Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: 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) and very rare (<1/10,000), including isolated reports.
Post-marketing data: Infections and Infestations:
Very rare: Opportunistic infection.
Immune System Disorders:
Very rare: Hypersensitivity, generalised rash.
Very rare: Hypothalamic-pituitary adrenal (HPA) axis suppression: Cushingoid features: (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, hyperglycaemia/glucosuria, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis.
Very rare: Cataract, central serous chorioretinopathy, glaucoma.
Skin and Subcutaneous Tissue Disorders:
Common: Pruritus, local skin burning/skin pain.
Uncommon: Skin atrophy*, striae*, telangiectasias*.
Very rare: Skin thinning*, skin wrinkling*, skin dryness*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms, allergic contact dermatitis/dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
General Disorders and Administration Site Conditions:
Very rare: Application site irritation/pain.