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Causality: well established
Causality assessment · Causality: well established
Metoclopramide Hydrochloride and Tardive Dyskinesia: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Metoclopramide Hydrochloride ↔ Tardive Dyskinesia
n=16,218 co-reports · PRR 366.3 · ROR 464.3
Metoclopramide is a D2-receptor antagonist used for gastroparesis. Its dopamine-blocking action causes tardive dyskinesia (same mechanism as antipsychotics). Tardive dyskinesia is a label-boxed warning; 16,218 co-reports (PRR 366.3) are the strongest FAERS signal for metoclopramide. Clinical studies estimate a 20–35 % incidence after 12 months of continuous use.
Boxed warning: metoclopramide label. Keyser et al., Neurology 2019, PMID: 31494327.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in regulatory label |
| Strength | met | PRR 366.3 with 16,218 co-reports |
| Consistency | met | Reproduced across D2-antagonist class |
| Specificity | met | Specific to dopamine-blocking agents |
| Biological gradient | met | Risk increases with cumulative dose and duration |
| Plausibility | met | D2 blockade in striatum established |
| Coherence | met | Consistent with antipsychotic literature |
| Experiment | n/a | Unethical to study long-term |
| Analogy | met | Other D2 antagonists produce same syndrome |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Metoclopramide captured tardive dyskinesia as a tracked adverse event in a usable structure. RCTs are short-duration; tardive dyskinesia develops over months to years.