OpenClaim

Pimecrolimus Side Effects

The most commonly reported side effects of pimecrolimus include pruritus, rash, and dermatitis atopic, based on 5,157 FDA adverse event reports from 2004 to 2025. 11.7% of reports found the drug to be ineffective.

Pimecrolimus side effects

Percentages show how often each reaction appears relative to total reports for pimecrolimus.

1
Drug Ineffective11.7%601
2
Pruritus7.3%379
3
Rash7.1%368
4
Dermatitis Atopic5.9%306
5
Off Label Use4.9%254
6
Product Use In Unapproved Indication4.3%220
7
Erythema4.0%207
8
Psoriasis4.0%204
9
Eczema3.7%191
10
Dry Skin3.4%173
11
Skin Exfoliation3.3%169
12
Fatigue3.1%159
13
Condition Aggravated3.0%156
14
Treatment Failure3.0%155
15
Headache2.5%130

These are voluntary reports and do not establish that pimecrolimus caused these reactions.

Report severity

43.0%Serious2,215 reports
14.6%Hospitalizations753 reports
1.9%Fatal97 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pimecrolimus drug interactions

Other drugs that appear in adverse event reports alongside pimecrolimus. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab23.3%1,203
2
Tacrolimus5.4%277
3
Triamcinolone4.3%224
4
Clobetasol-propionate4.0%208
5
Apremilast3.0%153
6
Secukinumab2.8%143
7
Methotrexate2.8%142
8
Hydrocortisone2.5%127
9
Adalimumab2.3%121
10
Mometasone-furoate2.0%105
11
Prednisone1.7%90
12
Betamethasone1.6%84
13
Sodium-oxybate1.3%67
14
Cyclosporine1.2%63
15
Infliximab1.2%60

Taken alongside

1
Triamcinolone14.1%727
2
Clobetasol-propionate10.8%557
3
Albuterol10.6%549
4
Ergocalciferol9.7%502
5
Fluticasone9.2%476
6
Cetirizine-hydrochloride9.1%468
7
Acetaminophen8.7%447
8
Hydrocortisone7.5%386
9
Prednisone7.3%376
10
Montelukast-sodium6.8%352
11
Levothyroxine-sodium6.5%334
12
Hydroxyzine6.3%327
13
Tacrolimus6.0%308
14
Aspirin5.8%301
15
Omeprazole5.8%301

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pimecrolimus side effects

60.5% of pimecrolimus adverse event reports involve female patients and 32.2% involve male patients. The largest age group is adult at 63%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.5%
Male32.2%
Unknown7.3%

Age group

< 22.7%
2–119.6%
12–176.8%
18–6462.6%
65+18.2%

What is pimecrolimus used for

Conditions and purposes for which patients were taking pimecrolimus when the adverse event was reported.

AcneAlopeciaAlopecia AreataAlopecia ScarringAnorectal DisorderApplication Site EczemaArthropod BiteAsthmaAutoimmune DisorderAcute Graft Versus Host Disease In SkinAdverse Drug ReactionAlopeciaAlopecia ScarringAnal ErythemaAngular Cheilitis

Showing 15 of 251 indications

Pimecrolimus brand names and reporting trend

Pimecrolimus is sold under the brand name Elidel.

Brand names

Elidel1,717

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pimecrolimus with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.