Dermavax Adverse Reactions

Summary of safety profile: Some of the side effects associated with the use of isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped. The following symptoms are the most commonly reported undesirable effects with isotretinoin: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis).
Tabulated list of adverse reactions: The incidence of the adverse reactions calculated from pooled clinical trial data involving 824 patients and from post-marketing data are presented in the table as follows. The adverse reactions are listed as follows by MedDRA system organ class (SOC) and categories of frequency. Frequency categories are defined as 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) and not known (cannot be estimated from the available data). Within each frequency grouping and SOC, adverse reactions are presented in order of decreasing seriousness. (See table.)

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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.