Uloric Side Effects

Uloric is a brand name for the generic febuxostat in America.

Uloric is the second choice of uric acid lowering treatment. It is recommended where side-effects or ineffectiveness rule the first-choice allopurinol.

Uloric (febuxostat) does not produce the serious rash problems that some gout patients have with allopurinol. However, it is not without side effects, and this page looks at the history and status of Uloric side effects.

Uloric Side-Effects

In a 2008 review, Hu & Tomlinson note that no serious side-effects of febuxostat have been found [1]. The mild to moderate adverse events are recorded as:

  • Abnormal liver function tests
  • Diarrhea
  • Headache

This list is extended in Reinders & Jansen’s 2009 review of febuxostat and allopurinol [2] to:

  1. Liver function abnormalities (3.5%)
  2. Diarrhea (2.7%)
  3. Headache (1.8%)
  4. Nausea (1.7%)
  5. Rash (1.5%)

They also add the warning that early trials raised heart disease concerns, but note that these were not repeated in later trials. Nevertheless, this concern is noted in the Uloric Prescribing Information [3]:

5.2 Cardiovascular Events
In the randomized controlled studies, there was a higher rate of cardiovascular thromboembolic events (cardiovascular deaths, non-fatal myocardial infarctions, and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)] [see Adverse Reactions (6.1)]. A causal relationship with ULORIC has not been established. Monitor for signs and symptoms of myocardial infarction (MI) and stroke.

Note that the Uloric Prescribing Information was updated in 2012 to include stricter guidance on liver side-effects.

Now, some people fear that this makes febuxostat dangerous, but that is not my interpretation. I believe the authorities are merely taking a cautious approach. The fact that gout patients taking Uloric are more likely to be monitored for early signs of heart disease implies that their overall risk should be lower than the general population. This is something that needs to be discussed with your doctor. Never lose sight of the fact that high uric acid itself is associated with higher risks of heart disease, yet nobody understands how these things are related. Your best health option is to reduce uric acid to safe levels and monitor all aspects of your health in conjunction with your doctor.

Remember, all uric acid lowering treatments might induce a gout attack, as dissolving uric acid crystals can provoke an immune system inflammatory reaction in the same way that newly formed crystals do. Learn about the different forms of gout pain relief elsewhere in this gout treatments section, and discuss options with your doctor.

Uloric Side Effects: Next Steps

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As post marketing testing and other studies reveal more information about Uloric side effects, I will update the information here, and in the Uloric Blog. Make sure you do not miss out by subscribing to my gout update service.

If you have experienced Uloric side effects, or if you have questions about this gout medication, please join my gout forum.

Leave Uloric Side Effects to browse the Uloric guidelines.


Uloric: References

  1. Author:
    Hu M, Tomlinson B.
    Title:
    Febuxostat in the management of hyperuricemia and chronic gout: a review.
    Published:
    Ther Clin Risk Manag. 2008 Dec;4(6):1209-20.
    Full report:
    Febuxostat Review
  2. Author:
    Reinders MK, Jansen TL.
    Title:
    Management of hyperuricemia in gout: focus on febuxostat.
    Published:
    Clin Interv Aging. 2010 Feb 2;5:7-18.
    Full report:
    Febuxostat Versus Allopurinol
  3. Author:
    Takeda Pharmaceuticals America, Inc.
    Title:
    Uloric Prescribing Information
    Published:
    Nov 2012.
    Full report:
    Uloric Prescribing Information

Related Gout Facts: , ,

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