Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Uloric (Febuxostat). If you are concerned about side effects, discuss the risks and benefits of Uloric (Febuxostat) with your doctor.

The following side effects have been reported by at least 1% of people taking Uloric (Febuxostat). Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• dizziness
• nausea
• rash

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• symptoms of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with Fever or discomfort
• signs of heart problems, such as shortness of breath, troubled breathing, pain or tightness in chest, or wheezing
• signs of Stroke, such as severe headache or vomiting, dizziness, seizures, faintness, changes in vision or speech, visual disturbances, weakness or numbness of the arms or legs
• symptoms of a serious allergic reaction such as swelling of the face or throat, Hives, or difficulty breathing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Uloric (Febuxostat).

Each light-green-to-green, teardrop-shaped tablet, embossed with "TAP" on one side and "80" on the other, contains Uloric (Febuxostat) 80 mg. Nonmedicinal ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide, and magnesium stearate; coating: Opadry II Green (contains polyvinyl alcohol, talc, PEG 3,000, titanium dioxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1, and FD&C Blue No. 2).

Do not take Uloric (Febuxostat) if you:

• are allergic to Uloric (Febuxostat) or any ingredients of the medication
• are being treated with Azathioprine or Mercaptopurine

There may be an interaction between Uloric (Febuxostat) and any of the following:

• azathioprine
• didanosine
• mercaptopurine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Uloric (Febuxostat). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Uloric (Febuxostat).

Conditions causing increased uric acid formation: Uloric (Febuxostat) is not intended to decrease uric acid levels for people with medical conditions causing increased uric acid formation (such as cancer or Lesch-Nyhan syndrome). If you have such a condition, discuss with your doctor how Uloric (Febuxostat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Uloric (Febuxostat), and whether any special monitoring is needed.

Gout: Do not start Uloric (Febuxostat) treatment until an acute attack of gout has completely subsided, as further attacks may be brought on by Uloric (Febuxostat). Acute gout attacks may be brought on at the start of treatment with Uloric (Febuxostat) for people who have not used Uloric (Febuxostat) before. If an acute gout attack develops after starting Uloric (Febuxostat), call your doctor.

Heart Attack: Studies indicate that people taking Uloric (Febuxostat) may have an increased risk of heart attack and strokes. In a recent study, people taking Uloric (Febuxostat) who also had heart disease, were found to be at an increased risk of heart-related deaths. If you experience signs of a heart attack, such as discomfort or pain in the chest, back, neck, jaw, arms, or stomach; difficulty breathing; sweating; nausea; lightheadedness or the feeling of impending doom contact your doctor or get medical attention immediately. People with Angina or congestive heart disease should not use Uloric (Febuxostat).

Kidney function: If you have Kidney Disease or reduced kidney function, discuss with your doctor how Uloric (Febuxostat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Uloric (Febuxostat), and whether any special monitoring is needed.

Lactose intolerance: Uloric (Febuxostat) contains lactose. If you have galactose intolerance (galactosemia, glucose-galactose malabsorption, or Lapp lactase deficiency) you should not take Uloric (Febuxostat).

Liver function: Uloric (Febuxostat) may reduce liver function and can cause liver failure. Your doctor may perform regular tests to check your liver function. If you have liver problems, discuss with your doctor how Uloric (Febuxostat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Uloric (Febuxostat), and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Skin rash: If you develop a skin rash, stop taking Uloric (Febuxostat) and contact your doctor. The skin rash may be the first sign of a serious reaction to Uloric (Febuxostat).

Stroke: Studies indicate that people taking Uloric (Febuxostat) may have an increased risk of heart attacks and strokes. If you experience signs of a stroke, such as confusion, difficulty speaking, loss of coordination, sudden headache or vision changes, contact your doctor or get medical attention immediately.

Pregnancy: Uloric (Febuxostat) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Uloric (Febuxostat), contact your doctor immediately.

Breast-feeding: It is not known if Uloric (Febuxostat) passes into breast milk. If you are a breast-feeding mother and are taking Uloric (Febuxostat), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Uloric (Febuxostat) have not been established for children.