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Causality: well established
Causality assessment · Causality: well established
Metoclopramide 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 ↔ Tardive dyskinesia
n=13,206 co-reports · PRR 335.0 · ROR 441.6
Metoclopramide, a central dopamine D2 antagonist used for nausea and gastroparesis, is the leading cause of drug-induced tardive dyskinesia, a potentially irreversible movement disorder; 13,206 co-reports give an extreme PRR of 335.0. Risk rises with duration and cumulative dose, and the label carries a boxed warning and advises limiting treatment to 12 weeks except in rare cases.
Regulatory basis: metoclopramide prescribing information — boxed warning for tardive dyskinesia; limit duration of use (12 weeks).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Months of exposure |
| Strength | met | PRR 335.0, an extreme signal |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to dopamine antagonists |
| Biological gradient | met | Cumulative-dose and duration related |
| Plausibility | met | Known D2-receptor blockade mechanism |
| Coherence | met | Fits metoclopramide's antidopaminergic action |
| Experiment | n/a | Too slow for trial capture |
| Analogy | met | Analogous to antipsychotic tardive dyskinesia |
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. Tardive dyskinesia evolves over months to years and is rarely coded in short antiemetic or gastroparesis trials.