Drug class · FAERS comparison
Proton Pump Inhibitor side effects compared: 10 drugs, 1,344,778 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Omeprazole | 444,238 | 72% | 39,121 | – | Renal failure; Tubulointerstitial nephritis; Pruritus genital | Chronic kidney disease; Acute kidney injury |
| Omeprazole | 342,054 | 74% | 31,116 | – | Hyponatraemia; Tubulointerstitial nephritis; Pruritus genital | Chronic kidney disease; Acute kidney injury |
| Esomeprazole | 232,620 | 72% | 19,443 | – | Tubulointerstitial nephritis; Pruritus genital; Gastric polyps | Chronic kidney disease; Acute kidney injury |
| Lansoprazole | 177,056 | 87% | 19,914 | – | Chronic kidney disease; Renal injury; Tubulointerstitial nephritis | End stage renal disease; Nephrogenic anaemia |
| Esomeprazole | 61,637 | 88% | 6,207 | – | Tension headache; Pruritus genital; Rhinitis allergic | Atrial tachycardia; Carotid artery occlusion |
| Dexlansoprazole (Dexlansoprazole Delayed Release) | 41,459 | 81% | 3,710 | – | Renal injury; Tubulointerstitial nephritis; Renal hypertension | Chronic kidney disease; End stage renal disease |
| Esomeprazole | 14,478 | 76% | 1,250 | – | Systemic lupus erythematosus rash | Sensitisation; Polycystic ovaries |
| Esomeprazole | 14,416 | 76% | 1,244 | – | Systemic lupus erythematosus rash | Sensitisation; Polycystic ovaries |
| Esomeprazole | 14,416 | 76% | 1,244 | – | Systemic lupus erythematosus rash | Sensitisation; Polycystic ovaries |
| Esomeprazole | 2,404 | 94% | 215 | – | Arthritis; Thyroid disorder; Eye haemorrhage | Pericardial effusion; Malnutrition |
Class-wide signals (flagged in at least 5 of 10 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Cardiospasm | 8/10 | 275.5 | 2,235 | 1/8 members' labels |
| Palmoplantar keratoderma | 8/10 | 169.8 | 2,185 | 0/8 members' labels |
| Immunisation | 7/10 | 206.1 | 1,162 | 0/7 members' labels |
| Hypertensive nephropathy | 6/10 | 52.2 | 2,230 | 0/6 members' labels |
| Neurologic neglect syndrome | 5/10 | 536.1 | 997 | 0/5 members' labels |
| Ejection fraction | 5/10 | 444.4 | 850 | 0/5 members' labels |
| Sensitisation | 5/10 | 433.1 | 1,111 | 0/5 members' labels |
| Carotid artery thrombosis | 5/10 | 314.0 | 1,020 | 0/5 members' labels |
| Adjustment disorder | 5/10 | 183.9 | 987 | 0/5 members' labels |
| Polycystic ovaries | 5/10 | 181.5 | 1,102 | 0/5 members' labels |
| Rebound acid hypersecretion | 5/10 | 164.4 | 8,346 | 0/5 members' labels |
| End stage renal disease | 5/10 | 115.0 | 39,249 | 0/5 members' labels |
| Chronic kidney disease-mineral and bone disorder | 5/10 | 111.0 | 2,428 | 0/5 members' labels |
| Nephrogenic anaemia | 5/10 | 107.0 | 9,805 | 0/5 members' labels |
| Tenosynovitis stenosans | 5/10 | 105.5 | 223 | 0/5 members' labels |
| Personality disorder | 5/10 | 92.3 | 1,120 | 0/5 members' labels |
| Chronic kidney disease | 5/10 | 78.1 | 134,791 | 1/5 members' labels |
| Hyperparathyroidism secondary | 5/10 | 66.6 | 4,372 | 0/5 members' labels |
| Granuloma skin | 5/10 | 66.0 | 303 | 0/5 members' labels |
| Renal injury | 5/10 | 41.7 | 35,982 | 2/5 members' labels |
| Tubulointerstitial nephritis | 5/10 | 26.1 | 18,386 | 5/5 members' labels |
| Atrial tachycardia | 5/10 | 23.1 | 2,209 | 0/5 members' labels |
| Diabetic nephropathy | 5/10 | 21.4 | 2,217 | 0/5 members' labels |
| Pruritus genital | 5/10 | 18.5 | 2,048 | 5/5 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Congenital hiatus hernia | Dexlansoprazole | 56 | 171.1 | Not in label — unassessed |
| Grip strength | Lansoprazole | 128 | 146.8 | Not in label — unassessed |
| Presbyacusis | Esomeprazole | 91 | 141.0 | Not in label — unassessed |
| Deep vein thrombosis postoperative | Lansoprazole | 754 | 73.9 | Not in label — unassessed |
| Enthesopathy | Dexlansoprazole | 200 | 73.4 | Not in label — unassessed |
| Lupus vulgaris | Lansoprazole | 444 | 70.4 | Not in label — unassessed |
| Subcutaneous drug absorption impaired | Lansoprazole | 177 | 56.8 | Labeled (related wording) |
| Malnutrition | Esomeprazole | 66 | 52.1 | Not in label — unassessed |
| Tenosynovitis | Dexlansoprazole | 246 | 49.3 | Not in label — unassessed |
| Total lung capacity decreased | Dexlansoprazole | 141 | 48.8 | Not in label — unassessed |
| Adjustment disorder with depressed mood | Lansoprazole | 581 | 47.8 | Not in label — unassessed |
| Pleural thickening | Esomeprazole | 77 | 43.2 | Not in label — unassessed |
| Hyperphosphataemia | Dexlansoprazole | 159 | 41.0 | Not in label — unassessed |
| Barrett's oesophagus | Esomeprazole | 245 | 38.7 | Likely indication confounding |
| Dislocation of vertebra | Lansoprazole | 520 | 36.0 | Not in label — unassessed |
| Eye haemorrhage | Esomeprazole | 54 | 35.4 | Labeled (related wording) |
| Thyroid disorder | Esomeprazole | 61 | 34.7 | Labeled (related wording) |
| Pleural fibrosis | Esomeprazole | 95 | 34.5 | Not in label — unassessed |
| Lung opacity | Dexlansoprazole | 164 | 34.4 | Not in label — unassessed |
| Facet joint syndrome | Lansoprazole | 709 | 34.2 | Not in label — unassessed |
| Panniculitis | Dexlansoprazole | 149 | 33.3 | Not in label — unassessed |
| Rheumatic fever | Lansoprazole | 927 | 31.7 | Not in label — unassessed |
| Burns second degree | Esomeprazole | 149 | 31.6 | Not in label — unassessed |
| Calcium deficiency | Esomeprazole | 325 | 29.7 | Labeled (related wording) |
| Nephrectomy | Esomeprazole | 110 | 27.2 | Not in label — unassessed |
Common questions
Which proton pump inhibitor has the most FDA adverse event reports?
Omeprazole has the most FAERS co-reports in this class (444,238), followed by Omeprazole (342,054). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across proton pump inhibitor drugs?
Reaction terms flagged in at least half of the 10 members include cardiospasm, palmoplantar keratoderma, immunisation, hypertensive nephropathy, neurologic neglect syndrome. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.