BACKGROUND: A warning for tuberculosis was added to the approved labeling for infliximab in October 2001. OBJECTIVE: To describe adverse event reports of tuberculosis during infliximab therapy after labeling changes. DESIGN: Case series. SETTING: Spontaneous adverse event reports maintained in the Adverse Event Reporting System database in the United States. PATIENTS: 130 patients with infliximab-associated tuberculosis. MEASUREMENTS: Clinical and laboratory data. RESULTS: The U.S. Food and Drug Administration received 130 domestic, spontaneous reports of tuberculosis in patients treated with infliximab between 1 November 2001 and 30 May 2006, including 59 (45%) with extrapulmonary disease. The most commonly reported risk factors included concomitant immunosuppressant use (n = 89), history of latent or active tuberculosis (n = 33), and being born into or having spent extensive time in an area where tuberculosis is endemic (n = 25). In the subset of 67 cases with documented initiation of infliximab therapy after the drug labeling change, 34 patients with a negative tuberculin skin test result before initiation of infliximab therapy developed tuberculosis after receiving infliximab. LIMITATION: Conclusions from spontaneous case reports may not be generalizable to the entire infliximab-receiving population. CONCLUSION: Clinicians should be vigilant in screening and monitoring for tuberculosis in patients receiving infliximab.