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Elidel
What is atopic dermatitis?
Atopic dermatitis is a very common, often chronic (long-lasting) skin disease that affects a large percentage of the world's population. It is also called eczema, dermatitis, or atopy. Most commonly, it may be thought of as a type of skin allergy or sensitivity. The atopic dermatitis triad includes asthma, allergies (hay fever), and eczema. There is a known hereditary component of the disease, and it is seen more in some families. The hallmarks of the disease include skin rashes and itching.
The word "dermatitis" means inflammation of the skin. "Atopic" refers to diseases that are hereditary, tend to run in families, and often occur together. In atopic dermatitis, the skin becomes extremely itchy and inflamed, causing redness, swelling, cracking, weeping, crusting, and scaling. Dry skin is a very common complaint and an underlying cause of some of the typical rash symptoms.
Although atopic dermatitis can occu...
Elidel
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SIDE EFFECTS
No phototoxicity and no photoallergenicity were detected in clinical studies with 24 and 33 normal volunteers, respectively. In human dermal safety studies, ELIDEL® (pimecrolimus) Cream 1% did not induce contact sensitization or cumulative irritation.
In a one-year safety study in pediatric patients age 2-17 years old involving sequential use of ELIDEL (pimecrolimus cream) Cream and a topical corticosteroid, 43% of ELIDEL (pimecrolimus cream) patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of ELIDEL (pimecrolimus cream) patients and 54% of vehicle patients. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the patients that had used ELIDEL (pimecrolimus cream) Cream and topical corticosteroid sequentially as compared to ELIDEL (pimecrolimus cream) Cream alone.
In 3 randomized, double-blind vehicle-controlled pediatric studies and one active-controlled adult study, 843 and 328 patients respectively, were treated with ELIDEL (pimecrolimus cream) Cream. In these clinical trials, 48 (4%) of the 1,171 ELIDEL (pimecrolimus cream) patients and 13 (3%) of 408 vehicle-treated patients discontinued therapy due to adverse events. Discontinuations for AEs were primarily due to application site reactions, and cutaneous infections. The most common application site reaction was application site burning, which occurred in 8%-26% of patients treated with ELIDEL (pimecrolimus cream) Cream.
The following table depicts the incidence of adverse events pooled across the 2 identically designed 6-week studies with their open label extensions and the 1-year safety study for pediatric patients ages 2-17. Data from the adult active-controlled study is also included in this table. Adverse events are listed regardless of relationship to study drug.
Treatment Emergent Adverse Events ( ≥ 1%) in Elidel® (pimecrolimus cream)
Treatment Groups
| Pediatric Patients* Vehicle-Controlled (6weeks) | Pediatric Patients* Open-Label (20 weeks) | Pediatric Patients* Vehicle-Controlled (1year) | Adult Active Comparator (1 year) | |||
| Elidel® (pimecrolimus cream) Cream (N=267) N (%) |
Vehicle (N=136) N (%) |
Elidel® (pimecrolimus cream) Cream (N=335) N (%) |
Elidel® (pimecrolimus cream) Cream (N=272) N (%) |
Vehicle (N=75) N (%) |
Elidel® (pimecrolimus cream) Cream (N=328) N (%) |
|
| At least 1 AE | 182 (68.2%) | 97 (71.3%) | 240 (72.0%) | 230 (84.6%) | 56 (74.7%) | 256 (78.0%) |
| Infections and Infestations | ||||||
| Upper Respiratory Tract Infection NOS | 38 (14.2%) | 18 (13.2%) | 65 (19.4%) | 13 (4.8%) | 6 (8.0%) | 14 (4.3%) |
| Nasopharyngitis | 27 (10.1%) | 10 (7.4%) | 32 (19.6%) | 72 (26.5%) | 16 (21.3%) | 25 (7.6%) |
| Skin Infection NOS | 8 (3.0%) | 9 (5.1%) | 18 (5.4%) | 6 (2.2%) | 3 (4.0%) | 21 (6.4%) |
| Influenza | 8 (3.0%) | 1 (0.7%) | 22 (6.6%) | 36 (13.2%) | 3 (4.0%) | 32 (9.8%) |
| Ear Infection NOS | 6 (2.2%) | 2 (1.5%) | 19 (5.7%) | 9 (3.3%) | 1 (1.3%) | 2 (0.6%) |
| Otitis Media | 6 (2.2%) | 1 (0.7%) | 10 (3.0%) | 8 (2.9%) | 4 (5.3%) | 2 (0.6%) |
| Impetigo | 5 (1.9%) | 3 (2.2%) | 12 (3.6%) | 11 (4.0%) | 4 (5.3%) | 8 (2.4%) |
| Bacterial Infection | 4 (1.5%) | 3 (2.2%) | 4 (1.2%) | 3 (1.1%) | 0 | 6 (1.8%) |
| Folliculitis | 3 (1.1%) | 1 (0.7%) | 3 (0.9%) | 6 (2.2%) | 3 (4.0%) | 20 (6.1%) |
| Sinusitis | 3 (1.1%) | 1 (0.7%) | 11 (3.3%) | 6 (2.2%) | 1 (1.3%) | 2 (0.6%) |
| Pneumonia NOS | 3 (1.1%) | 1 (0.7%) | 5 (1.5%) | 0 | 1 (1.3%) | 1 (0.3%) |
| Pharyngitis NOS | 2 (0.7%) | 2 (1.5%) | 3 (0.9%) | 22 (8.1%) | 2 (2.7%) | 3 (0.9%) |
| Pharyngitis Streptococcal | 2 (0.7%) | 2 (1.5%) | 10 (3.0%) | 0 | <1% | 0 |
| Molluscum Contagiosum | 2 (0.7%) | 0 | 4 (1.2%) | 5 (1.8%) | 0 | 0 |
| Staphylococcal Infection | 1 (0.4%) | 5 (3.7%) | 7 (2.1%) | 0 | <1% | 3 (0.9%) |
| Bronchitis NOS | 1 (0.4%) | 3 (2.2%) | 4 (1.2%) | 29 (10.7%) | 6 (8.0%) | 8 (2.4%) |
| Herpes Simplex | 1 (0.4%) | 0 | 4 (1.2%) | 9 (3.3%) | 2 (2.7%) | 13 (4.0%) |
| Tonsillitis NOS | 1 (0.4%) | 0 | 3 (0.9%) | 17 (6.3%) | 0 | 2 (0.6%) |
| Viral Infection NOS | 2 (0.7%) | 1 (0.7%) | 1 (0.3%) | 18 (6.6%) | 1 (1.3%) | 0 |
| Gastroenteritis NOS | 0 | 3 (2.2%) | 2 (0.6%) | 20 (7.4%) | 2 (2.7%) | 6 (1.8%) |
| Chickenpox | 2 (0.7%) | 0 | 3 (0.9%) | 8 (2.9%) | 3 (4.0%) | 1 (0.3%) |
| Skin Papilloma | 1 (0.4%) | 0 | 2 (0.6%) | 9 (3.3%) | < 1% | 0 |
| Tonsillitis Acute NOS | 0 | 0 | 0 | 7 (2.6%) | 0 | 0 |
| Upper Respiratory Tract Infection Viral NOS | 1 (0.4%) | 0 | 3 (0.9%) | 4 (1.5%) | 0 | 1 (0.3%) |
| Herpes Simplex Dermatitis | 0 | 0 | 1 (0.3%) | 4 (1.5%) | 0 | 2 (0.6%) |
| Bronchitis Acute NOS | 0 | 0 | 0 | 4 (1.5%) | 0 | 0 |
| Eye Infection NOS | 0 | 0 | 0 | 3 (1.1%) | < 1% | 1 (0.3%) |
| General Disorders and Administration Site Conditions | ||||||
| Application Site Burning | 28 (10.4%) | 17 (12.5%) | 5 (1.5%) | 23 (8.5%) | 5 (6.7%) | 85 (25.9%) |
| Pyrexia | 20 (7.5%) | 12 (8.8%) | 41 (12.2%) | 34 (12.5%) | 4 (5.3%) | 4 (1.2%) |
| Application Site Reaction NOS | 8 (3.0%) | 7 (5.1%) | 7 (2.1%) | 9 (3.3%) | 2 (2.7%) | 48 (14.6%) |
| Application Site Irritation | 8 (3.0%) | 8 (5.9%) | 3 (0.9%) | 1 (0.4%) | 3 (4.0%) | 21 (6.4%) |
| Influenza Like Illness | 1 (0.4%) | 0 | 2 (0.6%) | 5 (1.8%) | 2 (2.7%) | 6 (1.8%) |
| Application Site Erythema | 1 (0.4%) | 0 | 0 | 6 (2.2%) | 0 | 7 (2.1%) |
| Application Site Pruritus | 3 (1.1%) | 2 (1.5%) | 2 (0.6%) | 5 (1.8%) | 0 | 18 (5.5%) |
| Respiratory, Thoracic and Mediastinal Disorders | ||||||
| Cough | 31 (11.6%) | 11 (8.1%) | 31 (9.3%) | 43 (15.8%) | 8 (10.7%) | 8 (2.4%) |
| Nasal Congestion | 7 (2.6%) | 2 (1.5%) | 6 (1.8%) | 4 (1.5%) | 1 (1.3%) | 2 (0.6%) |
| Rhinorrhea | 5 (1.9%) | 1 (0.7%) | 3 (0.9%) | 1 (0.4%) | 1 (1.3%) | 0 |
| Asthma Aggravated | 4 (1.5%) | 3 (2.2%) | 13 (3.9%) | 3 (1.1%) | 1 (1.3%) | 0 |
| Sinus Congestion | 3 (1.1%) | 1 (0.7%) | 2 (0.6%) | <1% | <1% | 3 (0.9%) |
| Rhinitis | 1 (0.4%) | 0 | 5 (1.5%) | 12 (4.4%) | 5 (6.7%) | 7 (2.1%) |
| Wheezing | 1 (0.4%) | 1 (0.7%) | 4 (1.2%) | 2 (0.7%) | <1% | 0 |
| Asthma NOS | 2 (0.7%) | 1 (0.7%) | 11 (3.3%) | 10 (3.7%) | 2 (2.7%) | 8 (2.4%) |
| Epistaxis | 0 | 1 (0.7%) | 0 | 9 (3.3%) | 1 (1.3%) | 1 (0.3%) |
| Dyspnea NOS | 0 | 0 | 0 | 5 (1.8%) | 1 (1.3%) | 2 (0.6%) |
| Gastrointestinal Disorders | ||||||
| Abdominal Pain Upper | 11 (4.1%) | 6 (4.4%) | 10 (3.0%) | 15 (5.5%) | 5 (6.7%) | 1 (0.3%) |
| Sore Throat | 9 (3.4%) | 5 (3.7%) | 15 (5.4%) | 22 (8.1%) | 4 (5.3%) | 12 (3.7%) |
| Vomiting NOS | 8 (3.0%) | 6 (4.4%) | 14 (4.2%) | 18 (6.6%) | 6 (8.0%) | 2 (0.6%) |
| Diarrhea NOS | 3 (1.1%) | 1 (0.7%) | 2 (0.6%) | 21 (7.7%) | 4 (5.3%) | 7 (2.1%) |
| Nausea | 1 (0.4%) | 3 (2.2%) | 4 (1.2%) | 11 (4.0%) | 5 (6.7%) | 6 (1.8%) |
| Abdominal Pain NOS | 1 (0.4%) | 1 (0.7%) | 5 (1.5%) | 12 (4.4%) | 3 (4.0%) | 1 (0.3%) |
| Toothache | 1 (0.4%) | 1 (0.7%) | 2 (0.6%) | 7 (2.6%) | 1 (1.3%) | 2 (0.6%) |
| Constipation | 1 (0.4%) | 0 | 2 (0.6%) | 10 (3.7%) | < 1% | 0 |
| Loose Stools | 0 | 1 (0.7%) | 4 (1.2%) | < 1% | < 1% | 0 |
| Reproductive System and Breast Disorders | ||||||
| Dysmenorrhea | 3 (1.1%) | 0 | 5 (1.5%) | 3 (1.1%) | 1 (1.3%) | 4 (1.2%) |
| Eye Disorders | ||||||
| Conjunctivitis NEC | 2 (0.7%) | 1 (0.7%) | 7 (2.1%) | 6 (2.2%) | 3 (4.0%) | 10 (3.0%) |
| Skin & Subcutaneous Tissue Disorders | ||||||
| Urticaria | 3 (1.1%) | 0 | 1 (0.3%) | 1 (0.4%) | < 1% | 3 (0.9%) |
| Acne NOS | 0 | 1 (0.7%) | 1 (0.3%) | 4 (1.5%) | < 1% | 6 (1.8%) |
| Immune System Disorders | ||||||
| Hypersensitivity NOS | 11 (4.1%) | 6 (4.4%) | 16 (4.8%) | 14 (5.1%) | 1 (1.3%) | 11 (3.4%) |
| Injury and Poisoning | ||||||
| Accident NOS | 3 (1.1%) | 1 (0.7%) | 1 (0.3%) | < 1% | 1 (1.3%) | 0 |
| Laceration | 2 (0.7%) | 1 (0.7%) | 5 (1.5%) | < 1% | < 1% | 0 |
| Musculoskeletal, Connective Tissueand Bone Disorders | ||||||
| Back Pain | 1 (0.4%) | 2 (1.5%) | 1 (0.3%) | < 1% | 0 | 6 (1.8%) |
| Arthralgias | 0 | 0 | 1 (0.3%) | 3 (1.1%) | 1 (1.3%) | 5 (1.5%) |
| Ear and Labyrinth Disorders | ||||||
| Earache | 2 (0.7%) | 1 (0.7%) | 0 | 8 (2.9%) | 2 (2.7%) | 0 |
| Nervous System Disorders | ||||||
| Headache | 37 (13.9%) | 12 (8.8%) | 38 (11.3%) | 69 (25.4%) | 12 (16.0%) | 23 (7.0%) |
| *Ages 2-17 years | ||||||
Two cases of septic arthritis have been reported in infants less than one year of age in clinical trials conducted with ELIDEL (pimecrolimus cream) Cream (n = 2,443). Causality has not been established.
Post-Marketing Events
The following adverse reactions have been reported in patients using ELIDEL (pimecrolimus cream) Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General
Anaphylactic reactions, ocular irritation after application of the cream to the eye lids or near the eyes, angioneurotic edema, facial edema, skin flushing associated with alcohol use, skin discoloration
Hematology/Oncology
Lymphomas, basal cell carcinoma, malignant melanoma, squamous cell carcinoma
DRUG INTERACTIONS
Potential interactions between ELIDEL (pimecrolimus cream) 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.
Last reviewed on RxList: 8/11/2010
This monograph has been modified to include the generic and brand name in many instances.
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