Omeprazole and Bicarbonate side effects: what 929 FDA adverse event reports show
Drug class
Proton Pump Inhibitor
Label matched
Omeprazole (Omeprazole)
Who reports
929 reports · 61% serious · 63 with death outcome · 62% female
Used for
Omeprazole is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults (1.1) • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) • Treatment of active benign gastri.
What it is
The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion.
Boxed warning
None in the current label
Causality screen of the 13 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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.
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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 326 | 96.3 88.2–105.1ROR 147.7 · χ² 30,631 / p <1e-300 | 95.4 EB05 87.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 91.6 | no trial data cached |
| End stage renal disease | 77 | 94.6 76.4–117.3ROR 103.1 · χ² 7,018 / p <1e-300 | 92.2 EB05 76.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 88.6 · ♀ 36% (drug 62%) | no trial data cached |
| Renal injury | 91 | 68.6 56.4–83.4ROR 75.9 · χ² 5,980 / p <1e-300 | 67.4 EB05 56.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 64.4 | no trial data cached |
| Tubulointerstitial nephritis | 43 | 51.9 38.7–69.5ROR 54.3 · χ² 2,092 / p <1e-300 | 50.7 EB05 39.2 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 48.8 | no trial data cached |
| Incorrect product administration duration | 39 | 43.4 31.9–59.0ROR 45.3 · χ² 1,572 / p <1e-300 | 42.5 EB05 32.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Nephropathy | 18 | 43.3 27.4–68.5ROR 44.2 · χ² 701 / p 7e-155 | 41.5 EB05 27.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.4 | no trial data cached |
| Renal failure (kidney failure) | 155 | 26.2 22.7–30.2ROR 31.2 · χ² 3,744 / p <1e-300 | 26.1 EB05 22.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 168 | 24.9 21.7–28.6ROR 30.2 · χ² 3,853 / p <1e-300 | 24.8 EB05 21.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 | no trial data cached |
| Infusion site pain | 6 | 10.6 4.8–23.5ROR 10.7 · χ² 43 / p 3e-11 | 7.3 EB05 3.2 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Drug effect less than expected | 6 | 9.6 4.3–21.3ROR 9.7 · χ² 38 / p 3e-10 | 6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Dialysis | 6 | 9.5 4.3–21.1ROR 9.6 · χ² 38 / p 4e-10 | 6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Gastric cancer | 9 | 7.9 4.1–15.2ROR 8.0 · χ² 48 / p 2e-12 | 6.0 EB05 3.3 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.4 | no trial data cached |
| Dermatitis atopic | 7 | 3.2 1.5–6.6ROR 3.2 · χ² 8 / p 0.002 | 2.7 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 326 | 96.3 88.2–105.1ROR 147.7 · χ² 30,631 / p <1e-300 | 95.4 EB05 87.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 91.6 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 168 | 24.9 21.7–28.6ROR 30.2 · χ² 3,853 / p <1e-300 | 24.8 EB05 21.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 | no trial data cached |
| Renal failure (kidney failure) | 155 | 26.2 22.7–30.2ROR 31.2 · χ² 3,744 / p <1e-300 | 26.1 EB05 22.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.7 | no trial data cached |
| Renal injury | 91 | 68.6 56.4–83.4ROR 75.9 · χ² 5,980 / p <1e-300 | 67.4 EB05 56.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 64.4 | no trial data cached |
| End stage renal disease | 77 | 94.6 76.4–117.3ROR 103.1 · χ² 7,018 / p <1e-300 | 92.2 EB05 76.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 88.6 · ♀ 36% (drug 62%) | no trial data cached |
| Tubulointerstitial nephritis | 43 | 51.9 38.7–69.5ROR 54.3 · χ² 2,092 / p <1e-300 | 50.7 EB05 39.2 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 48.8 | no trial data cached |
| Incorrect product administration duration | 39 | 43.4 31.9–59.0ROR 45.3 · χ² 1,572 / p <1e-300 | 42.5 EB05 32.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Nephropathy | 18 | 43.3 27.4–68.5ROR 44.2 · χ² 701 / p 7e-155 | 41.5 EB05 27.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.4 | no trial data cached |
| Gastric cancer | 9 | 7.9 4.1–15.2ROR 8.0 · χ² 48 / p 2e-12 | 6.0 EB05 3.3 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.4 | no trial data cached |
| Dermatitis atopic | 7 | 3.2 1.5–6.6ROR 3.2 · χ² 8 / p 0.002 | 2.7 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | – | no trial data cached |
| Dialysis | 6 | 9.5 4.3–21.1ROR 9.6 · χ² 38 / p 4e-10 | 6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Drug effect less than expected | 6 | 9.6 4.3–21.3ROR 9.7 · χ² 38 / p 3e-10 | 6.5 EB05 3.0 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Infusion site pain | 6 | 10.6 4.8–23.5ROR 10.7 · χ² 43 / p 3e-11 | 7.3 EB05 3.2 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Coronary artery occlusion | 4 | 6.5 2.5–17.4ROR 6.6 · χ² 14 / p 1e-4 | 4.1 EB05 1.8 · IC025 +0.3 | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Rebound effect | 3 | 6.0 1.9–18.5ROR 6.0 · χ² 8 / p 0.002 | 3.5 EB05 1.4 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Chronic kidney disease — n=326, PRR 96.3
- End stage renal disease — n=77, PRR 94.6
- Renal injury — n=91, PRR 68.6
- Acute kidney injury — n=168, PRR 24.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Omeprazole (proton-pump inhibitors) ↔ Chronic kidney disease.
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 Omeprazole and Bicarbonate?
In FDA FAERS, the most frequently co-reported reaction terms for Omeprazole 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 Omeprazole and Bicarbonate have an FDA boxed warning?
No. The FDA label retrieved for Omeprazole and Bicarbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Omeprazole 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 0344268f-d8e6-48d5-b1e1-f750ed1d8a52, effective 20260717; matched on
openfda.generic_name.exact:"OMEPRAZOLE") - 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, fieldpatient.drug.openfda.generic_name.exact, 15 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.