Event explorer
| Event | Status | Section | Frequency | Evidence | Source page |
|---|---|---|---|---|---|
| Anaphylactic reactions | Under review | — | Not stated | General; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| angioneurotic edema | Under review | — | Not stated | General; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| application site burning | Listed | — | Not stated | Most common local adverse event in pediatric patients ages 2–17; incidence reported in short-term and long-term studies. | — |
| application site reactions | Listed | — | Not stated | Reported as a primary reason for discontinuation due to adverse events in patients treated with ELIDEL Cream. | — |
| basal cell carcinoma | Under review | — | Not stated | Hematology/Oncology; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| burning or a feeling of warmth | Listed | — | Not stated | Identified as the most common side effect at the skin application site. | — |
| cancer (for example, skin or lymphoma) | Under review | — | Not stated | A very small number of ELIDEL Cream users had cancer, but the label states that a link with use has not been shown. | — |
| common cold or stuffy nose | Listed | — | Not stated | Included among other side effects. | — |
| cough | Listed | — | Not stated | Increased over vehicle in the 1-year safety study and in the infant safety study. | — |
| cutaneous infections | Listed | — | Not stated | Reported as a primary reason for discontinuation due to adverse events in patients treated with ELIDEL Cream. | — |
| diarrhea | Listed | — | Not stated | Increased over vehicle in the 6-week infant study. | — |
| eczema herpeticum | Listed | — | Not stated | Developed in patients treated with ELIDEL Cream; no cases were reported in patients on vehicle alone. | — |
| facial edema | Under review | — | Not stated | General; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| fever | Listed | — | Not stated | Included among other side effects. | — |
| gastroenteritis | Listed | — | Not stated | Increased over vehicle in the 6-week infant study. | — |
| headache | Listed | — | Not stated | More frequent than vehicle in the short-term trial and increased over vehicle in the 1-year safety study. | — |
| hypersensitivity | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
| hypersensitivity to pimecrolimus or any of the components of the cream | Listed | — | Not stated | A history of hypersensitivity is stated as a contraindication. | — |
| impetigo | Listed | — | Not stated | Increased incidence reported with sequential use of ELIDEL Cream and a topical corticosteroid compared with ELIDEL Cream alone. | — |
| influenza | Listed | — | Not stated | Increased over vehicle in the 1-year safety study. | — |
| lymphadenopathy | Under review | — | Not stated | Cases were reported while using ELIDEL Cream; the label says they were usually related to infections and resolved upon appropriate antibiotic therapy. | — |
| Lymphomas | Under review | — | Not stated | Hematology/Oncology; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| malignancy (e.g., skin and lymphoma) | Under review | — | Not stated | Rare cases were reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream; a causal relationship has not been established. | — |
| malignant melanoma | Under review | — | Not stated | Hematology/Oncology; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| nasopharyngitis | Listed | — | Not stated | Increased over vehicle in the 1-year safety study; also among adverse events with increased incidence in the 6-week infant study. | — |
| ocular irritation after application of the cream to the eye lids or near the eyes | Under review | — | Not stated | General; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| otitis media | Listed | — | Not stated | Increased over vehicle in the 6-week infant study. | — |
| pharyngitis | Listed | — | Not stated | Increased over vehicle in the 1-year safety study. | — |
| pyrexia | Listed | — | Not stated | Increased over vehicle in the 1-year safety study and in both infant studies. | — |
| rhinitis | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
| rhinorrhea | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
| septic arthritis | Under review | — | Not stated | Two cases were reported in infants less than one year of age in clinical trials; causality was not established. | — |
| serious adverse reactions in nursing infants | Under review | — | Not stated | The label identifies a potential risk from pimecrolimus in nursing infants. | — |
| skin burning (burning sensation, stinging, soreness) or pruritus | Listed | — | Not stated | The section states that use of ELIDEL Cream may cause these local symptoms. | — |
| skin discoloration | Under review | — | Not stated | General; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| skin flushing associated with alcohol use | Under review | — | Not stated | General; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| skin infection | Listed | — | Not stated | Increased incidence reported with sequential use of ELIDEL Cream and a topical corticosteroid compared with ELIDEL Cream alone. | — |
| skin malignancy and lymphoma | Under review | — | Not stated | Rare cases were reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream; a causal relationship has not been established, and the section describes a potential risk. | — |
| skin papilloma (warts) | Under review | — | Not stated | Cases were observed in patients using ELIDEL Cream; the section does not state that ELIDEL Cream caused them. | — |
| sore throat | Listed | — | Not stated | Included among other side effects. | — |
| squamous cell carcinoma | Under review | — | Not stated | Hematology/Oncology; reported in patients using ELIDEL Cream. The label states that frequency cannot always be reliably estimated or a causal relationship to drug exposure established. | — |
| superinfection (infected atopic dermatitis) | Listed | — | Not stated | Increased incidence reported with sequential use of ELIDEL Cream and a topical corticosteroid compared with ELIDEL Cream alone. | — |
| swollen lymph nodes (glands) | Listed | — | Not stated | The guide says some people may get this as a side effect. | — |
| teething | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
| upper respiratory symptoms/infections | Under review | — | Not stated | A higher incidence was seen in the pediatric patient population relative to the older age group in the PK studies; a causal relationship with ELIDEL use cannot be ruled out. | — |
| URI | Listed | — | Not stated | Increased over vehicle in both infant studies. | — |
| urticaria | Listed | — | Not stated | Increased incidence reported with sequential use of ELIDEL Cream and a topical corticosteroid compared with ELIDEL Cream alone. | — |
| varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum | Under review | — | Not stated | The label says treatment may be independently associated with an increased risk of these infections; it also notes that patients with atopic dermatitis are predisposed to superficial skin infections. | — |
| viral infection | Listed | — | Not stated | Increased over vehicle in the 1-year safety study. | — |
| viral rash | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
| viral skin infections (like cold sores, chicken pox, shingles, or warts) | Listed | — | Not stated | The guide says some people may get these as side effects. | — |
| vomiting | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
| wheezing | Listed | — | Not stated | Greater incidence than vehicle in the infant safety study. | — |
No indexed event matched this search.
A search miss is not a negative listedness finding.