The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence ≥1%.
The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated form the available clinical trial data).
System Organ Class
|
Adverse Drug Reactions
|
Frequency Category
|
Uncommon
(≥1/1,000 to <1/100)
|
Rare
(≥1/10,000 and <1/1,000)
|
Not Known
|
Immune System disorders
|
|
Hypersensitvity
|
|
Nervous System Disorders
|
|
Dysgeusia
|
|
Infections and Infestations
|
Folliculitis
|
|
|
Eye Disorders
|
Increased lacrimation
|
Eye irritation
|
|
Skin and Subcutaneous Tissue Disorders
|
Alopecia
Dry skin
Hair texture abnormal
Rash
Skin burning sensation
|
Acne
Dermatitis contact
Skin disorder
Skin exfoliation
|
Angioedema
Urticaria
Hair colour changes
|
General Disorders and Administration Site Conditions
|
Application site erythema
Application site irritation
Application site pruritus
Application site reaction
|
Application site hypersensitivity
Application site pustules
|
|
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.