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Label Changes for:

Terazol 7 (terconazole) Vaginal Cream, 0.4%Terazol 3 (terconazole) Vaginal Suppositories, 80 mgTerazol 3 (terconazole) Vaginal Cream, 0.8%

September 2013

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

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


September 2013


  • Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. Terazol therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops


Post-marketing Experience..... new section added