Published: 12 December 2013

Discontinuation of Supply of Oral Ketoconazole

Prescriber Update 34(4): 39
December 2013

Key Messages

  • Oral ketoconazole (Nizoral) 200 mg tablets were discontinued on 1 December 2013.
  • Patients requiring long-term oral anti-fungal therapy will need to be changed to an alternative oral anti-fungal treatment.
  • Topical ketoconazole products are not affected and continue to be available.

Healthcare professionals are advised that Janssen-Cilag (New Zealand) have discontinued oral ketoconazole (Nizoral) 200 mg tablets.

Due to on-going safety concerns regarding liver toxicity with the use of oral ketoconazole tablets, the manufacturer has decided to stop making this medicine. This adverse reaction is well known with oral ketoconazole and was most recently discussed by the Medicines Adverse Reactions Committee (MARC) in September 2011.

Oral ketoconazole is used in the treatment of mycoses that cannot be treated topically due to the site or extent of lesions. Other effective oral antifungal treatment options are available.

Topical ketoconazole formulations, including shampoos and cream, have low systemic absorption and therefore are not affected by these safety concerns and continue to be available.

Further information about the discontinuation of oral ketoconazole was published last month on the Medsafe website (