ADENURIC (Febuxostat)
Xanthine oxidase inhibitor for the treatment of chronic hyperuricemia and gout
📊 Quick Facts About ADENURIC
💡 Key Takeaways About ADENURIC
- Once-daily dosing: ADENURIC is taken as a single tablet each day, with or without food, making it convenient for long-term gout management
- More potent urate lowering: Clinical trials show febuxostat achieves target serum urate levels (<6 mg/dL) more frequently than allopurinol 300 mg
- Gout flares may occur initially: Increased gout attacks are common when starting treatment – continue taking ADENURIC 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 ADENURIC and seek immediate medical attention if you develop severe rash, blisters, or mouth sores
What Is ADENURIC and What Is It Used For?
ADENURIC (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. ADENURIC 120 mg is also used to prevent tumour lysis syndrome during chemotherapy.
ADENURIC 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. In some people, the amount of uric acid builds up in the blood and may become too high to remain in solution. When this happens, urate crystals may form in and around joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth, and swelling in a joint – this is known as a gout attack (acute gouty arthritis).
Left untreated, larger deposits called tophi can form in and around joints. Tophi are firm, chalky lumps that can grow over time and cause permanent damage to joint cartilage and underlying bone. Chronic tophaceous gout represents the most advanced stage of the disease and can significantly impair joint function and quality of life.
ADENURIC works by lowering uric acid levels through selective inhibition of the enzyme xanthine oxidase (XO). This enzyme is responsible for converting hypoxanthine to xanthine, and xanthine to uric acid. By blocking this enzyme, febuxostat reduces the production of uric acid throughout the body. Taking ADENURIC once every day keeps uric acid levels low, preventing the formation of new crystals. Over time, existing crystals and tophi gradually dissolve, and symptoms improve.
ADENURIC 120 mg tablets are also used for the prevention and treatment of high uric acid levels in the blood that can occur when chemotherapy for blood cancers is initiated. Chemotherapy destroys cancer cells rapidly, releasing their contents – including purines – into the bloodstream, which leads to a surge in uric acid production. This condition, known as tumour lysis syndrome (TLS), can be dangerous if uric acid levels are not controlled, as it may lead to acute kidney injury.
ADENURIC is indicated for use in adults only (18 years of age and older). It is not approved for use in children and adolescents.
Both ADENURIC 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, APEX, and CONFIRMS – have demonstrated that febuxostat 80 mg and 120 mg are more effective at achieving the target serum urate level of <6 mg/dL compared to allopurinol 300 mg. ADENURIC may be prescribed when allopurinol is not tolerated, has caused adverse reactions, or has failed to achieve adequate urate lowering.
What Should You Know Before Taking ADENURIC?
Do not take ADENURIC 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.
Contraindications
You must not take ADENURIC if you are allergic (hypersensitive) to febuxostat or any of the other ingredients in the tablet. The inactive ingredients 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.
Warnings and Precautions
Talk to your doctor before taking ADENURIC 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. Your doctor will assess whether ADENURIC is appropriate for you.
- You have or have had kidney disease and/or a serious allergic reaction to allopurinol
- You have or have had liver disease or abnormal liver function tests
- You are being treated for high uric acid levels related to Lesch-Nyhan syndrome (a rare hereditary condition with excessive uric acid in the blood)
- You have thyroid problems
- 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 arrest
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. 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 ADENURIC, especially during the first weeks or months of treatment. It is important to continue taking ADENURIC even if you get a flare, as the medicine is still working to lower uric acid. Over time, gout attacks will become less frequent and less painful if you take ADENURIC every day. Your doctor may prescribe additional medicines – such as colchicine or non-steroidal anti-inflammatory drugs (NSAIDs) – to help prevent or treat 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 ADENURIC for the first time.
Your doctor may ask you to have blood tests to check that your liver is functioning normally during treatment.
Pregnancy and Breastfeeding
It is not known whether ADENURIC can harm an unborn child. ADENURIC should not be used during pregnancy. It is also not known whether febuxostat is excreted in human breast milk. You should not take ADENURIC 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 ADENURIC. If you are affected by any of these symptoms, you should not drive vehicles or operate machinery until the symptoms resolve.
ADENURIC tablets 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 ADENURIC Interact with Other Drugs?
ADENURIC 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. Some medicines can affect or be affected by ADENURIC, and your doctor may need to adjust your treatment accordingly.
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 toxicity. | Contraindicated | Do not use together. If unavoidable, substantial dose reduction of mercaptopurine is required with close monitoring. |
| Azathioprine | Azathioprine is metabolised to mercaptopurine, which is then metabolised by xanthine oxidase. Concomitant use with febuxostat can increase immunosuppressant levels. | Contraindicated | Do not use together. If unavoidable, substantial dose reduction and intensive haematological monitoring are required. |
| Theophylline | Febuxostat may increase plasma levels of theophylline by inhibiting its metabolism via xanthine oxidase. | Moderate | Monitor theophylline levels and adjust dose if necessary. Caution is advised. |
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. However, always inform your healthcare provider about all medications you use, as individual responses may vary.
There is limited data on the interaction between febuxostat and cytotoxic chemotherapy agents used in the treatment of blood cancers. When ADENURIC 120 mg is used for the prevention of tumour lysis syndrome, treatment duration is usually short (7–9 days), but vigilance is still recommended.
What Is the Correct Dosage of ADENURIC?
The recommended dose of ADENURIC for gout is one 80 mg tablet daily, which may be increased to 120 mg if uric acid levels remain too high. For tumour lysis syndrome prevention, the dose is 120 mg daily starting 2 days before chemotherapy. Take ADENURIC with or without food at the same time each day.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The back of the blister pack is marked with the days of the week to help you verify that you have taken your daily dose.
Adults – Gout
ADENURIC is available as 80 mg and 120 mg tablets. Your doctor will prescribe the strength that is most appropriate for you.
Standard Dosing for Gout in Adults
- Starting dose: 80 mg once daily
- Dose adjustment: If serum urate remains above target (>6 mg/dL or 360 μmol/L) after 2–4 weeks, the dose may be increased to 120 mg once daily
- Administration: Swallow the tablet whole, with or without food
- Duration: Long-term (indefinite) – continue taking ADENURIC every day, even when you are not having a gout attack
Tumour Lysis Syndrome Prevention
Dosing for TLS Prevention in Adults
- Dose: 120 mg once daily
- Start: Begin 2 days before chemotherapy
- Duration: Continue according to your doctor’s instructions; treatment is usually short-term (typically 7–9 days)
Children and Adolescents
ADENURIC should not be given to children under 18 years of age, as safety and efficacy have not been established in this age group.
Elderly Patients
No dose adjustment is necessary in elderly patients. However, as older adults are more likely to have cardiovascular disease, kidney impairment, or liver disease, your doctor will carefully evaluate whether ADENURIC is suitable for you and may monitor you more closely.
Missed Dose
If you miss a dose of ADENURIC, 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.
Overdose
If you accidentally take more ADENURIC 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. However, any overdose should be evaluated by a healthcare professional.
If you stop taking ADENURIC, your uric acid levels may begin to rise again, and your symptoms may worsen due to the formation of new urate crystals in and around your joints and kidneys. Always consult your doctor before discontinuing treatment, even if you are feeling well.
What Are the Side Effects of ADENURIC?
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 ADENURIC and seek emergency care for severe skin reactions, difficulty breathing, or facial swelling.
Like all medicines, ADENURIC can cause side effects, although not everybody gets them. Most side effects are mild to moderate and resolve on their own. However, some rare side effects can be serious and require immediate medical attention.
Common Side Effects
- Abnormal liver function test results
- Diarrhoea
- Headache
- Rash (various types)
- Nausea
- Increased gout symptoms / gout flares
- Localised swelling due to fluid retention (oedema)
- Dizziness
- Shortness of breath
- Itching (pruritus)
- Pain in limbs, muscles, or joints
- Fatigue
Uncommon Side Effects
- Decreased appetite, changes in blood sugar levels, increased blood fat levels, weight gain
- Loss of libido
- Difficulty sleeping (insomnia), drowsiness
- Numbness, tingling, reduced or altered sensation, altered taste, reduced sense of smell
- Abnormal ECG, irregular or rapid heartbeat, palpitations
- Hot flushes, high blood pressure
- Cough, chest discomfort, upper respiratory tract infection, bronchitis
- Dry mouth, abdominal pain, heartburn, constipation, vomiting
- Urticaria (hives), skin inflammation, hair loss, skin redness, increased sweating
- Muscle cramp, muscle weakness, bursitis, arthritis, back pain
- Blood in urine, frequent urination, urinary tract infection, kidney stones
- Gallstones (cholelithiasis)
- Erectile dysfunction
- 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 blistering, peeling skin, and mucous membrane involvement
- Rhabdomyolysis (muscle breakdown) – contact your doctor immediately for muscle pain, tenderness, or weakness, especially with fever
- Severe swelling (angioedema) around eyes, genitals, hands, feet, or tongue, possibly with sudden difficulty breathing
- Hepatitis (inflammation of the liver), jaundice (yellowing of the skin), liver failure
- Tubulointerstitial nephritis (kidney inflammation with reduced urine output)
- Decreased red blood cells (anaemia), decreased white blood cells, decreased platelets
- Sudden cardiac death
- Depression, nervousness, sleep disturbances
- Loss of taste, burning sensation, vertigo
- Circulatory failure, pneumonia
- Sudden vision loss due to arterial blockage in the eye
- Severe skin rash with blistering, peeling, or ulcers in the mouth or genitals
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- High fever with swollen lymph nodes and/or enlarged liver
- Unexplained muscle pain, tenderness, or weakness (especially with fever)
- Yellowing of skin or eyes, dark urine
How Should You Store ADENURIC?
Store ADENURIC at room temperature, out of the sight and reach of children. No special storage conditions are required. Do not use after the expiry date printed on the carton and blister. Dispose of unused medicines through your pharmacy – do not flush them down the drain or put them in household waste.
Keep this medicine out of the sight and reach of children. Do not use ADENURIC after the expiry date stated on the carton and blister foil after “EXP”. The expiry date refers to the last day of that month.
There are no special storage requirements for ADENURIC tablets. Store them in the original packaging to protect from moisture and light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
What Does ADENURIC Contain?
Each ADENURIC tablet contains 80 mg or 120 mg of febuxostat as the active ingredient. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, magnesium stearate, and a yellow film coating containing polyvinyl alcohol, titanium dioxide (E171), and yellow iron oxide (E172).
Active Ingredient
Each film-coated tablet contains either 80 mg or 120 mg of febuxostat.
Inactive Ingredients
Tablet core: Lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, hydrated colloidal silicon dioxide.
Film coating: Opadry II yellow (85F42129), containing polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, yellow iron oxide (E172).
Appearance and Pack Sizes
ADENURIC film-coated tablets are pale yellow to yellow in colour and capsule-shaped. The 80 mg tablets are marked with “80” on one side and a score line on the other. The 120 mg tablets are marked with “120” on one side. The score line is to facilitate breaking the tablet for easier swallowing – it is not intended for splitting into equal halves.
ADENURIC is available in transparent blister packs (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) containing 14 tablets. Pack sizes include 14, 28, 42, 56, 84, and 98 film-coated tablets. Not all pack sizes may be marketed in every country.
Marketing authorisation holder: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg.
Frequently Asked Questions About ADENURIC
Medical References and Sources
This article is based on current medical research and international guidelines. All claims are supported by scientific evidence from peer-reviewed sources.
- European Medicines Agency (EMA). ADENURIC (febuxostat) – Summary of Product Characteristics (SmPC). Available at: ema.europa.eu/en/medicines/human/EPAR/adenuric
- Becker MA, Schumacher HR, Wortmann RL, et al. (2005). "Febuxostat compared with allopurinol in patients with hyperuricemia and gout." New England Journal of Medicine, 353(23):2450-2461. DOI: 10.1056/NEJMoa050373
- Becker MA, Schumacher HR, Espinoza LR, et al. (2010). "The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial." Arthritis Research & Therapy, 12(2):R63.
- White WB, Saag KG, Becker MA, et al. (2018). "Cardiovascular Safety of Febuxostat or Allopurinol in Patients with Gout (CARES)." New England Journal of Medicine, 378(13):1200-1210. DOI: 10.1056/NEJMoa1710895
- FitzGerald JD, Dalbeth N, Mikuls T, et al. (2020). "2020 American College of Rheumatology Guideline for Management of Gout." Arthritis Care & Research, 72(6):744-760. DOI: 10.1002/acr.24180
- Richette P, Doherty M, Pascual E, et al. (2024). "2024 updated EULAR evidence-based recommendations for the management of gout." Annals of the Rheumatic Diseases. DOI: 10.1136/ard-2024-225657
- Hershfield MS, Roberts LJ, Ganson NJ, et al. (2010). "Treating gout with pegloticase, a PEGylated urate oxidase, provides insight into the importance of uric acid as an antioxidant in vivo." Proceedings of the National Academy of Sciences, 107(32):14351-6.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: WHO.
- British National Formulary (BNF). Febuxostat – Drug Monograph. Available at: bnf.nice.org.uk
- Mackenzie IS, Ford I, Nuki G, et al. (2020). "Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial." The Lancet, 396(10264):1745-1757. DOI: 10.1016/S0140-6736(20)32234-0
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising board-certified physicians with expertise in rheumatology, clinical pharmacology, and internal medicine.
iMedic Medical Editorial Team
Specialists in Clinical Pharmacology
iMedic Medical Review Board
Independent medical expert panel
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