Elidel Adverse Reactions





Pharmline Marketing
Full Prescribing Info
Adverse Reactions
The safety profile of Elidel 1% cream has been established in more than 2000 patients including infants (≥ 3 months), children, adolescents and adults enrolled in phase 2 and 3 studies. Over 1500 of these patients were treated with Elidel 1% cream and over 500 were treated with control treatment i.e. either Elidel vehicle and/or topical corticosteroids.
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.
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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The following adverse reactions have been reported during post-marketing experience. The frequency has been estimated from the reporting rates. Because these reactions are reported voluntarily from a population of uncertain size, the frequency reflects only an estimate. (See Table 3.)

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Rare cases of malignancy, including cutaneous and other types of lymphoma and skin cancers, have been reported in patients using pimecrolimus cream, although no causal relationship has been established (see PRECAUTIONS).
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