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.