Pantoprazole side effects: what 251,540 FDA adverse event reports show

Pantoprazole · 1,185 reaction terms · 1,376,136 drug–reaction co-reports · data 2026-09-14

Drug class

Proton pump inhibitor (ppi)

FDA label, Indications wording

Who reports

251,540 reports · 83% serious · 28,518 with death outcome · 58% 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 (related wording) 4Reporting / coding artifact 1Lab value / disease marker 9Not in label — unassessed 26

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.
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). 1,145 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
Deep vein thrombosis postoperative	1,104	107.8 98.5–117.9ROR 108.3 · calibrated p 6e-8 ✓	46.9 EB05 44.6 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=1,104 · ♀ 100% (drug 58%) · 92% clinician	not reported in cached trials
Lupus vulgaris	638	96.5 86.1–108.2ROR 96.8 · calibrated p 2e-7 ✓	44.6 EB05 41.8 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=638 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
C-reactive protein	467	88.4 77.6–100.8ROR 88.6 · calibrated p 3e-7 ✓	42.8 EB05 39.6 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=466 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Swollen joint count increased	1,507	77.9 72.6–83.6ROR 78.3 · calibrated p 7e-7 ✓	40.2 EB05 38.6 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=1,506 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	320	76.7 65.8–89.3ROR 76.8 · calibrated p 9e-7 ✓	39.8 EB05 36.3 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=320 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	3,010	61.1 58.2–64.0ROR 61.8 · calibrated p 3e-6 ✓	35.3 EB05 34.2 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious PRR 24.4 · ♀ 100% (drug 58%) · 94% clinician	not reported in cached trials
Adjustment disorder with depressed mood	853	60.9 55.8–66.6ROR 61.1 · calibrated p 4e-6 ✓	35.2 EB05 33.3 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=852 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Duodenal ulcer perforation	3,064	59.5 56.8–62.3ROR 60.2 · calibrated p 4e-6 ✓	34.8 EB05 33.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 24.0 · ♀ 100% (drug 58%) · 93% clinician	not reported in cached trials
Rheumatic fever	1,780	57.1 53.8–60.7ROR 57.5 · calibrated p 6e-6 ✓	33.9 EB05 32.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=1,779 · ♀ 100% (drug 58%) · 95% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	222	57.1 48.1–67.8ROR 57.1 · calibrated p 7e-6 ✓	33.8 EB05 30.3 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious n=221 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
X-ray abnormal	699	53.4 48.6–58.8ROR 53.6 · calibrated p 9e-6 ✓	32.6 EB05 30.6 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=699 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	2,489	52.3 49.7–55.0ROR 52.8 · calibrated p 1e-5 ✓	32.2 EB05 31.2 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=2,476 · ♀ 100% (drug 58%) · 93% clinician	not reported in cached trials
Muscle injury	3,156	51.8 49.6–54.2ROR 52.5 · calibrated p 1e-5 ✓	32.0 EB05 31.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.9 · ♀ 100% (drug 58%) · 93% clinician	not reported in cached trials
Dislocation of vertebra	827	49.1 45.0–53.5ROR 49.2 · calibrated p 2e-5 ✓	30.9 EB05 29.2 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=827 · ♀ 100% (drug 58%) · 93% clinician	not reported in cached trials
Facet joint syndrome	1,159	48.2 44.8–51.8ROR 48.4 · calibrated p 2e-5 ✓	30.6 EB05 29.2 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=1,158 · ♀ 100% (drug 58%) · 94% clinician	not reported in cached trials
Rheumatoid factor positive	1,949	42.3 40.0–44.6ROR 42.6 · calibrated p 4e-5 ✓	28.1 EB05 27.1 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious n=1,949 · ♀ 100% (drug 58%) · 96% clinician	not reported in cached trials
Folliculitis	3,324	39.3 37.7–41.0ROR 39.8 · calibrated p 5e-5 ✓	26.8 EB05 26.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 21.7 · ♀ 100% (drug 58%) · 93% clinician	not reported in cached trials
Helicobacter infection	3,259	38.9 37.3–40.6ROR 39.4 · calibrated p 6e-5 ✓	26.6 EB05 25.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.4 · ♀ 100% (drug 58%) · 92% clinician	not reported in cached trials
Retinitis	531	38.6 34.8–42.8ROR 38.7 · calibrated p 7e-5 ✓	26.5 EB05 24.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=531 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Pemphigus	3,885	37.6 36.2–39.1ROR 38.2 · calibrated p 7e-5 ✓	26.0 EB05 25.4 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 18.0 · ♀ 100% (drug 58%) · 94% clinician	not reported in cached trials
Peripheral venous disease	1,141	33.1 30.9–35.4ROR 33.2 · calibrated p 2e-4 ✓	23.8 EB05 22.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=1,135 · ♀ 100% (drug 58%) · 94% clinician	not reported in cached trials
Systemic infection	457	31.3 28.1–34.9ROR 31.4 · calibrated p 2e-4 ✓	22.9 EB05 21.2 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious n=457 · 100% clinician	not reported in cached trials
Hand deformity	3,551	30.8 29.6–32.0ROR 31.2 · calibrated p 2e-4 ✓	22.6 EB05 22.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 17.0 · ♀ 100% (drug 58%) · 92% clinician	not reported in cached trials
Hypertensive nephropathy	277	28.6 24.9–32.7ROR 28.6 · calibrated p 4e-4 ✓	21.4 EB05 19.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=277 · 100% consumer	not reported in cached trials
Blood pressure diastolic abnormal	638	27.3 25.0–29.8ROR 27.4 · calibrated p 4e-4 ✓	20.7 EB05 19.4 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=613 · 90% clinician	not reported in cached trials
Blood pressure systolic abnormal	569	24.5 22.3–26.9ROR 24.5 · calibrated p 8e-4 ✓	19.0 EB05 17.7 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=546 · 100% clinician	not reported in cached trials
Pericarditis	3,630	23.0 22.2–23.9ROR 23.3 · calibrated p 9e-4 ✓	18.1 EB05 17.7 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.6 · ♀ 96% (drug 58%) · 92% clinician	not reported in cached trials
Porphyria acute	298	22.7 20.0–25.8ROR 22.8 · calibrated p 0.001 ✓	18.0 EB05 16.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=298 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Synovitis	3,833	22.3 21.5–23.1ROR 22.6 · calibrated p 0.001 ✓	17.7 EB05 17.2 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.8 · ♀ 100% (drug 58%) · 93% clinician	not reported in cached trials
C-reactive protein abnormal	1,355	22.2 20.9–23.5ROR 22.3 · calibrated p 0.001 ✓	17.6 EB05 16.8 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=1,347 · ♀ 100% (drug 58%) · 94% clinician	not reported in cached trials
Seronegative arthritis	225	20.7 17.9–24.0ROR 20.7 · calibrated p 0.002 ✓	16.7 EB05 14.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=225 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Bone erosion	693	20.1 18.5–21.8ROR 20.1 · calibrated p 0.002 ✓	16.3 EB05 15.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=691 · ♀ 100% (drug 58%) · 90% clinician	not reported in cached trials
Drug tolerance decreased	511	18.4 16.7–20.3ROR 18.5 · calibrated p 0.003 ✓	15.2 EB05 14.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=498 · ♀ 100% (drug 58%)	not reported in cached trials
Product monitoring error	257	18.0 15.7–20.6ROR 18.0 · calibrated p 0.003 ✓	14.9 EB05 13.4 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=257 · 100% clinician	not reported in cached trials
Nephrogenic anaemia	835	17.9 16.7–19.3ROR 18.0 · calibrated p 0.003 ✓	14.9 EB05 14.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=834 · 100% consumer	not reported in cached trials
Adjustment disorder	231	17.8 15.4–20.5ROR 17.8 · calibrated p 0.004 ✓	14.7 EB05 13.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=230 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	3,951	17.7 17.1–18.3ROR 18.0 · calibrated p 0.003 ✓	14.7 EB05 14.3 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.5 · ♀ 98% (drug 58%) · 91% clinician	not reported in cached trials
Temperature regulation disorder	383	17.5 15.7–19.6ROR 17.6 · calibrated p 0.004 ✓	14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=383 · ♀ 100% (drug 58%) · 100% clinician	not reported in cached trials
Irritable bowel syndrome	3,652	17.0 16.4–17.6ROR 17.3 · calibrated p 0.004 ✓	14.2 EB05 13.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.3 · ♀ 100% (drug 58%)	not reported in cached trials
End stage renal disease	2,897	15.4 14.8–16.0ROR 15.6 · calibrated p 0.006 ✓	13.1 EB05 12.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	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	20,499	3.93.8–3.9	signal
Hyponatraemia	3,573	3.83.7–4.0	signal
Liver injury	11,755	3.33.3–3.4	signal
Interstitial lung disease	3,720	3.33.2–3.4	signal
Gi bleeding	6,626	3.13.0–3.2	signal
Anaemia	10,788	3.13.0–3.1	signal
Severe cutaneous reaction	2,415	2.82.7–2.9	signal
Serious infection	24,102	2.72.6–2.7	signal
Arrhythmia / qt	5,656	2.52.4–2.5	signal
Neutropenia / agranulocytosis	7,227	2.52.4–2.5	signal
Pancreatitis	2,348	2.52.4–2.6	signal
Rhabdomyolysis / myopathy	2,273	2.42.3–2.5	signal
Thrombocytopenia	6,007	2.32.3–2.4	signal
Fall / fracture	9,443	2.12.1–2.1	signal
Heart failure	4,365	2.12.0–2.1	raised
Venous thromboembolism	4,658	1.81.8–1.9	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Pantoprazole 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
Fatigue (tiredness)	20,773	2.3 2.2–2.3ROR 2.4 · calibrated p 0.868	2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 1.9 · serious PRR 2.4	not reported in cached trials
Off label use (used outside approved label)	18,623	1.8 1.8–1.8ROR 1.9 · calibrated p 0.871	1.8 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	age-adj. PRR 1.7 · serious PRR 2.0	not reported in cached trials
Nausea	17,856	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 1.8 · serious PRR 2.1	not reported in cached trials
Diarrhoea (diarrhea)	17,556	2.3 2.3–2.3ROR 2.4 · calibrated p 0.853	2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.3	not reported in cached trials
Dyspnoea (shortness of breath)	17,289	2.6 2.6–2.6ROR 2.7 · calibrated p 0.727	2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.2 · serious PRR 2.2	not reported in cached trials
Drug ineffective (drug did not work)	17,204	1.1 1.1–1.1ROR 1.1 · calibrated p 0.370	1.1 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	age-adj. PRR 1.2 · serious PRR 1.7	not reported in cached trials
Pain	15,528	2.1 2.1–2.2ROR 2.2 · calibrated p 0.948	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.1 · ♀ 79% (drug 58%)	NCT00562094: 1/8,616 (0.0%) on Pantoprazole
Headache	13,324	1.8 1.8–1.8ROR 1.8 · calibrated p 0.850	1.8 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.7 · serious PRR 2.1 · ♀ 79% (drug 58%)	not reported in cached trials
Vomiting	12,780	2.3 2.3–2.3ROR 2.4 · calibrated p 0.867	2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.1	not reported in cached trials
Arthralgia (joint pain)	12,261	2.5 2.5–2.6ROR 2.6 · calibrated p 0.776	2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.8 · ♀ 80% (drug 58%)	NCT00562094: 1/8,616 (0.0%) on Pantoprazole
Pyrexia (fever)	11,594	2.9 2.8–2.9ROR 2.9 · calibrated p 0.645	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.5 · serious PRR 2.3	not reported in cached trials
Acute kidney injury (sudden kidney damage)	11,548	6.8 6.6–6.9ROR 7.0 · calibrated p 0.097	6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.1 · serious PRR 4.4	not reported in cached trials
Asthenia (weakness)	11,435	2.6 2.5–2.6ROR 2.7 · calibrated p 0.748	2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.3	not reported in cached trials
Dizziness	10,900	1.8 1.8–1.9ROR 1.9 · calibrated p 0.877	1.8 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 1.9	NCT00562094: 1/8,616 (0.0%) on Pantoprazole
Pneumonia (lung infection)	10,705	2.8 2.8–2.9ROR 2.9 · calibrated p 0.659	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 2.2 · serious PRR 2.0	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.

Deep vein thrombosis postoperative — n=1,104, PRR 107.8
Lupus vulgaris — n=638, PRR 96.5
Adjustment disorder with depressed mood — n=853, PRR 60.9
Duodenal ulcer perforation — n=3,064, PRR 59.5
Rheumatic fever — n=1,780, PRR 57.1
Muscle injury — n=3,156, PRR 51.8
Dislocation of vertebra — n=827, PRR 49.1
Facet joint syndrome — n=1,159, PRR 48.2
Folliculitis — n=3,324, PRR 39.3
Helicobacter infection — n=3,259, PRR 38.9

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?

In FDA FAERS, the most frequently co-reported reaction terms for Pantoprazole are fatigue, nausea, diarrhoea, dyspnoea, pain, headache. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Pantoprazole 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, 1,185 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.