Drug · FAERS side-effect profile with label screen

Omeprazole and Bicarbonate side effects: what 669 FDA adverse event reports show

Omeprazole And Sodium Bicarbonate · 116 reaction terms · 3,577 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

Omeprazole (Omeprazole)

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

Who reports

669 reports · 44% serious · 36 with death outcome · 64% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

FDA label, Description section

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 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 28

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. 76 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	212	87.7 77.0–99.9ROR 94.8 · χ² 17,888 / p <1e-300	86.0 EB05 76.7 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Chronic kidney disease	788	78.2 73.7–83.0ROR 108.7 · χ² 59,598 / p <1e-300	77.3 EB05 72.9 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 58.1	no trial data cached
Renal injury	195	49.2 43.0–56.4ROR 52.9 · χ² 9,120 / p <1e-300	48.7 EB05 43.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Tubulointerstitial nephritis	101	40.8 33.7–49.5ROR 42.3 · χ² 3,867 / p <1e-300	40.3 EB05 34.1 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.9	no trial data cached
Nephropathy	50	40.3 30.6–53.1ROR 41.1 · χ² 1,870 / p <1e-300	39.6 EB05 31.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 18.5	no trial data cached
Renal failure (kidney failure)	431	24.3 22.3–26.6ROR 28.6 · χ² 9,654 / p <1e-300	24.2 EB05 22.4 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4	no trial data cached
Acute kidney injury (sudden kidney damage)	456	22.6 20.8–24.6ROR 26.9 · χ² 9,440 / p <1e-300	22.5 EB05 20.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Incorrect product administration duration	40	14.9 10.9–20.2ROR 15.1 · χ² 503 / p 9e-112	14.6 EB05 11.1 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=1 · 100% consumer	no trial data cached
Vitamin d deficiency	19	14.7 9.4–23.0ROR 14.8 · χ² 229 / p 5e-52	14.0 EB05 9.0 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.0	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	155	14.6 12.5–17.0ROR 15.4 · χ² 1,951 / p <1e-300	14.5 EB05 12.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Nocturia (night-time urination)	20	12.5 8.0–19.3ROR 12.5 · χ² 199 / p 2e-45	11.6 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Renal tubular necrosis	16	12.3 7.5–20.0ROR 12.3 · χ² 154 / p 9e-36	11.1 EB05 6.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dialysis	20	10.6 6.8–16.4ROR 10.7 · χ² 164 / p 6e-38	9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Gallbladder disorder	21	8.8 5.8–13.5ROR 8.9 · χ² 138 / p 3e-32	7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Intervertebral disc degeneration	10	8.1 4.4–15.0ROR 8.1 · χ² 55 / p 5e-14	6.3 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Rebound effect	12	8.0 4.5–14.0ROR 8.0 · χ² 66 / p 2e-16	6.5 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Hiatus hernia	13	7.6 4.4–13.0ROR 7.6 · χ² 67 / p 1e-16	6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Economic problem	15	7.3 4.4–12.2ROR 7.4 · χ² 76 / p 2e-18	6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Cholecystectomy	11	7.3 4.0–13.2ROR 7.3 · χ² 54 / p 1e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Osteoporosis	37	6.8 4.9–9.3ROR 6.8 · χ² 176 / p 1e-40	6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Micturition urgency	10	6.6 3.6–12.3ROR 6.7 · χ² 42 / p 4e-11	5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hyperlipidaemia	10	6.3 3.4–11.7ROR 6.3 · χ² 39 / p 2e-10	5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Multiple fractures	13	5.9 3.4–10.2ROR 5.9 · χ² 48 / p 2e-12	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Nephrolithiasis (kidney stones)	33	5.4 3.9–7.6ROR 5.5 · χ² 115 / p 3e-27	5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	no trial data cached
Restless legs syndrome	13	5.4 3.1–9.3ROR 5.4 · χ² 42 / p 4e-11	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bone disorder	13	5.3 3.1–9.2ROR 5.4 · χ² 42 / p 6e-11	4.5 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Renal impairment	59	5.3 4.1–6.8ROR 5.4 · χ² 203 / p 2e-46	5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Osteopenia	10	4.9 2.7–9.2ROR 5.0 · χ² 28 / p 7e-8	4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Proteinuria	12	4.8 2.7–8.4ROR 4.8 · χ² 32 / p 6e-9	4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Sleep apnoea syndrome	12	4.7 2.7–8.3ROR 4.7 · χ² 32 / p 9e-9	4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product prescribing issue	12	4.4 2.5–7.8ROR 4.5 · χ² 29 / p 4e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Renal disorder	27	4.4 3.0–6.3ROR 4.4 · χ² 67 / p 2e-16	4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.2	no trial data cached
Gastritis	15	4.3 2.6–7.1ROR 4.3 · χ² 35 / p 2e-9	3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 1.8	no trial data cached
Kidney infection	11	4.2 2.3–7.6ROR 4.2 · χ² 24 / p 5e-7	3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Gout	10	4.2 2.3–7.8ROR 4.2 · χ² 21 / p 2e-6	3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Pollakiuria (frequent urination)	23	4.2 2.8–6.3ROR 4.2 · χ² 52 / p 3e-13	3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Cholelithiasis	18	4.1 2.6–6.6ROR 4.2 · χ² 40 / p 1e-10	3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Intervertebral disc protrusion	12	4.1 2.3–7.3ROR 4.1 · χ² 25 / p 2e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.2	no trial data cached
Injury	38	4.1 3.0–5.6ROR 4.1 · χ² 85 / p 2e-20	3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Foot fracture	10	4.0 2.1–7.4ROR 4.0 · χ² 19 / p 6e-6	3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	–	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	788	78.2 73.7–83.0ROR 108.7 · χ² 59,598 / p <1e-300	77.3 EB05 72.9 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 58.1	no trial data cached
Acute kidney injury (sudden kidney damage)	456	22.6 20.8–24.6ROR 26.9 · χ² 9,440 / p <1e-300	22.5 EB05 20.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Renal failure (kidney failure)	431	24.3 22.3–26.6ROR 28.6 · χ² 9,654 / p <1e-300	24.2 EB05 22.4 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4	no trial data cached
End stage renal disease	212	87.7 77.0–99.9ROR 94.8 · χ² 17,888 / p <1e-300	86.0 EB05 76.7 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Renal injury	195	49.2 43.0–56.4ROR 52.9 · χ² 9,120 / p <1e-300	48.7 EB05 43.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	155	14.6 12.5–17.0ROR 15.4 · χ² 1,951 / p <1e-300	14.5 EB05 12.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Tubulointerstitial nephritis	101	40.8 33.7–49.5ROR 42.3 · χ² 3,867 / p <1e-300	40.3 EB05 34.1 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.9	no trial data cached
Renal impairment	59	5.3 4.1–6.8ROR 5.4 · χ² 203 / p 2e-46	5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial data cached
Nephropathy	50	40.3 30.6–53.1ROR 41.1 · χ² 1,870 / p <1e-300	39.6 EB05 31.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 18.5	no trial data cached
Incorrect product administration duration	40	14.9 10.9–20.2ROR 15.1 · χ² 503 / p 9e-112	14.6 EB05 11.1 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=1 · 100% consumer	no trial data cached
Injury	38	4.1 3.0–5.6ROR 4.1 · χ² 85 / p 2e-20	3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Osteoporosis	37	6.8 4.9–9.3ROR 6.8 · χ² 176 / p 1e-40	6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Nephrolithiasis (kidney stones)	33	5.4 3.9–7.6ROR 5.5 · χ² 115 / p 3e-27	5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	no trial data cached
Drug dose omission	28	1.3 0.9–1.8ROR 1.3 · χ² 1 / p 0.133	1.3 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Renal disorder	27	4.4 3.0–6.3ROR 4.4 · χ² 67 / p 2e-16	4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.2	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.

End stage renal disease — n=212, PRR 87.7
Chronic kidney disease — n=788, PRR 78.2
Renal injury — n=195, PRR 49.2
Nephropathy — n=50, PRR 40.3
Acute kidney injury — n=456, PRR 22.6
Gastrooesophageal reflux disease — n=155, PRR 14.6
Nocturia — n=20, PRR 12.5
Dialysis — n=20, PRR 10.6
Gallbladder disorder — n=21, PRR 8.8
Nephrolithiasis — n=33, PRR 5.4

✓ 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, end stage renal disease, renal injury, gastrooesophageal reflux disease. 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, field patient.drug.openfda.generic_name.exact, 116 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.