Pimecrolimus
ELIDEL
What it isTopical calcineurin inhibitor; mild-to-moderate atopic dermatitis.
Why this oneIts cream vehicle suits mild facial or flexural eczema; it is weaker than tacrolimus ointment but avoids steroid atrophy.
What limits itEarly application burning can stop treatment; photoprotection is advised, and long-term safety remains uncertain.
FDA-approved for
- mild-to-moderate atopic dermatitis (2001)
Off-label
- vitiligo
- oral and genital lichen planus
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Atopic dermatitis (second-line, short-term & intermittent) | Adults & children ≥2 yr | Apply thin layer BID | BID |
Renal Undefined
Hepatic Undefined
Instructions
- Apply a thin layer to affected skin twice daily; stop when signs/symptoms resolve
- Re-examine if disease persists beyond 6 wk
- Avoid continuous long-term use; limit to areas of involvement
- Avoid occlusive dressings
- Minimize/avoid natural or artificial sunlight
Cautions
- Not for immunocompromised adults/children or those on systemic immunosuppressants
- Avoid on malignant or pre-malignant skin conditions (e.g., cutaneous T-cell lymphoma)
- Not for Netherton's syndrome or conditions with increased systemic absorption
- Resolve bacterial/viral skin infections before use
- Investigate etiology of lymphadenopathy if it develops
Adverse reactions
- Application site burning
- Headache
- Nasopharyngitis
- Cough
- Influenza
- Pyrexia
- Viral infection
Pregnancy Category C; no adequate studies; use only if benefit justifies risk.
Lactation Unknown whether excreted in human milk; decide whether to discontinue nursing or drug.
⚠ BOXED WARNING
- Long-term safety not established; rare malignancy reported
Principal riskBurning on application; less potent than tacrolimus
Cost, est. cash$10–$300/month
Generic entry2018
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.
Mechanism of action: Pimecrolimus ballicule
