Pantoprazole Sodium side effects: what 147,344 FDA adverse event reports show

Pantoprazole Sodium · 1,190 reaction terms · 834,345 drug–reaction co-reports · data 2026-09-14

Drug class

Proton pump inhibitor (ppi)

FDA label, Indications wording

Who reports

147,344 reports · 78% serious · 16,414 with death outcome · 63% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) .

FDA label, Indications and Usage

What it is

Pantoprazole is a member of the class of benzimidazoles that is 1H-benzimidazole substituted by a difluoromethoxy group at position 5 and a [(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl group at position 2.

PubChem CID 4679 (ChEBI)

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 1Labeled (related wording) 2Likely indication confounding 1Lab value / disease marker 7Not in label — unassessed 29

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,150 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
Renal haemangioma	789	13,745.0 6,849.8–27,581.0ROR 13,819.0 · calibrated p 2e-27 ✓	138.5 EB05 130.6 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=789 · 72% consumer	not reported in cached trials
Grip strength	128	176.6 136.1–229.3ROR 176.8 · calibrated p 2e-9 ✓	77.6 EB05 66.9 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=128 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Rebound acid hypersecretion	1,321	107.9 100.5–115.9ROR 108.9 · calibrated p 6e-8 ✓	61.2 EB05 58.5 · IC025 +5.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,317	not reported in cached trials
End stage renal disease	7,560	99.2 96.4–102.2ROR 104.5 · calibrated p 8e-8 ✓	58.4 EB05 57.3 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 43.1	not reported in cached trials
Deep vein thrombosis postoperative	778	93.6 85.5–102.5ROR 94.1 · calibrated p 2e-7 ✓	56.3 EB05 53.1 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=778 · ♀ 100% (drug 63%) · 91% clinician	not reported in cached trials
Lupus vulgaris	471	93.2 83.0–104.8ROR 93.5 · calibrated p 2e-7 ✓	56.1 EB05 52.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=471 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
C-reactive protein	346	87.7 76.6–100.3ROR 87.9 · calibrated p 3e-7 ✓	54.1 EB05 49.4 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	serious n=345 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	206	86.5 72.7–102.9ROR 86.6 · calibrated p 4e-7 ✓	53.5 EB05 47.6 · IC025 +5.3 3/3 methods agree	Labeled (related wording) related wording	serious n=201 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Nephrogenic anaemia	1,628	76.0 71.5–80.7ROR 76.8 · calibrated p 8e-7 ✓	49.5 EB05 47.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=1,628	not reported in cached trials
Chronic kidney disease-mineral and bone disorder	365	73.0 64.3–82.8ROR 73.2 · calibrated p 1e-6 ✓	48.1 EB05 44.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=365	not reported in cached trials
Chronic kidney disease	24,469	66.6 65.7–67.6ROR 79.7 · calibrated p 6e-7 ✓	45.4 EB05 44.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 34.8 · serious PRR 33.6	not reported in cached trials
Hyperparathyroidism secondary	785	63.8 58.7–69.4ROR 64.2 · calibrated p 3e-6 ✓	44.0 EB05 41.5 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=784 · 100% consumer	not reported in cached trials
Adjustment disorder with depressed mood	585	58.0 52.7–63.9ROR 58.3 · calibrated p 5e-6 ✓	41.2 EB05 38.5 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=584 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Swollen joint count increased	889	56.6 52.3–61.1ROR 56.9 · calibrated p 6e-6 ✓	40.5 EB05 38.3 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=888 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
X-ray abnormal	494	54.3 48.9–60.2ROR 54.5 · calibrated p 8e-6 ✓	39.3 EB05 36.5 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=494 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	1,666	49.5 46.8–52.4ROR 50.1 · calibrated p 1e-5 ✓	36.8 EB05 35.3 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious n=1,648 · ♀ 100% (drug 63%) · 92% clinician	not reported in cached trials
Duodenal ulcer perforation	1,896	49.4 46.9–52.0ROR 50.0 · calibrated p 1e-5 ✓	36.7 EB05 35.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.1 · ♀ 100% (drug 63%) · 91% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	1,821	48.9 46.3–51.5ROR 49.5 · calibrated p 1e-5 ✓	36.4 EB05 35.0 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious PRR 27.0 · ♀ 100% (drug 63%) · 93% clinician	not reported in cached trials
Dislocation of vertebra	568	48.6 44.2–53.5ROR 48.8 · calibrated p 2e-5 ✓	36.3 EB05 33.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=568 · ♀ 100% (drug 63%) · 92% clinician	not reported in cached trials
Muscle injury	2,027	46.5 44.2–48.9ROR 47.1 · calibrated p 2e-5 ✓	35.1 EB05 33.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 28.1 · ♀ 100% (drug 63%) · 93% clinician	not reported in cached trials
Rheumatic fever	1,039	44.2 41.3–47.4ROR 44.5 · calibrated p 3e-5 ✓	33.8 EB05 32.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=1,039 · ♀ 100% (drug 63%) · 94% clinician	not reported in cached trials
Facet joint syndrome	743	43.7 40.3–47.5ROR 43.9 · calibrated p 3e-5 ✓	33.5 EB05 31.5 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=742 · ♀ 100% (drug 63%) · 93% clinician	not reported in cached trials
Neurologic neglect syndrome	125	40.7 33.4–49.7ROR 40.7 · calibrated p 5e-5 ✓	31.6 EB05 27.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=125 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Retinitis	366	39.8 35.4–44.7ROR 39.9 · calibrated p 6e-5 ✓	31.1 EB05 28.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=366 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	146	39.7 33.0–47.7ROR 39.7 · calibrated p 6e-5 ✓	31.0 EB05 27.0 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=146 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Pulmonary vasculitis	115	39.4 32.0–48.4ROR 39.4 · calibrated p 7e-5 ✓	30.8 EB05 26.3 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=115 · ♀ 0% (drug 63%) · 100% clinician	not reported in cached trials
Rheumatoid factor positive	1,199	37.2 34.9–39.6ROR 37.5 · calibrated p 8e-5 ✓	29.5 EB05 28.2 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=1,199 · ♀ 100% (drug 63%) · 95% clinician	not reported in cached trials
Renal injury	6,217	37.0 36.0–38.0ROR 38.6 · calibrated p 6e-5 ✓	29.5 EB05 28.8 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.8	not reported in cached trials
Folliculitis	2,139	37.0 35.3–38.8ROR 37.5 · calibrated p 8e-5 ✓	29.4 EB05 28.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · ♀ 100% (drug 63%) · 93% clinician	not reported in cached trials
Helicobacter infection	1,997	34.5 32.9–36.2ROR 35.0 · calibrated p 1e-4 ✓	27.9 EB05 26.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 21.7 · ♀ 100% (drug 63%) · 91% clinician	not reported in cached trials
Hyperchlorhydria	1,111	32.6 30.5–34.8ROR 32.8 · calibrated p 2e-4 ✓	26.6 EB05 25.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=927 · 100% consumer	not reported in cached trials
Peripheral venous disease	736	32.0 29.5–34.7ROR 32.1 · calibrated p 2e-4 ✓	26.2 EB05 24.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=730 · ♀ 100% (drug 63%) · 93% clinician	not reported in cached trials
Porphyria acute	244	30.4 26.5–34.9ROR 30.4 · calibrated p 3e-4 ✓	25.1 EB05 22.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=244 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Pemphigus	2,113	29.0 27.7–30.4ROR 29.4 · calibrated p 3e-4 ✓	24.2 EB05 23.3 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 17.9 · ♀ 100% (drug 63%) · 92% clinician	not reported in cached trials
Tubulointerstitial nephritis	2,995	26.9 25.9–28.0ROR 27.5 · calibrated p 4e-4 ✓	22.7 EB05 22.1 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 8.3 · serious PRR 16.9	not reported in cached trials
Hand deformity	1,969	25.1 23.9–26.3ROR 25.4 · calibrated p 6e-4 ✓	21.4 EB05 20.6 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.2 · ♀ 100% (drug 63%) · 92% clinician	not reported in cached trials
Carotid artery thrombosis	126	24.5 20.3–29.6ROR 24.5 · calibrated p 8e-4 ✓	20.9 EB05 18.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=126 · ♀ 100% (drug 63%) · 100% clinician	not reported in cached trials
Hypertensive nephropathy	157	24.1 20.3–28.5ROR 24.1 · calibrated p 9e-4 ✓	20.6 EB05 18.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=157 · 100% consumer	not reported in cached trials
C-reactive protein abnormal	915	23.6 22.0–25.3ROR 23.7 · calibrated p 9e-4 ✓	20.3 EB05 19.2 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=915 · ♀ 100% (drug 63%) · 94% clinician	not reported in cached trials
Adjustment disorder	173	21.6 18.4–25.4ROR 21.6 · calibrated p 0.001 ✓	18.8 EB05 16.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=172 · 100% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Kidney injury	24,790	8.18.0–8.2	signal
Gi bleeding	3,840	3.02.9–3.1	signal
Interstitial lung disease	1,781	2.72.6–2.8	signal
Liver injury	5,494	2.62.6–2.7	signal
Anaemia	5,394	2.62.5–2.7	signal
Hyponatraemia	1,419	2.52.4–2.7	signal
Serious infection	13,470	2.52.5–2.5	signal
Pancreatitis	1,352	2.42.3–2.5	signal
Arrhythmia / qt	2,781	2.12.0–2.1	raised
Venous thromboembolism	3,072	2.02.0–2.1	raised
Heart failure	2,527	2.01.9–2.1	raised
Thrombocytopenia	2,979	1.91.9–2.0	raised
Depression	3,757	1.91.9–2.0	raised
Fall / fracture	5,044	1.91.8–1.9	raised
Hyperglycaemia / diabetes	4,543	1.91.8–1.9	raised
Rhabdomyolysis / myopathy	892	1.61.5–1.7	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Pantoprazole Sodium as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

NCT00562094 — Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS) (N=8616, phase n/a; 20 AE terms posted; arms: Pantoprazole)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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	24,469	66.6 65.7–67.6ROR 79.7 · calibrated p 6e-7 ✓	45.4 EB05 44.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 34.8 · serious PRR 33.6	not reported in cached trials
Acute kidney injury (sudden kidney damage)	13,851	14.1 13.9–14.4ROR 15.5 · calibrated p 0.006 ✓	12.9 EB05 12.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 5.7 · serious PRR 9.6	not reported in cached trials
Fatigue (tiredness)	11,415	2.1 2.1–2.1ROR 2.2 · calibrated p 0.952	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.2 · serious PRR 2.3	not reported in cached trials
Renal failure (kidney failure)	10,872	12.5 12.3–12.7ROR 13.4 · calibrated p 0.011 ✓	11.6 EB05 11.4 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 5.9 · serious PRR 8.6	NCT00562094: 1/8,616 (0.0%) on Pantoprazole Sodium (serious AE)
Nausea	10,508	1.9 1.9–1.9ROR 2.0 · calibrated p 0.931	1.9 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.0	not reported in cached trials
Pain	9,843	2.3 2.3–2.3ROR 2.4 · calibrated p 0.862	2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 2.3	NCT00562094: 1/8,616 (0.0%) on Pantoprazole Sodium
Dyspnoea (shortness of breath)	9,565	2.4 2.4–2.5ROR 2.5 · calibrated p 0.801	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.4 · serious PRR 2.2	not reported in cached trials
Diarrhoea (diarrhea)	9,429	2.1 2.1–2.1ROR 2.2 · calibrated p 0.963	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.1	not reported in cached trials
Drug ineffective (drug did not work)	8,846	1.0 0.9–1.0ROR 1.0 · calibrated p 0.276	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 1.3 · serious PRR 1.4	not reported in cached trials
Headache	8,255	1.9 1.8–1.9ROR 1.9 · calibrated p 0.911	1.9 EB05 1.8 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.2	not reported in cached trials
Off label use (used outside approved label)	8,014	1.3 1.3–1.3ROR 1.3 · calibrated p 0.531	1.3 EB05 1.3 · IC025 +0.4	Reporting / coding artifact	age-adj. PRR 1.5 · serious PRR 1.5	not reported in cached trials
End stage renal disease	7,560	99.2 96.4–102.2ROR 104.5 · calibrated p 8e-8 ✓	58.4 EB05 57.3 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 43.1	not reported in cached trials
Vomiting	6,944	2.1 2.1–2.2ROR 2.2 · calibrated p 0.962	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.3 · serious PRR 2.0	not reported in cached trials
Arthralgia (joint pain)	6,913	2.4 2.3–2.5ROR 2.5 · calibrated p 0.828	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.5 · serious PRR 2.7	NCT00562094: 1/8,616 (0.0%) on Pantoprazole Sodium
Asthenia (weakness)	6,361	2.4 2.4–2.5ROR 2.5 · calibrated p 0.815	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.4 · serious PRR 2.2	not reported in cached trials

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.

Renal haemangioma — n=789, PRR 13,745.0
Grip strength — n=128, PRR 176.6
End stage renal disease — n=7,560, PRR 99.2
Deep vein thrombosis postoperative — n=778, PRR 93.6
Lupus vulgaris — n=471, PRR 93.2
Nephrogenic anaemia — n=1,628, PRR 76.0
Chronic kidney disease-mineral and bone disorder — n=365, PRR 73.0
Chronic kidney disease — n=24,469, PRR 66.6
Hyperparathyroidism secondary — n=785, PRR 63.8
Adjustment disorder with depressed mood — n=585, PRR 58.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.

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 Pantoprazole Sodium?

In FDA FAERS, the most frequently co-reported reaction terms for Pantoprazole Sodium are chronic kidney disease, acute kidney injury, fatigue, renal failure, nausea, pain. 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 Pantoprazole Sodium have an FDA boxed warning?

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

Do FAERS signals prove that Pantoprazole Sodium 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 07ff83f9-7039-ac26-e063-6394a90a37ce, effective 20250203; matched on openfda.generic_name.exact:"PANTOPRAZOLE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 4679 description (ChEBI)
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, 1,190 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
ClinicalTrials.gov API v2 (query PANTOPRAZOLE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.