LOW-VOLUME · SEX-BALANCED

pimecrolimus Side Effects

pimecrolimus (also sold as Elidel) is a LOW-VOLUME FAERS extract #472 of 524 by FAERS report count. Still opens on SEX-BALANCED: 64% of sex-coded reports are female (891 F / 491 M).

Data updated 2026-05-15

1,541
FAERS reports

Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.

pimecrolimus reporting skew - 64% of sex-coded reports are female (891 F / 491 M). Volume band LOW-VOLUME #472 of 524 by FAERS report count; caseload SIGNAL.

Thinner FAERS extract for pimecrolimus (Elidel) (1,541 reports #472 of 524 by FAERS report count). 64% of sex-coded reports are female (891 F / 491 M). Sparse books still carry named reaction rows when present; not medical advice.

Counts from the openFDA FAERS extract (2004–2025). Stamps SIGNAL · DEATH-MARKED · HOSP-MID · SEX-BALANCED.

DERMATITIS ATOPIC leads 178 of 1,541 reports

DERMATITIS ATOPIC
178
RASH
169
PRURITUS
160
ECZEMA
80
DRY SKIN
79
ERYTHEMA
68
CONDITION AGGRAVATED
64
SKIN EXFOLIATION
64
INJECTION SITE PAIN
63
PAIN
60
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION
55
FATIGUE
52
DISCOMFORT
50
ARTHRALGIA
49
SLEEP DISORDER
47
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
45

Who reports · age peak 45-64 (SEX-BALANCED)

Sex coding · SEX-BALANCED

Female 891 (64%)
Male 491 (35%)
Unknown 7

Age peak 45-64 (294 reports)

0-17 193 (21%)
18-44 275 (29%)
45-64 294 (31%)
65-74 97 (10%)
75+ 75 (8%)

FAERS filings rising toward 2025

2004 2025

Reactions in Death Reports

Death appears on 21 reports (1.4% - MARKED). Reactions below co-occur in those rows only.

Reaction Reports
DEATH 8
ASCITES 3
AZOTAEMIA 3
CANDIDA SEPSIS 3
MULTIPLE ORGAN DYSFUNCTION SYNDROME 3
PNEUMONIA ASPIRATION 3
PRURITUS 3
ACUTE PULMONARY OEDEMA 2
BACTERAEMIA 2
BLOOD BILIRUBIN INCREASED 2
CHOLESTASIS 2
DISEASE PROGRESSION 2
FALL 2
FLUID OVERLOAD 2
LACTIC ACIDOSIS 2
MALIGNANT NEOPLASM PROGRESSION 2
PORTAL HYPERTENSION 2
URINARY TRACT INFECTION 2
ABDOMINAL PAIN UPPER 1

Reactions in Hospitalization Reports

Hospitalization mid-share (183, 11.9%). Co-reported reactions:

Reaction Reports
FATIGUE 12
CROHN^S DISEASE 11
PNEUMONIA 10
ARTHRALGIA 9
DIARRHOEA 9
HOSPITALISATION 9
PAIN 9
COVID-19 8
ERYTHEMA 8
HYPOTENSION 8
URINARY TRACT INFECTION 8
BACK PAIN 7
DYSPNOEA 7
NAUSEA 7
PYREXIA 7
RASH 7
SKIN INFECTION 7
COUGH 6
How to read pimecrolimus FAERS figures (SIGNAL · DEATH-MARKED · HOSP-MID)

FAERS holds 1,541 voluntary reports linked to pimecrolimus (Elidel), 2004-2025. Death is listed on 21 (1.4%). Hospitalization appears on 183 (11.9%). Top co-reported indication: Dermatitis Atopic.

Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.

Read with pimecrolimus

Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.