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Abatacept Adverse Events Reported to the FDA Over Time

How are Abatacept adverse event reports trending over time?

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

Most Common Abatacept Adverse Events Reported to the FDA

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

Pneumonia
83 (2.99%)
Pyrexia
52 (1.88%)
Anaemia
45 (1.62%)
Sepsis
39 (1.41%)
Septic Shock
39 (1.41%)
Basal Cell Carcinoma
33 (1.19%)
Renal Failure Acute
33 (1.19%)
Urinary Tract Infection
31 (1.12%)
Renal Failure
28 (1.01%)
Gastroenteritis
26 (.94%)
Vomiting
25 (.9%)
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Colitis Ulcerative
24 (.87%)
Diarrhoea
24 (.87%)
Dehydration
22 (.79%)
Respiratory Failure
22 (.79%)
Cholecystitis
21 (.76%)
Abdominal Pain
20 (.72%)
Cardiac Failure
20 (.72%)
Dyspnoea
20 (.72%)
Chest Pain
17 (.61%)
Systemic Lupus Erythematosus
17 (.61%)
Lung Neoplasm Malignant
16 (.58%)
Arthritis Bacterial
15 (.54%)
Asthenia
15 (.54%)
Breast Cancer
15 (.54%)
Drug Ineffective
15 (.54%)
Interstitial Lung Disease
15 (.54%)
Multi-organ Failure
15 (.54%)
Cardiac Arrest
14 (.51%)
Deep Vein Thrombosis
14 (.51%)
Headache
14 (.51%)
Osteonecrosis
14 (.51%)
Pulmonary Embolism
14 (.51%)
Pulmonary Tuberculosis
14 (.51%)
Subcutaneous Abscess
14 (.51%)
Abscess
13 (.47%)
Appendicitis
13 (.47%)
Cardiac Failure Congestive
13 (.47%)
Nausea
13 (.47%)
Pancytopenia
13 (.47%)
Rheumatoid Arthritis
13 (.47%)
Lung Adenocarcinoma Metastatic
12 (.43%)
Condition Aggravated
11 (.4%)
Convulsion
11 (.4%)
Diabetes Mellitus
11 (.4%)
Infection
11 (.4%)
Lower Respiratory Tract Infection
11 (.4%)
Pneumonia Aspiration
11 (.4%)
Psoriasis
11 (.4%)
Chills
10 (.36%)
Coma
10 (.36%)
Fall
10 (.36%)
Pleural Effusion
10 (.36%)
Squamous Cell Carcinoma
10 (.36%)
Tetanus
10 (.36%)
Ventricular Extrasystoles
10 (.36%)
Atrial Fibrillation
9 (.32%)
Breast Cancer Female
9 (.32%)
Cellulitis
9 (.32%)
Deafness
9 (.32%)
Death
9 (.32%)
Gastric Ulcer
9 (.32%)
Hepatic Enzyme Increased
9 (.32%)
Lobar Pneumonia
9 (.32%)
Myocardial Infarction
9 (.32%)
Nasopharyngitis
9 (.32%)
Pneumothorax
9 (.32%)
Skin Cancer
9 (.32%)
Abscess Limb
8 (.29%)
Clostridium Difficile Colitis
8 (.29%)
Colitis
8 (.29%)
Compression Fracture
8 (.29%)
Diverticulitis
8 (.29%)
Encephalopathy
8 (.29%)
Endocarditis
8 (.29%)
Gastric Cancer
8 (.29%)
Multiple Sclerosis
8 (.29%)
Pneumonitis
8 (.29%)
Sinusitis
8 (.29%)
Skin Ulcer
8 (.29%)
Temporal Lobe Epilepsy
8 (.29%)
Acute Coronary Syndrome
7 (.25%)
Acute Respiratory Failure
7 (.25%)
Anxiety
7 (.25%)
Arthritis
7 (.25%)
Ascites
7 (.25%)
Back Pain
7 (.25%)
Cholelithiasis
7 (.25%)
Depression
7 (.25%)
Diverticular Perforation
7 (.25%)
Dizziness
7 (.25%)
Febrile Neutropenia
7 (.25%)
Herpes Zoster
7 (.25%)
Hypotension
7 (.25%)
Hypovolaemic Shock
7 (.25%)
Influenza Like Illness
7 (.25%)
Iron Deficiency Anaemia
7 (.25%)
Lung Adenocarcinoma
7 (.25%)
Pain
7 (.25%)
Pyelonephritis Acute
7 (.25%)
Rash
7 (.25%)

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

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

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

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

Rheumatoid Arthritis
861
Systemic Lupus Erythematosus
130
Crohns Disease
60
Colitis Ulcerative
40
Product Used For Unknown Indication
19
Juvenile Arthritis
18
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Ankylosing Spondylitis
12
Glomerulonephritis Proliferative
11
Drug Use For Unknown Indication
10
Psoriatic Arthropathy
8
Polyarthritis
5
Vasculitis
4
Wegeners Granulomatosis
3
Uveitis
2
Erythrodermic Psoriasis
1
Deep Vein Thrombosis
1

Drug Labels

LabelLabelerEffective
OrenciaE.R. Squibb & Sons, L.L.C.15-DEC-11

Abatacept Case Reports

What Abatacept 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 Abatacept. 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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