Pimecrolimus: Side Effects, Uses & Monitoring
ELIDEL ® (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of
- Data source
- FDA labeling via NIH DailyMed (label 6f94f6e7…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Pharyngitis streptococcal | 1% |
| Staphylococcal infection | 1% |
| Skin papilloma | 1% |
| Eye infection nos | 1% |
| Sinus congestion | 1% |
| Wheezing | 1% |
| Constipation | 1% |
| Loose stools | 1% |
| Urticaria | 1% |
| Acne nos | 1% |
| Accident nos | 1% |
| Laceration | 1% |
| Back pain | 1% |
| Bacterial infection | 0% |
| Pneumonia nos | 0% |
| Molluscum contagiosum | 0% |
| Herpes simplex | 0% |
| Tonsillitis nos | 0% |
| Viral infection nos | 0% |
| Gastroenteritis nos | 0% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
ELIDEL ® (pimecrolimus) Cream 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. ELIDEL Cream is not indicated for use in children less than 2 years of age (see WARNINGS, boxed WARNING, and PRECAUTIONS, Pediatric Use).
Conditions associated with Pimecrolimus in labeling
Frequently Asked Questions
What is Pimecrolimus used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Pimecrolimus?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Pimecrolimus. Individual risk varies.
Does Pimecrolimus require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Pimecrolimus.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.