Causality assessment · Causality: well established

Flutamide and Hepatic function abnormal: is the FAERS signal real?

n=24 co-reports · PRR 13.8 · ROR 14.1

Flutamide 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.

Causality: well established

Flutamide ↔ Hepatic function abnormal

n=24 co-reports · PRR 13.8 · ROR 14.1

Flutamide carries a warning for severe hepatic injury, including hepatic failure, and requires liver-function monitoring with prompt withdrawal if injury develops; 24 co-reports give PRR 13.8. The label advises baseline and periodic liver tests.

Regulatory basis: flutamide prescribing information — hepatotoxicity; liver-function monitoring and prompt withdrawal.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Weeks to months
Strength	met	PRR 13.8, an extreme signal
Consistency	met	Reproduced across reports
Specificity	met	Fairly specific to flutamide
Biological gradient	not established	Not clearly dose-related
Plausibility	met	Plausible hepatocellular injury
Coherence	met	Fits flutamide hepatotoxicity
Experiment	n/a	Too rare for trial detection
Analogy	met	Analogous to other antiandrogen hepatotoxicity

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 — Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer (NCT02918968)

Adverse event	Enzalutamide 160mg 1st Line AAT (n=102) · Enzalutamide 160mg 2nd Line AAT (n=85) · Flutamide 375mg 1st Line AAT (n=104) · Flutamide 375mg 2nd Line AAT (n=48)
Hepatic function abnormal	1/102	2/85	1/104	0/48

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 →