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Causality assessment · Causality: well established

Clonidine and Blood pressure increased (rebound): is the FAERS signal real?

n=1,733 co-reports · PRR 4.7 · ROR 4.8
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.
Causality: well established

Clonidine ↔ Blood pressure increased (rebound)

n=1,733 co-reports · PRR 4.7 · ROR 4.8

Abrupt withdrawal of clonidine causes rebound hypertension with catecholamine surge, especially after high doses or concomitant beta-blockade; 1,733 co-reports give PRR 4.7. The label warns against abrupt discontinuation and advises tapering.

Regulatory basis: clonidine (Catapres) prescribing information — rebound hypertension on abrupt withdrawal; taper guidance.

Bradford Hill viewpointStatusNote
Temporality (necessary)metHours to days after stopping
StrengthmetPRR 4.7 with 1,733 co-reports
ConsistencymetReproduced across reports
Specificitynot establishedBP readings are non-specific
Biological gradientmetHigher with higher doses
PlausibilitymetKnown withdrawal catecholamine surge
CoherencemetFits clonidine's mechanism
Experimentn/aWithdrawal not studied in trials
AnalogymetAnalogous to beta-blocker withdrawal

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 clonidine captured blood pressure increased (rebound) as a tracked adverse event in a usable structure. Trials rarely study the withdrawal phase, so rebound hypertension is not captured as an on-treatment event.