Drug · FAERS side-effect profile with label screen
Esomeprazole Magnesium side effects: what 232,620 FDA adverse event reports show
Who reports
232,620 reports · 72% serious · 19,443 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1 ) • Maintenance of healing of EE in adults.
FDA label, Indications and Usage
What it is
Esomeprazole is a 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has S configuration at the sulfur atom.
PubChem CID 9568614 (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) 3Likely indication confounding 4Not in label — unassessed 32
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.
- 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). 1,144 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 | 789 | 8,672.9 4,322.1–17,403.4ROR 8,702.4 · calibrated p 8e-25 ✓ | 87.9 EB05 82.8 · IC025 +6.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.0–5.8) | Not in label — unassessed | serious n=789 · 100% consumer | not reported in cached trials |
| Rebound acid hypersecretion | 2,505 | 422.0 384.1–463.7ROR 426.6 · calibrated p 3e-13 ✓ | 73.6 EB05 71.2 · IC025 +6.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.8 (6.5–7.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=2,501 | not reported in cached trials |
| Cardiospasm | 395 | 222.7 185.0–268.0ROR 223.0 · calibrated p 2e-10 ✓ | 63.6 EB05 58.5 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.5 (3.1–3.9) | Not in label — unassessed | serious n=395 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 723 | 187.6 164.9–213.4ROR 188.1 · calibrated p 8e-10 ✓ | 60.5 EB05 56.8 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.5 (5.9–7.0) | Not in label — unassessed | serious n=722 · 100% consumer | not reported in cached trials |
| Nephrogenic anaemia | 2,916 | 151.0 142.3–160.3ROR 152.9 · calibrated p 4e-9 ✓ | 56.2 EB05 54.5 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.5 (6.3–6.8) | Not in label — unassessed | serious n=2,915 | not reported in cached trials |
| Immunisation | 250 | 123.5 101.9–149.7ROR 123.6 · calibrated p 3e-8 ✓ | 51.8 EB05 46.6 · IC025 +5.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.4 (3.9–5.1) | Not in label — unassessed | serious n=250 | not reported in cached trials |
| End stage renal disease | 10,300 | 115.0 111.7–118.4ROR 120.3 · calibrated p 3e-8 ✓ | 50.4 EB05 49.6 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.5) | Not in label — unassessed | serious PRR 40.5 | not reported in cached trials |
| Hyperparathyroidism secondary | 1,389 | 110.0 101.7–119.1ROR 110.7 · calibrated p 5e-8 ✓ | 49.4 EB05 47.3 · IC025 +5.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.3 (6.9–7.8) | Not in label — unassessed | serious n=1,388 | not reported in cached trials |
| Palmoplantar keratoderma | 385 | 103.9 89.6–120.4ROR 104.0 · calibrated p 1e-7 ✓ | 48.1 EB05 44.2 · IC025 +5.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.5 (3.1–3.9) | Not in label — unassessed | serious n=385 | not reported in cached trials |
| Neurologic neglect syndrome | 287 | 94.9 80.3–112.1ROR 95.0 · calibrated p 2e-7 ✓ | 46.0 EB05 41.7 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.5 (5.7–7.5) | Not in label — unassessed | serious n=287 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Chronic kidney disease | 35,578 | 78.1 77.0–79.2ROR 92.0 · calibrated p 2e-7 ✓ | 41.8 EB05 41.5 · IC025 +5.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.4–5.4) | Not in label — unassessed | age-adj. PRR 30.3 · serious PRR 33.5 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Hypertensive nephropathy | 429 | 59.3 52.5–67.0ROR 59.4 · calibrated p 5e-6 ✓ | 35.8 EB05 33.0 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.7 (3.3–4.1) | Not in label — unassessed | serious n=429 | not reported in cached trials |
| Sensitisation | 293 | 55.7 48.1–64.4ROR 55.7 · calibrated p 7e-6 ✓ | 34.4 EB05 31.2 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.8 (5.1–6.6) | Not in label — unassessed | serious n=289 · ♀ 100% (drug 63%) | not reported in cached trials |
| Ejection fraction | 221 | 54.6 46.2–64.6ROR 54.6 · calibrated p 9e-6 ✓ | 34.0 EB05 30.4 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.7 (4.9–6.6) | Not in label — unassessed | serious n=221 · ♀ 100% (drug 63%) | not reported in cached trials |
| Carotid artery thrombosis | 301 | 48.8 42.4–56.2ROR 48.9 · calibrated p 2e-5 ✓ | 31.7 EB05 28.8 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.8 (5.9–7.8) | Not in label — unassessed | serious n=301 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Hyperchlorhydria | 1,959 | 44.1 41.8–46.5ROR 44.5 · calibrated p 3e-5 ✓ | 29.7 EB05 28.6 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.3 (5.0–5.6) | Not in label — unassessed | serious n=1,328 · 100% consumer | not reported in cached trials |
| Renal injury | 9,528 | 41.7 40.7–42.7ROR 43.4 · calibrated p 3e-5 ✓ | 28.6 EB05 28.1 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.6) | Not in label — unassessed | serious PRR 23.0 | not reported in cached trials |
| Barrett's oesophagus | 245 | 38.7 33.3–45.0ROR 38.8 · calibrated p 7e-5 ✓ | 27.2 EB05 24.4 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | 100% consumer | not reported in cached trials |
| Calcium deficiency | 325 | 29.7 26.2–33.7ROR 29.8 · calibrated p 3e-4 ✓ | 22.5 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 35.6 (29.3–43.2) | Labeled (related wording) related wording | serious n=284 | not reported in cached trials |
| Tubulointerstitial nephritis | 4,232 | 26.1 25.2–27.0ROR 26.6 · calibrated p 5e-4 ✓ | 20.4 EB05 19.9 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.5 (4.3–4.6) | Labeled adverse reaction exact term | age-adj. PRR 9.1 · serious PRR 16.4 | not reported in cached trials |
| Adjustment disorder | 294 | 26.0 22.8–29.6ROR 26.0 · calibrated p 6e-4 ✓ | 20.3 EB05 18.4 · IC025 +4.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.9 (6.0–7.9) | Not in label — unassessed | serious n=291 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Amaurosis fugax | 223 | 23.5 20.3–27.3ROR 23.6 · calibrated p 1e-3 ✓ | 18.8 EB05 16.8 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 17.3 (14.3–20.9) | Not in label — unassessed | serious n=222 · 100% clinician | not reported in cached trials |
| Atrial tachycardia | 433 | 23.1 20.8–25.7ROR 23.1 · calibrated p 0.001 ✓ | 18.5 EB05 17.1 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.4 (3.1–3.8) | Not in label — unassessed | serious n=430 | not reported in cached trials |
| Diabetic nephropathy | 428 | 21.4 19.3–23.8ROR 21.5 · calibrated p 0.001 ✓ | 17.4 EB05 16.1 · IC025 +3.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.6 (3.2–4.0) | Not in label — unassessed | serious n=426 | not reported in cached trials |
| Polycystic ovaries | 298 | 20.9 18.4–23.7ROR 20.9 · calibrated p 0.002 ✓ | 17.1 EB05 15.5 · IC025 +3.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.0 (5.3–6.9) | Not in label — unassessed | serious n=294 · ♀ 100% (drug 63%) | not reported in cached trials |
| Aphagia | 882 | 19.7 18.3–21.2ROR 19.8 · calibrated p 0.002 ✓ | 16.3 EB05 15.4 · IC025 +3.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 41.3 (36.5–46.7) | Not in label — unassessed | serious n=278 · 100% consumer | not reported in cached trials |
| Regurgitation | 611 | 19.5 17.8–21.2ROR 19.5 · calibrated p 0.002 ✓ | 16.1 EB05 15.1 · IC025 +3.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 28.4 (24.9–32.4) | Not in label — unassessed | serious n=255 · 100% consumer | not reported in cached trials |
| Catarrh | 158 | 19.3 16.2–22.9ROR 19.3 · calibrated p 0.002 ✓ | 16.0 EB05 14.0 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.8 (6.5–9.5) | Not in label — unassessed | serious n=158 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Steroid dependence | 149 | 19.0 15.9–22.7ROR 19.0 · calibrated p 0.003 ✓ | 15.8 EB05 13.7 · IC025 +3.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 9.0 (7.4–11.0) | Not in label — unassessed | serious n=149 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Nephrosclerosis | 195 | 18.8 16.1–22.0ROR 18.8 · calibrated p 0.003 ✓ | 15.7 EB05 13.9 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.3 (6.1–8.6) | Not in label — unassessed | serious n=194 · 100% consumer | not reported in cached trials |
| Pruritus genital | 399 | 18.5 16.6–20.6ROR 18.5 · calibrated p 0.003 ✓ | 15.4 EB05 14.2 · IC025 +3.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.4 (3.0–3.8) | Labeled (related wording) related wording | serious n=396 | not reported in cached trials |
| Adenocarcinoma gastric | 146 | 16.8 14.1–20.1ROR 16.8 · calibrated p 0.005 ✓ | 14.2 EB05 12.4 · IC025 +3.5 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=146 · ♀ 0% (drug 63%) | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Gastric polyps | 339 | 15.7 14.0–17.7ROR 15.8 · calibrated p 0.006 ✓ | 13.5 EB05 12.3 · IC025 +3.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.0 (5.3–6.8) | Labeled (related wording) related wording | serious n=262 | not reported in cached trials |
| Gastrooesophageal reflux disease (acid reflux) | 11,987 | 15.7 15.4–16.0ROR 16.5 · calibrated p 0.005 ✓ | 13.5 EB05 13.3 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.3 (8.1–8.4) | Not in label — unassessed | age-adj. PRR 15.6 · serious PRR 8.9 · 82% consumer | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Erosive oesophagitis | 233 | 14.2 12.3–16.3ROR 14.2 · calibrated p 0.009 ✓ | 12.3 EB05 11.0 · IC025 +3.4 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Likely indication confounding term in indications | serious n=135 · 100% consumer | not reported in cached trials |
| Rebound effect | 1,549 | 14.1 13.4–14.9ROR 14.2 · calibrated p 0.009 ✓ | 12.3 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.1 (4.9–5.4) | Not in label — unassessed | serious PRR 11.2 · 100% consumer | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 20,433 | 13.8 13.6–14.0ROR 15.1 · calibrated p 0.007 ✓ | 12.1 EB05 12.0 · IC025 +3.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.8 (4.7–4.8) | Not in label — unassessed | age-adj. PRR 5.0 · serious PRR 9.7 | NCT00357682: 3/1,138 (0.3%) on Esomeprazole (serious AE) |
| Nephropathy | 1,252 | 13.7 13.0–14.6ROR 13.8 · calibrated p 0.010 ✓ | 12.0 EB05 11.5 · IC025 +3.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.4 (4.1–4.7) | Not in label — unassessed | serious PRR 10.2 | not reported in cached trials |
| Personality disorder | 350 | 13.7 12.2–15.3ROR 13.7 · calibrated p 0.010 ✓ | 11.9 EB05 10.9 · IC025 +3.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.4 (6.5–8.3) | Not in label — unassessed | serious n=347 · ♀ 100% (drug 63%) | not reported in cached trials |
| Physical deconditioning | 328 | 13.5 12.0–15.1ROR 13.5 · calibrated p 0.011 ✓ | 11.8 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 9.2 (8.0–10.5) | Not in label — unassessed | serious n=327 | 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 | 36,365 | 7.77.6–7.8 | signal |
| Hyponatraemia | 2,169 | 2.52.4–2.6 | signal |
| Interstitial lung disease | 2,168 | 2.12.0–2.2 | raised |
| Gi bleeding | 4,054 | 2.02.0–2.1 | raised |
| Pancreatitis | 1,757 | 2.01.9–2.1 | raised |
| Fall / fracture | 7,482 | 1.81.7–1.8 | raised |
| Anaemia | 5,785 | 1.81.7–1.8 | raised |
| Depression | 5,323 | 1.71.7–1.8 | raised |
| Arrhythmia / qt | 3,587 | 1.71.6–1.7 | raised |
| Heart failure | 3,249 | 1.61.6–1.7 | raised |
| Myocardial infarction | 3,652 | 1.61.6–1.7 | raised |
| Rhabdomyolysis / myopathy | 1,433 | 1.61.5–1.7 | raised |
| Anaphylaxis / angioedema | 2,152 | 1.61.5–1.6 | raised |
| Severe cutaneous reaction | 1,275 | 1.61.5–1.6 | raised |
| Hyperglycaemia / diabetes | 5,712 | 1.51.5–1.5 | raised |
| Stroke | 4,106 | 1.51.4–1.5 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Esomeprazole 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 (4 of 40 signal terms matched).
- NCT00444275 — Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients (N=3029, PHASE4; 49 AE terms posted; arms: Esomeprazole 20 mg Once Daily (Initial P; Esomeprazole 40 mg Once Daily (Initial P; Esomeprazole 20 mg Once Daily (Maintenan; Esomeprazole 20 mg on Demand (Maintenanc)
- NCT00357682 — A Phase III, Randomized, Study of Aspirin and Esomeprazole Chemoprevention in Barrett's Metaplasia (N=2557, PHASE3; 231 AE terms posted; arms: Aspirin; No Aspirin; Low Dose PPI; High Dose PPI)
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 | 35,578 | 78.1 77.0–79.2ROR 92.0 · calibrated p 2e-7 ✓ | 41.8 EB05 41.5 · IC025 +5.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.4–5.4) | Not in label — unassessed | age-adj. PRR 30.3 · serious PRR 33.5 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Acute kidney injury (sudden kidney damage) | 20,433 | 13.8 13.6–14.0ROR 15.1 · calibrated p 0.007 ✓ | 12.1 EB05 12.0 · IC025 +3.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.8 (4.7–4.8) | Not in label — unassessed | age-adj. PRR 5.0 · serious PRR 9.7 | NCT00357682: 3/1,138 (0.3%) on Esomeprazole (serious AE) |
| Renal failure (kidney failure) | 16,270 | 12.4 12.2–12.6ROR 13.2 · calibrated p 0.012 ✓ | 11.0 EB05 10.8 · IC025 +3.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.4) | Labeled (related wording) related wording | age-adj. PRR 5.3 · serious PRR 8.8 | not reported in cached trials |
| Drug ineffective (drug did not work) | 14,330 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.293 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Proton Pump Inhibitors: PRR 4.1 (4.1–4.2) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.0 | not reported in cached trials |
| Nausea | 13,454 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.693 | 1.5 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 3.2 (3.2–3.3) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.6 | NCT00444275: 1/873 (0.1%) on Esomeprazole |
| Gastrooesophageal reflux disease (acid reflux) | 11,987 | 15.7 15.4–16.0ROR 16.5 · calibrated p 0.005 ✓ | 13.5 EB05 13.3 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.3 (8.1–8.4) | Not in label — unassessed | age-adj. PRR 15.6 · serious PRR 8.9 · 82% consumer | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Diarrhoea (diarrhea) | 11,150 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.707 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 2.8 (2.8–2.9) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.6 | NCT00444275: 3/2,156 (0.1%) on Esomeprazole |
| Drug dose omission | 11,124 | 6.3 6.2–6.5ROR 6.6 · calibrated p 0.116 | 6.0 EB05 5.9 · IC025 +2.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 20.1 (19.6–20.6) | Reporting / coding artifact | age-adj. PRR 7.6 · serious PRR 5.2 · 94% consumer | not reported in cached trials |
| Pain | 10,677 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.707 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 3.5 (3.5–3.6) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.4 | NCT00444275: 1/873 (0.1%) on Esomeprazole |
| End stage renal disease | 10,300 | 115.0 111.7–118.4ROR 120.3 · calibrated p 3e-8 ✓ | 50.4 EB05 49.6 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.5) | Not in label — unassessed | serious PRR 40.5 | not reported in cached trials |
| Malaise (feeling unwell) | 9,939 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.997 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.3 (4.2–4.4) | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 1.7 | not reported in cached trials |
| Fatigue (tiredness) | 9,892 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.410 | 1.1 EB05 1.1 · IC025 +0.2 vs other Proton Pump Inhibitors: PRR 2.5 (2.5–2.5) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.3 | not reported in cached trials |
| Off label use (used outside approved label) | 9,570 | 1.0 1.0–1.0ROR 1.0 · calibrated p 0.302 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Proton Pump Inhibitors: PRR 3.4 (3.3–3.5) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.0 | not reported in cached trials |
| Headache | 9,569 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.575 | 1.4 EB05 1.4 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 3.0 (3.0–3.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.6 | NCT00444275: 1/886 (0.1%) on Esomeprazole |
| Renal injury | 9,528 | 41.7 40.7–42.7ROR 43.4 · calibrated p 3e-5 ✓ | 28.6 EB05 28.1 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.4 (5.3–5.6) | Not in label — unassessed | serious PRR 23.0 | 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.
- Renal haemangioma — n=789, PRR 8,672.9
- Cardiospasm — n=395, PRR 222.7
- Chronic kidney disease-mineral and bone disorder — n=723, PRR 187.6
- Nephrogenic anaemia — n=2,916, PRR 151.0
- Immunisation — n=250, PRR 123.5
- End stage renal disease — n=10,300, PRR 115.0
- Hyperparathyroidism secondary — n=1,389, PRR 110.0
- Palmoplantar keratoderma — n=385, PRR 103.9
- Neurologic neglect syndrome — n=287, PRR 94.9
- Chronic kidney disease — n=35,578, PRR 78.1 (also seen in trial arm)
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 Esomeprazole?
In FDA FAERS, the most frequently co-reported reaction terms for Esomeprazole are chronic kidney disease, acute kidney injury, renal failure, nausea, gastrooesophageal reflux disease, diarrhoea. 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 Esomeprazole have an FDA boxed warning?
No. The FDA label retrieved for Esomeprazole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Esomeprazole 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 d68c9247-91c7-4e0f-adc4-2cfa7446580f, effective 20241130; matched on
openfda.generic_name.exact:"ESOMEPRAZOLE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 9568614 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, fieldpatient.drug.openfda.generic_name.exact, 1,184 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
ESOMEPRAZOLE, 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.