Mirvaso Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients in clinical studies. They are typically mild to moderate in severity, and usually do not require discontinuation of treatment. No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age.
Aggravated erythema, flushing and skin burning sensation have been reported during the post-marketing period (see Precautions).
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 Mirvaso in clinical studies (see Table 4).

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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.