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Causality: well established
Causality assessment · Causality: well established
Cabergoline and Pleural effusion: 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.
Cabergoline ↔ Pleural effusion
n=77 co-reports · PRR 5.5 · ROR 5.6
Cabergoline is an ergot dopamine agonist used for hyperprolactinaemia and Parkinson's disease; like other ergots it can cause fibrotic reactions, and pleural effusion appears here as 77 co-reports (PRR 5.5). Risk is greatest with prolonged high-dose therapy, and the label advises periodic echocardiography and monitoring for pleuropulmonary changes.
Regulatory basis: cabergoline prescribing information — fibrotic reactions (pleuropulmonary, pericardial, retroperitoneal); monitoring guidance.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Effusion after months of therapy |
| Strength | met | PRR 5.5, modest |
| Consistency | met | Reproduced across case series |
| Specificity | partial | Shared across ergot agonists |
| Biological gradient | met | Higher with higher cumulative dose |
| Plausibility | met | Serotonin-mediated fibroblast proliferation |
| Coherence | met | Fits the mechanism |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to pergolide fibrotic reactions |
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 cabergoline captured pleural effusion as a tracked adverse event in a usable structure. Pleural effusion develops slowly and is uncommon, so the trials that studied cabergoline did not capture it as a coded event.