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

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using pimecrolimus and call your doctor at once if you have a serious side effect such as:

  • severe burning of treated skin;
  • new symptoms of viral skin infection (warts, unusual rash or skin lesions, blistering or oozing, burning pain or tingling);
  • worsened skin symptoms;
  • swollen glands, sore throat; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • mild burning or warm feeling of treated skin;
  • headache;
  • cold symptoms such as stuffy nose, sneezing;
  • swollen hair follicles;
  • acne or warts;
  • burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);
  • upset stomach;
  • muscle pain; or
  • feeling more sensitive to hot or cold temperatures.

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.

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

SIDE EFFECTS: Mild burning or irritation at the application site may occur during the first few days of treatment. Headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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

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 entire FDA prescribing information for Elidel (Pimecrolimus Cream) »

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.


NIH talks about Ebola on WebMD