Soolantra Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions are skin burning sensation, skin irritation, pruritus and dry skin, all occurring in 1% or less of patients treated with the medicinal product in clinical trials.
They are typically mild to moderate in severity, and usually decrease when treatment is continued.
No meaningful differences in the safety profile were observed between subjects 18 to 65 years and subjects ≥65 years of age.
Tabulated list of adverse reactions: The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) and were reported with Soolantra in clinical studies (see Table 3).

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.