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USTEKINUMAB

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Ustekinumab Adverse Events Reported to the FDA Over Time

How are Ustekinumab adverse event reports trending over time?

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

Most Common Ustekinumab Adverse Events Reported to the FDA

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

Pneumonia
48 (2.19%)
Cellulitis
45 (2.05%)
Myocardial Infarction
44 (2%)
Renal Failure Acute
38 (1.73%)
Drug Ineffective
36 (1.64%)
Prostate Cancer
34 (1.55%)
Psoriasis
33 (1.5%)
Anal Abscess
29 (1.32%)
Septic Shock
26 (1.18%)
Syncope
26 (1.18%)
Liver Function Test Abnormal
25 (1.14%)
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Cerebrovascular Accident
24 (1.09%)
Off Label Use
23 (1.05%)
Breast Cancer
22 (1%)
Hypotension
22 (1%)
Device Related Infection
21 (.96%)
Pyrexia
21 (.96%)
Colon Cancer
19 (.87%)
Cervical Vertebral Fracture
16 (.73%)
Bronchitis
15 (.68%)
Gastrointestinal Haemorrhage
14 (.64%)
Hypoxia
14 (.64%)
Oesophageal Carcinoma
14 (.64%)
Pustular Psoriasis
14 (.64%)
Arthritis
13 (.59%)
Diarrhoea
13 (.59%)
Headache
13 (.59%)
Lymphadenopathy
13 (.59%)
Upper Respiratory Tract Infection
13 (.59%)
Arthritis Bacterial
12 (.55%)
Asthenia
12 (.55%)
Eosinophilic Pneumonia
12 (.55%)
Foot Fracture
12 (.55%)
Gastroenteritis
12 (.55%)
Hypertension
12 (.55%)
Hyponatraemia
12 (.55%)
Mental Status Changes
12 (.55%)
Pulmonary Tuberculosis
12 (.55%)
Respiratory Tract Infection
12 (.55%)
Staphylococcal Bacteraemia
12 (.55%)
Upper Gastrointestinal Haemorrhage
12 (.55%)
Abscess Intestinal
11 (.5%)
Transient Ischaemic Attack
11 (.5%)
Alanine Aminotransferase Increased
10 (.46%)
Alcohol Withdrawal Syndrome
10 (.46%)
Anal Stenosis
10 (.46%)
Aspartate Aminotransferase Increase...
10 (.46%)
Chest Pain
10 (.46%)
Convulsion
10 (.46%)
Deep Vein Thrombosis
10 (.46%)
Dermatitis Exfoliative
10 (.46%)
Empyema
10 (.46%)
Epithelioid Sarcoma
10 (.46%)
Gastric Ulcer
10 (.46%)
Gastrointestinal Candidiasis
10 (.46%)
Herpes Zoster
10 (.46%)
Jaundice
10 (.46%)
Laryngeal Cancer Stage Iii
10 (.46%)
Malignant Melanoma
10 (.46%)
Ovarian Cancer Metastatic
10 (.46%)
Small Cell Lung Cancer Stage Unspec...
10 (.46%)
Arthralgia
9 (.41%)
Tooth Abscess
9 (.41%)
Weight Decreased
9 (.41%)
Acute Sinusitis
8 (.36%)
Confusional State
8 (.36%)
Coronary Artery Stenosis
8 (.36%)
Diverticulitis
8 (.36%)
Dyspnoea
8 (.36%)
Fall
8 (.36%)
Fatigue
8 (.36%)
Henoch-schonlein Purpura
8 (.36%)
International Normalised Ratio Incr...
8 (.36%)
Interstitial Lung Disease
8 (.36%)
Intestinal Obstruction
8 (.36%)
Loss Of Consciousness
8 (.36%)
Meningitis
8 (.36%)
Multiple Sclerosis Relapse
8 (.36%)
Myeloid Leukaemia
8 (.36%)
Myocarditis
8 (.36%)
Nausea
8 (.36%)
Necrotising Fasciitis
8 (.36%)
Nerve Compression
8 (.36%)
Oesophageal Spasm
8 (.36%)
Sepsis
8 (.36%)
Weight Increased
8 (.36%)
Anal Fistula
7 (.32%)
Appendicitis
7 (.32%)
Ascites
7 (.32%)
B-cell Lymphoma
7 (.32%)
Drug Ineffective For Unapproved Ind...
7 (.32%)
Erysipelas
7 (.32%)
Erythrodermic Psoriasis
7 (.32%)
Laryngitis
7 (.32%)
Pancreatitis Acute
7 (.32%)
Rash Pustular
7 (.32%)
Squamous Cell Carcinoma
7 (.32%)
Abdominal Cavity Drainage
6 (.27%)
Bladder Cancer
6 (.27%)
Cholecystitis
6 (.27%)
Clostridial Infection
6 (.27%)

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

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

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

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

Psoriasis
573
Crohns Disease
108
Psoriatic Arthropathy
72
Product Used For Unknown Indication
18
Pustular Psoriasis
12
Sarcoidosis
9
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Drug Use For Unknown Indication
3
Dermatitis Contact
2
Erythrodermic Psoriasis
2
Prophylaxis Against Graft Versus Ho...
2
Hidradenitis
1
Ill-defined Disorder
1
Dermatitis Atopic
1
Dermatitis Exfoliative
1

Drug Labels

LabelLabelerEffective
StelaraJanssen Biotech, Inc.18-APR-13

Ustekinumab Case Reports

What Ustekinumab 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 Ustekinumab. 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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