KERYDIN SIDE EFFECTS
Clinical Trials Experience
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.
In two clinical trials, 791 subjects were treated with KERYDIN. The most commonly reported adverse reactions are listed below (Table 1).
Table 1: Adverse Reactions Occurring in ≥1% of KERYDIN Topical Solution, 5%-Treated Subjects and at a Greater Frequency than Observed with Vehicle
|Application site exfoliation||21 (2.7%)||1 (0.3%)|
|Ingrown toenail||20 (2.5%)||1 (0.3%)|
|Application site erythema||13 (1.6%)||0 (0%)|
|Application site dermatitis||10 (1.3%)||0 (0%)|
The following adverse reactions have been identified during postmarketing use of KERYDIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug product exposure:
Hypersensitivity; contact allergy
SRC: NLM .