Betnovate-N Adverse Reactions

The adverse reactions listed as follows are classified by MedDRA System Organ Class and frequency defined as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1,000) and very rare (<1/10,000), including isolated reports. Information on very common, common and uncommon adverse reactions has been determined mainly based on clinical trial data. Information on rare and very rare adverse reactions has been determined from spontaneous reporting.
Infections and infestations: Very rare: opportunistic infections.
Immune system disorders: Very rare: local hypersensitivity.
Endocrine disorders: Very rare: HPA axis suppression (see Skin and subcutaneous tissue disorders as follows), Cushingoid features (e.g. moon face, central obesity), delayed bone growth in children, osteoporosis, glaucoma, hyperglycaemia/glycosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels.
Eye disorders: Not known: Blurred vision (see Precautions).
Skin and subcutaneous tissue disorders: Common: local skin burning/pain and pruritus.
Very rare: skin thinning*/atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasia*, pigmentation changes*, hypertrichosis, alopecia*, trichorrhexis nodosa*, exacerbation of disease symptoms, allergic contact dermatitis/dermatitis, erythema, rash, urticarial, pustular psoriasis (see Precautions).
*Symptoms of HPA axis suppression.
Due to the content of a potent corticosteroid, long-term use of the medicinal product may result in local atrophic lesion, such as skin thinning, striae and telangiectasia, especially when used in skin folds or with occlusion.
General disorders and administration site conditions: Very rare: application site irritation/pain.
Betnovate-N cream is usually well-tolerated; nevertheless, symptoms of hypersensitivity to ingredients of the medicinal product constitute an indication for immediate treatment discontinuation.
In rare cases, the use (or discontinuation) of the medicinal product in psoriatic patients is associated with the risk of generalized pustular psoriasis.