In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment. Erythema was a common skin irritation adverse reaction. Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed. Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
Patients may be at an increased risk of folliculitis, acne and herpes viral infections.
Adverse reactions with suspected relationship to treatment are listed as follows by system organ class. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 < 1/10) and uncommon (≥ 1/1,000 to < 1/100). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 5.)
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Post-Marketing: Cases of malignancies, including cutaneous (i.e. cutaneous T Cell lymphomas) and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see Precautions).
Maintenance treatment: In a study of maintenance treatment (twice weekly treatment) in adults and children with moderate and severe atopic dermatitis, the following adverse events were noted to occur more frequently than in the control group: application site impetigo (7.7% in children) and application site infections (6.4% in children and 6.3% in adults).
Paediatric population: Frequency, type and severity of adverse reactions in children are similar to those reported in adults.