Drug · FAERS side-effect profile with label screen
Dexlansoprazole side effects: what 41,459 FDA adverse event reports show
Brand names
Dexlansoprazole Delayed Release
openFDA label
Who reports
41,459 reports · 81% serious · 3,710 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dexlansoprazole delayed-release capsules are proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD).
FDA label, Indications and Usage
What it is
The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] 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 1Labeled (related wording) 2Reporting / coding artifact 6Lab value / disease marker 5Not 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.
- 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). 1,149 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 |
|---|---|---|---|---|---|---|
| Renal haemangioma | 786 | 35,587.2 19,628.5–64,521.1ROR 36,274.8 · calibrated p 4e-35 ✓ | 486.3 EB05 458.4 · IC025 +8.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.0–5.8) | Not in label — unassessed | serious n=786 · 72% consumer | not reported in cached trials |
| Antacid therapy | 80 | 1,021.6 696.8–1,497.9ROR 1,023.6 · calibrated p 2e-16 ✓ | 310.6 EB05 257.5 · IC025 +6.4 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Reporting / coding artifact | serious n=80 · ♀ 22% (drug 68%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 115 | 830.1 616.0–1,118.6ROR 832.4 · calibrated p 9e-16 ✓ | 296.5 EB05 253.7 · IC025 +6.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 15.1 (11.7–19.5) | Reporting / coding artifact | serious n=115 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Synovial fluid analysis | 36 | 358.6 233.7–550.3ROR 358.9 · calibrated p 1e-11 ✓ | 188.2 EB05 142.0 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.8 (5.2–11.6) | Reporting / coding artifact | serious n=36 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 115 | 351.4 276.8–446.0ROR 352.4 · calibrated p 4e-12 ✓ | 199.6 EB05 170.8 · IC025 +6.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=115 · 90% clinician | not reported in cached trials |
| Analgesic therapy | 123 | 340.3 270.6–427.9ROR 341.3 · calibrated p 5e-12 ✓ | 196.4 EB05 169.0 · IC025 +6.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 16.1 (12.5–20.6) | Reporting / coding artifact | serious n=123 · ♀ 14% (drug 68%) · 100% clinician | not reported in cached trials |
| Appendicolith | 152 | 339.5 276.3–417.1ROR 340.7 · calibrated p 5e-12 ✓ | 197.3 EB05 172.3 · IC025 +6.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.4 (6.9–10.2) | Not in label — unassessed | serious n=152 · ♀ 11% (drug 68%) · 100% clinician | not reported in cached trials |
| Rebound acid hypersecretion | 1,167 | 312.5 290.6–336.0ROR 321.5 · calibrated p 5e-12 ✓ | 191.8 EB05 182.7 · IC025 +7.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.6 (2.4–2.7) | Not in label — unassessed | serious n=1,167 | not reported in cached trials |
| Drug therapy | 112 | 273.4 217.2–344.2ROR 274.2 · calibrated p 4e-11 ✓ | 171.7 EB05 146.7 · IC025 +6.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 16.5 (12.7–21.4) | Reporting / coding artifact | serious n=112 · ♀ 15% (drug 68%) · 100% clinician | not reported in cached trials |
| Anticoagulant therapy | 82 | 212.7 164.3–275.4ROR 213.1 · calibrated p 4e-10 ✓ | 144.4 EB05 120.0 · IC025 +5.9 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Reporting / coding artifact | serious n=82 · ♀ 23% (drug 68%) · 100% clinician | not reported in cached trials |
| End stage renal disease | 4,872 | 182.4 176.7–188.2ROR 206.5 · calibrated p 3e-10 ✓ | 133.7 EB05 130.6 · IC025 +7.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.2 (2.1–2.2) | Not in label — unassessed | serious PRR 95.1 | not reported in cached trials |
| Malignant melanoma stage 0 | 47 | 177.3 127.1–247.4ROR 177.5 · calibrated p 3e-9 ✓ | 124.5 EB05 97.4 · IC025 +5.3 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=47 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 56 | 171.1 126.3–231.8ROR 171.3 · calibrated p 3e-9 ✓ | 122.4 EB05 97.8 · IC025 +5.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=56 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease | 16,102 | 134.7 132.7–136.7ROR 219.6 · calibrated p 2e-10 ✓ | 106.2 EB05 104.8 · IC025 +6.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.1 (2.0–2.1) | Not in label — unassessed | serious PRR 75.5 | not reported in cached trials |
| Nephrogenic anaemia | 840 | 110.9 102.9–119.4ROR 113.1 · calibrated p 5e-8 ✓ | 90.7 EB05 85.6 · IC025 +6.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.5 (1.4–1.6) | Not in label — unassessed | serious n=840 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 158 | 105.3 88.8–125.0ROR 105.7 · calibrated p 9e-8 ✓ | 86.2 EB05 75.5 · IC025 +5.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 16.3 (13.1–20.3) | Not in label — unassessed | serious n=158 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 180 | 101.6 86.6–119.3ROR 102.1 · calibrated p 1e-7 ✓ | 83.9 EB05 74.1 · IC025 +5.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.2 (1.1–1.4) | Not in label — unassessed | serious n=180 | not reported in cached trials |
| Hyperparathyroidism secondary | 392 | 92.7 83.2–103.2ROR 93.5 · calibrated p 2e-7 ✓ | 78.0 EB05 71.7 · IC025 +6.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.6 (1.4–1.7) | Not in label — unassessed | serious n=392 | not reported in cached trials |
| Granuloma skin | 128 | 92.4 76.5–111.5ROR 92.7 · calibrated p 3e-7 ✓ | 77.2 EB05 66.6 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 11.8 (9.4–14.9) | Not in label — unassessed | serious n=128 · 91% clinician | not reported in cached trials |
| Renal injury | 4,339 | 85.5 82.9–88.1ROR 95.3 · calibrated p 2e-7 ✓ | 73.1 EB05 71.3 · IC025 +6.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.1 (2.0–2.2) | Labeled (related wording) related wording | serious PRR 52.1 | not reported in cached trials |
| Serum amyloid a protein increased | 22 | 83.0 52.9–130.3ROR 83.1 · calibrated p 1e-6 ✓ | 67.3 EB05 46.9 · IC025 +4.1 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=22 · 100% clinician | not reported in cached trials |
| Cervix neoplasm | 19 | 80.9 49.8–131.3ROR 80.9 · calibrated p 2e-6 ✓ | 65.3 EB05 44.2 · IC025 +3.9 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Hyperchlorhydria | 755 | 73.6 68.2–79.4ROR 74.9 · calibrated p 9e-7 ✓ | 64.1 EB05 60.4 · IC025 +5.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.7 (1.6–1.8) | Not in label — unassessed | serious n=690 · 82% consumer | not reported in cached trials |
| Enthesopathy | 200 | 73.4 63.3–85.1ROR 73.8 · calibrated p 1e-6 ✓ | 63.7 EB05 56.7 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 72.0 (52.1–99.4) | Not in label — unassessed | serious n=199 · 90% clinician | not reported in cached trials |
| Arteriovenous fistula occlusion | 22 | 72.1 46.1–112.7ROR 72.1 · calibrated p 4e-6 ✓ | 60.0 EB05 41.8 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=22 · ♀ 100% (drug 68%) | not reported in cached trials |
| Bacteroides infection | 31 | 68.6 47.1–99.9ROR 68.7 · calibrated p 4e-6 ✓ | 58.4 EB05 43.1 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=31 · ♀ 0% (drug 68%) · 100% clinician | not reported in cached trials |
| Tubulointerstitial nephritis | 2,191 | 67.0 64.1–70.0ROR 70.7 · calibrated p 1e-6 ✓ | 59.1 EB05 57.1 · IC025 +5.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.0 (2.0–2.1) | Labeled adverse reaction exact term | serious PRR 42.2 | not reported in cached trials |
| Total lung capacity increased | 27 | 55.3 37.2–82.3ROR 55.4 · calibrated p 1e-5 ✓ | 48.3 EB05 34.9 · IC025 +4.1 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=27 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 147 | 55.3 46.6–65.5ROR 55.4 · calibrated p 8e-6 ✓ | 49.5 EB05 43.2 · IC025 +5.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 11.7 (9.5–14.5) | Lab value / disease marker | serious n=147 | not reported in cached trials |
| Tenosynovitis | 246 | 49.3 43.3–56.2ROR 49.6 · calibrated p 2e-5 ✓ | 44.8 EB05 40.3 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 14.3 (12.0–16.9) | Not in label — unassessed | serious n=246 · 92% clinician | not reported in cached trials |
| Total lung capacity decreased | 141 | 48.8 41.0–58.0ROR 48.9 · calibrated p 2e-5 ✓ | 44.3 EB05 38.5 · IC025 +5.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 12.8 (10.3–16.0) | Not in label — unassessed | serious n=140 | not reported in cached trials |
| Tenosynovitis stenosans | 46 | 45.3 33.5–61.2ROR 45.3 · calibrated p 4e-5 ✓ | 40.9 EB05 31.9 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.2 (3.0–5.8) | Not in label — unassessed | serious n=46 · ♀ 100% (drug 68%) · 100% clinician | not reported in cached trials |
| Hyperphosphataemia | 159 | 41.0 34.9–48.1ROR 41.1 · calibrated p 5e-5 ✓ | 37.8 EB05 33.1 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 12.7 (10.4–15.7) | Not in label — unassessed | serious n=159 · ♀ 11% (drug 68%) · 100% clinician | not reported in cached trials |
| Renal hypertension | 23 | 39.6 25.9–60.6ROR 39.7 · calibrated p 1e-4 ✓ | 35.8 EB05 25.1 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Labeled (related wording) related wording | serious n=23 | not reported in cached trials |
| Alanine aminotransferase abnormal | 147 | 38.1 32.2–45.0ROR 38.2 · calibrated p 8e-5 ✓ | 35.3 EB05 30.7 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=147 · ♀ 45% (drug 68%) | not reported in cached trials |
| Rheumatoid nodule | 186 | 36.1 31.2–41.9ROR 36.3 · calibrated p 1e-4 ✓ | 33.7 EB05 29.8 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.8 (3.2–4.4) | Not in label — unassessed | serious n=186 · 91% clinician | not reported in cached trials |
| Drug specific antibody | 89 | 35.2 28.4–43.7ROR 35.3 · calibrated p 1e-4 ✓ | 32.8 EB05 27.4 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Lab value / disease marker | serious n=89 · ♀ 100% (drug 68%) | not reported in cached trials |
| Lung opacity | 164 | 34.4 29.3–40.2ROR 34.5 · calibrated p 1e-4 ✓ | 32.1 EB05 28.2 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 9.9 (8.2–12.0) | Not in label — unassessed | serious n=164 | not reported in cached trials |
| Hypertensive nephropathy | 68 | 34.0 26.6–43.4ROR 34.0 · calibrated p 2e-4 ✓ | 31.6 EB05 25.8 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.5 (0.4–0.6) | Not in label — unassessed | serious n=67 | not reported in cached trials |
| Panniculitis | 149 | 33.3 28.2–39.3ROR 33.4 · calibrated p 2e-4 ✓ | 31.1 EB05 27.2 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 12.1 (9.8–14.9) | Not in label — unassessed | serious n=148 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Dexlansoprazole 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).
- NCT00251719 — Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis (N=2054, PHASE3; 10 AE terms posted; arms: Dexlansoprazole MR 60 mg QD; Dexlansoprazole MR 90 mg QD; Lansoprazole 30 mg QD)
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 | 16,102 | 134.7 132.7–136.7ROR 219.6 · calibrated p 2e-10 ✓ | 106.2 EB05 104.8 · IC025 +6.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.1 (2.0–2.1) | Not in label — unassessed | serious PRR 75.5 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 7,808 | 27.3 26.7–27.9ROR 33.4 · calibrated p 1e-4 ✓ | 25.9 EB05 25.4 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.5 (1.5–1.6) | Labeled (related wording) related wording | serious PRR 18.5 | not reported in cached trials |
| Renal failure (kidney failure) | 6,722 | 26.7 26.1–27.3ROR 31.7 · calibrated p 2e-4 ✓ | 25.4 EB05 24.9 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.9 (1.8–1.9) | Labeled adverse reaction exact term | serious PRR 18.2 | not reported in cached trials |
| End stage renal disease | 4,872 | 182.4 176.7–188.2ROR 206.5 · calibrated p 3e-10 ✓ | 133.7 EB05 130.6 · IC025 +7.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.2 (2.1–2.2) | Not in label — unassessed | serious PRR 95.1 | not reported in cached trials |
| Renal injury | 4,339 | 85.5 82.9–88.1ROR 95.3 · calibrated p 2e-7 ✓ | 73.1 EB05 71.3 · IC025 +6.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.1 (2.0–2.2) | Labeled (related wording) related wording | serious PRR 52.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,592 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.303 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Proton Pump Inhibitors: PRR 0.6 (0.6–0.6) | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Fatigue (tiredness) | 2,418 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.714 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.5 (0.5–0.6) | Labeled (related wording) related wording | serious PRR 1.7 | not reported in cached trials |
| Off label use (used outside approved label) | 2,314 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.555 | 1.3 EB05 1.3 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 0.7 (0.7–0.7) | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Nausea | 2,219 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.607 | 1.4 EB05 1.4 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 0.5 (0.4–0.5) | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Tubulointerstitial nephritis | 2,191 | 67.0 64.1–70.0ROR 70.7 · calibrated p 1e-6 ✓ | 59.1 EB05 57.1 · IC025 +5.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.0 (2.0–2.1) | Labeled adverse reaction exact term | serious PRR 42.2 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,996 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.706 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.4 (0.4–0.5) | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00251719: 31/687 (4.5%) on Dexlansoprazole |
| Headache | 1,952 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.711 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 1.8 | not reported in cached trials |
| Pain | 1,947 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.727 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00251719: 1/694 (0.1%) on Dexlansoprazole (serious AE) |
| Death | 1,872 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.375 | 1.1 EB05 1.1 · IC025 +0.1 vs other Proton Pump Inhibitors: PRR 0.9 (0.8–0.9) | Outcome field, not a reaction | serious PRR 0.8 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,622 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.622 | 1.5 EB05 1.4 · IC025 +0.5 vs other Proton Pump Inhibitors: PRR 0.4 (0.4–0.4) | Labeled adverse reaction exact term | serious PRR 1.2 | 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=786, PRR 35,587.2
- Appendicolith — n=152, PRR 339.5
- Rebound acid hypersecretion — n=1,167, PRR 312.5
- End stage renal disease — n=4,872, PRR 182.4
- Malignant melanoma stage 0 — n=47, PRR 177.3
- Congenital hiatus hernia — n=56, PRR 171.1
- Chronic kidney disease — n=16,102, PRR 134.7
- Nephrogenic anaemia — n=840, PRR 110.9
- Bronchopulmonary aspergillosis allergic — n=158, PRR 105.3
- Chronic kidney disease-mineral and bone disorder — n=180, PRR 101.6
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 Dexlansoprazole?
In FDA FAERS, the most frequently co-reported reaction terms for Dexlansoprazole are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, renal injury, fatigue. 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 Dexlansoprazole have an FDA boxed warning?
No. The FDA label retrieved for Dexlansoprazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dexlansoprazole 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 31d3d485-5f87-4405-b940-490fa4ccf9cc, effective 20260209; matched on
openfda.generic_name.exact:"DEXLANSOPRAZOLE") - 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, 1,189 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
DEXLANSOPRAZOLE, 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.