Formulary
Febuxostat: Indications, Dosing, Side Effects and Interactions
Febuxostat clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Febuxostat: Indications, Dosing, Side Effects and Interactions
Febuxostat clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Treatment of chronic hyperuricaemia in gout**
- **Adult** (By Mouth): Initially 80 mg once daily, if after 2-4 weeks of initial dose, serum uric acid greater than 6 mg/100 mL then increase dose; increased if necessary to 120 mg once daily.
**Prophylaxis and treatment of acute hyperuricaemia with initial chemotherapy**
- **Adult** (By Mouth): for haematologic malignancies 120 mg once daily, to be started 2 days before start of cytotoxic therapy and continued for 7-9 days, according to chemotherapy duration.
Cautions
Major cardiovascular disease, see Important safety information ; thyroid disorders; transplant recipients Cautions, further information Administer prophylactic NSAID ( not aspirin or salicylates) or colchicine for at least 6 months after starting febuxostat to avoid precipitating an acute attack. M
Contraindications
Not a treatment for acute gout but continue if attack develops when already receiving febuxostat, and treat attack separately
Side effects
Common or very common Diarrhoea; dizziness; dyspnoea; fatigue; gout aggravated; headache; hepatic disorders; joint disorders; muscle complaints; nausea; oedema; pain; skin reactions Uncommon Alopecia; altered smell sensation; appetite abnormal; arrhythmias; arthritis; bundle branch block; chest discomfort; constipation; cough; diabetes mellitus; drowsiness; dry mouth; gallbladder disorders; gastrointestinal discomfort; gastrointestinal disorders; haemorrhage; hemiparesis; hyperlipidaemia; hypertension; hypothyroidism; increased risk of infection; malaise; muscle weakness; musculoskeletal stiffness; nephrolithiasis; oral disorders; palpitations; pancreatitis; proteinuria; renal failure; rhinorrhoea; sensation abnormal; sexual dysfunction; sleep disorders; sweat changes; taste altered; tinnitus; urinary disorders; vasodilation; vision blurred; vomiting; weight changes Rare or very rare Agranulocytosis; anaemia; angioedema; circulatory collapse; depressed mood; feeling hot; hypersensitivity; nephritis tubulointerstitial; nervousness; pancytopenia; polymyalgia rheumatica; retinal occlusion; rhabdomyolysis; severe cutaneous adverse reactions (SCARs); sudden cardiac death; thirst; thrombocytopenia; vertigo
Interactions
**Severe interactions:**
- In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors were not related to any clinically significant increase in adverse events.
- Antacids Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32%...
**Other interactions (28):**
- Mercaptopurine/azathioprine On the basis of the mechanism of action of febuxostat on XO inhibition concomitant use is not recommended.
- Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to myelotoxicity.
- In case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose (see sections 4.4 and 5.3).
- The adequacy of the proposed dose adjustment, which was based on a modelling and simulation analysis from preclinical data in rats, was confirmed by the results of a clinical drug-drug interaction...
- Drug interaction studies of febuxostat with other cytotoxic chemotherapy have not been conducted.
- In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Pregnancy
Manufacturer advises avoid-limited information available.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution. Dose adjustments Manufacturer advises max. 80 mg daily in mild impairment; no dose information available in moderate to severe impairment.
Renal impairment
Use with caution if creatinine clearance less than 30 mL/minute (limited information available). M See Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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