Omeprazole vs Lansoprazole: side effects in FDA adverse event reports
At a glance
| Omeprazole | Lansoprazole | |
|---|---|---|
| Drug class | Proton Pump Inhibitor | Proton Pump Inhibitor |
| Brand names | – | – |
| FAERS reports | 444,238 | 177,056 |
| Serious | 72% | 87% |
| Death outcome | 39,121 | 19,914 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Omeprazole | Lansoprazole | Label screen (A / B) |
|---|---|---|---|
| Chronic kidney disease | 36,748 · PRR 43.0 | 32,791 · PRR 88.7 | Not in label — unassessed / Labeled (related wording) |
| Renal injury | 9,730 · PRR 22.3 | 9,519 · PRR 54.9 | Not in label — unassessed / Labeled (related wording) |
| Tubulointerstitial nephritis | 5,325 · PRR 18.4 | 4,175 · PRR 33.8 | Labeled adverse reaction / Labeled adverse reaction |
| Pruritus genital | 428 · PRR 10.4 | 423 · PRR 26.1 | Labeled (related wording) / Labeled (related wording) |
| Cardiospasm | 394 · PRR 114.3 | 404 · PRR 318.5 | Not in label — unassessed / Labeled adverse reaction |
| End stage renal disease | 10,574 · PRR 63.4 | 9,798 · PRR 135.5 | Not in label — unassessed / Not in label — unassessed |
| Nephrogenic anaemia | 2,967 · PRR 82.1 | 2,215 · PRR 107.0 | Not in label — unassessed / Not in label — unassessed |
| Hyperchlorhydria | 2,758 · PRR 40.4 | 2,028 · PRR 61.2 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 2,370 · PRR 164.4 | 1,718 · PRR 152.1 | Likely indication confounding / Likely indication confounding |
| Hyperparathyroidism secondary | 1,340 · PRR 52.7 | 912 · PRR 66.6 | Not in label — unassessed / Not in label — unassessed |
| Renal haemangioma | 791 · PRR 6,006.8 | 790 · PRR 13,077.1 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 753 · PRR 111.0 | 542 · PRR 120.8 | Not in label — unassessed / Not in label — unassessed |
| Diabetic nephropathy | 554 · PRR 15.5 | 661 · PRR 50.3 | Not in label — unassessed / Not in label — unassessed |
| Hypertensive nephropathy | 530 · PRR 45.1 | 671 · PRR 197.3 | Not in label — unassessed / Not in label — unassessed |
| Atrial tachycardia | 480 · PRR 13.7 | 435 · PRR 30.6 | Not in label — unassessed / Not in label — unassessed |
| Palmoplantar keratoderma | 386 · PRR 54.1 | 393 · PRR 143.2 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Omeprazole
- Renal failure — n=18,173, PRR 7.3 Labeled (related wording)
- Gastric polyps — n=337, PRR 8.1 Labeled (related wording)
- Subacute cutaneous lupus erythematosus — n=315, PRR 10.1 Labeled (related wording)
- Regurgitation — n=314, PRR 4.7 Labeled adverse reaction
Labeled signals distinctive to Lansoprazole
- Peripheral venous disease — n=682, PRR 24.2 Labeled (related wording)
- Subcutaneous drug absorption impaired — n=177, PRR 56.8 Labeled (related wording)
Common questions
Which has more reported side effects, Omeprazole or Lansoprazole?
Omeprazole has 444,238 FAERS reports and Lansoprazole 177,056. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (72% vs 87%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Omeprazole and Lansoprazole share?
Both drugs carry disproportionality signals for chronic kidney disease, renal injury, tubulointerstitial nephritis, pruritus genital, cardiospasm. Shared signals often reflect a shared drug class or the condition both are used for.
Is Omeprazole or Lansoprazole safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.