What are the guidelines for discontinuing allopurinol (xanthine oxidase inhibitor) therapy?

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Last updated: December 11, 2025View editorial policy

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Discontinuation of Allopurinol

Allopurinol should be continued indefinitely rather than discontinued, even in patients who achieve clinical remission with no gout flares for ≥1 year and no tophi. 1

Evidence Against Discontinuation

The 2020 American College of Rheumatology guidelines conditionally recommend continuing urate-lowering therapy (ULT) indefinitely over stopping it, though this recommendation is based on very low-quality evidence. 1

Key Data on Relapse After Discontinuation

  • In a case series of patients in clinical remission who stopped ULT after years of well-controlled serum urate (SU) levels, only 13% (27 of 211 patients) remained flare-free during 5-year follow-up when their SU stayed <7 mg/dL off therapy. 1

  • Patients with higher SU concentrations after withholding therapy experienced more frequent flares, with a direct correlation between higher SU levels and increased likelihood of flares. 1

  • A systematic review found relapse rates of 36-81% in gout patients after ULT discontinuation, with relapses typically occurring 1-4.5 years after stopping therapy. 2

  • Relapse rates were lower (15%) in patients with urolithiasis compared to those with gouty arthritis. 2

When Discontinuation Might Be Considered

If discontinuation is being contemplated despite guideline recommendations, the following factors suggest lower relapse risk:

  • Low serum urate levels both before and after ULT discontinuation are associated with reduced gout recurrence. 2

  • Patients must be in clinical remission: no flares for ≥1 year and complete resolution of tophi. 1

Patient Perspective

Patient panels consistently express concerns about return or worsening of gout symptoms, tophi, or joint damage with ULT cessation. If therapy is well-tolerated and not burdensome, patients prefer to continue treatment. 1

FDA Labeling Guidance

The FDA label states that "treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present," specifically referencing patients with leukemia, lymphoma, or malignancies receiving cancer therapy. 3 This does not apply to chronic gout management, where urate overproduction or underexcretion persists lifelong.

Clinical Approach

The treat-to-target strategy requires maintaining serum urate <6 mg/dL indefinitely to prevent crystal formation and disease recurrence. 1, 4 Discontinuation undermines this fundamental therapeutic principle, as the underlying metabolic abnormality causing hyperuricemia does not resolve.

Common Pitfall

Do not discontinue allopurinol simply because a patient has been symptom-free for an extended period—this reflects successful disease control, not disease resolution. 1

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Effects of Discontinuation of Urate-Lowering Therapy: A Systematic Review.

Journal of general internal medicine, 2018

Guideline

Allopurinol Therapy Monitoring

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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