Drug Safety Information for ELIDEL (Pimecrolimus)

Required post-approval safety study:

The preclinical rodent studies found an increased risk for lymphoma and follicular cell thyroid adenoma in the studies evaluating an oral formulation of pimecrolimus. We agree to conduct a registry study of pediatric patients (aged 2-17, with emphasis on the younger ages) with atopic dermatitis followed through adulthood for those who have long-term intermittent treatment with Elidel (pimecrolimus) 1% Cream to assess the risk of developing systemic malignancies. Study proposal for review: April 30, 2002. Report: Every 5 years after the division reviews and accepts the proposal and the study is initiated. Data will be submitted with NDA annual report. b. A preclinical mouse photocarcinogenicity study showed an accelerated rate of development of cutaneous malignancies. We agree to conduct a registry or case-controlled study of sun-exposed adult patients, aged 40 and above, with atopic dermatitis, who have long-term intermittent treatment with Elidel (pimecrolimus) 1%Cream to assess the risk of developing cutaneous malignancies. Study proposal for review: June 30, 2002. Report: Every 5 years after the division reviews and accepts the proposal and the study is initiated. Data will be submitted with NDA annual report. Due Date: 2026-12-31

Original FDA Drug Approval Date for ELIDEL: 2001-12-13

Adverse Drug Reactions for ELIDEL* (Pimecrolimus)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ELIDEL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pyrexia	89
2	Pruritus	89
3	Rash	85
4	Erythema	84
5	Application site pain	80
6	Condition aggravated	77
7	Application site erythema	77
8	Drug ineffective	75
9	Fatigue	73
10	Lymphadenopathy	72
11	Vomiting	67
12	Nausea	67
13	Dyspnoea	66
14	Pain	66
15	Headache	56
16	Diarrhoea	55
17	Eye irritation	50
18	Insomnia	48
19	Cough	47
20	Dizziness	46

* This side effect also appears in "Top 10 Side Effects of ELIDEL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ELIDEL
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Eczema	3036
2	Dermatitis atopic	739
3	Dermatitis*	434
4	Rash	278
5	Product used for unknown indication	274
6	Vitiligo	199
7	Psoriasis	159
8	Rosacea*	99
9	Dry skin	62
10	Seborrhoeic dermatitis	61

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for ELIDEL

Total Reports Filed with FDA: 9210

Number of FDA Adverse Event Reports by Patient Age for ELIDEL

Total Reports Filed with FDA: 9210*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pimecrolimus (Elidel)

Charts are based on 9210 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.