Drug · FAERS side-effect profile with label screen
Esomeprazole Sodium side effects: what 2,404 FDA adverse event reports show
Who reports
2,404 reports · 94% serious · 215 with death outcome · 57% 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 adverse reaction 1Labeled (related wording) 6Likely indication confounding 1Lab value / disease marker 6Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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). 231 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 |
|---|---|---|---|---|---|---|
| Malnutrition | 66 | 52.1 41.1–66.2ROR 53.6 · calibrated p 1e-5 ✓ | 51.1 EB05 41.6 · IC025 +4.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 32.9 · ♀ 97% (drug 57%) | no trial data cached |
| Eye haemorrhage | 54 | 35.4 27.2–46.1ROR 36.2 · calibrated p 1e-4 ✓ | 34.8 EB05 27.7 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.1) | Labeled (related wording) related wording | serious PRR 24.2 · ♀ 100% (drug 57%) | no trial data cached |
| Thyroid disorder | 61 | 34.7 27.0–44.4ROR 35.5 · calibrated p 1e-4 ✓ | 34.2 EB05 27.6 · IC025 +4.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious PRR 29.4 · ♀ 100% (drug 57%) | no trial data cached |
| Ocular discomfort | 35 | 28.2 20.3–39.2ROR 28.6 · calibrated p 5e-4 ✓ | 27.7 EB05 20.9 · IC025 +3.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious n=35 | no trial data cached |
| Body temperature decreased | 31 | 27.3 19.3–38.8ROR 27.7 · calibrated p 6e-4 ✓ | 26.8 EB05 19.8 · IC025 +3.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Lab value / disease marker | serious PRR 18.5 | no trial data cached |
| Sopor | 41 | 26.8 19.8–36.4ROR 27.3 · calibrated p 6e-4 ✓ | 26.5 EB05 20.3 · IC025 +3.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.1 (0.0–0.1) | Not in label — unassessed | serious PRR 16.4 · 93% clinician | no trial data cached |
| Motor dysfunction | 31 | 26.8 18.9–38.1ROR 27.2 · calibrated p 6e-4 ✓ | 26.4 EB05 19.4 · IC025 +3.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 20.6 · ♀ 96% (drug 57%) · 97% clinician | no trial data cached |
| Affect lability | 29 | 26.2 18.3–37.7ROR 26.6 · calibrated p 7e-4 ✓ | 25.8 EB05 18.8 · IC025 +3.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 22.4 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Pericardial effusion | 68 | 25.9 20.4–32.7ROR 26.6 · calibrated p 6e-4 ✓ | 25.6 EB05 20.9 · IC025 +4.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 16.0 · ♀ 81% (drug 57%) | no trial data cached |
| Sinus congestion | 31 | 20.0 14.1–28.4ROR 20.3 · calibrated p 0.003 ✓ | 19.8 EB05 14.5 · IC025 +3.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious n=30 · ♀ 93% (drug 57%) · 94% clinician | no trial data cached |
| Head discomfort | 40 | 19.9 14.6–27.0ROR 20.2 · calibrated p 0.002 ✓ | 19.6 EB05 15.0 · IC025 +3.5 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 21.1 | no trial data cached |
| Muscle spasticity | 28 | 19.7 13.7–28.5ROR 20.0 · calibrated p 0.003 ✓ | 19.4 EB05 14.0 · IC025 +3.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 17.3 · ♀ 100% (drug 57%) · 96% clinician | no trial data cached |
| Coordination abnormal | 29 | 18.0 12.6–25.9ROR 18.3 · calibrated p 0.004 ✓ | 17.8 EB05 12.9 · IC025 +3.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 15.3 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Altered state of consciousness | 44 | 17.8 13.3–23.9ROR 18.2 · calibrated p 0.004 ✓ | 17.7 EB05 13.7 · IC025 +3.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Ulcer | 32 | 17.6 12.4–24.8ROR 17.8 · calibrated p 0.004 ✓ | 17.3 EB05 12.7 · IC025 +3.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Likely indication confounding term in indications; also in warnings | serious PRR 13.5 · ♀ 100% (drug 57%) · 94% clinician | no trial data cached |
| Blood calcium decreased | 22 | 17.0 11.2–25.8ROR 17.2 · calibrated p 0.006 ✓ | 16.6 EB05 11.3 · IC025 +2.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Lab value / disease marker | serious PRR 13.0 · 95% clinician | no trial data cached |
| Skin haemorrhage | 28 | 17.0 11.7–24.5ROR 17.2 · calibrated p 0.005 ✓ | 16.7 EB05 11.9 · IC025 +3.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious n=28 · ♀ 100% (drug 57%) · 96% clinician | no trial data cached |
| Angina pectoris | 55 | 16.7 12.8–21.6ROR 17.0 · calibrated p 0.005 ✓ | 16.5 EB05 13.1 · IC025 +3.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 10.5 · ♀ 90% (drug 57%) · 93% clinician | no trial data cached |
| Respiratory tract congestion | 30 | 16.5 11.5–23.5ROR 16.7 · calibrated p 0.006 ✓ | 16.2 EB05 11.7 · IC025 +3.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 22.5 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Hemiparesis | 32 | 16.4 11.6–23.2ROR 16.6 · calibrated p 0.006 ✓ | 16.1 EB05 11.8 · IC025 +3.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 10.9 · ♀ 93% (drug 57%) · 97% clinician | no trial data cached |
| Breast pain | 20 | 16.4 10.6–25.4ROR 16.5 · calibrated p 0.007 ✓ | 15.9 EB05 10.5 · IC025 +2.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious n=20 · 90% clinician | no trial data cached |
| Blood pressure systolic increased | 36 | 16.1 11.6–22.2ROR 16.3 · calibrated p 0.006 ✓ | 15.8 EB05 11.8 · IC025 +3.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Lab value / disease marker | serious PRR 10.7 | no trial data cached |
| Lymphocyte count decreased | 31 | 15.3 10.8–21.7ROR 15.5 · calibrated p 0.008 ✓ | 15.0 EB05 10.9 · IC025 +3.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Lab value / disease marker | serious PRR 10.7 · 97% clinician | no trial data cached |
| Ventricular tachycardia | 29 | 15.3 10.6–22.0ROR 15.5 · calibrated p 0.008 ✓ | 15.0 EB05 10.7 · IC025 +3.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Haematemesis (vomiting blood) | 44 | 15.1 11.3–20.3ROR 15.4 · calibrated p 0.007 ✓ | 14.9 EB05 11.5 · IC025 +3.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 9.5 · 91% clinician | no trial data cached |
| Sinus disorder | 34 | 15.0 10.7–20.9ROR 15.2 · calibrated p 0.008 ✓ | 14.7 EB05 10.8 · IC025 +3.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious PRR 19.8 · ♀ 100% (drug 57%) · 94% clinician | no trial data cached |
| Mass | 24 | 15.0 10.0–22.3ROR 15.1 · calibrated p 0.009 ✓ | 14.5 EB05 9.9 · IC025 +2.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Ascites | 46 | 13.7 10.3–18.2ROR 13.9 · calibrated p 0.011 ✓ | 13.4 EB05 10.3 · IC025 +3.1 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 8.5 · 91% clinician | no trial data cached |
| Supraventricular tachycardia | 14 | 12.8 7.6–21.6ROR 12.9 · calibrated p 0.020 ✓ | 11.5 EB05 6.6 · IC025 +2.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Arthritis | 114 | 12.6 10.6–15.1ROR 13.2 · calibrated p 0.012 ✓ | 12.5 EB05 10.7 · IC025 +3.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 12.0 · ♀ 98% (drug 57%) | no trial data cached |
| Mitral valve incompetence | 16 | 12.4 7.6–20.1ROR 12.4 · calibrated p 0.021 ✓ | 11.2 EB05 6.7 · IC025 +2.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Hypercalcaemia | 17 | 12.0 7.5–19.3ROR 12.1 · calibrated p 0.022 ✓ | 11.0 EB05 6.7 · IC025 +2.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Vasculitis | 16 | 12.0 7.4–19.5ROR 12.1 · calibrated p 0.023 ✓ | 10.8 EB05 6.5 · IC025 +2.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Neutrophil count increased | 14 | 11.9 7.1–20.1ROR 12.0 · calibrated p 0.025 ✓ | 10.5 EB05 6.1 · IC025 +2.2 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Eating disorder | 29 | 11.9 8.3–17.0ROR 12.0 · calibrated p 0.021 ✓ | 11.3 EB05 8.0 · IC025 +2.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious PRR 10.1 · ♀ 96% (drug 57%) · 97% clinician | no trial data cached |
| Sedation | 35 | 11.7 8.4–16.3ROR 11.9 · calibrated p 0.020 ✓ | 11.3 EB05 8.2 · IC025 +2.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 9.9 · ♀ 10% (drug 57%) | no trial data cached |
| Haemorrhoids | 26 | 11.6 7.9–17.0ROR 11.7 · calibrated p 0.023 ✓ | 10.9 EB05 7.5 · IC025 +2.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 8.8 · 96% clinician | no trial data cached |
| Blood pressure fluctuation | 32 | 11.6 8.2–16.4ROR 11.8 · calibrated p 0.022 ✓ | 11.1 EB05 8.0 · IC025 +2.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Lab value / disease marker | serious PRR 9.0 · ♀ 95% (drug 57%) | no trial data cached |
| Sneezing | 29 | 11.3 7.9–16.3ROR 11.5 · calibrated p 0.024 ✓ | 10.7 EB05 7.6 · IC025 +2.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 17.3 · ♀ 100% (drug 57%) · 97% clinician | no trial data cached |
| Pulmonary oedema | 57 | 11.1 8.6–14.4ROR 11.4 · calibrated p 0.023 ✓ | 10.8 EB05 8.5 · IC025 +2.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 6.9 · ♀ 100% (drug 57%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pruritus (itching) | 177 | 4.1 3.5–4.7ROR 4.3 · calibrated p 0.324 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 5.9 · ♀ 84% (drug 57%) | no trial data cached |
| Abdominal pain upper | 151 | 6.4 5.5–7.5ROR 6.8 · calibrated p 0.110 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious PRR 7.1 · ♀ 93% (drug 57%) | no trial data cached |
| Abdominal pain | 134 | 5.0 4.3–5.9ROR 5.3 · calibrated p 0.210 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Cough | 132 | 4.1 3.5–4.9ROR 4.3 · calibrated p 0.330 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Arthritis | 114 | 12.6 10.6–15.1ROR 13.2 · calibrated p 0.012 ✓ | 12.5 EB05 10.7 · IC025 +3.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 12.0 · ♀ 98% (drug 57%) | no trial data cached |
| Chills | 113 | 8.4 7.0–10.1ROR 8.8 · calibrated p 0.052 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 8.0 · 93% clinician | no trial data cached |
| Blood pressure increased | 107 | 6.1 5.1–7.3ROR 6.3 · calibrated p 0.133 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled (related wording) related wording | serious PRR 5.3 · ♀ 83% (drug 57%) · 91% clinician | no trial data cached |
| Anaemia (low red blood cells) | 104 | 4.8 3.9–5.7ROR 4.9 · calibrated p 0.247 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 3.2 · 92% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 104 | 10.2 8.5–12.3ROR 10.6 · calibrated p 0.027 ✓ | 10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 6.9 · ♀ 80% (drug 57%) | no trial data cached |
| Nasopharyngitis (common cold) | 98 | 4.6 3.8–5.6ROR 4.8 · calibrated p 0.264 | 4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 6.2 · ♀ 85% (drug 57%) | no trial data cached |
| Chest discomfort | 96 | 8.2 6.8–10.0ROR 8.5 · calibrated p 0.057 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 7.4 · ♀ 78% (drug 57%) | no trial data cached |
| Myalgia (muscle pain) | 89 | 4.6 3.7–5.6ROR 4.7 · calibrated p 0.274 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Labeled adverse reaction exact term | serious PRR 4.7 · ♀ 92% (drug 57%) | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 89 | 8.2 6.7–10.1ROR 8.5 · calibrated p 0.058 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 5.9 · ♀ 96% (drug 57%) | no trial data cached |
| Palpitations (pounding heartbeat) | 87 | 6.5 5.3–8.0ROR 6.7 · calibrated p 0.116 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Rheumatoid arthritis | 85 | 6.6 5.3–8.1ROR 6.8 · calibrated p 0.112 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree vs other Proton Pump Inhibitors: PRR 0.0 (0.0–0.0) | Not in label — unassessed | serious PRR 4.9 · ♀ 100% (drug 57%) · 91% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Malnutrition — n=66, PRR 52.1
- Ocular discomfort — n=35, PRR 28.2
- Sopor — n=41, PRR 26.8
- Motor dysfunction — n=31, PRR 26.8
- Affect lability — n=29, PRR 26.2
- Pericardial effusion — n=68, PRR 25.9
- Sinus congestion — n=31, PRR 20.0
- Head discomfort — n=40, PRR 19.9
- Muscle spasticity — n=28, PRR 19.7
- Coordination abnormal — n=29, PRR 18.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
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 Sodium?
In FDA FAERS, the most frequently co-reported reaction terms for Esomeprazole Sodium are pruritus, abdominal pain upper, abdominal pain, cough, arthritis, chills. 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 Sodium have an FDA boxed warning?
No. The FDA label retrieved for Esomeprazole Sodium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Esomeprazole Sodium 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, 271 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-14. 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.