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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Nitroglycerin and Hypotension: 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.
Nitroglycerin ↔ Hypotension
n=2,299 co-reports · PRR 4.6 · ROR 4.7
Nitroglycerin releases nitric oxide to dilate veins and arteries, lowering preload and blood pressure; hypotension and headache (from meningeal vasodilation) are its classic, expected effects, and hypotension carries 2,299 co-reports here (PRR 4.6). The risk is greatest with volume depletion, right-ventricular infarction, and concomitant PDE5 inhibitors, where the combination can cause profound, refractory hypotension — an absolute contraindication.
Regulatory basis: nitroglycerin prescribing information — hypotension; contraindicated with PDE5 inhibitors.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Blood-pressure fall is immediate |
| Strength | met | PRR 4.6, modest |
| Consistency | met | Consistent across nitrate use |
| Specificity | partial | Shared across nitrates |
| Biological gradient | met | Dose-related |
| Plausibility | met | Nitric-oxide vasodilation mechanism |
| Coherence | met | Fits the mechanism |
| Experiment | met | Haemodynamic effect measured in trials |
| Analogy | met | Analogous to isosorbide hypotension |
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 nitroglycerin captured hypotension as a tracked adverse event in a usable structure. Trials capture nitrate blood-pressure effects as haemodynamic endpoints rather than as coded adverse events.