FDA label 453bbc1a-ecba-08b9-e054-00144ff8d46c

WARNINGS See the boxed warning.

ADVERSE REACTIONS The most frequent reactions are those affecting the nervous system and the liver. Nervous System Reactions: Peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most often in the malnourished and in those predisposed to neuritis (e.g., alcoholics and diabetics) and is usually preceded by paresthesias of the feet and hands. The incidence is higher in "slow inactivators". Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment, and toxic psychosis. Hepatic Reactions: See boxed warning. Elevated serum transaminase (SGOT; SGPT), bilirubinemia, bilirubinuria, jaundice, and occasionally severe and sometimes fatal hepatitis. The common prodromal symptoms of hepatitis are anorexia, nausea, vomiting, fatigue, malaise, and weakness. Mild hepatic dysfunction, evidenced by mild and transient elevation of serum transaminase levels occurs in 10 to 20 percent of patients taking isoniazid. This abnormality usually appears in the first 1 to 3 months of treatment but can occur at any time during therapy. In most instances, enzyme levels return to normal and generally, there is no necessity to discontinue medication during the period of mild serum transaminase elevation. In occasional instances, progressive liver damage occurs, with accompanying symptoms. If the SGOT value exceeds three to five times the upper limit of normal, discontinuation of the isoniazid should be strongly considered. The frequency of progressive liver damage increases with age. It is rare in persons under 20, but occurs in up to 2.3 percent of those over 50 years of age. Gastrointestinal Reactions: Nausea, vomiting and epigastric distress. Hematologic Reactions: Agranulocytosis; hemolytic, sideroblastic or aplastic anemia, thrombocytopenia and eosinophilia. Hypersensitivity Reactions: Fever, skin eruptions (morbilliform, maculopapular, purpuric or exfoliative), lymphadenopathy and vasculitis. Metabolic And Endocrine Reactions: Pyridoxine deficiency, pellagra, hyperglycemia, metabolic acidosis and gynecomastia. Miscellaneous Reactions: Rheumatic syndrome and systemic lupus erythematosus-like syndrome.