Recommended Topic Related To:

Elidel

" Allergy medications overview

The arsenal of allergy drugs includes dozens of medications that relieve allergy symptoms when confronted with a trigger known as an allergen. That trigger could be something from a plant, such as polle"...

Elidel

SIDE EFFECTS

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, ELIDEL (pimecrolimus) Cream, 1% did not induce contact sensitization or cumulative irritation.

In a one-year safety trial in pediatric subjects age 2-17 years old involving sequential use of ELIDEL Cream, 1% and a topical corticosteroid, 43% of ELIDEL Cream, 1% treated subjects and 68% of vehicle -treated subjects used corticosteroids during the trial. Corticosteroids were used for more than 7 days by 34% of ELIDEL Cream, 1% treated subjects and 54% of vehicle -treated subjects. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the subjects that had used ELIDEL Cream, 1% and topical corticosteroid sequentially as compared to ELIDEL Cream, 1% alone.

In 3 randomized, double-blind vehicle-controlled pediatric trials and one active-controlled adult trial, 843 and 328 subjects respectively, were treated with ELIDEL Cream, 1%. In these clinical trials, 48 (4%) of the 1,171 ELIDEL treated subjects and 13 (3%) of 408 vehicle-treated subjects 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 subjects treated with ELIDEL Cream, 1%.

Table 1 depicts the incidence of adverse events pooled across the 2 identically designed 6-week trials with their open label extensions and the 1-year safety trial for pediatric subjects ages 2-17. Data from the adult active-controlled trial is also included in Table 1. Adverse events are listed regardless of relationship to trial drug.

Table 1: Treatment Emergent Adverse Events ( ≥ 1%) in Elidel® Treatment Groups

Pediatric Subjects* Vehicle-Controlled (6 weeks) Pediatric Subjects* Open-Label (20 weeks) Pediatric Subjects*Vehicle-Controlled (1 year) Adult ActiveComparator (1 year)
Elidel® Cream
(N=267)
N(%)
Vehicle
(N=136)
N (%)
Elidel® Cream
(N=335)
N (%)
Elidel® Cream
(N=272)
N(%)
Vehicle
(N=75)
N (%)
Elidel® Cream
(N=328)
N (%)
At least 1 AE 182(68.20%) 97(71.30%) 240 (72.0%) 230 (84.6%) 56(74.70%) 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 Tissue and 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 Cream, 1% (n = 2,443). Causality has not been established.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ELIDEL Cream, 1%. 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.

Read the Elidel (pimecrolimus cream) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Potential interactions between ELIDEL 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.

Read the Elidel Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Elidel - User Reviews

Elidel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Elidel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.