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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Atomoxetine and Hypertension: 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.
Atomoxetine ↔ Hypertension
n=400 co-reports · PRR 11.2 · ROR 12.4
Atomoxetine is a selective noradrenaline-reuptake inhibitor for ADHD; by raising noradrenaline it increases heart rate and blood pressure, a labelled effect (400 co-reports, PRR 11.2) that requires monitoring in patients with hypertension, tachycardia, or cardiovascular disease. The increases are usually modest but prompt the label's caution against use in severe cardiovascular disorders.
Regulatory basis: atomoxetine (Strattera) prescribing information — increased blood pressure and heart rate.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Blood-pressure rise within weeks |
| Strength | met | PRR 11.2, moderate |
| Consistency | met | Consistent across trials |
| Specificity | partial | Shared with other noradrenergic drugs |
| Biological gradient | met | Dose-related |
| Plausibility | met | Noradrenaline re-uptake inhibition |
| Coherence | met | Fits the pharmacology |
| Experiment | met | Trials measured blood-pressure change |
| Analogy | met | Analogous to SNRI blood-pressure effects |
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 atomoxetine captured hypertension as a tracked adverse event in a usable structure. Atomoxetine trials measured blood pressure as a vital-sign safety parameter rather than reporting hypertension as a coded event.