Nizoral (ketoconazole) 2% shampoo
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009
- 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.
- 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.