Uloric

DRUG DESCRIPTION

ULORIC (febuxostat) is a xanthine oxidase inhibitor. The active ingredient in ULORIC (febuxostat) is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C16H16N2O3S.

The chemical structure is:

ULORIC
  (febuxostat) Structural Formula Illustration

Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205C to 208C.

ULORIC (febuxostat) tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, silicon dioxide and magnesium stearate. ULORIC (febuxostat) tablets are coated with Opadry II, green.

What are the possible side effects of febuxostat (Uloric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using febuxostat and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • ...

Read All Potential Side Effects and See Pictures of Uloric

What are the precautions when taking febuxostat (Uloric)?

Before taking febuxostat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, heart disease, liver disease, kidney disease, organ transplant, stroke.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if febuxostat passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Uloric


Uloric Consumer (continued)

SIDE EFFECTS: Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Febuxostat may cause an increase in liver enzymes. Your doctor will order blood tests to measure these enzymes. Keep all medical/lab appointments. Tell your doctor immediately if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain/pressure, sudden tiredness, weakness, jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes, confusion, pink/bloody urine, painful urination.

Febuxostat may cause a rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking febuxostat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, heart disease, liver disease, kidney disease, organ transplant, stroke.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if febuxostat passes into breast milk. Consult your doctor before breast-feeding.


Uloric Patient Information Including Side Effects

Brand Names: Uloric

Generic Name: febuxostat (Pronunciation: fe BUX oh stat)

  • What is febuxostat (Uloric)?
  • What are the possible side effects of febuxostat (Uloric)?
  • What is the most important information I should know about febuxostat (Uloric)?
  • What should I discuss with my healthcare provider before taking febuxostat (Uloric)?
  • How should I take febuxostat (Uloric)?
  • What happens if I miss a dose (Uloric)?
  • What happens if I overdose (Uloric)?
  • What should I avoid while taking febuxostat (Uloric)?
  • What other drugs will affect febuxostat (Uloric)?
  • Where can I get more information?

What is febuxostat (Uloric)?

Febuxostat reduces the production of uric acid in your body. Uric acid buildup can lead to gout or kidney stones.

Febuxostat is used to treat gout.

Febuxostat may also be used for other purposes not listed in this medication guide.

What are the possible side effects of febuxostat (Uloric)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using febuxostat and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pale skin, easy bruising or bleeding;
  • hearing problems, ringing in your ears;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • blood in your urine; or
  • urinating less than usual;

Less serious side effects may include:

  • fever, chills, body aches, flu symptoms;
  • upset stomach;
  • dry mouth, thirst;
  • blurred vision;
  • dizziness, spinning sensation;
  • joint pain, swelling, or stiffness;
  • muscle pain; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about febuxostat (Uloric)?

You should not use this medication if you are allergic to febuxostat, or if you are also being treated with azathioprine (Azasan, Imuran), mercaptopurine (Purinethol), or theophylline (Elixophyllin, TheoCap, Theochron, Uniphyl).

Before taking febuxostat, tell your doctor if you have kidney disease, liver disease, diabetes, heart disease, or high blood pressure.

You may have an increase in gout symptom flares when you first start taking febuxostat. For best results, keep taking the medication as directed. Your doctor may prescribe other gout medications for you to use during the first 6 months of treatment with febuxostat.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using febuxostat.

Related Drug Centers
  • Uloric


Related Drugs Index: