Causality assessment · Expected pharmacological effect

Bevacizumab and Hypertension: is the FAERS signal real?

n=5,851 co-reports · PRR 4.8 · ROR 5.0

Bevacizumab side-effect profile All assessments See in the full list

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.

Expected pharmacological effect

Bevacizumab ↔ Hypertension

n=5,851 co-reports · PRR 4.8 · ROR 5.0

Bevacizumab, a VEGF inhibitor, commonly raises blood pressure and can cause severe hypertension through reduced nitric-oxide signalling; 5,851 co-reports give PRR 4.8. The label advises blood-pressure monitoring and management.

Regulatory basis: bevacizumab (Avastin) prescribing information — hypertension including hypertensive crisis; BP monitoring.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Weeks of therapy
Strength	met	PRR 4.8 with 5,851 co-reports
Consistency	met	Consistent across cohorts
Specificity	not established	Hypertension is common generally
Biological gradient	met	Dose-related
Plausibility	met	Known VEGF-inhibition mechanism
Coherence	met	Fits bevacizumab's vascular effect
Experiment	n/a	Often monitored in trials
Analogy	met	Analogous to other VEGF-inhibitor hypertension

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.

✓ Trial evidence found — A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC (NCT02364999)

Adverse event	PF-06439535 (n=356) · Bevacizumab-EU (n=358) · Total (n=714)
Hypertension	60/356	62/358	122/714

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →