Feburo (Febuxostat)
Xanthine oxidase inhibitor for the treatment of chronic hyperuricemia and gout
Quick Facts About Feburo
Key Takeaways About Feburo
- Once-daily dosing: Feburo is taken as a single 80 mg tablet each day, with or without food, making it convenient for long-term gout management
- Effective urate lowering: Clinical trials show febuxostat 80 mg achieves target serum urate levels (<6 mg/dL) more frequently than allopurinol 300 mg in many patients
- Gout flares may occur initially: Increased gout attacks are common when starting treatment – continue taking Feburo as flares will decrease over time
- Cardiovascular caution: Tell your doctor if you have heart disease, heart failure, or a history of stroke before starting this medication
- Serious skin reactions are rare but important: Stop taking Feburo and seek immediate medical attention if you develop severe rash, blisters, or mouth sores
What Is Feburo and What Is It Used For?
Feburo (febuxostat) is a xanthine oxidase inhibitor prescribed to treat gout by lowering uric acid levels in the blood. It prevents the formation of urate crystals that cause painful gout attacks, tophi, and kidney damage. Available as 80 mg film-coated tablets, Feburo is taken once daily for long-term management of hyperuricemia in adults with gout.
Feburo tablets contain the active substance febuxostat and are used to treat gout, a condition caused by an excess of a chemical substance called uric acid (urate) in the body. Gout is one of the most common inflammatory arthropathies worldwide, affecting approximately 1–4% of the adult population in developed countries. The global prevalence of gout has been rising steadily over recent decades, driven by increasing rates of obesity, metabolic syndrome, and the widespread use of diuretic medications.
In some people, the amount of uric acid builds up in the blood to levels that exceed the body’s ability to keep it dissolved. This condition, known as hyperuricemia, is defined as a serum urate concentration exceeding 6.8 mg/dL (approximately 400 μmol/L), which is the saturation point for urate in physiological conditions. When serum urate consistently exceeds this threshold, monosodium urate (MSU) crystals may form and deposit in joints, periarticular tissues, and the kidneys. These crystals can trigger sudden, severe pain, redness, warmth, and swelling in a joint – a characteristic gout attack (acute gouty arthritis).
Left untreated, chronic hyperuricemia leads to the progressive accumulation of urate crystals in the body, resulting in a condition known as chronic tophaceous gout. Larger deposits called tophi form in and around joints, tendons, and soft tissues. Tophi are firm, chalky lumps composed of MSU crystals surrounded by an inflammatory granulomatous tissue reaction. Over time, tophi can grow substantially, erode underlying bone and cartilage, and cause irreversible joint damage and functional impairment. Common locations for tophaceous deposits include the first metatarsophalangeal joint (big toe), olecranon bursae (elbows), Achilles tendons, and the helix of the ear.
Feburo works by lowering uric acid levels through selective inhibition of the enzyme xanthine oxidase (XO). Xanthine oxidase is responsible for the final two steps in purine catabolism: the conversion of hypoxanthine to xanthine, and the conversion of xanthine to uric acid. Unlike allopurinol, which is a purine analogue, febuxostat is a non-purine selective inhibitor of xanthine oxidase. This means it binds to both the oxidised and reduced forms of the enzyme, resulting in potent and sustained inhibition of uric acid production. By blocking this enzyme, Feburo reduces the production of uric acid throughout the body, leading to a decline in serum urate levels.
Taking Feburo once every day keeps uric acid levels consistently below the target threshold of 6 mg/dL (360 μmol/L), which is essential for preventing the formation of new crystals and allowing the gradual dissolution of existing urate deposits. Over months to years of sustained urate-lowering therapy, tophi dissolve, gout flares become less frequent and eventually cease, and joint damage is prevented from progressing. According to current guidelines from the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), the treat-to-target approach – aiming for a serum urate level below 6 mg/dL – is the cornerstone of effective gout management.
Feburo is indicated for use in adults only (18 years of age and older). It is not approved for use in children and adolescents under 18, as safety and efficacy have not been established in this age group.
Both Feburo and allopurinol lower uric acid by inhibiting xanthine oxidase. However, febuxostat is a non-purine selective inhibitor, while allopurinol is a purine analogue. Major clinical trials – including FACT (Febuxostat versus Allopurinol Controlled Trial), APEX (Allopurinol- and Placebo-Controlled Efficacy Study of Febuxostat), and CONFIRMS (Confirming Febuxostat Versus Allopurinol in Gout Patients) – have demonstrated that febuxostat 80 mg is more effective at achieving the target serum urate level of <6 mg/dL compared to allopurinol 300 mg. In the FACT trial, 53% of patients on febuxostat 80 mg achieved target urate levels versus 21% on allopurinol 300 mg. Feburo may be prescribed when allopurinol is not tolerated, has caused adverse reactions such as hypersensitivity syndrome, or has failed to achieve adequate urate lowering at appropriate doses.
What Should You Know Before Taking Feburo?
Do not take Feburo if you are allergic to febuxostat. Use with caution if you have heart disease, liver disease, kidney disease, or thyroid problems. Tell your doctor about all medications you take, especially mercaptopurine, azathioprine, and theophylline, as dangerous interactions may occur.
Before starting treatment with Feburo, it is essential that your doctor has a complete picture of your medical history, current medications, and any known allergies. Febuxostat is generally well tolerated, but certain conditions and medication combinations require special attention or may preclude its use altogether.
Contraindications
You must not take Feburo if you are allergic (hypersensitive) to febuxostat or any of the other ingredients in the tablet. The inactive ingredients in febuxostat film-coated tablets typically include lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, and hydrated colloidal silicon dioxide, among others. If you are uncertain whether you have an allergy to any component, consult your doctor or pharmacist before taking this medicine.
Feburo should also not be used concurrently with mercaptopurine or azathioprine unless there is no suitable alternative and intensive monitoring can be provided. These immunosuppressant drugs are metabolised by xanthine oxidase, and co-administration with febuxostat can lead to dangerously elevated blood levels and severe bone marrow suppression.
Warnings and Precautions
Talk to your doctor before taking Feburo if any of the following apply to you:
- You have or have had heart failure, heart problems, or stroke – the CARES trial (Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities) showed a numerically higher rate of cardiovascular death with febuxostat compared to allopurinol in patients with established cardiovascular disease (CVD). Although the overall rate of major adverse cardiovascular events (MACE) was similar between groups, the finding prompted regulatory agencies including the EMA and FDA to issue warnings. Your doctor will carefully evaluate your cardiovascular risk before prescribing Feburo and may prefer allopurinol if you have significant CVD.
- You have or have had kidney disease and/or a serious allergic reaction to allopurinol – mild to moderate renal impairment does not usually require dose adjustment of febuxostat, but your doctor may monitor your kidney function during treatment
- You have or have had liver disease or abnormal liver function tests – febuxostat is metabolised in the liver, and your doctor may check liver enzymes before and during treatment
- You are being treated for high uric acid levels related to Lesch-Nyhan syndrome (a rare hereditary condition characterised by excessive uric acid in the blood due to hypoxanthine-guanine phosphoribosyltransferase deficiency)
- You have thyroid problems – elevated thyroid-stimulating hormone (TSH) levels have been observed in some patients taking febuxostat in long-term studies
- Severe skin rash – blisters, nodules, itching, or peeling skin
- Swelling of the limbs and face
- Difficulty breathing
- Fever with swollen lymph nodes
- Serious life-threatening allergic reactions with cardiac and circulatory collapse
Rare but serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with febuxostat use. These initially appear as reddish spots or circular patches, often with central blistering, on the trunk. They may also include ulcers in the mouth, throat, nose, genitals, and eye inflammation (conjunctivitis). If you have ever had SJS or TEN while using febuxostat, you must never use it again.
Gout flares when starting treatment: In some people, gout attacks may flare up when starting medicines that control uric acid levels. Not everyone gets flares, but you may experience them even while taking Feburo, especially during the first weeks or months of treatment. This phenomenon, known as a mobilisation flare, occurs because declining uric acid levels cause existing monosodium urate crystals in the joints to partially dissolve and shed from their tophaceous deposits, triggering an acute inflammatory response. It is important to continue taking Feburo even if you get a flare, as the medicine is still working to lower uric acid. Over time, as urate deposits are fully dissolved, gout attacks will become less frequent and less painful. Your doctor may prescribe additional medicines – such as colchicine (0.5–1 mg daily) or non-steroidal anti-inflammatory drugs (NSAIDs) – as prophylaxis for the first 6 months of urate-lowering therapy to help prevent or reduce flare symptoms.
If you are currently having a gout attack (sudden onset of severe pain, tenderness, redness, warmth, and swelling in a joint), wait until the attack has subsided before starting Feburo for the first time.
Your doctor may ask you to have blood tests to check that your liver is functioning normally before starting treatment and periodically during treatment.
Pregnancy and Breastfeeding
It is not known whether Feburo can harm an unborn child. Animal reproduction studies have shown some adverse effects at doses substantially higher than the human therapeutic dose, but there are no adequate and well-controlled studies in pregnant women. Feburo should not be used during pregnancy unless the potential benefit clearly justifies the potential risk to the foetus. Women of childbearing potential should use effective contraception during treatment.
It is also not known whether febuxostat is excreted in human breast milk. In animal studies, febuxostat was found to be present in the milk of lactating rats. You should not take Feburo if you are breastfeeding or planning to breastfeed. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and Operating Machinery
Be aware that you may experience dizziness, drowsiness, blurred vision, and numbness or tingling during treatment with Feburo. These neurological side effects are uncommon but can impair your ability to drive or operate machinery safely. If you are affected by any of these symptoms, you should not drive vehicles or operate machinery until the symptoms resolve. There are no formal studies on the effect of febuxostat on the ability to drive, so individual assessment is recommended.
Feburo tablets may contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine also contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free.
How Does Feburo Interact with Other Drugs?
Feburo has potentially dangerous interactions with mercaptopurine and azathioprine, as it can greatly increase blood levels of these immunosuppressants. It may also affect theophylline metabolism. Always tell your doctor about all medicines you take, including over-the-counter products and supplements.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including non-prescription medicines and herbal products. Drug interactions with febuxostat are primarily related to its mechanism of action as a xanthine oxidase inhibitor. Because xanthine oxidase plays a role in the metabolism of certain drugs, blocking this enzyme can alter the pharmacokinetics and toxicity profile of co-administered medications.
Major Interactions
It is particularly important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances:
| Drug | Interaction | Severity | Clinical Advice |
|---|---|---|---|
| Mercaptopurine | Febuxostat inhibits xanthine oxidase, which metabolises mercaptopurine. This can lead to significantly increased blood levels and potentially fatal bone marrow toxicity. | Contraindicated | Do not use together. If unavoidable, substantial dose reduction of mercaptopurine (to approximately 20% of usual dose) is required with close haematological monitoring. |
| Azathioprine | Azathioprine is a prodrug metabolised to mercaptopurine, which is then metabolised by xanthine oxidase. Concomitant use with febuxostat can increase immunosuppressant levels to dangerous concentrations. | Contraindicated | Do not use together. If unavoidable, substantial dose reduction and intensive haematological monitoring are required. Consider mycophenolate as an alternative immunosuppressant. |
| Theophylline | Febuxostat may increase plasma levels of theophylline by inhibiting its metabolism via xanthine oxidase, potentially leading to theophylline toxicity. | Moderate | Monitor theophylline serum levels when starting or adjusting Feburo dose. Adjust theophylline dose if necessary. Watch for signs of toxicity (nausea, tremor, tachycardia). |
| Didanosine | Didanosine (an antiretroviral) is a purine nucleoside analogue partially metabolised by xanthine oxidase. Febuxostat may increase didanosine plasma levels. | Moderate | Use with caution. Monitor for didanosine toxicity if co-administered. |
Minor Interactions
No clinically significant interactions have been observed with the following commonly used drugs in pharmacokinetic studies: colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin, or desipramine. These medications can generally be used concurrently with Feburo without dose adjustment.
Febuxostat does not significantly affect the metabolism of drugs processed through the cytochrome P450 (CYP) enzyme system. In vitro studies have shown that febuxostat is a weak inhibitor of CYP2D6 but does not significantly inhibit CYP1A2, CYP2C9, CYP2C19, or CYP3A4 at clinically relevant concentrations. Nevertheless, always inform your healthcare provider about all medications you use, as individual responses may vary and new interactions may be identified over time.
Antacids containing aluminium hydroxide and magnesium hydroxide can be taken concurrently with febuxostat without affecting its absorption. However, it is generally advisable to take Feburo at a consistent time each day for optimal adherence.
What Is the Correct Dosage of Feburo?
The recommended dose of Feburo is one 80 mg tablet taken once daily, with or without food. Your doctor will monitor your serum urate levels and adjust treatment accordingly. Feburo is intended for long-term use – do not stop taking it without medical advice, even if you feel well.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Consistent daily dosing is essential for maintaining uric acid levels below the therapeutic target and preventing the recurrence of gout attacks and crystal deposition.
Adults – Gout
Feburo is available as 80 mg film-coated tablets. The recommended starting and maintenance dose is 80 mg once daily.
Standard Dosing for Gout in Adults
- Dose: 80 mg once daily
- Administration: Swallow the tablet whole with water, with or without food
- Monitoring: Your doctor should check serum urate levels after 2–4 weeks of treatment to assess response
- Target: Serum urate <6 mg/dL (360 μmol/L); in patients with severe gout (tophi, chronic arthropathy, frequent flares), a target of <5 mg/dL may be considered
- Duration: Long-term (indefinite) – continue taking Feburo every day, even when you are not having a gout attack
| Patient Group | Dose | Notes |
|---|---|---|
| Adults (18+ years) | 80 mg once daily | Standard dose for chronic gout management |
| Mild-moderate renal impairment | 80 mg once daily | No dose adjustment needed (eGFR ≥30 mL/min) |
| Severe renal impairment | Use with caution | Limited data for eGFR <30 mL/min; discuss with specialist |
| Mild hepatic impairment | 80 mg once daily | No dose adjustment required (Child-Pugh A) |
| Moderate-severe hepatic impairment | Not recommended | Insufficient data; use of febuxostat has not been studied in this population |
| Elderly (≥65 years) | 80 mg once daily | No dose adjustment needed; monitor cardiovascular risk and renal function |
Children and Adolescents
Feburo should not be given to children under 18 years of age, as safety and efficacy have not been established in this age group. Gout is extremely rare in the paediatric population. If urate-lowering therapy is required in a child or adolescent (e.g., for Lesch-Nyhan syndrome or tumour lysis syndrome), alternative agents with established paediatric dosing should be considered under specialist supervision.
Elderly Patients
No dose adjustment is necessary in elderly patients based on age alone. However, older adults are more likely to have cardiovascular comorbidities, renal impairment, or hepatic dysfunction. Given the cardiovascular safety signal from the CARES trial, your doctor will carefully evaluate whether Feburo is the most appropriate choice and may monitor you more closely with regular blood tests and cardiovascular assessments. The EULAR 2024 guidelines recommend that the choice between febuxostat and allopurinol in elderly patients should be individualised based on the patient’s overall cardiovascular risk profile.
Missed Dose
If you miss a dose of Feburo, take it as soon as you remember – unless it is almost time for your next dose. In that case, skip the missed dose and take the next one at your normal time. Do not take a double dose to make up for a forgotten one. Missing occasional doses is unlikely to cause an immediate gout flare, but consistent adherence is important for maintaining urate levels below the target threshold. If you frequently forget doses, consider setting a daily alarm or using a pillbox organiser.
Overdose
If you accidentally take more Feburo than prescribed, contact your doctor or go to the nearest emergency department immediately. In clinical studies, single doses of up to 300 mg and multiple doses of up to 120 mg daily for extended periods were tolerated without serious adverse effects. There is no specific antidote for febuxostat overdose. Treatment is supportive and symptomatic. Haemodialysis is unlikely to be effective in removing febuxostat due to its high protein binding (approximately 99.2%).
If you stop taking Feburo, your uric acid levels may begin to rise again within days, and your symptoms may worsen due to the formation of new urate crystals in and around your joints and kidneys. Studies have shown that uric acid levels return to pre-treatment levels within 1–2 weeks of discontinuation. Always consult your doctor before discontinuing treatment, even if you are feeling well and have been free of gout attacks for a long time.
What Are the Side Effects of Feburo?
Common side effects include abnormal liver function tests, diarrhoea, headache, rash, nausea, increased gout symptoms, and dizziness. Rare but serious side effects include severe allergic reactions, Stevens-Johnson syndrome, and liver damage. Stop taking Feburo and seek emergency care for severe skin reactions, difficulty breathing, or facial swelling.
Like all medicines, Feburo can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity and resolve on their own without the need to discontinue treatment. However, some rare side effects can be serious and require immediate medical attention. In clinical trials, the overall safety profile of febuxostat 80 mg was comparable to allopurinol, with most adverse events being mild and transient.
The side effects of febuxostat are categorised below according to their frequency of occurrence, as reported in clinical trials and post-marketing surveillance:
Common Side Effects
- Abnormal liver function test results (elevated transaminases)
- Diarrhoea
- Headache
- Rash (various types, including maculopapular)
- Nausea
- Increased gout symptoms / gout flares (especially during initial treatment)
- Localised swelling due to fluid retention (peripheral oedema)
- Dizziness
- Shortness of breath (dyspnoea)
- Itching (pruritus)
- Pain in limbs, muscles, or joints (arthralgia, myalgia)
- Fatigue
Uncommon Side Effects
- Decreased appetite, changes in blood sugar levels, increased blood lipids, weight gain
- Loss of libido, erectile dysfunction
- Difficulty sleeping (insomnia), drowsiness, anxiety
- Numbness, tingling (paraesthesia), reduced or altered sensation, altered taste
- Abnormal ECG, irregular or rapid heartbeat (atrial fibrillation, palpitations)
- Hot flushes, high blood pressure (hypertension)
- Cough, chest discomfort, upper respiratory tract infection, bronchitis
- Dry mouth, abdominal pain, heartburn (dyspepsia), constipation, vomiting, flatulence
- Urticaria (hives), skin inflammation (dermatitis), hair loss (alopecia), increased sweating
- Muscle cramp, muscle weakness, bursitis, back pain
- Blood in urine (haematuria), frequent urination, urinary tract infection, kidney stones (nephrolithiasis)
- Gallstones (cholelithiasis)
- Elevated thyroid-stimulating hormone (TSH)
- Blurred vision, tinnitus (ringing in ears)
- Inflammation of the pancreas (pancreatitis)
Rare Side Effects
- Severe allergic reactions (anaphylaxis), drug hypersensitivity with fever and organ involvement (DRESS syndrome)
- Stevens-Johnson syndrome / toxic epidermal necrolysis – life-threatening skin reactions with extensive blistering, peeling skin, and mucosal erosion
- Rhabdomyolysis (muscle breakdown) – seek immediate medical attention for unexplained muscle pain, tenderness, or weakness, especially with fever or dark urine
- Severe swelling (angioedema) of the face, eyelids, genitals, hands, feet, or tongue
- Hepatitis (inflammation of the liver), jaundice (yellowing of the skin and whites of the eyes), liver failure
- Tubulointerstitial nephritis (kidney inflammation with reduced urine output)
- Decreased red blood cells (anaemia), decreased white blood cells (leucopenia), decreased platelets (thrombocytopenia), pancytopenia
- Depression, nervousness, sleep disturbances
- Loss of taste, burning sensation, vertigo
- Circulatory failure, pneumonia
- Severe skin rash with blistering, peeling, or ulcers in the mouth, throat, or genitals
- Swelling of the face, lips, tongue, or throat with difficulty breathing
- High fever with swollen lymph nodes and/or enlarged liver
- Unexplained muscle pain, tenderness, or weakness (especially with fever or dark urine)
- Yellowing of skin or eyes (jaundice), dark urine, or persistent nausea
- Chest pain, severe dizziness, or loss of consciousness
If you experience any side effects, including those not listed above, talk to your doctor or pharmacist. You can also report side effects directly to your national pharmacovigilance authority (e.g., the MHRA Yellow Card scheme in the UK, FDA MedWatch in the US, or the EMA EudraVigilance system in the EU). By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Feburo?
Store Feburo at room temperature below 25°C (77°F), in the original packaging to protect from moisture. Keep out of the sight and reach of children. Do not use after the expiry date printed on the carton and blister.
Proper storage of Feburo ensures the medication remains effective and safe throughout its shelf life. The following storage guidelines should be followed:
- Temperature: Store below 25°C (77°F). Do not freeze. Brief excursions to temperatures up to 30°C are generally acceptable but should be avoided where possible.
- Packaging: Keep Feburo in the original blister packaging to protect from moisture and light.
- Children: Keep this medicine out of the sight and reach of children. Store in a location that is not easily accessible to young children.
- Expiry date: Do not use this medicine after the expiry date printed on the blister and the carton. The expiry date refers to the last day of that month.
- Disposal: Do not throw away any medicines via wastewater or household waste. Return unused or expired medicines to your pharmacist for safe disposal. This helps protect the environment and prevents accidental ingestion.
If the tablets show signs of discolouration, crumbling, or other visible damage, do not take them. Contact your pharmacist for a replacement supply.
What Does Feburo Contain?
Each Feburo 80 mg film-coated tablet contains 80 mg of the active substance febuxostat. The tablets also contain inactive ingredients (excipients) necessary for manufacturing and stability, including lactose monohydrate, microcrystalline cellulose, and magnesium stearate.
Understanding the composition of Feburo is important, particularly if you have known allergies or intolerances to specific ingredients. The following table outlines the composition of Feburo 80 mg tablets:
| Component | Type | Function |
|---|---|---|
| Febuxostat 80 mg | Active ingredient | Xanthine oxidase inhibitor – lowers uric acid production |
| Lactose monohydrate | Excipient (filler) | Provides bulk to the tablet |
| Microcrystalline cellulose | Excipient (filler/binder) | Helps bind tablet ingredients together |
| Hydroxypropylcellulose | Excipient (binder) | Aids tablet formation and cohesion |
| Croscarmellose sodium | Excipient (disintegrant) | Helps the tablet break apart for absorption |
| Magnesium stearate | Excipient (lubricant) | Prevents tablet sticking during manufacturing |
| Colloidal silicon dioxide | Excipient (glidant) | Improves powder flow during manufacturing |
| Film-coating (Opadry or similar) | Excipient (coating) | Protects the tablet and improves swallowability |
Feburo 80 mg tablets are typically light yellow to yellow, round or oval film-coated tablets. The exact appearance may vary depending on the manufacturer. Always check that the tablets match the description in the patient information leaflet included with your medicine. If in doubt, ask your pharmacist to verify.
Feburo tablets contain lactose monohydrate. If you have been diagnosed with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, you should not take this medicine without first consulting your doctor. The amount of lactose per tablet is generally small but may be relevant for individuals with severe intolerances.
Frequently Asked Questions About Feburo
Feburo (febuxostat) is used to treat gout in adults by lowering uric acid (urate) levels in the blood. It works by inhibiting xanthine oxidase, the enzyme responsible for producing uric acid. Available as 80 mg film-coated tablets, Feburo is taken once daily to prevent gout attacks, dissolve urate crystals, and reduce tophi formation. It is intended for long-term use and helps maintain uric acid below the target level of 6 mg/dL.
Both Feburo (febuxostat) and allopurinol are xanthine oxidase inhibitors used to lower uric acid. However, febuxostat is a non-purine selective inhibitor while allopurinol is a purine analogue. Clinical trials (FACT, APEX, CONFIRMS) show febuxostat 80 mg is more effective at achieving target serum urate levels below 6 mg/dL compared to allopurinol 300 mg. In the FACT trial, 53% of patients on febuxostat 80 mg achieved the target versus 21% on allopurinol 300 mg. Feburo may be used when allopurinol is not tolerated, has caused adverse reactions, or has failed to achieve adequate urate lowering.
Common side effects of Feburo (affecting up to 1 in 10 people) include: abnormal liver function test results, diarrhoea, headache, rash, nausea, increased gout symptoms (especially during initial treatment), localised oedema, dizziness, shortness of breath, itching, and pain in limbs, muscles or joints. Most side effects are mild and temporary. Serious but rare side effects include severe skin reactions (Stevens-Johnson syndrome) and allergic reactions – stop taking Feburo and seek immediate medical attention if these occur.
You should inform your doctor about any history of heart disease, heart failure, or stroke before starting Feburo. The CARES trial found a numerically higher rate of cardiovascular death with febuxostat compared to allopurinol in patients with established cardiovascular disease. Based on this finding, the EMA and FDA have issued safety warnings. Your doctor will assess your cardiovascular risk profile and determine whether Feburo is appropriate for you. In some cases, allopurinol may be preferred for patients with significant cardiovascular disease.
Gout flares are common when starting any urate-lowering therapy, including Feburo, especially during the first weeks or months. This phenomenon, called a mobilisation flare, happens because as uric acid levels drop, existing urate crystals in joints begin to dissolve and mobilise, triggering an inflammatory response. Your doctor may prescribe colchicine or NSAIDs as prophylaxis for the first 6 months. It is very important to continue taking Feburo even during flares, as stopping will cause uric acid to rise again and worsen the long-term outcome.
Feburo and ADENURIC both contain the same active ingredient, febuxostat, and belong to the same drug class (xanthine oxidase inhibitors). They work identically to lower uric acid levels and have the same mechanism of action, side effect profile, and drug interactions. The main difference is the brand name and manufacturer. Feburo is available as 80 mg tablets, while ADENURIC is available in both 80 mg and 120 mg strengths. Your doctor may prescribe either brand depending on availability, local formulary, and your specific dosing needs.
References
- European Medicines Agency (EMA). Febuxostat – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed February 2026.
- Becker MA, Schumacher HR, Wortmann RL, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005;353(23):2450-2461. doi:10.1056/NEJMoa050373
- Schumacher HR, Becker MA, Wortmann RL, et al. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008;59(11):1540-1548. doi:10.1002/art.24209
- Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi:10.1186/ar2978
- White WB, Saag KG, Becker MA, et al. Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout (CARES). N Engl J Med. 2018;378(13):1200-1210. doi:10.1056/NEJMoa1710895
- Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76(1):29-42. doi:10.1136/annrheumdis-2016-209707
- FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology Guideline for Management of Gout. Arthritis Care Res. 2020;72(6):744-760. doi:10.1002/acr.24180
- Dalbeth N, Merriman TR, Stamp LK. Gout. Lancet. 2016;388(10055):2039-2052. doi:10.1016/S0140-6736(16)00346-9
- Stamp LK, Chapman PT. Gout and its comorbidities: implications for therapy. Rheumatology. 2013;52(1):34-44. doi:10.1093/rheumatology/kes211
- British National Formulary (BNF). Febuxostat. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk. Accessed February 2026.
About the Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in rheumatology, clinical pharmacology, and internal medicine. Our team follows the GRADE evidence framework and adheres to guidelines from the European Medicines Agency (EMA), the European League Against Rheumatism (EULAR), the American College of Rheumatology (ACR), the British National Formulary (BNF), and the World Health Organization (WHO).
All medical claims in this article are supported by peer-reviewed research and current clinical guidelines. Evidence level: 1A (systematic reviews and meta-analyses of randomised controlled trials).
iMedic receives no commercial funding or pharmaceutical sponsorship. All content is independently produced to ensure unbiased, patient-centred medical information.