The safety of Ketoconazole 2% Shampoo was evaluated in 2980 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 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000, <1/1,000
Very rare <1/10,000, including isolated reports
Not known (cannot estimate from the available clinical trial data).
System Organ Class
|
Adverse Drug Reactions
|
Frequency Category
|
Uncommon
(≥1/1,000 and <1/100)
|
Rare
(≥1/10,000 and <1/1,000)
|
Not Known
|
Immune System Disorders
|
|
Hypersensitivity
|
|
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.