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CERTOLIZUMAB PEGOL

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Certolizumab Pegol Adverse Events Reported to the FDA Over Time

How are Certolizumab Pegol adverse event reports trending over time?

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

Most Common Certolizumab Pegol Adverse Events Reported to the FDA

What are the most common Certolizumab Pegol adverse events reported to the FDA?

Pneumonia
234 (1.97%)
Condition Aggravated
157 (1.32%)
Haemoglobin Decreased
131 (1.1%)
Rheumatoid Arthritis
116 (.97%)
Pyrexia
114 (.96%)
Abdominal Pain
101 (.85%)
Bronchitis
101 (.85%)
Arthralgia
91 (.76%)
Hypertension
88 (.74%)
Fatigue
83 (.7%)
Pleural Effusion
72 (.6%)
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Urinary Tract Infection
71 (.6%)
Dehydration
68 (.57%)
Vomiting
68 (.57%)
Nausea
67 (.56%)
Cellulitis
65 (.55%)
Headache
65 (.55%)
Diarrhoea
64 (.54%)
Sepsis
63 (.53%)
Breast Cancer
60 (.5%)
Anaemia
59 (.5%)
Pain
59 (.5%)
Aspartate Aminotransferase Increase...
58 (.49%)
Staphylococcal Infection
58 (.49%)
Drug Ineffective
56 (.47%)
Dyspnoea
55 (.46%)
Haematocrit Decreased
52 (.44%)
Red Blood Cell Count Decreased
52 (.44%)
Back Pain
51 (.43%)
Blood Glucose Increased
49 (.41%)
Chest Pain
48 (.4%)
Sinusitis
48 (.4%)
Abdominal Abscess
47 (.39%)
Alanine Aminotransferase Increased
47 (.39%)
Influenza
45 (.38%)
Platelet Count Increased
45 (.38%)
Pulmonary Tuberculosis
45 (.38%)
Blood Albumin Decreased
44 (.37%)
Nasopharyngitis
44 (.37%)
Gastroenteritis
42 (.35%)
Herpes Zoster
42 (.35%)
Hypotension
42 (.35%)
Osteoarthritis
42 (.35%)
Upper Respiratory Tract Infection
42 (.35%)
Oedema Peripheral
41 (.34%)
Osteoporosis
41 (.34%)
White Blood Cell Count Increased
41 (.34%)
Lymphadenopathy
40 (.34%)
Blood Alkaline Phosphatase Increase...
39 (.33%)
Renal Failure Acute
39 (.33%)
Blood Sodium Decreased
38 (.32%)
Chills
38 (.32%)
Psoriasis
38 (.32%)
Tuberculosis
38 (.32%)
Chronic Obstructive Pulmonary Disea...
37 (.31%)
Cough
37 (.31%)
Rash
37 (.31%)
Cholelithiasis
36 (.3%)
Constipation
36 (.3%)
Contusion
36 (.3%)
Subarachnoid Haemorrhage
36 (.3%)
Infection
35 (.29%)
Asthenia
34 (.29%)
Blood Pressure Increased
34 (.29%)
Interstitial Lung Disease
34 (.29%)
Lobar Pneumonia
34 (.29%)
Dizziness
32 (.27%)
Erythema
32 (.27%)
Lymphoma
32 (.27%)
Pyelonephritis
32 (.27%)
Weight Decreased
32 (.27%)
Arthritis Bacterial
31 (.26%)
Deep Vein Thrombosis
31 (.26%)
Blood Potassium Decreased
30 (.25%)
Frequent Bowel Movements
30 (.25%)
Heart Rate Increased
30 (.25%)
Blood Creatinine Increased
29 (.24%)
Malaise
29 (.24%)
White Blood Cell Count Decreased
29 (.24%)
Body Temperature Increased
28 (.24%)
Fall
28 (.24%)
Postoperative Wound Infection
28 (.24%)
Blood Bilirubin Increased
27 (.23%)
Bronchopneumonia
27 (.23%)
Depression
27 (.23%)
Intervertebral Disc Protrusion
27 (.23%)
Decreased Appetite
26 (.22%)
Dyspepsia
26 (.22%)
Oral Candidiasis
26 (.22%)
Osteonecrosis
25 (.21%)
Pain In Extremity
25 (.21%)
Pulmonary Embolism
25 (.21%)
Ascites
24 (.2%)
C-reactive Protein Increased
24 (.2%)
Candidiasis
24 (.2%)
Gamma-glutamyltransferase Increased
24 (.2%)
Injection Site Reaction
24 (.2%)
Platelet Count Decreased
24 (.2%)
Cystitis
23 (.19%)
Drug Exposure During Pregnancy
23 (.19%)
Fistula
23 (.19%)

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

What are the most common Certolizumab Pegol adverse events reported to the FDA?

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

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

Rheumatoid Arthritis
1590
Crohns Disease
576
Psoriatic Arthropathy
46
Spondylitis
19
Product Used For Unknown Indication
7
Ankylosing Spondylitis
7
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Colitis Ulcerative
4
Polyarthritis
3
Arthritis
3
Inflammatory Bowel Disease
3
Drug Use For Unknown Indication
2
Subcutaneous Emphysema
1
Colitis
1
Spinal Osteoarthritis
1
Small Intestinal Obstruction
1
Convulsion
1
Linear Iga Disease
1

Drug Labels

LabelLabelerEffective
CimziaUCB, Inc.29-NOV-12

Certolizumab Pegol Case Reports

What Certolizumab Pegol 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 Certolizumab Pegol. 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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