Tablet: Hepatotoxicity, primarily of the hepatocellular type has been associated with the use of ketoconazole. Hence, it should not be given to patients with preexisting liver disease. Liver function tests should be performed before starting therapy. Patients should be instructed to report promptly any signs and symptoms of liver dysfunction eg, anorexia, nausea/vomiting, fatigue, jaundice, dark urine or pale stools.
Ointment: Ketoconazole ointment is not for ophthalmic use. If reaction suggesting sensitivity or chemical irritation should occur, use of Phytoral Ointment should be discontinued.
Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Since ketoconazole is excreted in the milk, mothers who are under treatment should not breastfeed.