Febuxostat · Takeda Pharmaceuticals · updated June 2026
Uloric (febuxostat) is a prescription gout medication. On February 21, 2019, the FDA added a Boxed Warning to Uloric after concluding, from the manufacturer's required CARES safety trial, that the drug was associated with a higher risk of cardiovascular death and death from all causes compared with allopurinol. Plaintiffs allege that Takeda failed to adequately warn of these cardiovascular risks. These are allegations, not findings of fact; as of mid-2026 the cases have been filed individually and have not been consolidated into a federal multidistrict litigation (MDL). A later trial (FAST) did not find the same increased risk, and courts have not established that Uloric caused the claimed injuries.
This page is general information about ongoing litigation and FDA safety actions — not medical or legal advice, and not a statement that Uloric caused any injury. Allegations described here are claims that have not been proven in court. Always consult a licensed professional.
Plaintiffs allege that Takeda Pharmaceuticals designed, marketed, and sold Uloric (febuxostat) while failing to adequately warn patients and prescribers of an alleged increased risk of cardiovascular death, heart attack, stroke, and all-cause mortality, and that the company knew or should have known of these risks from its FDA-required CARES safety trial. Plaintiffs further allege that, had adequate warnings been provided sooner, they or their family members would not have taken the drug or would have used a different option such as allopurinol. These are unproven allegations. Courts have not established that Uloric causes the claimed injuries; the science is contested, and a separate randomized trial (FAST, published 2020) did not find the increased cardiovascular risk seen in CARES. This entry is informational only and does not constitute legal or medical advice.
Real and verifiable. On February 21, 2019, the FDA issued a Drug Safety Communication adding a Boxed Warning to Uloric (febuxostat) for an increased risk of cardiovascular death and death from all causes versus allopurinol, based on the CARES outcomes trial (cardiovascular death hazard ratio 1.34, 95% CI 1.03-1.73; all-cause death hazard ratio 1.22, 95% CI 1.01-1.47). The FDA also restricted Uloric's approved use to patients who have not responded to or cannot tolerate allopurinol and required a new patient Medication Guide. The agency had earlier flagged the concern in a November 15, 2017 safety communication based on preliminary CARES results. Separately, on January 22, 2025 the FDA noted Takeda's planned discontinuation of Uloric (40 mg and 80 mg tablets) in the U.S., with an anticipated effective date of March 31, 2026; this discontinuation was attributed to commercial/generic-competition factors, not a new safety action.
As of mid-2026, Uloric/febuxostat claims have NOT been centralized into a federal multidistrict litigation (MDL) — there is no JPML-assigned MDL number for this drug, and the JPML pending-MDL list shows no Uloric, febuxostat, or Takeda gout-drug docket. According to litigation trackers, cases have been filed individually in state and federal courts rather than consolidated, no bellwether trials have been scheduled, and no global or major settlements have been announced. Reported case volumes remain qualitative and modest relative to large consolidated mass torts; any specific MDL number, court assignment, or precise consolidated case count circulating online should be treated as unconfirmed. Some legal sources report that, as of 2026, the litigation has seen no substantial recent developments and certain firms are no longer accepting new Uloric cases.