Black Box Warning

Pancreatitis (sometimes fatal), peripheral neuropathy (sometimes irreversible), lactic acidosis with hepatic steatosis (sometimes fatal), and severe hepatomegaly with steatosis have been reported. Fatal and nonfatal pancreatitis have occurred; patients should be informed of the risk and advised to discontinue didanosine if abdominal pain, nausea, vomiting, or unexplained anorexia develops. Peripheral neuropathy, characterized by bilateral distal symmetrical numbness, tingling, or pain in the feet and, less frequently, in the hands has occurred. Lactic acidosis and severe hepatomegaly with steatosis have been reported with antiretroviral nucleoside analogs alone or in combination, including didanosine. Women appear to be more susceptible to this adverse effect.