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: Local hypersensitivity.
Endocrine Disorders: Very Rare: Hypothalamic-pituitary adrenal (HPA) axis suppression; cushingoid features (eg, moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels, alopecia, trichorrhexis.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus, local skin burning/skin pain. Very Rare: Allergic contact dermatitis/dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning
*/skin atrophy
*, skin wrinkling
*, skin dryness
*, striae
*, telangiectasias
*, pigmentation changes
*, hypertrichosis, exacerbation of underlying symptoms.
General Disorders and Administration Site Conditions: Very Rare: Application site irritation/pain.
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.