Adverse reactions : תופעות לוואי

4.8 Undesirable effects
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).
Adverse Drug Reactions
Frequency Category
System Organ Class
Uncommon                        Rare                 Not Known
(≥1/1,000 to <1/100)      (≥1/10,000 and <1/1,000)
Immune System
Hypersensitvity disorders
Nervous System
Dysgeusia
Disorders
Infections and
Folliculitis
Infestations
Eye Disorders              Increased lacrimation               Eye irritation Alopecia                                              Angioedema
Acne
Dry skin                                                Urticaria
Skin and Subcutaneous                                       Dermatitis contact Hair texture abnormal                                         Hair colour Tissue Disorders                                              Skin disorder Rash                                                  changes
Skin exfoliation
Skin burning sensation
Application site erythema
General Disorders and                                        Application site Application site irritation
Administration Site                                          hypersensitivity Application site pruritus
Conditions                                               Application site pustules Application site reaction
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/ Additionally, you can also report to www.Padagis.co.il