"Spring break is on the way, or maybe summer vacation. Time to pack your swim suit, hit the beach, and perhaps indulge in a little harmless fun. What about getting a temporary tattoo to mark the occasion? Who could it hurt to get a temporary tatto"...
Adverse Reactions in Clinical Trials
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The safety data presented in Table 1 (below) reflect exposure to Extina (ketoconazole foam, 2%) Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied Extina (ketoconazole foam, 2%) Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1.
Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials
|Adverse Reactions||Extina (ketoconazole foam, 2%) Foam
N = 672
N = 497
|Subjects with an Adverse Reaction||188 (28%)||122 (25%)|
|Application site burning||67 (10%)||49 (10%)|
|Application site reaction||41 (6%)||24 (5%)|
Dermal Safety Studies
In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with Extina (ketoconazole foam, 2%) Foam. Extina (ketoconazole foam, 2%) Foam may cause contact sensitization.
Read the Extina (ketoconazole foam, 2%) Side Effects Center for a complete guide to possible side effects
Additional Extina Information
Extina - User Reviews
Extina User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.