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Xanthine Oxidase Inhibitor — Urate-Lowering Therapy Pregnancy: Avoid — insufficient data; animal studies showed fetal harm

Febuxostat (Rheumatology — Gout)

Brand names: Adenuric

Adult dose

Dose: 80–120 mg once daily
Route: Oral
Frequency: Once daily
Max: 120 mg/day
Start at 80 mg; increase to 120 mg after 2–4 weeks if serum urate remains above target (<360 µmol/L). Co-prescribe colchicine or NSAID prophylaxis for first 3–6 months to prevent acute gout flares. Non-purine selective inhibitor — does not require dose reduction for mild-moderate renal impairment unlike allopurinol.

Paediatric dose

Route:
Not licensed in patients under 18 years — seek specialist opinion

Dose adjustments

Renal

No dose adjustment for mild-moderate CKD (eGFR 30–59 mL/min); limited data for eGFR <30 mL/min — use with caution. Key advantage over allopurinol in CKD.

Hepatic

Mild-moderate: no adjustment. Severe: avoid — limited data

Clinical pearls

  • MHRA 2019 Safety Update (FAST trial): febuxostat associated with increased risk of cardiovascular death compared to allopurinol in patients with pre-existing IHD or heart failure — CONTRAINDICATED in these patients; switch to allopurinol
  • FAST trial (Lancet 2020): open-label, non-inferiority trial in patients with gout and CV disease — febuxostat showed higher all-cause mortality and CV death than allopurinol despite similar urate lowering
  • Advantage over allopurinol: no dose adjustment in mild-moderate CKD; allopurinol requires dose reduction and slow titration in CKD — febuxostat is non-purine and renally excreted as inactive metabolites
  • Flare prophylaxis: start colchicine 500 mcg BD or low-dose NSAID for at least 3–6 months after starting febuxostat — urate mobilisation from tophi precipitates acute gout flares even as serum urate falls
  • NICE NG219 (Gout 2022): febuxostat is second-line after allopurinol; suitable if allopurinol intolerant or if eGFR 30–59 where allopurinol dose titration is complex

Contraindications

  • Established ischaemic heart disease (MHRA 2019 — FAST trial)
  • Heart failure (MHRA 2019 — FAST trial)
  • Concurrent azathioprine or 6-mercaptopurine — CRITICAL (xanthine oxidase inhibition → toxicity)
  • Concurrent mercaptopurine or didanosine

Side effects

  • Acute gout flares — especially during first 3–6 months of treatment
  • GI disturbance — nausea, diarrhoea
  • Elevated liver enzymes
  • Rash
  • Cardiovascular events — FAST trial safety signal

Interactions

  • Azathioprine / 6-mercaptopurine — FATAL if combined; xanthine oxidase inhibition leads to massive accumulation of active thiopurine metabolites; contraindicated
  • Theophylline — increased theophylline levels (reduced XO-mediated metabolism)
  • Probenecid — may increase febuxostat exposure

Monitoring

  • Serum urate — target <360 µmol/L (<300 µmol/L in tophaceous gout)
  • LFTs at baseline and 3-monthly for first year
  • Cardiovascular risk assessment before initiating
  • Gout flare frequency

Reference: BNFc; BNF 90; MHRA DSU 2019 (cardiovascular safety); FAST Trial (Lancet 2020); NICE NG219 (Gout 2022); SPC Adenuric. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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