Drug · FAERS side-effect profile with label screen
Vonoprazan side effects: what 7,358 FDA adverse event reports show
Drug class
Potassium-competitive acid blocker
FDA label, Indications wording of the closest related product
Label matched
Vonoprazan Fumarate (Voquezna)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
7,358 reports · 67% serious · 1,007 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
VOQUEZNA is indicated: for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults.
FDA label, Indications and Usage
What it is
Vonoprazan (as the fumarate), is a potassium-competitive acid blocker.
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 4Labeled (related wording) 8Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 26
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. 259 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Interstitial lung disease | 193 | 11.4 9.9–13.1ROR 11.7 · χ² 1,822 / p <1e-300 | 11.3 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 · ♀ 31% (drug 56%) · 91% clinician | no trial data cached |
| Cerebral infarction | 96 | 11.2 9.2–13.7ROR 11.4 · χ² 881 / p 5e-194 | 11.0 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 99% clinician | no trial data cached |
| Hepatic function abnormal | 144 | 11.1 9.4–13.1ROR 11.3 · χ² 1,312 / p 2e-287 | 11.0 EB05 9.5 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 · 95% clinician | no trial data cached |
| Adrenal insufficiency | 44 | 10.5 7.8–14.1ROR 10.6 · χ² 368 / p 3e-82 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 20% (drug 56%) · 98% clinician | no trial data cached |
| Pneumonia aspiration | 85 | 9.7 7.9–12.0ROR 9.9 · χ² 657 / p 3e-145 | 9.5 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 31% (drug 56%) · 91% clinician | no trial data cached |
| Cytokine release syndrome | 64 | 9.6 7.5–12.3ROR 9.7 · χ² 483 / p 2e-107 | 9.3 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 35% (drug 56%) · 100% clinician | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 265 | 9.4 8.4–10.6ROR 9.8 · χ² 1,993 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 84% consumer | no trial data cached |
| Pneumocystis jirovecii pneumonia | 33 | 9.4 6.7–13.3ROR 9.5 · χ² 240 / p 2e-54 | 8.8 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 100% clinician | no trial data cached |
| Altered state of consciousness | 69 | 9.1 7.2–11.6ROR 9.2 · χ² 492 / p 3e-109 | 8.8 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 96% clinician | no trial data cached |
| Drug eruption | 56 | 9.1 7.0–11.8ROR 9.1 · χ² 394 / p 7e-88 | 8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 98% clinician | no trial data cached |
| Disseminated intravascular coagulation | 43 | 8.7 6.5–11.7ROR 8.7 · χ² 285 / p 4e-64 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Oesophagitis | 32 | 8.4 5.9–11.8ROR 8.4 · χ² 199 / p 1e-45 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.4 | no trial data cached |
| Liver disorder | 103 | 6.6 5.5–8.0ROR 6.7 · χ² 488 / p 2e-108 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | no trial data cached |
| Hypomagnesaemia | 31 | 6.4 4.5–9.1ROR 6.4 · χ² 135 / p 2e-31 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 97% clinician | no trial data cached |
| Incorrect product administration duration | 45 | 6.3 4.7–8.5ROR 6.4 · χ² 196 / p 6e-45 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=40 · ♀ 77% (drug 56%) · 76% consumer | no trial data cached |
| Iron deficiency anaemia | 20 | 6.2 4.0–9.6ROR 6.2 · χ² 82 / p 6e-20 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 90% clinician | no trial data cached |
| Neutrophil count decreased | 87 | 6.1 5.0–7.6ROR 6.2 · χ² 368 / p 2e-82 | 5.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 97% clinician | no trial data cached |
| Drug-induced liver injury | 64 | 5.9 4.6–7.6ROR 6.0 · χ² 257 / p 4e-58 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 100% clinician | no trial data cached |
| Gastric ulcer | 39 | 5.8 4.3–8.0ROR 5.9 · χ² 152 / p 4e-35 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Ileus | 25 | 5.8 3.9–8.6ROR 5.8 · χ² 94 / p 1e-22 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Covid-19 pneumonia | 24 | 5.8 3.9–8.6ROR 5.8 · χ² 90 / p 1e-21 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · ♀ 33% (drug 56%) · 100% clinician | no trial data cached |
| Renal impairment | 167 | 5.7 4.9–6.6ROR 5.8 · χ² 643 / p 3e-142 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Cholecystitis | 23 | 5.5 3.7–8.3ROR 5.5 · χ² 81 / p 1e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Erythema multiforme | 18 | 5.5 3.5–8.7ROR 5.5 · χ² 62 / p 2e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Hiatus hernia | 25 | 5.5 3.7–8.1ROR 5.5 · χ² 87 / p 4e-21 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Cardiac failure (heart failure) | 150 | 5.3 4.5–6.2ROR 5.4 · χ² 524 / p 3e-116 | 5.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Hypophagia | 46 | 5.2 3.9–6.9ROR 5.2 · χ² 151 / p 6e-35 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Feeding disorder | 36 | 5.2 3.7–7.1ROR 5.2 · χ² 116 / p 2e-27 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 78% (drug 56%) | no trial data cached |
| Bacteraemia | 21 | 5.1 3.3–7.8ROR 5.1 · χ² 65 / p 4e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 90% clinician | no trial data cached |
| Pharyngeal swelling | 17 | 5.1 3.2–8.1ROR 5.1 · χ² 51 / p 4e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 18 | 5.0 3.2–8.0ROR 5.1 · χ² 54 / p 8e-14 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Gastric cancer | 45 | 5.0 3.7–6.7ROR 5.0 · χ² 140 / p 1e-32 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 91% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 33 | 5.0 3.5–7.0ROR 5.0 · χ² 101 / p 4e-24 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 100% clinician | no trial data cached |
| Gastric haemorrhage | 20 | 4.9 3.2–7.6ROR 4.9 · χ² 59 / p 1e-14 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Pulmonary arterial hypertension | 25 | 4.9 3.3–7.2ROR 4.9 · χ² 74 / p 5e-18 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 84% (drug 56%) | no trial data cached |
| Eructation (belching) | 32 | 4.8 3.4–6.8ROR 4.8 · χ² 92 / p 3e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=6 · 100% consumer | no trial data cached |
| Thirst | 29 | 4.6 3.2–6.7ROR 4.7 · χ² 79 / p 3e-19 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hepatic encephalopathy | 15 | 4.6 2.8–7.6ROR 4.6 · χ² 38 / p 3e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Febrile neutropenia | 106 | 4.6 3.8–5.5ROR 4.6 · χ² 292 / p 8e-66 | 4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · ♀ 27% (drug 56%) · 94% clinician | no trial data cached |
| Ascites | 47 | 4.6 3.4–6.1ROR 4.6 · χ² 127 / p 9e-30 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 91% clinician | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 472 | 1.6 1.4–1.7ROR 1.6 · χ² 95 / p 7e-23 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 466 | 2.1 1.9–2.3ROR 2.1 · χ² 263 / p 2e-59 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Nausea | 430 | 1.6 1.4–1.7ROR 1.6 · χ² 87 / p 4e-21 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Malaise (feeling unwell) | 286 | 1.9 1.7–2.1ROR 1.9 · χ² 114 / p 6e-27 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 265 | 9.4 8.4–10.6ROR 9.8 · χ² 1,993 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 84% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 258 | 3.2 2.8–3.6ROR 3.3 · χ² 386 / p 2e-86 | 3.2 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Pyrexia (fever) | 240 | 2.0 1.7–2.2ROR 2.0 · χ² 117 / p 2e-27 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Abdominal pain upper | 213 | 3.0 2.6–3.4ROR 3.0 · χ² 276 / p 2e-62 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.4 · 83% consumer | no trial data cached |
| Interstitial lung disease | 193 | 11.4 9.9–13.1ROR 11.7 · χ² 1,822 / p <1e-300 | 11.3 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 · ♀ 31% (drug 56%) · 91% clinician | no trial data cached |
| Product dose omission issue | 184 | 1.8 1.6–2.1ROR 1.9 · χ² 71 / p 2e-17 | 1.8 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.1 · ♀ 77% (drug 56%) · 91% consumer | no trial data cached |
| Anaemia (low red blood cells) | 181 | 2.7 2.3–3.1ROR 2.7 · χ² 194 / p 2e-44 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Renal impairment | 167 | 5.7 4.9–6.6ROR 5.8 · χ² 643 / p 3e-142 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Dyspepsia (indigestion) | 155 | 4.5 3.9–5.3ROR 4.6 · χ² 421 / p 8e-94 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · ♀ 76% (drug 56%) · 86% consumer | no trial data cached |
| Abdominal distension (bloating) | 152 | 4.2 3.6–4.9ROR 4.2 · χ² 364 / p 2e-81 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · 75% consumer | no trial data cached |
| Illness | 152 | 4.3 3.7–5.1ROR 4.4 · χ² 385 / p 5e-86 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 0.7 · ♀ 82% (drug 56%) · 98% consumer | 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.
- Cerebral infarction — n=96, PRR 11.2
- Adrenal insufficiency — n=44, PRR 10.5
- Pneumonia aspiration — n=85, PRR 9.7
- Cytokine release syndrome — n=64, PRR 9.6
- Gastrooesophageal reflux disease — n=265, PRR 9.4
- Pneumocystis jirovecii pneumonia — n=33, PRR 9.4
- Altered state of consciousness — n=69, PRR 9.1
- Disseminated intravascular coagulation — n=43, PRR 8.7
- Hypomagnesaemia — n=31, PRR 6.4
- Iron deficiency anaemia — n=20, PRR 6.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Vonoprazan?
In FDA FAERS, the most frequently co-reported reaction terms for Vonoprazan are diarrhoea, nausea, malaise, gastrooesophageal reflux disease, decreased appetite, pyrexia. 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 Vonoprazan have an FDA boxed warning?
No. The FDA label retrieved for Vonoprazan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Vonoprazan 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 0cc52ac5-77ec-4d66-a770-762a1a960914, effective 20260716; matched on
openfda.generic_name.exact:"VONOPRAZAN FUMARATE") - 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, 299 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.