Drug · FAERS side-effect profile with label screen

Pantoprazole In 0.9% side effects: what 61,584 FDA adverse event reports show

Pantoprazole Sodium In 0.9% Sodium Chloride · 1,219 reaction terms · 498,155 drug–reaction co-reports · data 2026-09-14

Drug class

Proton pump inhibitor (ppi)

FDA label, Indications wording of the closest related product

Label matched

Pantoprazole Sodium In 0.9% Sodium Chloride (Pantoprazole Sodium)

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

Who reports

61,584 reports · 81% serious · 7,569 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). ( 1.1 ) • Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome.

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) 1Lab value / disease marker 8Not in label — unassessed 31

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.
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). 1,179 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
Grip strength	128	424.2 326.9–550.6ROR 425.1 · calibrated p 7e-13 ✓	182.6 EB05 157.5 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=128 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
Congenital hiatus hernia	102	291.8 223.8–380.5ROR 292.3 · calibrated p 3e-11 ✓	152.0 EB05 128.8 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=102 · ♀ 0% (drug 62%) · 100% clinician	not reported in cached trials
Lupus vulgaris	471	224.0 199.3–251.6ROR 225.7 · calibrated p 2e-10 ✓	133.9 EB05 124.0 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=471 · ♀ 100% (drug 62%) · 94% clinician	not reported in cached trials
Deep vein thrombosis postoperative	776	223.9 204.5–245.2ROR 226.8 · calibrated p 1e-10 ✓	134.1 EB05 126.4 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=776 · ♀ 100% (drug 62%) · 91% clinician	not reported in cached trials
Swollen joint count	97	222.4 172.1–287.5ROR 222.7 · calibrated p 3e-10 ✓	130.6 EB05 110.2 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=97 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
C-reactive protein	346	210.6 184.1–240.8ROR 211.8 · calibrated p 3e-10 ✓	128.7 EB05 117.8 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=345 · ♀ 100% (drug 62%) · 94% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	200	198.1 166.3–235.9ROR 198.7 · calibrated p 5e-10 ✓	123.4 EB05 109.7 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=199 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
Adjustment disorder with depressed mood	581	138.0 125.4–152.0ROR 139.3 · calibrated p 9e-9 ✓	97.7 EB05 91.2 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=580 · ♀ 100% (drug 62%) · 95% clinician	not reported in cached trials
Swollen joint count increased	889	135.9 125.7–146.8ROR 137.9 · calibrated p 9e-9 ✓	96.7 EB05 91.5 · IC025 +6.4 3/3 methods agree	Lab value / disease marker	serious n=888 · ♀ 100% (drug 62%) · 96% clinician	not reported in cached trials
Hypocholesterolaemia	86	132.1 102.9–169.5ROR 132.2 · calibrated p 2e-8 ✓	93.1 EB05 77.7 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=86 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
X-ray abnormal	484	126.8 114.2–140.7ROR 127.8 · calibrated p 2e-8 ✓	91.9 EB05 85.2 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=484 · ♀ 100% (drug 62%) · 96% clinician	not reported in cached trials
Duodenal ulcer perforation	1,883	117.5 111.6–123.8ROR 121.2 · calibrated p 3e-8 ✓	87.2 EB05 83.9 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 62.2 · ♀ 100% (drug 62%) · 92% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	1,820	117.3 111.2–123.6ROR 120.8 · calibrated p 3e-8 ✓	87.0 EB05 83.7 · IC025 +6.3 3/3 methods agree	Lab value / disease marker	serious PRR 62.4 · ♀ 100% (drug 62%) · 93% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	1,640	116.4 110.1–123.1ROR 119.6 · calibrated p 3e-8 ✓	86.6 EB05 83.1 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious n=1,635 · ♀ 100% (drug 62%) · 93% clinician	not reported in cached trials
Dislocation of vertebra	562	115.1 104.6–126.7ROR 116.2 · calibrated p 4e-8 ✓	85.7 EB05 79.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=562 · ♀ 100% (drug 62%) · 93% clinician	not reported in cached trials
Muscle injury	2,015	110.8 105.4–116.5ROR 114.5 · calibrated p 4e-8 ✓	83.4 EB05 80.4 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 64.5 · ♀ 100% (drug 62%) · 93% clinician	not reported in cached trials
Vaginal flatulence	74	108.6 83.6–141.2ROR 108.8 · calibrated p 1e-7 ✓	80.6 EB05 66.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=74 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
Rheumatic fever	1,036	105.9 98.8–113.5ROR 107.7 · calibrated p 7e-8 ✓	80.5 EB05 76.5 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=1,036 · ♀ 100% (drug 62%) · 94% clinician	not reported in cached trials
Facet joint syndrome	720	100.8 92.7–109.5ROR 101.9 · calibrated p 1e-7 ✓	77.5 EB05 72.9 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=719 · ♀ 100% (drug 62%) · 94% clinician	not reported in cached trials
Neurologic neglect syndrome	123	95.8 78.4–117.0ROR 95.9 · calibrated p 2e-7 ✓	73.9 EB05 63.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=123 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
Retinitis	366	95.6 85.1–107.3ROR 96.1 · calibrated p 2e-7 ✓	74.3 EB05 68.1 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=366 · ♀ 100% (drug 62%) · 93% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	146	95.3 79.3–114.5ROR 95.5 · calibrated p 2e-7 ✓	73.7 EB05 64.2 · IC025 +5.6 3/3 methods agree	Lab value / disease marker	serious n=146 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
Pulmonary vasculitis	112	91.4 74.2–112.7ROR 91.6 · calibrated p 3e-7 ✓	71.2 EB05 60.8 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=112 · ♀ 0% (drug 62%)	not reported in cached trials
Rheumatoid factor positive	1,197	89.1 83.6–94.9ROR 90.8 · calibrated p 2e-7 ✓	70.5 EB05 67.2 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=1,197 · ♀ 100% (drug 62%) · 95% clinician	not reported in cached trials
Folliculitis	2,111	87.4 83.4–91.6ROR 90.5 · calibrated p 2e-7 ✓	69.5 EB05 67.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 58.3 · ♀ 99% (drug 62%) · 93% clinician	not reported in cached trials
Total lung capacity abnormal	76	84.8 65.9–109.1ROR 84.9 · calibrated p 6e-7 ✓	66.8 EB05 55.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=76 · ♀ 0% (drug 62%) · 100% clinician	not reported in cached trials
Helicobacter infection	1,949	80.4 76.6–84.4ROR 83.0 · calibrated p 4e-7 ✓	65.0 EB05 62.6 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 49.0 · ♀ 99% (drug 62%) · 92% clinician	not reported in cached trials
Peripheral venous disease	721	74.9 69.1–81.2ROR 75.8 · calibrated p 9e-7 ✓	61.3 EB05 57.6 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=717 · ♀ 100% (drug 62%) · 94% clinician	not reported in cached trials
Porphyria acute	243	72.6 63.2–83.4ROR 72.9 · calibrated p 1e-6 ✓	59.6 EB05 53.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=243 · ♀ 100% (drug 62%) · 92% clinician	not reported in cached trials
Pemphigus	2,111	69.6 66.4–72.8ROR 72.0 · calibrated p 1e-6 ✓	57.7 EB05 55.7 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 41.3 · ♀ 100% (drug 62%) · 92% clinician	not reported in cached trials
Hand deformity	1,956	59.8 57.0–62.7ROR 61.7 · calibrated p 3e-6 ✓	50.8 EB05 49.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 39.5 · ♀ 100% (drug 62%) · 92% clinician	not reported in cached trials
Spirometry abnormal	87	59.1 47.0–74.2ROR 59.2 · calibrated p 6e-6 ✓	49.8 EB05 41.7 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=87 · ♀ 0% (drug 62%) · 100% clinician	not reported in cached trials
Carotid artery thrombosis	123	57.2 47.2–69.2ROR 57.3 · calibrated p 7e-6 ✓	48.6 EB05 41.8 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=123 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
C-reactive protein abnormal	913	56.5 52.7–60.6ROR 57.3 · calibrated p 6e-6 ✓	48.4 EB05 45.8 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	serious n=913 · ♀ 100% (drug 62%) · 94% clinician	not reported in cached trials
Synovial disorder	62	53.5 40.9–69.9ROR 53.5 · calibrated p 1e-5 ✓	45.7 EB05 36.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=62 · ♀ 100% (drug 62%) · 100% clinician	not reported in cached trials
Bronchopulmonary aspergillosis allergic	118	50.2 41.4–60.9ROR 50.3 · calibrated p 2e-5 ✓	43.5 EB05 37.3 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=117	not reported in cached trials
Adjustment disorder	166	49.5 42.1–58.3ROR 49.7 · calibrated p 2e-5 ✓	43.1 EB05 37.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=165	not reported in cached trials
Mite allergy	80	48.7 38.5–61.6ROR 48.8 · calibrated p 2e-5 ✓	42.2 EB05 35.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=80 · ♀ 0% (drug 62%) · 100% clinician	not reported in cached trials
Pericarditis	2,082	48.5 46.4–50.8ROR 50.2 · calibrated p 1e-5 ✓	42.5 EB05 41.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.6 · ♀ 97% (drug 62%) · 92% clinician	not reported in cached trials
Bone erosion	442	48.4 43.8–53.5ROR 48.8 · calibrated p 2e-5 ✓	42.4 EB05 39.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=440 · ♀ 100% (drug 62%) · 95% 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
Liver injury	4,511	5.25.0–5.3	signal
Interstitial lung disease	1,403	5.04.8–5.3	signal
Serious infection	8,228	3.73.6–3.7	signal
Hyponatraemia	843	3.63.4–3.8	signal
Anaemia	2,881	3.33.2–3.4	signal
Gi bleeding	1,611	3.02.9–3.2	signal
Pancreatitis	641	2.72.5–2.9	signal
Rhabdomyolysis / myopathy	638	2.72.5–2.9	signal
Thrombocytopenia	1,708	2.72.5–2.8	signal
Hyperglycaemia / diabetes	2,402	2.42.3–2.5	signal
Fall / fracture	2,584	2.32.2–2.4	signal
Arrhythmia / qt	1,307	2.32.2–2.4	signal
Kidney injury	2,961	2.22.1–2.3	signal
Severe cutaneous reaction	476	2.22.0–2.4	raised
Neutropenia / agranulocytosis	1,556	2.12.0–2.3	signal
Venous thromboembolism	1,287	2.01.9–2.1	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Pantoprazole In 0.9% 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).

NCT01281501 — Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole (N=87, PHASE4; 6 AE terms posted; arms: Conventional; 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)	7,336	3.2 3.2–3.3ROR 3.5 · calibrated p 0.476	3.2 EB05 3.2 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.9 · serious PRR 3.8	not reported in cached trials
Off label use (used outside approved label)	6,262	2.5 2.4–2.5ROR 2.6 · calibrated p 0.759	2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.4 · serious PRR 3.0	not reported in cached trials
Dyspnoea (shortness of breath)	6,057	3.7 3.6–3.8ROR 4.0 · calibrated p 0.384	3.6 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.1 · serious PRR 3.3	not reported in cached trials
Pain	5,966	3.3 3.2–3.4ROR 3.6 · calibrated p 0.468	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.5 · serious PRR 3.4 · ♀ 86% (drug 62%)	not reported in cached trials
Drug ineffective (drug did not work)	5,736	1.5 1.4–1.5ROR 1.5 · calibrated p 0.664	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	age-adj. PRR 1.9 · serious PRR 2.6 · ♀ 83% (drug 62%)	not reported in cached trials
Diarrhoea (diarrhea)	5,628	3.0 2.9–3.1ROR 3.2 · calibrated p 0.566	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 3.2	not reported in cached trials
Nausea	5,530	2.4 2.3–2.5ROR 2.5 · calibrated p 0.799	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.2 · serious PRR 2.8	NCT01281501: 2/44 (4.5%) on Pantoprazole In 0.9%
Headache	5,169	2.8 2.8–2.9ROR 3.0 · calibrated p 0.629	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 3.5 · ♀ 84% (drug 62%)	NCT01281501: 2/44 (4.5%) on Pantoprazole In 0.9%
Arthralgia (joint pain)	4,884	4.0 3.9–4.2ROR 4.3 · calibrated p 0.325	4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.6 · serious PRR 4.9 · ♀ 86% (drug 62%)	not reported in cached trials
Pyrexia (fever)	4,756	4.7 4.6–4.9ROR 5.0 · calibrated p 0.230	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 4.2 · serious PRR 4.1	not reported in cached trials
Rash	4,301	3.4 3.3–3.5ROR 3.6 · calibrated p 0.466	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.3 · serious PRR 4.8 · ♀ 85% (drug 62%)	not reported in cached trials
Vomiting	4,056	3.0 2.9–3.1ROR 3.1 · calibrated p 0.595	2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.8 · serious PRR 2.9	not reported in cached trials
Pruritus (itching)	3,766	3.4 3.3–3.5ROR 3.6 · calibrated p 0.467	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.0 · serious PRR 5.2 · ♀ 87% (drug 62%)	not reported in cached trials
Pneumonia (lung infection)	3,695	3.9 3.8–4.0ROR 4.1 · calibrated p 0.358	3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 3.3 · serious PRR 2.9	not reported in cached trials
Asthenia (weakness)	3,663	3.3 3.2–3.4ROR 3.5 · calibrated p 0.488	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.9 · serious PRR 3.1	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.

Grip strength — n=128, PRR 424.2
Congenital hiatus hernia — n=102, PRR 291.8
Lupus vulgaris — n=471, PRR 224.0
Deep vein thrombosis postoperative — n=776, PRR 223.9
Swollen joint count — n=97, PRR 222.4
Subcutaneous drug absorption impaired — n=200, PRR 198.1
Adjustment disorder with depressed mood — n=581, PRR 138.0
Hypocholesterolaemia — n=86, PRR 132.1
Duodenal ulcer perforation — n=1,883, PRR 117.5
Dislocation of vertebra — n=562, PRR 115.1

✓ 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 In 0.9%?

In FDA FAERS, the most frequently co-reported reaction terms for Pantoprazole In 0.9% are fatigue, dyspnoea, pain, diarrhoea, nausea, 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 In 0.9% have an FDA boxed warning?

No. The FDA label retrieved for Pantoprazole In 0.9% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Pantoprazole In 0.9% 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 a476e063-9450-4793-9a22-16b0a0a61cd0, effective 20240214; matched on openfda.generic_name.exact:"PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE")
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, 1,219 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 IN 0.9%, 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.