Gris-PEG is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin. Griseofulvin should not be prescribed to pregnant patients. Two cases of conjoined twins have been reported since 1977 in patients taking griseofulvin during the first trimester of pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use. When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, uticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. (See WARNINGS section of full Prescribing Information).

For more information on Gris-PEG, please see the full Prescribing Information.