The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies and spontaneous reporting.
The most frequently reported adverse reactions during treatment are application site reactions including pruritus, burning and irritation.
Adverse reactions are listed by MedDRA system organ class (SOC) and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10, Common ≥1/100 and < 1/10, Uncommon ≥1/1,000 and <1/100, Rare ≥1/10,000 and <1/1,000, Very rare <1/10,000. (See table.)
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Systemic undesirable class effects of mild corticosteroids, like hydrocortisone, include adrenal suppression especially during prolonged topical administration (see Precautions).
Raised intra-ocular pressure and glaucoma may also occur after topical use of corticosteroids near the eyes, particularly with prolonged use and in patients predisposed to developing glaucoma (see Precautions).
Dermatological undesirable class effects of mild corticosteroids like hydrocortisone include: Atrophy, dermatitis (incl. dermatitis contact, dermatitis acneiform and perioral dermatitis), skin striae, telangiectasia, rosacea, erythema, depigmentation, hypertrichosis and hyperhidrosis. Ecchymosis may also occur with prolonged use of topical corticosteroids.
Class effects for corticosteroids have been uncommonly reported for Fucidin H as described in the frequency table as previously mentioned.
The observed safety profile is similar in children and adults (see Precautions).