Pimecrolimus — Membership Pricing

Related medications

Other medications associated with the same conditions in this catalog.

Also listed for Eczema

• Hydrocortisone
• Tacrolimus
• Triamcinolone

Other medications in Dermatology

• Podophyllotoxin
• Ruxolitinib Cream
• Salicylic Acid
• Selenium Sulfide
• Silver Sulfadiazine
• Spinosad
• Tacrolimus 0.03%
• Tacrolimus Topical

What Pimecrolimus is approved for (FDA label)

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.

Source: Read the full FDA label on DailyMed. Label effective date: April 30, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Pimecrolimus (FDA label)

WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. [see Warnings and Precautions (5.1) ] . Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis [see Dosage and Administration (2) , Warnings and Precautions (5.1) ] . • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED See full prescribing information for complete boxed warning. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. ( 5.1 ) Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis. ( 2 , 5.1 ) • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age. ( 1 , 5.1 , 8.4 )

Source: FDA prescribing information (DailyMed). Set ID: 6601e43e-ce7d-446a-8568-8e7b24b86f06. SPL document ID: e391204d-95f9-4c57-a0db-578bdd1b8bde. Label effective date: April 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Pimecrolimus (FDA label)

Cream, 1%. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base. Cream, 1%. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 6601e43e-ce7d-446a-8568-8e7b24b86f06. SPL document ID: e391204d-95f9-4c57-a0db-578bdd1b8bde. Label effective date: April 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Pimecrolimus (FDA label)

The most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. No phototoxicity and no photoallergenicity were detected in clinical trials with 24 and 33 normal volunteers, respectively. In human dermal safety trials, Pimecrolimus Cream, 1% did not induce contact sensitization or cumulative irritation.

Source: FDA prescribing information (DailyMed). Set ID: 6601e43e-ce7d-446a-8568-8e7b24b86f06. SPL document ID: e391204d-95f9-4c57-a0db-578bdd1b8bde. Label effective date: April 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Pimecrolimus (FDA label)

Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. ( 4 , 6.2 )

Source: FDA prescribing information (DailyMed). Set ID: 6601e43e-ce7d-446a-8568-8e7b24b86f06. SPL document ID: e391204d-95f9-4c57-a0db-578bdd1b8bde. Label effective date: April 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Pimecrolimus (FDA label)

• Should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. ( 5.1 ) • Avoid treatment on malignant or pre-malignant skin conditions, as these can present as dermatitis. ( 5.2 ) • Should not be used in patients with Netherton’s Syndrome or skin diseases with a potential for increased systemic absorption. ( 5.2 ) 5.1 Risk of Immunosuppression Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.

Source: FDA prescribing information (DailyMed). Set ID: 6601e43e-ce7d-446a-8568-8e7b24b86f06. SPL document ID: e391204d-95f9-4c57-a0db-578bdd1b8bde. Label effective date: April 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Pimecrolimus (FDA label)

Potential interactions between Pimecrolimus Cream, 1% and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Source: FDA prescribing information (DailyMed). Set ID: 6601e43e-ce7d-446a-8568-8e7b24b86f06. SPL document ID: e391204d-95f9-4c57-a0db-578bdd1b8bde. Label effective date: April 30, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.