300	183.1 EB05 163.5 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 123.2	no trial data cached
Renal injury	78	172.9 142.5–209.6ROR 229.2 · χ² 13,140 / p <1e-300	165.5 EB05 136.9 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 112.6	no trial data cached
Tubulointerstitial nephritis	37	131.3 97.0–177.8ROR 148.6 · χ² 4,651 / p <1e-300	122.9 EB05 93.1 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 85.7	no trial data cached
Nephropathy	14	99.1 59.4–165.5ROR 103.7 · χ² 1,262 / p 9e-277	87.5 EB05 55.4 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 68.8	no trial data cached
Renal failure (kidney failure)	104	51.6 44.1–60.4ROR 76.5 · χ² 5,142 / p <1e-300	51.1 EB05 43.4 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.8	no trial data cached
Acute kidney injury (sudden kidney damage)	118	51.5 44.6–59.4ROR 81.5 · χ² 5,825 / p <1e-300	51.0 EB05 43.7 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.6	no trial data cached
Dialysis	6	28.0 12.7–61.9ROR 28.5 · χ² 130 / p 2e-30	25.0 EB05 10.8 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Chronic kidney disease	215	186.7 173.0–201.4ROR 581.8 · χ² 39,548 / p <1e-300	183.1 EB05 163.5 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 123.2	no trial data cached
Acute kidney injury (sudden kidney damage)	118	51.5 44.6–59.4ROR 81.5 · χ² 5,825 / p <1e-300	51.0 EB05 43.7 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.6	no trial data cached
Renal failure (kidney failure)	104	51.6 44.1–60.4ROR 76.5 · χ² 5,142 / p <1e-300	51.1 EB05 43.4 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.8	no trial data cached
Renal injury	78	172.9 142.5–209.6ROR 229.2 · χ² 13,140 / p <1e-300	165.5 EB05 136.9 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 112.6	no trial data cached
End stage renal disease	63	227.7 182.5–284.2ROR 284.2 · χ² 13,959 / p <1e-300	212.4 EB05 171.9 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 147.8 · ♀ 34% (drug 57%)	no trial data cached
Tubulointerstitial nephritis	37	131.3 97.0–177.8ROR 148.6 · χ² 4,651 / p <1e-300	122.9 EB05 93.1 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 85.7	no trial data cached
Nephropathy	14	99.1 59.4–165.5ROR 103.7 · χ² 1,262 / p 9e-277	87.5 EB05 55.4 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 68.8	no trial data cached
Dialysis	6	28.0 12.7–61.9ROR 28.5 · χ² 130 / p 2e-30	25.0 EB05 10.8 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.1	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Omepraole and Bicarbonate?

In FDA FAERS, the most frequently co-reported reaction terms for Omepraole and Bicarbonate are chronic kidney disease, acute kidney injury, renal failure, renal injury, end stage renal disease, tubulointerstitial nephritis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Omepraole and Bicarbonate have an FDA boxed warning?

No. The FDA label retrieved for Omepraole and Bicarbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Omepraole and Bicarbonate causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 8d00c19a-d86b-4a2f-8791-b320ad3ca781, effective 20250715; matched on openfda.generic_name.exact:"OMEPRAOLE, SODIUM BICARBONATE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 8 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.