Gout in CKD Pregnancy: Data on a very limited number of exposed pregnancies have not indicated adverse effects of febuxostat on pregnancy or on the health of the foetus/newborn, and animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition; the potential risk for humans is unknown. Febuxostat should NOT be used during pregnancy. Breastfeeding: it is unknown whether febuxostat is excreted in human breast milk; animal studies show excretion in breast milk and impaired development of suckling pups, and a risk to a suckling infant cannot be excluded — febuxostat should NOT be used while breastfeeding. Fertility: animal reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility; the effect on human fertility is unknown.

Febuxostat (CKD)

Brand names: Adenuric

Febuxostat in chronic kidney disease (CKD) is a non-purine xanthine oxidase inhibitor used for chronic gout where allopurinol is unsuitable, and is often favoured in renal impairment as it is predominantly metabolised by the liver.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Gout: 80 mg once daily. If serum uric acid is above 6 mg/dL (357 micromol/L) after 2-4 weeks, 120 mg once daily may be considered

Route: Oral — can be taken with or without food

Frequency: Once daily

Max: No absolute maximum dose is stated in section 4.2; the highest dose given for any indication is 120 mg once daily

Source: UK SPC (eMC) for Adenuric 120 mg film-coated tablets, section 4.2 (https://www.medicines.org.uk/emc/product/1925/smpc). GOUT: febuxostat works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 micromol/L). Gout flare prophylaxis of at least 6 months is recommended. SEPARATE INDICATION — TUMOUR LYSIS SYNDROME: the recommended oral dose is 120 mg once daily without regard to food, started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment. ELDERLY: no dose adjustment is required. HEPATIC IMPAIRMENT: efficacy and safety have not been studied in severe hepatic impairment (Child Pugh Class C). For gout, the recommended dose in mild hepatic impairment is 80 mg; limited information is available in moderate hepatic impairment. For tumour lysis syndrome, only subjects with severe hepatic insufficiency were excluded from the pivotal FLORENCE trial and no dose adjustment was required for enrolled patients on the basis of hepatic function. PAEDIATRIC: the safety and efficacy of febuxostat in children below 18 years have not been established and no data are available (the US label states the same), so paedDose is null. Verify any paediatric use against a children's formulary. SOURCE LIMITATION: eMC section 4.5 was NOT captured in this bundle — the interactions listed below are taken from section 7 of the US label (openFDA/DailyMed) and must be checked against the UK SPC; the US interactions text was itself truncated at the fetch limit. Sections 4.4 and 4.8 were truncated at the fetch limit.

Dose adjustments

Renal

No dose adjustment is necessary in patients with mild or moderate renal impairment. The efficacy and safety of febuxostat have NOT been fully evaluated in patients with severe renal impairment (creatinine clearance below 30 mL/min).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

UK SPC section 4.3: hypersensitivity to the active substance or to any of the excipients (see also section 4.8)
US labelling additionally states febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine — this is NOT in the UK section 4.3 as retrieved and must be checked against the current SPC

Side effects

Most commonly reported in gout patients: gout flares, liver function abnormalities, diarrhoea, nausea, headache, dizziness, dyspnoea, rash, pruritus, arthralgia, myalgia, pain in extremity, oedema and fatigue — mostly mild or moderate in severity
Common: gout flares; headache, dizziness; dyspnoea; diarrhoea, nausea
Uncommon: blood thyroid stimulating hormone increased, hypothyroidism; blurred vision; diabetes mellitus, hyperlipidaemia, decreased appetite, weight increase; libido decreased, insomnia; paraesthesia, hemiparesis, somnolence, lethargy, altered taste, hypoaesthesia, hyposmia; tinnitus; atrial fibrillation, palpitations, abnormal ECG, left bundle branch block, sinus tachycardia; hypertension, flushing, hot flush, haemorrhage
Rare but serious: anaphylactic reaction and drug hypersensitivity; sudden cardiac death; pancytopenia, thrombocytopenia, agranulocytosis, anaemia; retinal artery occlusion; circulatory collapse
NOTE: the section 4.8 table was truncated at the source-fetch limit, so this list is not the complete adverse-reaction table

Interactions

US label section 7 — xanthine oxidase (XO) substrate drugs: concomitant administration with azathioprine or mercaptopurine could increase plasma concentrations of these drugs, resulting in severe toxicity; the US label contraindicates the combination. A drug interaction study of febuxostat and azathioprine showed increased exposure to 6-mercaptopurine, which may lead to toxicity
US label section 7.1 — theophylline (an XO substrate): febuxostat altered theophylline metabolism in humans; use with caution when co-administering
US label section 7.2 — cytotoxic chemotherapy: drug interaction studies have not been conducted and no data are available regarding safety during cytotoxic chemotherapy
US label section 7.3 — no clinically significant interactions were seen with colchicine, naproxen or indometacin in healthy-subject studies (this passage was truncated at the fetch limit)
eMC section 4.5 was not captured in the source bundle and must be checked on the SPC

Clinical monograph

How it works

It selectively inhibits xanthine oxidase, blocking conversion of hypoxanthine and xanthine to uric acid and thereby lowering serum urate.

Prescribing in practice

Use with caution in significant cardiovascular disease, as an MHRA review highlighted a possible increased risk of cardiovascular death compared with allopurinol in patients with pre-existing major cardiac disease.
Hepatic metabolism makes dose adjustment less critical in mild-to-moderate renal impairment than for allopurinol, but caution and SPC checks apply in severe impairment.
Co-prescribe gout flare prophylaxis when starting, since urate-lowering can precipitate acute attacks.

Monitoring

Monitor serum urate to target and check liver function tests, particularly in the early months of treatment.

Counselling the patient

An increase in gout flares when first starting is common and does not mean the drug is failing.
Report chest pain, breathlessness or symptoms of stroke promptly if you have heart disease.
Continue taking it long term and do not stop during a flare.

Evidence & guidelines

The CARES trial and a subsequent MHRA safety review informed cardiovascular cautions in patients with established heart disease.

Reference: FAST Trial (Wilson et al. Lancet 2020); MHRA DSU 2019 (CV Risk); NICE CG56 (Gout); SPC Adenuric; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways