Omeprazole vs Metoclopramide: side effects in FDA adverse event reports
At a glance
| Omeprazole | Metoclopramide | |
|---|---|---|
| Drug class | Proton Pump Inhibitor | – |
| Brand names | – | – |
| FAERS reports | 444,238 | 76,703 |
| Serious | 72% | 89% |
| Death outcome | 39,121 | 9,885 |
| Boxed warning | No | Yes TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. |
Signals both drugs share
| Reaction | Omeprazole | Metoclopramide | Label screen (A / B) |
|---|---|---|---|
| Nephrogenic anaemia | 2,967 · PRR 82.1 | 289 · PRR 18.0 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 1,340 · PRR 52.7 | 149 · PRR 17.0 | Not in label — unassessed / Not in label — unassessed |
| Chronic kidney disease-mineral and bone disorder | 753 · PRR 111.0 | 63 · 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 Metoclopramide
- Tardive dyskinesia — n=16,218, PRR 366.3 Labeled — boxed warning
- Nervous system disorder — n=7,526, PRR 86.5 Labeled adverse reaction
- Movement disorder — n=3,273, PRR 30.8 Labeled — boxed warning
- Dyskinesia — n=3,221, PRR 23.5 Labeled — boxed warning
- Akathisia — n=1,898, PRR 44.1 Labeled adverse reaction
- Parkinsonism — n=614, PRR 18.3 Labeled adverse reaction
- Depression suicidal — n=369, PRR 32.5 Labeled (related wording)
- Grimacing — n=233, PRR 117.0 Labeled adverse reaction
Common questions
Which has more reported side effects, Omeprazole or Metoclopramide?
Omeprazole has 444,238 FAERS reports and Metoclopramide 76,703. 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 89%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Omeprazole and Metoclopramide share?
Both drugs carry disproportionality signals for nephrogenic anaemia, hyperparathyroidism secondary, 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 Metoclopramide 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.