Rare cases of autoimmune disorder, including lupus-like syndrome reported. Serious and potentially fatal infections (including sepsis, pneumonia, and invasive fungal and other opportunist infections) reported in patients receiving TNF-blocking agents. Severe hepatic reactions (including hepatitis, jaundice, acute hepatic failure, and cholestasis) reported. Rare reactivation of hepatitis B virus has occurred. Hypersensitivity reactions might occur. Hepatosplenic T-cell lymphoma reported (rarely) in adolescent and young adults with Crohn’s disease. Use caution in history of chronic obstructive pulmonary disease. Reactivation of latent infections possible. Use with caution in pre-existing or recent onset CNS demyelinating disorders. Use with caution in mild heart failure or decreased left ventricular function. Hematologic toxicities (e.g. leukopenia, neutropenia, thrombocytopenia, pancytopenia) reported (use with caution in history of hematologic abnormalities). Use with caution in history of seizures. Concurrent use of infliximab and anakinra not recommended. Live vaccines should not be given concurrently.