Elidel Side Effects
Please note - some side effects for Elidel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Elidel - for the Consumer
Elidel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Elidel:
Seek medical attention right away if any of these SEVERE side effects occur when using Elidel:Burning sensation or feeling of warmth at the application site; cough; headache; nose or throat irritation.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); flu syndrome (eg, fever, muscle aches); severe or persistent burning sensation at the application site; skin infection (eg, redness, swelling, pus discharge); swollen lymph nodes (glands); warts, sores, or other new growths on the skin, including herpes skin infections (eg, cold sores, chickenpox, shingles); worsening of condition.
Elidel Side Effects - for the Professional
Elidel
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 Cream and a topical corticosteroid, 43% of Elidel patients and 68% of vehicle patients used corticosteroids during the study. Corticosteroids were used for more than 7 days by 34% of Elidel 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 Cream and topical corticosteroid sequentially as compared to Elidel 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 Cream. In these clinical trials, 48 (4%) of the 1,171 Elidel 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 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.
| Pediatric Patients*Vehicle-Controlled(6 weeks) | Pediatric Patients* Open-Label (20 weeks) | Pediatric Patients* Vehicle-Controlled(1 year) | Adult Active Comparator (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 (68.2%) | 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 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 (n = 2,443). Causality has not been established.
TopSide Effects by Body System
Local
Most application site reactions were considered mild to moderate, started within 1 to 5 days of treatment initiation, and lasted for up to 5 days.
Local reactions have most commonly included application site reactions including burning (26%), irritation (6.4%), pruritus (5.5%), erythema (2.1%), and unspecified reactions (14.6%).
Other
Other side effects have included systemic and cutaneous infections. These have included bacterial infection (1.8%), staphylococcal infections (0.9%), ear infection (0.6%), and otitis media (0.6%). Influenza-like illness (1.8%) and pyrexia (1.2%) have also been reported.
Oncologic
Ten cases of cancer have been reported in postmarketing experience. Six cases were reported as cutaneous tumors, 1 as lymph node/cutaneous tumor, and the remaining 3 without specifying location. Four of these cases occurred in children (3 cases under the age of 6) with the remaining 6 cases were reported in adults. Four cases were reported as lymphomas, 1 as granulomatous lymphadenitis, and the remaining 5 as a variety of tumors (including basal cell carcinoma and squamous cell carcinoma). In addition, 2 of the cases reported lymphadenopathy. The median time to diagnosis was 90 days (range 7 to 300 days) following initiation of treatment with pimecrolimus topical. One adult was hospitalized. A causal relationship has not been established.
Oncologic side effects have included lymphoma and skin cancer. A definite causal relationship between these reports and pimecrolimus topical has not been clearly established. At least 10 cases of cancer have been reported during postmarketing experience.
Respiratory
In comparison to patients using pimecrolimus alone, patients using pimecrolimus topical and a topical corticosteroid sequentially experienced an increased incidence of rhinitis.
Respiratory side effects have included influenza (9.8%), nasopharyngitis (7.6%), upper respiratory infections (4.3%), cough (2.4%), asthma (2.4%), rhinitis (2.1%), sinus congestion (0.9%), pharyngitis (0.9%), nasal congestion (0.6%), tonsillitis (0.6%), sinusitis (0.6%), dyspnea (0.6%), epistaxis (0.3%), pneumonia (0.3%), viral upper respiratory tract infections (0.3%), and pharyngolaryngeal pain.
Gastrointestinal
Gastrointestinal side effects have included sore throat (3.7%), diarrhea (2.1%), nausea (1.8%), vomiting (0.6%), toothache (0.6%), upper abdominal pain (0.3%), abdominal pain (0.3%), and gastroenteritis (0.3%).
Genitourinary
Genitourinary side effects have included dysmenorrhea (1.2%).
Ocular
Ocular side effects have included conjunctivitis (3%) and eye infections (0.3%).
Dermatologic
A 43-year-old male with a history of seborrheic dermatitis experienced rosacea-like demodicidosis coincident with pimecrolimus therapy. The patient presented with a recurrence of seborrheic dermatitis. He was restarted on pimecrolimus 1% since he had previously responded to the therapy. After one week of therapy, the patient developed new, erythematous papules and confluent plaques around the nose and both cheeks. A diagnosis of demodicidosis was made based on clinical findings. Pimecrolimus therapy was discontinued, and the patient was started on 100 mg of minocycline once daily. After 4 weeks of therapy, the lesion had resolved completely.
Dermatologic side effects have included skin infections (6.4%), folliculitis (6.1%), herpes simplex (4%), impetigo (2.4%), acne (1.8%), urticaria (0.9%), herpes simplex dermatitis (0.6%), and chicken pox (0.3%). Skin discoloration has been reported during postmarketing experience. At least one case of rosacea-like demodicidosis has also been reported.
Hypersensitivity
Hypersensitivity reactions (not specified) have been reported in 3.4% of patients. Seasonal allergy has also been reported.
Musculoskeletal
Musculoskeletal side effects have included back pain (1.8%) and arthralgias (1.5%).
Nervous system
Nervous system side effects have included headache (7%).
Top
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
