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GoutSmart

Understanding ULORIC—Safety & Side Effects

If you're beginning treatment with ULORIC, it's important to know that it has been studied extensively, in multiple clinical studies; more than 4000 patients with gout took part in them—some for more than 5 years. In fact, these clinical studies comprised the largest study of gout patients ever. See how ULORIC measured up—review some of the findings from clinical studies.

Possible Side Effects

ULORIC may cause side effects in some people. The most common side effects are:

  • Liver problems
  • Nausea
  • Gout flares
  • Joint pain
  • Rash

Your healthcare professional may do blood tests to check your liver function while you are taking ULORIC.

A small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events.

Tell your healthcare professional about liver or kidney problems or a history of heart disease or stroke.

What if I Experience a Gout Flare While Taking ULORIC?

If you have gout and you begin taking any medication to lower uric acid levels, including ULORIC, the crystals built up in your joints may begin to dissolve as your uric acid levels begin to decrease.

This "shedding" of the crystals may lead to a gout flare. Do not stop taking ULORIC if you experience a flare. ULORIC is still working to lower your uric acid and you should keep taking it both during and between gout attacks. Talk to your healthcare professional in advance about other medicines to help prevent or manage flares during initial treatment. Tell your healthcare provider if you have any side effects while taking ULORIC.

These are not all of the possible side effects of ULORIC. For more information, ask your healthcare professional or download our Prescribing Information.

ULORIC and Other Medications

Be sure to tell your healthcare provider about any medications, vitamins, or nutritional supplements you're taking. There are certain types of medications that shouldn't be taken with ULORIC. These include:

  • Azathioprine
  • Mercaptopurine
  • Theophylline

If you have gout and you're taking Colchicine, Naproxen, Indomethacin, Hydrochlorothiazide, or Warfarin (Coumadin®), your healthcare professional can still prescribe ULORIC along with these medicines without worrying about switching medicines or changing the dose.

What Dose Should I Take?

ULORIC is available in two doses: 40 mg or 80 mg once daily. Talk with your healthcare professional about which dose is right for you. Patients with mild to moderate kidney or liver problems can take the same dose of ULORIC as anyone else*. Older patients can take the same doses, too.

*Only a small number of patients with severe kidney problems were studied with ULORIC. Patients with severe liver problems were not studied.

This information does not take the place of talking with your healthcare professional about your medical condition or your treatment.


Taking allopurinol?

Clinical studies on the treatment of adults with gout found that ULORIC 40 mg was similar, and ULORIC 80 mg was significantly better at helping gout patients reach a healthy uric acid level (less than 6 mg/dL) compared with allopurinol.

See the Comparison


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Use of ULORIC

ULORIC is a prescription medicine used to lower blood uric acid levels in adults with gout. ULORIC is not for the treatment of high uric acid without a history of gout.

Individual results may vary.

Important Safety Information

Do not take ULORIC if you are taking Azathioprine, Mercaptopurine, or Theophylline.

For some people, gout may flare up when starting certain gout medicines, including ULORIC. If you have a flare while taking ULORIC, do not stop taking your medicine. Your healthcare provider may give you other medicines to help prevent your gout flares.

A small number of heart attacks, strokes, and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events.

Your healthcare professional may do blood tests to check your liver function while you are taking ULORIC.

Tell your healthcare professional about liver or kidney problems or a history of heart disease or stroke.

The most common side effects of ULORIC are liver problems, nausea, gout flares, joint pain, and rash.

Please see the complete Prescribing Information and talk to your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.
All other trademark names are the property of their respective owners.
©2010 Takeda Pharmaceuticals North America, Inc.
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