Drug · FAERS side-effect profile with label screen
Esomeprazole Magnesium Dihydrate side effects: what 14,478 FDA adverse event reports show
Who reports
14,478 reports · 76% serious · 1,250 with death outcome · 61% 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) 1Reporting / coding artifact 3Lab value / disease marker 7Not in label — unassessed 29
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.
- 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). 1,167 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 |
|---|---|---|---|---|---|---|
| Synovial fluid analysis | 25 | 584.9 367.4–931.4ROR 586.0 · calibrated p 2e-13 ✓ | 315.0 EB05 224.4 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.7 (3.0–7.3) | Reporting / coding artifact | serious n=25 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Haemorrhage foetal | 15 | 548.9 302.7–995.5ROR 549.5 · calibrated p 2e-12 ✓ | 263.6 EB05 169.6 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.4–15.0) | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Neurologic neglect syndrome | 151 | 536.1 445.0–645.9ROR 541.7 · calibrated p 4e-14 ✓ | 371.6 EB05 324.4 · IC025 +7.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.9 (2.4–3.4) | Not in label — unassessed | serious n=151 · ♀ 100% (drug 61%) | not reported in cached trials |
| Ejection fraction | 137 | 444.4 367.1–538.0ROR 448.6 · calibrated p 3e-13 ✓ | 323.8 EB05 280.8 · IC025 +7.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.1 (2.6–3.7) | Not in label — unassessed | serious n=137 · ♀ 100% (drug 61%) | not reported in cached trials |
| Sensitisation | 176 | 433.1 366.2–512.3ROR 438.4 · calibrated p 3e-13 ✓ | 320.9 EB05 283.0 · IC025 +7.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.0 (2.6–3.6) | Not in label — unassessed | serious n=176 · ♀ 100% (drug 61%) | not reported in cached trials |
| Bronchial neoplasm | 27 | 356.8 234.1–543.8ROR 357.5 · calibrated p 1e-11 ✓ | 237.7 EB05 171.6 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.1–12.9) | Not in label — unassessed | serious n=27 · ♀ 100% (drug 61%) | not reported in cached trials |
| Carotid artery thrombosis | 152 | 314.0 263.6–373.9ROR 317.3 · calibrated p 8e-12 ✓ | 249.5 EB05 217.9 · IC025 +6.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.8 (2.4–3.4) | Not in label — unassessed | serious n=152 · ♀ 100% (drug 61%) | not reported in cached trials |
| Cardiospasm | 89 | 274.9 219.3–344.8ROR 276.6 · calibrated p 4e-11 ✓ | 219.8 EB05 184.1 · IC025 +6.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.7 (0.5–0.8) | Not in label — unassessed | serious n=89 | not reported in cached trials |
| Foetal anaemia | 18 | 229.4 139.5–377.2ROR 229.7 · calibrated p 1e-9 ✓ | 163.7 EB05 109.6 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.6–14.3) | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Immunisation | 54 | 206.1 155.0–274.0ROR 206.8 · calibrated p 6e-10 ✓ | 169.5 EB05 134.8 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.8 (0.6–1.0) | Not in label — unassessed | serious n=54 | not reported in cached trials |
| Nipple swelling | 31 | 201.1 138.1–292.8ROR 201.5 · calibrated p 1e-9 ✓ | 159.3 EB05 117.5 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.3–12.5) | Not in label — unassessed | serious n=31 · ♀ 0% (drug 61%) | not reported in cached trials |
| Palmoplantar keratoderma | 86 | 196.4 156.8–245.9ROR 197.6 · calibrated p 7e-10 ✓ | 166.4 EB05 138.9 · IC025 +6.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.7 (0.5–0.8) | Not in label — unassessed | serious n=86 | not reported in cached trials |
| Post cholecystectomy syndrome | 33 | 192.2 133.7–276.4ROR 192.7 · calibrated p 2e-9 ✓ | 154.5 EB05 115.1 · IC025 +5.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.3–12.3) | Not in label — unassessed | serious n=33 · ♀ 100% (drug 61%) | not reported in cached trials |
| Hepatojugular reflux | 19 | 184.5 114.4–297.4ROR 184.7 · calibrated p 5e-9 ✓ | 140.7 EB05 95.2 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.7–14.0) | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Adjustment disorder | 147 | 183.9 155.0–218.2ROR 185.8 · calibrated p 1e-9 ✓ | 159.7 EB05 139.1 · IC025 +6.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.8 (2.4–3.4) | Not in label — unassessed | serious n=147 · ♀ 100% (drug 61%) | not reported in cached trials |
| Polycystic ovaries | 175 | 181.5 155.2–212.3ROR 183.7 · calibrated p 1e-9 ✓ | 158.4 EB05 139.7 · IC025 +6.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.1 (2.6–3.6) | Not in label — unassessed | serious n=175 · ♀ 100% (drug 61%) | not reported in cached trials |
| Bronchial haemorrhage | 27 | 135.7 91.5–201.3ROR 135.9 · calibrated p 3e-8 ✓ | 114.2 EB05 82.4 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.1–12.9) | Not in label — unassessed | serious n=27 · ♀ 100% (drug 61%) | not reported in cached trials |
| Systemic lupus erythematosus rash | 67 | 131.9 102.7–169.3ROR 132.5 · calibrated p 2e-8 ✓ | 116.9 EB05 95.2 · IC025 +5.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.3 (4.0–7.0) | Labeled (related wording) related wording | serious n=66 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Granulocyte count increased | 33 | 128.3 89.9–183.2ROR 128.6 · calibrated p 4e-8 ✓ | 110.5 EB05 82.3 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.7 (3.2–7.0) | Lab value / disease marker | serious n=33 · ♀ 100% (drug 61%) | not reported in cached trials |
| Electrocardiogram q wave abnormal | 18 | 121.8 75.3–197.0ROR 121.9 · calibrated p 1e-7 ✓ | 100.6 EB05 67.3 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.6–14.3) | Lab value / disease marker | serious n=18 | not reported in cached trials |
| Jaw clicking | 15 | 117.6 69.5–199.1ROR 117.8 · calibrated p 2e-7 ✓ | 95.8 EB05 61.6 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.4–15.0) | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Viral test positive | 27 | 115.0 77.7–170.2ROR 115.2 · calibrated p 1e-7 ✓ | 99.2 EB05 71.6 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.1–12.9) | Lab value / disease marker | serious n=27 · ♀ 100% (drug 61%) | not reported in cached trials |
| Endometrial ablation | 26 | 114.5 76.8–170.7ROR 114.7 · calibrated p 1e-7 ✓ | 98.6 EB05 70.7 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.1–13.0) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 61%) | not reported in cached trials |
| Human rhinovirus test positive | 27 | 113.0 76.4–167.2ROR 113.2 · calibrated p 1e-7 ✓ | 97.7 EB05 70.5 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.8 (2.5–5.7) | Lab value / disease marker | serious n=27 · ♀ 100% (drug 61%) | not reported in cached trials |
| Nasal turbinate hypertrophy | 27 | 112.0 75.7–165.7ROR 112.2 · calibrated p 1e-7 ✓ | 97.0 EB05 70.0 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.3 (2.8–6.6) | Not in label — unassessed | serious n=27 · ♀ 100% (drug 61%) | not reported in cached trials |
| Tenosynovitis stenosans | 38 | 105.5 75.9–146.6ROR 105.8 · calibrated p 2e-7 ✓ | 93.8 EB05 71.3 · IC025 +4.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 3.3 (2.3–4.7) | Not in label — unassessed | serious n=38 · ♀ 100% (drug 61%) | not reported in cached trials |
| Pneumonia haemophilus | 33 | 105.1 73.9–149.7ROR 105.4 · calibrated p 2e-7 ✓ | 92.9 EB05 69.2 · IC025 +4.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.2 (2.9–6.2) | Not in label — unassessed | serious n=33 · ♀ 100% (drug 61%) | not reported in cached trials |
| Personality disorder | 158 | 92.3 78.6–108.3ROR 93.3 · calibrated p 2e-7 ✓ | 85.9 EB05 75.2 · IC025 +5.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.7 (2.2–3.1) | Not in label — unassessed | serious n=158 · ♀ 100% (drug 61%) | not reported in cached trials |
| Blood immunoglobulin a increased | 32 | 91.9 64.3–131.3ROR 92.1 · calibrated p 5e-7 ✓ | 82.3 EB05 61.0 · IC025 +4.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.3–12.4) | Lab value / disease marker | serious n=32 · ♀ 100% (drug 61%) | not reported in cached trials |
| Aspartate aminotransferase | 14 | 88.4 51.5–151.7ROR 88.5 · calibrated p 2e-6 ✓ | 75.1 EB05 47.5 · IC025 +3.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.3–15.4) | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Ejection fraction abnormal | 70 | 87.4 68.7–111.2ROR 87.8 · calibrated p 4e-7 ✓ | 80.7 EB05 66.0 · IC025 +5.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.0 (3.8–6.5) | Lab value / disease marker | serious n=70 · ♀ 100% (drug 61%) | not reported in cached trials |
| Nephritic syndrome | 16 | 79.0 47.8–130.7ROR 79.1 · calibrated p 3e-6 ✓ | 69.0 EB05 45.0 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (4.4–14.8) | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Bunion operation | 29 | 78.8 54.3–114.5ROR 79.0 · calibrated p 1e-6 ✓ | 71.4 EB05 52.1 · IC025 +4.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.2–12.6) | Reporting / coding artifact | serious n=29 · ♀ 100% (drug 61%) | not reported in cached trials |
| Synovial disorder | 23 | 76.9 50.6–116.9ROR 77.0 · calibrated p 2e-6 ✓ | 69.0 EB05 48.4 · IC025 +4.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 5.2 (3.2–8.3) | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Cerebral artery thrombosis | 26 | 76.7 51.7–113.7ROR 76.8 · calibrated p 2e-6 ✓ | 69.3 EB05 49.7 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.1–13.0) | Not in label — unassessed | serious n=26 · ♀ 0% (drug 61%) · 100% clinician | not reported in cached trials |
| Electric shock | 42 | 75.4 55.3–102.8ROR 75.6 · calibrated p 2e-6 ✓ | 69.5 EB05 53.6 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.5 (1.8–3.5) | Not in label — unassessed | serious n=42 · ♀ 100% (drug 61%) | not reported in cached trials |
| Rheumatoid nodule | 136 | 74.3 62.6–88.2ROR 75.0 · calibrated p 1e-6 ✓ | 70.0 EB05 60.7 · IC025 +5.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.6 (2.2–3.1) | Not in label — unassessed | serious n=136 · ♀ 100% (drug 61%) · 90% clinician | not reported in cached trials |
| Brain scan abnormal | 27 | 73.3 49.8–107.8ROR 73.4 · calibrated p 2e-6 ✓ | 66.6 EB05 48.1 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 8.1 (5.1–12.9) | Reporting / coding artifact | serious n=27 · ♀ 0% (drug 61%) · 100% clinician | not reported in cached trials |
| Granuloma skin | 36 | 65.7 47.1–91.7ROR 65.9 · calibrated p 4e-6 ✓ | 60.9 EB05 46.0 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 2.2 (1.5–3.1) | Not in label — unassessed | serious n=36 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Glomerular filtration rate increased | 35 | 65.1 46.4–91.4ROR 65.3 · calibrated p 4e-6 ✓ | 60.4 EB05 45.4 · IC025 +4.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 4.7 (3.2–6.9) | Lab value / disease marker | serious n=35 · ♀ 100% (drug 61%) | 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 Esomeprazole Magnesium Dihydrate 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,418 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.719 | 1.6 EB05 1.5 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Reporting / coding artifact | serious PRR 2.2 | not reported in cached trials |
| Nausea | 1,349 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.760 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Labeled adverse reaction exact term | serious PRR 3.0 | NCT00444275: 1/873 (0.1%) on Esomeprazole Magnesium Dihydrate |
| Headache | 1,233 | 2.9 2.7–3.0ROR 3.0 · calibrated p 0.618 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.4) | Labeled adverse reaction exact term | serious PRR 3.7 · ♀ 85% (drug 61%) | NCT00444275: 1/886 (0.1%) on Esomeprazole Magnesium Dihydrate |
| Diarrhoea (diarrhea) | 1,081 | 2.4 2.3–2.6ROR 2.6 · calibrated p 0.792 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00444275: 3/2,156 (0.1%) on Esomeprazole Magnesium Dihydrate |
| Fatigue (tiredness) | 1,075 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.990 | 2.0 EB05 1.9 · IC025 +0.9 vs other Proton Pump Inhibitors: PRR 0.2 (0.2–0.3) | Labeled adverse reaction exact term | serious PRR 2.4 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,007 | 2.6 2.4–2.7ROR 2.7 · calibrated p 0.733 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.2–0.3) | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00357682: 3/1,138 (0.3%) on Esomeprazole Magnesium Dihydrate (serious AE) |
| Off label use (used outside approved label) | 994 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.774 | 1.7 EB05 1.6 · IC025 +0.6 vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Pain | 961 | 2.3 2.1–2.4ROR 2.4 · calibrated p 0.879 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.2–0.3) | Labeled adverse reaction exact term | serious PRR 2.4 · ♀ 82% (drug 61%) | NCT00444275: 1/873 (0.1%) on Esomeprazole Magnesium Dihydrate |
| Chronic kidney disease | 861 | 16.4 15.4–17.5ROR 17.4 · calibrated p 0.004 ✓ | 16.3 EB05 15.4 · IC025 +3.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 12.5 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole Magnesium Dihydrate (serious AE) |
| Arthralgia (joint pain) | 806 | 2.8 2.6–3.0ROR 2.9 · calibrated p 0.651 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Labeled adverse reaction exact term | serious PRR 3.5 | NCT00357682: 1/1,138 (0.1%) on Esomeprazole Magnesium Dihydrate (serious AE) |
| Malaise (feeling unwell) | 772 | 2.5 2.4–2.7ROR 2.6 · calibrated p 0.759 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Labeled adverse reaction exact term | serious PRR 2.8 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 740 | 7.1 6.6–7.6ROR 7.4 · calibrated p 0.085 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.1 (0.1–0.1) | Not in label — unassessed | serious PRR 5.3 | NCT00357682: 3/1,138 (0.3%) on Esomeprazole Magnesium Dihydrate (serious AE) |
| Vomiting | 683 | 2.1 2.0–2.3ROR 2.2 · calibrated p 0.969 | 2.1 EB05 2.0 · IC025 +0.9 vs other Proton Pump Inhibitors: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00357682: 6/1,138 (0.5%) on Esomeprazole Magnesium Dihydrate (serious AE) |
| Cough | 647 | 3.4 3.1–3.6ROR 3.5 · calibrated p 0.495 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Labeled adverse reaction exact term | serious PRR 3.7 · ♀ 84% (drug 61%) | NCT00444275: 1/851 (0.1%) on Esomeprazole Magnesium Dihydrate |
| Pneumonia (lung infection) | 628 | 2.8 2.6–3.0ROR 2.9 · calibrated p 0.661 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.3 (0.3–0.3) | Labeled (related wording) related wording | serious PRR 2.2 | 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.
- Neurologic neglect syndrome — n=151, PRR 536.1
- Ejection fraction — n=137, PRR 444.4
- Sensitisation — n=176, PRR 433.1
- Bronchial neoplasm — n=27, PRR 356.8
- Carotid artery thrombosis — n=152, PRR 314.0
- Cardiospasm — n=89, PRR 274.9
- Immunisation — n=54, PRR 206.1
- Nipple swelling — n=31, PRR 201.1
- Palmoplantar keratoderma — n=86, PRR 196.4
- Post cholecystectomy syndrome — n=33, PRR 192.2
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 Magnesium Dihydrate?
In FDA FAERS, the most frequently co-reported reaction terms for Esomeprazole Magnesium Dihydrate are nausea, headache, diarrhoea, fatigue, dyspnoea, pain. 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 Magnesium Dihydrate have an FDA boxed warning?
No. The FDA label retrieved for Esomeprazole Magnesium Dihydrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Esomeprazole Magnesium Dihydrate 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, 1,207 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.