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U.S. Department of Health and Human Services

Safety

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Nizoral (ketoconazole) 2% shampoo

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

 

Summary View

 

PRECAUTIONS

  • Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Nizoral (ketoconazole) 2% shampoo.
  • Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, or shortness of breath should discontinue Nizoral and contact their physician immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

  • Long-term studies to assess the carcinogenic potential of Nizoral (ketoconazole) 2% shampoo have not been conducted.  A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity

Pregnancy: Teratogenic effects: Pregnancy Category C

  • There are no adequate and well-controlled studies in pregnant women.  Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 
  • Nursing mothers: There are no adequate and well controlled studies in nursing women...Caution should be exercised when Nizoral (ketoconazole) 2% shampoo is administered to a nursing woman.

ADVERSE REACTIONS

  • In worldwide experience....hypersensitivity...Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.