Febuxostat (febuxostat)
Also sold as: Febudoc, Uloris, Febuxo, Zyloric-F
Pregnancy
Cat C
Lactation
Unknown
Schedule
H
Forms
Tablets 40 mg +2
Indications
- Chronic hyperuricaemia in gout — urate-lowering therapy when allopurinol is contraindicated or not tolerated
- Hyperuricaemia associated with Lesch-Nyhan syndrome (off-label, specialist use)
Adult Dosing
Gout — urate-lowering therapy (first dose)
40 mg orally once daily
After 2–4 weeks: check serum uric acid. If still >6 mg/dL, increase to 80 mg once daily
CRITICAL: Never initiate during an acute gout attack — wait until the attack fully resolves. Initiate colchicine or NSAID prophylaxis concurrently for 3–6 months to prevent mobilisation flares. FDA cardiovascular mortality warning (CARES trial): febuxostat associated with higher cardiovascular death rate vs allopurinol — use allopurinol as first-line urate-lowering therapy. Reserve febuxostat for patients intolerant or unable to take allopurinol.
Gout — dose escalation if target not achieved on 40 mg
80 mg orally once daily
Ongoing; recheck serum uric acid at 4–8 weeks
80 mg is the maximum approved dose in Europe; 120 mg approved in some countries including Japan and some Asian markets. Target serum uric acid <6 mg/dL (<5 mg/dL in tophaceous gout).
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl 15–89 mL/min | No dose adjustment required — major advantage over allopurinol in CKD patients |
| CrCl <15 mL/min | Use with caution; limited data |
Hepatic Adjustment
Mild hepatic impairment (Child-Pugh A): no dose adjustment. Moderate hepatic impairment (Child-Pugh B): no dose adjustment, but use with caution and monitor LFTs. Severe hepatic impairment (Child-Pugh C): no data — avoid use.
Pregnancy & Lactation
Pregnancy: Category C
No adequate human data. Animal studies show embryolethality and fetal toxicity at high doses. Avoid use during pregnancy. Gout in pregnancy is uncommon — benefit-risk assessment required on a case-by-case basis. Discontinue if pregnancy occurs.
Lactation: Unknown
No data on excretion into human breast milk. Animal data show drug excreted in milk. Avoid use during breastfeeding; if essential, consider expressing and discarding milk for 24 hours after each dose.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Azathioprine and 6-mercaptopurine (6-MP) | Febuxostat inhibits xanthine oxidase — same mechanism as allopurinol — resulting in markedly elevated azathioprine/6-MP plasma levels causing severe myelosuppression. Combination is contraindicated; can cause fatal bone marrow suppression | Major |
| Theophylline | Xanthine oxidase partially metabolises theophylline — febuxostat inhibition increases theophylline plasma levels; risk of theophylline toxicity (arrhythmia, seizures) | Moderate |
| Didanosine (ddI) | Xanthine oxidase contributes to didanosine metabolism — febuxostat increases didanosine exposure; monitor for didanosine toxicity (pancreatitis, peripheral neuropathy) | Moderate |
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Side Effects
Common
- Liver function test abnormalities (transient; usually mild)
- Nausea and gastrointestinal discomfort
- Arthralgia (joint pain)
- Gout flare on initiation (mobilisation flare — use colchicine prophylaxis)
- Headache
- Dizziness
- Rash
Serious / Discontinue If
- Cardiovascular events — increased risk of cardiovascular mortality and MACE (major adverse cardiovascular events) vs allopurinol per CARES trial; use with caution in patients with established cardiovascular disease
- Severe hypersensitivity reactions — rash, SJS, DRESS (less frequent than allopurinol but reported)
- Hepatotoxicity — severe liver injury (rare; monitor LFTs)
- Acute gout flare (mobilisation flare on initiation)
- Stroke and MI — reported in post-marketing surveillance
Contraindications
- Concurrent azathioprine or 6-mercaptopurine use
- Acute gout attack (do not initiate during attack)
- Established cardiovascular disease — use allopurinol preferentially (FDA warning)
- Hypersensitivity to febuxostat
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Febudoc 40 mg Tablets | Sun Pharma | ₹85/10 tablets |
| Uloris 40 mg Tablets | Cipla | ₹92/10 tablets |
| Febuxo 40 mg Tablets | Mankind Pharma | ₹78/10 tablets |
Monitoring Required
- Serum uric acid — at baseline, 4 weeks after initiation, 4 weeks after dose change, then every 3–6 months; target <6 mg/dL
- Liver function tests — baseline, at 2 months, at 4 months, then periodically; discontinue if ALT >3x ULN
- Serum creatinine and eGFR — baseline and annually (febuxostat does not require dose adjustment in CKD, but monitor renal progression)
- Cardiovascular risk assessment — ECG and cardiovascular evaluation in patients with cardiac history; monitor for chest pain, dyspnoea
- Gout flares — frequency and severity on treatment; ensure colchicine prophylaxis is prescribed concurrently for first 3–6 months
- Theophylline levels — if patient on theophylline; adjust theophylline dose accordingly
Patient Counseling Points
- Do NOT start febuxostat during a gout attack — wait until the attack is completely gone.
- Take febuxostat every day at the same time, with or without food.
- You may get a gout attack in the first few months of treatment — your doctor will prescribe colchicine to prevent this. Do not stop febuxostat if a gout attack occurs.
- Febuxostat is a long-term medicine — do not stop it without consulting your doctor even when you feel well.
- Report any chest pain, shortness of breath, or irregular heartbeat to your doctor immediately.
- Report any skin rash, jaundice, or yellowing of eyes — stop the medicine and seek medical attention.
- Avoid high-purine foods (red meat, organ meats, shellfish, beer) and limit alcohol.
- Blood tests (uric acid, liver function) will be done regularly — please attend these follow-ups.
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Clinically reviewed by: Dr. Sanjay Kulkarni, MD (Medicine), DM (Clinical Immunology & Rheumatology)
Last reviewed: 2026-04-15
References
- White WB, et al. Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout (CARES Trial). N Engl J Med. 2018;378(13):1200–1210.
- Becker MA, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005;353(23):2450–2461.
- FDA Drug Safety Communication: Febuxostat (Uloric) — cardiovascular death. 2019.
- Sun Pharma. Febudoc prescribing information. 2024.