Elidel Adverse Reactions

The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with Elidel 1% cream and 16% of patients in the control group. These reactions generally occurred early in treatment, were mild/moderate in severity and were of short duration.
The following undesirable effects have been observed with the frequencies indicated as follows during clinical trials using pimecrolimus cream 1% and from spontaneous reporting.
Adverse reactions (Table 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports. (See Table 2.)

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Post-marketing: Cases of malignancy, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using Elidel.
Cases of lymphadenopathy have been reported in post-marketing use and in clinical trials, however a causal relationship with the pimecrolimus treatment has not been established.
Paediatric population: The clinical safety database of children aged 3 months and older treated with pimecrolimus 1% cream is extensive with long-term safety data available for up to 5 years. The safety profiles in infants, children and adolescent were comparable in nature and frequency of the adverse events observed. The most common observed adverse reactions were application site reactions.