Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse drug reactions (ADRs) of clobetasone butyrate cream are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <2/10), 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

Infections and Infestations
Very rare               Opportunistic infection
Immune System Disorders
Very rare               Hypersensitivity, generalised rash
Endocrine Disorders
Very rare               Hypothalamic-pituitary adrenal (HPA) axis suppression: Cushingoid features (e.g. moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria, cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels
Skin and Subcutaneous Tissue Disorders
Very rare               Allergic contact dermatitis, urticaria, skin atrophy*, pigmentation changes*, exacerbation of underlying symptoms, local skin burning, hypertrichosis, rash, pruritus, erythema
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.

Not known Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4)

Eye disorders

Not known             Vision, blurred (see also section 4.4)
In all controlled clinical studies with 514 patients using ciclopirox cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

In patients with dermatoses treated with gentamicin sulfate, irritation (erythema and pruritus) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with gentamicin sulfate on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin sulfate followed by exposure to ultraviolet radiation.
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. .
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/ Side effects can also be reported to the following email: safety@trima.co.il