Elidel
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Elidel
Elidel Side Effects Center
Pharmacy Editor: Charles Patrick Davis, MD, PhD
Elidel (pimecrolimus) is an immunodepressant cream formulation for short-term only treatment of mild to moderate atopic dermatitis (eczema) in nonimmunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Elidel cream is available in other countries as pimecrolimus cream. Common side effects are nausea, nosebleeds, painful menses, cough, warts or skin bumps on treated areas and skin warmth and redness.
Elidel (pimecrolimus) is available in strength of 1% in a cream base in 30, 60 and 100 gram tubes. Usual dosage is to apply a thin cream film twice daily to the affected area of skin. Do not get cream into the eyes. Serious side effects include skin cancer, lymphoma, fevers, and infections, short of breath, facial swelling and blisters. There are no adequate studies of Elidel in pregnant or breast feeding women. Use of this drug in these populations should outweigh the potential risks to the fetus and infant. Elidel has been used in pediatric patients, but use in children less than two years old is not advised.
Our Elidel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Elidel in Detail - Patient Information: Side Effects
Stop using pimecrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using pimecrolimus and call your doctor if you have:
- worsened skin symptoms;
- signs of a skin infection (redness, swelling, itching, oozing);
- swollen glands; or
- fever, chills, body aches, flu symptoms.
Less serious side effects are more likely to occur. Continue using pimecrolimus and talk with your doctor if you have any of these side effects:
- burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);
- swollen hair follicles;
- acne or warts;
- upset stomach;
- muscle pain;
- runny or stuffy nose;
- headache; or
- feeling more sensitive to hot or cold temperatures.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Elidel (Pimecrolimus Cream) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Elidel Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if the following unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Elidel (Pimecrolimus Cream)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Elidel FDA Prescribing Information: Side Effects
(Adverse Reactions)
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
Read the entire FDA prescribing information for Elidel (Pimecrolimus Cream) »
Additional Elidel Information
Elidel - User Reviews
Elidel User Reviews
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Here is a collection of user reviews for the medication Elidel sorted by most helpful.
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