EXTINA SIDE EFFECTS

  • Generic Name: ketoconazole foam, 2%
  • Brand Name: Extina
  • Drug Class: Antifungals, Topical
Last updated on MDtodate: 10/05/2022

SIDE EFFECTS

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® Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied EXTINA® 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® Foam
N = 672
n (%)
Vehicle Foam
N = 497
n (%)
Subjects with an Adverse Reaction 188 (28%) 122 (25%)
Application site burning 67 (10%) 49 (10%)
Application site reaction 41 (6%) 24 (5%)

 

Application site reactions that were reported in < 1% of subjects were dry­ness, erythema, irritation, paresthesia, pruritus, rash and warmth.

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® Foam. EXTINA® Foam may cause contact sensitization.

 

SRC: NLM .