Label Changes for:
Terazol 7 (terconazole) Vaginal Cream, 0.4%Terazol 3 (terconazole) Vaginal Suppositories, 80 mgTerazol 3 (terconazole) Vaginal Cream, 0.8%
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)
- 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