Drug · FAERS side-effect profile with label screen
Esomeprazole side effects: what 61,637 FDA adverse event reports show
Who reports
61,637 reports · 88% serious · 6,207 with death outcome · 58% 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
The active ingredient in the esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2 pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers.
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 (related wording) 4Likely indication confounding 1Lab value / disease marker 4Not 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.
- 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.
- 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). 1,184 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 |
|---|---|---|---|---|---|---|
| Cardiospasm | 384 | 769.4 641.7–922.5ROR 774.2 · calibrated p 8e-16 ✓ | 231.2 EB05 212.4 · IC025 +7.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.4 (3.0–3.7) | Not in label — unassessed | serious n=384 | not reported in cached trials |
| Immunisation | 244 | 443.7 366.5–537.2ROR 445.5 · calibrated p 3e-13 ✓ | 188.5 EB05 169.5 · IC025 +6.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.3 (3.7–5.0) | Not in label — unassessed | serious n=244 | not reported in cached trials |
| Palmoplantar keratoderma | 377 | 377.7 326.0–437.5ROR 380.0 · calibrated p 1e-12 ✓ | 176.4 EB05 161.9 · IC025 +7.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.4 (3.0–3.8) | Not in label — unassessed | serious n=377 | not reported in cached trials |
| Neurologic neglect syndrome | 257 | 290.5 245.9–343.3ROR 291.7 · calibrated p 2e-11 ✓ | 154.2 EB05 139.0 · IC025 +6.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.6 (4.9–6.5) | Not in label — unassessed | serious n=257 · ♀ 100% (drug 58%) | not reported in cached trials |
| Sensitisation | 290 | 208.2 179.9–241.1ROR 209.2 · calibrated p 3e-10 ✓ | 127.7 EB05 115.8 · IC025 +6.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.7 (5.0–6.5) | Not in label — unassessed | serious n=288 · ♀ 100% (drug 58%) | not reported in cached trials |
| Ejection fraction | 218 | 203.2 171.8–240.4ROR 203.9 · calibrated p 4e-10 ✓ | 125.4 EB05 112.1 · IC025 +6.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.6 (4.8–6.5) | Not in label — unassessed | serious n=218 · ♀ 100% (drug 58%) | not reported in cached trials |
| Carotid artery thrombosis | 263 | 151.7 131.2–175.5ROR 152.4 · calibrated p 5e-9 ✓ | 103.9 EB05 93.8 · IC025 +6.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.6 (4.9–6.5) | Not in label — unassessed | serious n=263 · ♀ 100% (drug 58%) | not reported in cached trials |
| Presbyacusis | 91 | 141.0 110.4–180.1ROR 141.2 · calibrated p 1e-8 ✓ | 97.5 EB05 81.8 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=91 · ♀ 100% (drug 58%) | not reported in cached trials |
| Amaurosis fugax | 209 | 82.6 71.0–96.0ROR 82.8 · calibrated p 5e-7 ✓ | 66.0 EB05 58.9 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 15.2 (12.6–18.3) | Not in label — unassessed | serious n=209 · 94% clinician | not reported in cached trials |
| Adjustment disorder | 252 | 81.4 70.9–93.4ROR 81.7 · calibrated p 6e-7 ✓ | 65.4 EB05 58.9 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.6 (4.8–6.4) | Not in label — unassessed | serious n=252 · ♀ 100% (drug 58%) | not reported in cached trials |
| Atrial tachycardia | 403 | 80.3 72.1–89.5ROR 80.8 · calibrated p 6e-7 ✓ | 64.8 EB05 59.6 · IC025 +5.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.1 (2.8–3.5) | Not in label — unassessed | serious n=401 | not reported in cached trials |
| Hypertensive nephropathy | 199 | 76.9 65.9–89.7ROR 77.1 · calibrated p 9e-7 ✓ | 62.4 EB05 55.4 · IC025 +5.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.5 (1.3–1.8) | Not in label — unassessed | serious n=199 · 100% consumer | not reported in cached trials |
| Polycystic ovaries | 279 | 73.4 64.5–83.5ROR 73.7 · calibrated p 1e-6 ✓ | 60.1 EB05 54.4 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.5 (4.8–6.3) | Not in label — unassessed | serious n=279 · ♀ 100% (drug 58%) | not reported in cached trials |
| Human rhinovirus test positive | 62 | 67.8 51.6–89.1ROR 67.9 · calibrated p 3e-6 ✓ | 55.6 EB05 44.9 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 12.4 (8.9–17.3) | Lab value / disease marker | serious n=62 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Pruritus genital | 381 | 66.5 59.6–74.2ROR 66.9 · calibrated p 2e-6 ✓ | 55.5 EB05 51.0 · IC025 +5.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.2 (2.9–3.6) | Labeled (related wording) related wording | serious n=381 | not reported in cached trials |
| Steroid dependence | 138 | 65.9 54.9–79.1ROR 66.0 · calibrated p 3e-6 ✓ | 54.8 EB05 47.6 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.0 (6.5–9.8) | Not in label — unassessed | serious n=138 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Catarrh | 143 | 65.1 54.4–77.9ROR 65.3 · calibrated p 3e-6 ✓ | 54.3 EB05 47.2 · IC025 +5.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.8 (5.6–8.2) | Not in label — unassessed | serious n=143 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Nasal turbinate hypertrophy | 48 | 49.7 36.7–67.3ROR 49.8 · calibrated p 2e-5 ✓ | 42.7 EB05 33.5 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 9.6 (6.7–13.7) | Not in label — unassessed | serious n=48 · ♀ 100% (drug 58%) · 100% consumer | not reported in cached trials |
| Pneumonia haemophilus | 61 | 48.6 37.2–63.6ROR 48.6 · calibrated p 2e-5 ✓ | 42.0 EB05 33.9 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 10.0 (7.3–13.7) | Not in label — unassessed | serious n=61 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Physical deconditioning | 294 | 45.2 40.0–51.0ROR 45.4 · calibrated p 3e-5 ✓ | 39.8 EB05 36.1 · IC025 +5.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.8 (6.8–8.9) | Not in label — unassessed | serious n=294 | not reported in cached trials |
| Granulocyte count increased | 47 | 44.6 32.9–60.4ROR 44.6 · calibrated p 4e-5 ✓ | 38.9 EB05 30.4 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.7 (5.4–10.9) | Lab value / disease marker | serious n=47 · ♀ 100% (drug 58%) | not reported in cached trials |
| Pleural thickening | 77 | 43.2 34.1–54.8ROR 43.3 · calibrated p 4e-5 ✓ | 38.1 EB05 31.5 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=77 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Tenosynovitis stenosans | 63 | 43.1 33.2–56.0ROR 43.2 · calibrated p 4e-5 ✓ | 37.9 EB05 30.7 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.4 (4.8–8.5) | Not in label — unassessed | serious n=63 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Personality disorder | 296 | 43.0 38.1–48.5ROR 43.2 · calibrated p 4e-5 ✓ | 38.1 EB05 34.6 · IC025 +5.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.8 (5.1–6.6) | Not in label — unassessed | serious n=296 · ♀ 100% (drug 58%) | not reported in cached trials |
| Carotid artery occlusion | 387 | 40.2 36.1–44.6ROR 40.4 · calibrated p 5e-5 ✓ | 35.9 EB05 33.0 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.9 (2.6–3.2) | Not in label — unassessed | serious n=387 | not reported in cached trials |
| Tension headache | 402 | 35.0 31.6–38.8ROR 35.3 · calibrated p 1e-4 ✓ | 31.8 EB05 29.2 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.9 (2.6–3.3) | Labeled (related wording) related wording | serious n=399 | not reported in cached trials |
| Pleural fibrosis | 95 | 34.5 27.9–42.6ROR 34.5 · calibrated p 1e-4 ✓ | 31.2 EB05 26.3 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Not in label — unassessed | serious n=95 · ♀ 100% (drug 58%) | not reported in cached trials |
| Respiratory syncytial virus test positive | 64 | 33.9 26.2–43.8ROR 33.9 · calibrated p 2e-4 ✓ | 30.6 EB05 24.8 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 11.9 (8.6–16.4) | Lab value / disease marker | serious n=64 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Sleep terror | 379 | 33.6 30.3–37.3ROR 33.8 · calibrated p 1e-4 ✓ | 30.6 EB05 28.1 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.2 (2.9–3.6) | Not in label — unassessed | serious n=378 | not reported in cached trials |
| Systemic lupus erythematosus rash | 71 | 33.0 25.8–42.0ROR 33.0 · calibrated p 2e-4 ✓ | 29.9 EB05 24.5 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.7 (4.4–7.5) | Labeled (related wording) related wording | serious n=70 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Occult blood | 47 | 32.8 24.3–44.2ROR 32.8 · calibrated p 2e-4 ✓ | 29.6 EB05 23.2 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 14.9 (10.0–22.2) | Not in label — unassessed | serious n=47 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Diabetic nephropathy | 194 | 32.6 28.1–37.8ROR 32.7 · calibrated p 2e-4 ✓ | 29.7 EB05 26.4 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.4 (1.3–1.7) | Not in label — unassessed | serious n=193 · 100% consumer | not reported in cached trials |
| Burns second degree | 149 | 31.6 26.7–37.4ROR 31.7 · calibrated p 2e-4 ✓ | 28.9 EB05 25.2 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 7.0 (5.8–8.5) | Not in label — unassessed | serious n=149 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Granuloma skin | 67 | 29.9 23.3–38.3ROR 29.9 · calibrated p 3e-4 ✓ | 27.3 EB05 22.2 · IC025 +4.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.6 (3.5–6.0) | Not in label — unassessed | serious n=67 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Blood magnesium increased | 73 | 29.8 23.5–37.9ROR 29.9 · calibrated p 3e-4 ✓ | 27.3 EB05 22.4 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: only this drug | Likely indication confounding term in indications; also in warnings | serious n=73 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Nephrosclerosis | 90 | 29.6 23.9–36.8ROR 29.7 · calibrated p 3e-4 ✓ | 27.2 EB05 22.8 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.7 (2.2–3.4) | Not in label — unassessed | serious n=90 · 100% consumer | not reported in cached trials |
| Electric shock | 63 | 27.2 21.1–35.2ROR 27.3 · calibrated p 5e-4 ✓ | 25.1 EB05 20.3 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.1 (3.1–5.5) | Not in label — unassessed | serious n=63 · ♀ 100% (drug 58%) | not reported in cached trials |
| Nephrectomy | 110 | 27.2 22.4–33.0ROR 27.2 · calibrated p 5e-4 ✓ | 25.1 EB05 21.4 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.9 (4.7–7.3) | Not in label — unassessed | serious n=108 · ♀ 100% (drug 58%) | not reported in cached trials |
| Ejection fraction abnormal | 89 | 26.5 21.4–32.9ROR 26.5 · calibrated p 6e-4 ✓ | 24.5 EB05 20.5 · IC025 +4.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 6.9 (5.4–8.8) | Lab value / disease marker | serious n=89 · ♀ 100% (drug 58%) | not reported in cached trials |
| Rhinitis allergic | 302 | 24.8 22.0–27.8ROR 24.9 · calibrated p 7e-4 ✓ | 23.1 EB05 21.0 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.8 (3.3–4.3) | Labeled (related wording) related wording | serious n=302 · ♀ 100% (drug 58%) | 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 | 7,669 | 5.85.7–5.9 | signal |
| Hyponatraemia | 1,195 | 5.14.8–5.4 | signal |
| Anaphylaxis / angioedema | 1,398 | 3.83.6–4.0 | signal |
| Severe cutaneous reaction | 758 | 3.53.2–3.7 | signal |
| Interstitial lung disease | 964 | 3.43.2–3.7 | signal |
| Gi bleeding | 1,524 | 2.82.7–3.0 | signal |
| Rhabdomyolysis / myopathy | 670 | 2.82.6–3.0 | signal |
| Pancreatitis | 658 | 2.82.6–3.0 | signal |
| Arrhythmia / qt | 1,580 | 2.82.7–2.9 | signal |
| Liver injury | 2,240 | 2.52.4–2.6 | signal |
| Anaemia | 2,019 | 2.32.2–2.4 | signal |
| Neutropenia / agranulocytosis | 1,587 | 2.22.1–2.3 | signal |
| Fall / fracture | 2,378 | 2.12.0–2.2 | signal |
| Heart failure | 1,106 | 2.12.0–2.2 | raised |
| Thrombocytopenia | 1,299 | 2.01.9–2.1 | raised |
| Serious infection | 4,548 | 2.02.0–2.1 | 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 (0 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 | 5,033 | 23.9 23.2–24.5ROR 25.9 · calibrated p 6e-4 ✓ | 22.3 EB05 21.8 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.6 (0.6–0.6) | Not in label — unassessed | age-adj. PRR 16.9 · serious PRR 14.8 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Acute kidney injury (sudden kidney damage) | 4,707 | 10.8 10.5–11.1ROR 11.6 · calibrated p 0.019 ✓ | 10.5 EB05 10.3 · IC025 +3.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.9 (0.9–0.9) | Not in label — unassessed | age-adj. PRR 6.0 · serious PRR 6.9 | NCT00357682: 3/1,138 (0.3%) on Esomeprazole (serious AE) |
| Nausea | 4,281 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.896 | 1.8 EB05 1.8 · IC025 +0.8 vs other Proton Pump Inhibitors: PRR 0.9 (0.9–0.9) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.1 | NCT00444275: 1/873 (0.1%) on Esomeprazole |
| Diarrhoea (diarrhea) | 4,111 | 2.2 2.1–2.2ROR 2.3 · calibrated p 0.919 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.9 (0.9–1.0) | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.2 | NCT00444275: 3/2,156 (0.1%) on Esomeprazole |
| Headache | 3,744 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.999 | 2.0 EB05 2.0 · IC025 +1.0 vs other Proton Pump Inhibitors: PRR 1.1 (1.0–1.1) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.5 | NCT00444275: 1/886 (0.1%) on Esomeprazole |
| Fatigue (tiredness) | 3,727 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.754 | 1.6 EB05 1.6 · IC025 +0.7 vs other Proton Pump Inhibitors: PRR 0.9 (0.8–0.9) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.8 | not reported in cached trials |
| Off label use (used outside approved label) | 3,533 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.582 | 1.4 EB05 1.3 · IC025 +0.4 vs other Proton Pump Inhibitors: PRR 1.1 (1.1–1.1) | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.6 | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,520 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.245 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Proton Pump Inhibitors: PRR 0.9 (0.8–0.9) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.3 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 3,482 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.968 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.9 (0.9–1.0) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 1.8 | NCT00357682: 3/1,138 (0.3%) on Esomeprazole (serious AE) |
| Pain | 2,904 | 1.6 1.6–1.7ROR 1.6 · calibrated p 0.731 | 1.6 EB05 1.6 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.8 (0.8–0.9) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.5 | NCT00444275: 1/873 (0.1%) on Esomeprazole |
| Vomiting | 2,902 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.968 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.9 (0.9–1.0) | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 1.9 | NCT00357682: 6/1,138 (0.5%) on Esomeprazole (serious AE) |
| Arthralgia (joint pain) | 2,754 | 2.3 2.2–2.4ROR 2.3 · calibrated p 0.890 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.1 (1.1–1.1) | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.5 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
| Pyrexia (fever) | 2,651 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.736 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 1.2 (1.2–1.3) | Labeled (related wording) related wording | age-adj. PRR 2.2 · serious PRR 2.1 | not reported in cached trials |
| Malaise (feeling unwell) | 2,611 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.983 | 2.0 EB05 2.0 · IC025 +0.9 vs other Proton Pump Inhibitors: PRR 0.9 (0.9–1.0) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.1 | not reported in cached trials |
| Dizziness | 2,254 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.683 | 1.5 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.8 (0.7–0.8) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole (serious AE) |
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.
- Cardiospasm — n=384, PRR 769.4
- Immunisation — n=244, PRR 443.7
- Palmoplantar keratoderma — n=377, PRR 377.7
- Neurologic neglect syndrome — n=257, PRR 290.5
- Sensitisation — n=290, PRR 208.2
- Ejection fraction — n=218, PRR 203.2
- Carotid artery thrombosis — n=263, PRR 151.7
- Presbyacusis — n=91, PRR 141.0
- Amaurosis fugax — n=209, PRR 82.6
- Adjustment disorder — n=252, PRR 81.4
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, nausea, diarrhoea, headache, 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 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") - 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, 1,224 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.