Omeprazole vs Ranitidine: side effects in FDA adverse event reports
At a glance
| Omeprazole | Ranitidine | |
|---|---|---|
| Drug class | Proton Pump Inhibitor | – |
| Brand names | – | – |
| FAERS reports | 444,238 | 197,701 |
| Serious | 72% | 93% |
| Death outcome | 39,121 | 15,520 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Omeprazole | Ranitidine | Label screen (A / B) |
|---|---|---|---|
| Chronic kidney disease-mineral and bone disorder | 753 · PRR 111.0 | 149 · PRR 16.9 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Omeprazole
- Renal failure — n=18,173, PRR 7.3 Labeled (related wording)
- Tubulointerstitial nephritis — n=5,325, PRR 18.4 Labeled adverse reaction
- Pruritus genital — n=428, PRR 10.4 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 Ranitidine
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Omeprazole or Ranitidine?
Omeprazole has 444,238 FAERS reports and Ranitidine 197,701. 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 93%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Omeprazole and Ranitidine share?
Both drugs carry disproportionality signals for chronic kidney disease-mineral and bone disorder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Omeprazole or Ranitidine 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.