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Elidel Adverse Events Reported to the FDA Over Time

How are Elidel adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Elidel, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Elidel is flagged as the suspect drug causing the adverse event.

Most Common Elidel Adverse Events Reported to the FDA

What are the most common Elidel adverse events reported to the FDA?

Lymphadenopathy
167 (1.42%)
Pyrexia
155 (1.32%)
Injury
113 (.96%)
Pruritus
111 (.94%)
Fatigue
110 (.94%)
Rash
102 (.87%)
Dyspnoea
92 (.78%)
Erythema
92 (.78%)
Anaemia
90 (.77%)
Sinusitis
90 (.77%)
Lymphoma
87 (.74%)
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Eczema
81 (.69%)
Abdominal Pain
79 (.67%)
Alopecia
79 (.67%)
Weight Decreased
79 (.67%)
Diarrhoea
76 (.65%)
Arthralgia
74 (.63%)
Nausea
74 (.63%)
Vomiting
74 (.63%)
Upper Respiratory Tract Infection
72 (.61%)
Headache
70 (.6%)
Drug Ineffective
68 (.58%)
Pain
68 (.58%)
Bronchitis
65 (.55%)
Condition Aggravated
65 (.55%)
Acute Lymphocytic Leukaemia
58 (.49%)
Application Site Erythema
58 (.49%)
Fall
57 (.49%)
Constipation
56 (.48%)
Pain In Extremity
56 (.48%)
Ear Pain
55 (.47%)
Neuropathy Peripheral
55 (.47%)
Dysphagia
54 (.46%)
Neutropenia
53 (.45%)
Asthenia
49 (.42%)
Cough
49 (.42%)
Drug Exposure During Pregnancy
49 (.42%)
Mycosis Fungoides
49 (.42%)
Mucosal Inflammation
48 (.41%)
Chest Pain
47 (.4%)
Dizziness
47 (.4%)
Pharyngitis
47 (.4%)
Decreased Appetite
46 (.39%)
Depression
46 (.39%)
Night Sweats
46 (.39%)
Pancytopenia
46 (.39%)
Pneumonia
46 (.39%)
Conjunctivitis
45 (.38%)
Rhinorrhoea
44 (.37%)
Eye Irritation
42 (.36%)
Oedema Peripheral
41 (.35%)
Swelling
40 (.34%)
Anxiety
39 (.33%)
Application Site Irritation
38 (.32%)
Application Site Pruritus
38 (.32%)
Back Pain
38 (.32%)
General Physical Health Deteriorati...
38 (.32%)
Cellulitis
37 (.31%)
Contusion
37 (.31%)
Hypothyroidism
37 (.31%)
Myalgia
37 (.31%)
Rhinitis Allergic
37 (.31%)
Application Site Dryness
36 (.31%)
Gait Disturbance
36 (.31%)
Intervertebral Disc Protrusion
35 (.3%)
Scoliosis
35 (.3%)
Abdominal Pain Upper
34 (.29%)
Otitis Media
33 (.28%)
B-cell Lymphoma
32 (.27%)
Bone Pain
32 (.27%)
Insomnia
32 (.27%)
Ear Infection
31 (.26%)
Migraine
31 (.26%)
Urinary Tract Infection
31 (.26%)
Influenza
30 (.26%)
Skin Lesion
30 (.26%)
Oropharyngeal Pain
29 (.25%)
Rash Erythematous
29 (.25%)
Basal Cell Carcinoma
28 (.24%)
Blood Triglycerides Increased
28 (.24%)
Central Venous Catheterisation
28 (.24%)
Dysuria
28 (.24%)
Hypoaesthesia
28 (.24%)
Oral Disorder
28 (.24%)
Stomatitis
28 (.24%)
Asthma
27 (.23%)
Hepatic Lesion
27 (.23%)
Blister
26 (.22%)
Gastrooesophageal Reflux Disease
26 (.22%)
Hypertension
26 (.22%)
Skin Exfoliation
26 (.22%)
Thrombocytopenia
26 (.22%)
Blood Cholesterol Increased
25 (.21%)
Blood Glucose Increased
25 (.21%)
Caesarean Section
25 (.21%)
Lung Disorder
25 (.21%)
Swelling Face
25 (.21%)
Alcohol Interaction
24 (.2%)
Application Site Pain
24 (.2%)
Dermatitis
24 (.2%)
Leukocytosis
24 (.2%)

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This graph shows the top adverse events submitted to the FDA for Elidel, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Elidel is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Elidel

What are the most common Elidel adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Elidel, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Elidel is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Elidel According to Those Reporting Adverse Events

Why are people taking Elidel, according to those reporting adverse events to the FDA?

Eczema
838
Dermatitis Atopic
240
Dermatitis
99
Rash
78
Vitiligo
68
Rosacea
47
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Psoriasis
25
Seborrhoeic Dermatitis
22
Neurodermatitis
20
Product Used For Unknown Indication
19
Dry Skin
17
Acne
17
Erythema
17
Blepharitis
16
Pruritus
15
Alopecia
15
Hypersensitivity
13
Skin Disorder
13
Drug Use For Unknown Indication
11
Dermatitis Contact
10
Skin Irritation
8
Lichen Sclerosus
8
Rectal Fissure
4
Skin Cancer
4
Rash Papular
4
Graft Versus Host Disease
3
Rash Generalised
3
Rash Macular
3
Oral Lichen Planus
3
Pigmentation Disorder
3
Eczema Infantile
3
Skin Exfoliation
3
Neoplasm Malignant
2
Alopecia Areata
2
Eyelid Irritation
2
Vasculitic Rash
2
Seborrhoea
2
Hand Dermatitis
2
Eyelid Oedema
2
Parapsoriasis
2
Thermal Burn
2
Arthropod Bite
2
Rash Vesicular
2
Serratia Infection
2
Phlebitis
2
Acne Infantile
2
Skin Discolouration
2
Skin Fissures
1
Scleroderma
1
Wound
1
Fungal Skin Infection
1

Drug Labels

LabelLabelerEffective
ElidelPhysicians Total Care, Inc.09-AUG-09
ElidelNovartis Pharmaceuticals Corporation01-AUG-10
ElidelValeant Pharmaceuticals North America LLC18-NOV-11

Elidel Case Reports

What Elidel safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Elidel. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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