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Orencia Adverse Events Reported to the FDA Over Time

How are Orencia adverse event reports trending over time?

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

Most Common Orencia Adverse Events Reported to the FDA

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

Drug Ineffective
359 (2.97%)
Headache
263 (2.17%)
Nausea
253 (2.09%)
Fatigue
213 (1.76%)
Pneumonia
187 (1.54%)
Dyspnoea
172 (1.42%)
Rash
167 (1.38%)
Arthralgia
140 (1.16%)
Vomiting
127 (1.05%)
Diarrhoea
115 (.95%)
Dizziness
111 (.92%)
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Death
107 (.88%)
Pyrexia
104 (.86%)
Pain
101 (.83%)
Asthenia
95 (.78%)
Rheumatoid Arthritis
95 (.78%)
Cough
93 (.77%)
Malaise
89 (.74%)
Oedema Peripheral
89 (.74%)
Weight Decreased
88 (.73%)
Interstitial Lung Disease
87 (.72%)
Blood Pressure Increased
77 (.64%)
Pruritus
77 (.64%)
Urticaria
77 (.64%)
Chest Pain
76 (.63%)
Medication Error
75 (.62%)
Hypertension
72 (.59%)
Joint Swelling
72 (.59%)
Pain In Extremity
69 (.57%)
Back Pain
64 (.53%)
Urinary Tract Infection
64 (.53%)
Infection
62 (.51%)
Nasopharyngitis
62 (.51%)
Hypersensitivity
60 (.5%)
Alopecia
59 (.49%)
Hypotension
58 (.48%)
Sepsis
58 (.48%)
Stomatitis
56 (.46%)
Herpes Zoster
54 (.45%)
Cerebrovascular Accident
53 (.44%)
Chest Discomfort
51 (.42%)
Circumstance Or Information Capable...
51 (.42%)
Asthma
50 (.41%)
Anaemia
49 (.4%)
Fall
49 (.4%)
Weight Increased
49 (.4%)
Incorrect Storage Of Drug
48 (.4%)
Influenza Like Illness
47 (.39%)
Myocardial Infarction
47 (.39%)
Bronchitis
46 (.38%)
Cardiac Failure
45 (.37%)
Dehydration
45 (.37%)
Abdominal Pain
44 (.36%)
Migraine
44 (.36%)
Pulmonary Embolism
44 (.36%)
Anaphylactic Reaction
43 (.36%)
Depression
42 (.35%)
Hyperhidrosis
41 (.34%)
Psoriasis
41 (.34%)
Oropharyngeal Pain
40 (.33%)
Renal Failure
39 (.32%)
Sinusitis
39 (.32%)
Infusion Related Reaction
38 (.31%)
Arthropathy
37 (.31%)
Erythema
37 (.31%)
Flushing
37 (.31%)
Hypoaesthesia
37 (.31%)
Atrial Fibrillation
36 (.3%)
Liver Function Test Abnormal
35 (.29%)
Dysgeusia
34 (.28%)
Respiratory Failure
34 (.28%)
Muscle Spasms
33 (.27%)
Pleural Effusion
33 (.27%)
Chronic Obstructive Pulmonary Disea...
32 (.26%)
Paraesthesia
32 (.26%)
Swelling Face
31 (.26%)
Adverse Event
30 (.25%)
Chills
30 (.25%)
Condition Aggravated
30 (.25%)
Lower Respiratory Tract Infection
30 (.25%)
Vasculitis
30 (.25%)
Cardiac Disorder
29 (.24%)
Drug Administration Error
29 (.24%)
Fungal Infection
29 (.24%)
Pancreatitis
29 (.24%)
Therapeutic Response Decreased
29 (.24%)
Anxiety
28 (.23%)
Haemoglobin Decreased
28 (.23%)
Myalgia
28 (.23%)
Pneumocystis Jiroveci Pneumonia
28 (.23%)
Pyoderma Gangrenosum
28 (.23%)
Abdominal Discomfort
27 (.22%)
Decreased Appetite
27 (.22%)
Thrombosis
27 (.22%)
Breast Cancer Stage Iv
26 (.21%)
Gait Disturbance
26 (.21%)
Lung Disorder
26 (.21%)
Mouth Ulceration
26 (.21%)
Surgery
26 (.21%)
Hepatic Enzyme Increased
25 (.21%)
Influenza
25 (.21%)

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

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

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

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

Rheumatoid Arthritis
3015
Juvenile Arthritis
65
Polyarthritis
62
Arthritis
26
Psoriatic Arthropathy
25
Drug Use For Unknown Indication
21
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Musculoskeletal Pain
16
Product Used For Unknown Indication
15
Crohns Disease
12
Systemic Lupus Erythematosus
8
Ankylosing Spondylitis
8
Spondyloarthropathy
6
Vasculitis
6
Seronegative Arthritis
4
Immunosuppressant Drug Therapy
4
Mixed Connective Tissue Disease
4
Spondylitis
2
Osteoarthritis
2
Multiple Sclerosis
2
Erythrodermic Psoriasis
1
Pain
1
Hepatitis B
1
Scleroderma
1
Sle Arthritis
1
Biliary Cirrhosis Primary
1
Pain In Extremity
1
Gout
1
Spinal Disorder
1
Sjogrens Syndrome
1
Dermatitis
1
Psoriasis
1
Arthritis Reactive
1
Uveitis
1

Drug Labels

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

Orencia Case Reports

What Orencia 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 Orencia. 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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