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SORIATANE

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Soriatane Adverse Events Reported to the FDA Over Time

How are Soriatane adverse event reports trending over time?

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

Most Common Soriatane Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
61 (3.09%)
Pregnancy
55 (2.78%)
Alopecia
38 (1.92%)
Drug Ineffective
37 (1.87%)
Skin Exfoliation
28 (1.42%)
Psoriasis
27 (1.37%)
Abortion Induced
26 (1.32%)
Drug Exposure Before Pregnancy
25 (1.26%)
Erythema
23 (1.16%)
Headache
19 (.96%)
Condition Aggravated
18 (.91%)
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Dry Mouth
18 (.91%)
Off Label Use
17 (.86%)
Pain In Extremity
17 (.86%)
Pruritus
17 (.86%)
Arthralgia
16 (.81%)
Oedema Peripheral
16 (.81%)
Dry Skin
15 (.76%)
Chapped Lips
13 (.66%)
Myalgia
13 (.66%)
Myocardial Infarction
13 (.66%)
Dermatitis Exfoliative
12 (.61%)
Drug Interaction
12 (.61%)
Gait Disturbance
12 (.61%)
Pregnancy Of Partner
12 (.61%)
Rhabdomyolysis
12 (.61%)
Blood Triglycerides Increased
11 (.56%)
Chills
11 (.56%)
Lip Dry
11 (.56%)
Pain
11 (.56%)
Weight Decreased
11 (.56%)
Alanine Aminotransferase Increased
10 (.51%)
Aspartate Aminotransferase Increase...
10 (.51%)
Pyrexia
10 (.51%)
Renal Failure
10 (.51%)
Vision Blurred
10 (.51%)
Abortion Spontaneous
9 (.46%)
Alcohol Use
9 (.46%)
Asthenia
9 (.46%)
Coronary Artery Stenosis
9 (.46%)
Epistaxis
9 (.46%)
Fatigue
9 (.46%)
Hypoaesthesia
9 (.46%)
Hypotension
9 (.46%)
Pregnancy On Oral Contraceptive
9 (.46%)
Pulmonary Embolism
9 (.46%)
Treatment Noncompliance
9 (.46%)
Hypertriglyceridaemia
8 (.4%)
Lip Exfoliation
8 (.4%)
Maternal Drugs Affecting Foetus
8 (.4%)
Myositis
8 (.4%)
Nail Disorder
8 (.4%)
Paraesthesia
8 (.4%)
Renal Failure Acute
8 (.4%)
Ventricular Hypokinesia
8 (.4%)
Visual Acuity Reduced
8 (.4%)
Back Pain
7 (.35%)
Blood Cholesterol Increased
7 (.35%)
Cardiac Failure Congestive
7 (.35%)
Chest Pain
7 (.35%)
Diarrhoea
7 (.35%)
Dyspnoea
7 (.35%)
Muscular Weakness
7 (.35%)
Nausea
7 (.35%)
Pain Of Skin
7 (.35%)
Pustular Psoriasis
7 (.35%)
Staphylococcal Infection
7 (.35%)
Vomiting
7 (.35%)
Balance Disorder
6 (.3%)
Blister
6 (.3%)
Blood Creatine Phosphokinase Increa...
6 (.3%)
Blood Lactate Dehydrogenase Increas...
6 (.3%)
Cholestasis
6 (.3%)
Confusional State
6 (.3%)
Death
6 (.3%)
Decreased Appetite
6 (.3%)
Depression
6 (.3%)
Dry Eye
6 (.3%)
Eosinophilia
6 (.3%)
Grand Mal Convulsion
6 (.3%)
Hypothyroidism
6 (.3%)
Onychomadesis
6 (.3%)
Skin Chapped
6 (.3%)
Suicide Attempt
6 (.3%)
Wound Secretion
6 (.3%)
Acne
5 (.25%)
Amnesia
5 (.25%)
Autoimmune Disorder
5 (.25%)
Blood Pressure Increased
5 (.25%)
Drug Administration Error
5 (.25%)
Drug Dispensing Error
5 (.25%)
Drug Toxicity
5 (.25%)
Feeling Hot
5 (.25%)
Foetal Malformation
5 (.25%)
Gamma-glutamyltransferase Increased
5 (.25%)
Haemoglobin Decreased
5 (.25%)
Hepatic Enzyme Increased
5 (.25%)
Hypercholesterolaemia
5 (.25%)
Hyperkalaemia
5 (.25%)
Loss Of Consciousness
5 (.25%)
Lymphadenopathy
5 (.25%)

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This graph shows the top adverse events submitted to the FDA for Soriatane, 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 Soriatane 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 Soriatane

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

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This graph shows the top categories of adverse events submitted to the FDA for Soriatane, 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 Soriatane 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 Soriatane According to Those Reporting Adverse Events

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

Psoriasis
322
Drug Use For Unknown Indication
58
Product Used For Unknown Indication
32
Pustular Psoriasis
13
Keratosis Follicular
10
Pityriasis Rubra Pilaris
9
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Skin Cancer
9
Ichthyosis
8
Squamous Cell Carcinoma
8
Erythrodermic Psoriasis
6
Lichen Planus
6
Prophylaxis
4
Eczema
4
Mycosis Fungoides
3
Dermatosis
3
Skin Papilloma
2
Psoriatic Arthropathy
2
Dermatitis
2
Porokeratosis
2
Rash
2
Accidental Exposure
2
Transient Acantholytic Dermatosis
2
Malignant Melanoma
2
Skin Plaque
1
Cutaneous Lupus Erythematosus
1
Lichen Sclerosus
1
Nail Psoriasis
1
Guttate Psoriasis
1
Seborrhoea
1
Acne
1
Harlequin Foetus
1
Rash Pustular
1
Prophylactic Chemotherapy
1
Hyperkeratosis
1
Ichthyosis Acquired
1
Nephrogenic Fibrosing Dermopathy
1
Skin Disorder
1
Precancerous Skin Lesion
1
Hidradenitis
1

Drug Labels

LabelLabelerEffective
SoriataneStiefel Laboratories Inc13-JUL-12

Soriatane Case Reports

What Soriatane 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 Soriatane. 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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