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Xgeva Adverse Events Reported to the FDA Over Time

How are Xgeva adverse event reports trending over time?

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

Most Common Xgeva Adverse Events Reported to the FDA

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

Hypocalcaemia
286 (10.16%)
Bone Pain
90 (3.2%)
Dyspnoea
61 (2.17%)
Death
56 (1.99%)
Pain In Jaw
54 (1.92%)
Hypophosphataemia
50 (1.78%)
Incorrect Route Of Drug Administrat...
36 (1.28%)
Nausea
36 (1.28%)
Fatigue
35 (1.24%)
Vomiting
32 (1.14%)
Pain
31 (1.1%)
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Headache
30 (1.07%)
Arthralgia
29 (1.03%)
Asthenia
29 (1.03%)
Muscle Spasms
29 (1.03%)
Blood Calcium Decreased
27 (.96%)
Pyrexia
25 (.89%)
Pain In Extremity
22 (.78%)
Rash
22 (.78%)
Toothache
22 (.78%)
Back Pain
21 (.75%)
Hospitalisation
21 (.75%)
Malaise
19 (.68%)
Oedema Peripheral
19 (.68%)
Hypoaesthesia
18 (.64%)
Metastases To Bone
18 (.64%)
Paraesthesia
18 (.64%)
Hypercalcaemia
17 (.6%)
Diarrhoea
16 (.57%)
Dizziness
16 (.57%)
Anaemia
15 (.53%)
Influenza Like Illness
15 (.53%)
Muscular Weakness
15 (.53%)
Musculoskeletal Pain
15 (.53%)
Neoplasm Malignant
15 (.53%)
Feeling Abnormal
14 (.5%)
Thrombocytopenia
14 (.5%)
Decreased Appetite
13 (.46%)
Fall
13 (.46%)
Myalgia
13 (.46%)
Pruritus
13 (.46%)
Chills
12 (.43%)
Disease Progression
12 (.43%)
Renal Failure Acute
12 (.43%)
Convulsion
11 (.39%)
Vision Blurred
11 (.39%)
Cough
10 (.36%)
Metastasis
10 (.36%)
Muscle Twitching
10 (.36%)
Osteomyelitis
10 (.36%)
Pneumonia
10 (.36%)
Confusional State
9 (.32%)
Dysgeusia
9 (.32%)
Dysuria
9 (.32%)
Gait Disturbance
9 (.32%)
Hyperkalaemia
9 (.32%)
Hypertension
9 (.32%)
Paraesthesia Oral
9 (.32%)
Rash Erythematous
9 (.32%)
Abdominal Pain
8 (.28%)
Accidental Exposure
8 (.28%)
Blood Alkaline Phosphatase Increase...
8 (.28%)
General Physical Health Deteriorati...
8 (.28%)
Hypotension
8 (.28%)
Injection Site Reaction
8 (.28%)
Metastases To Central Nervous Syste...
8 (.28%)
Neuropathy Peripheral
8 (.28%)
Prostate Cancer
8 (.28%)
Swelling
8 (.28%)
Tooth Disorder
8 (.28%)
Tremor
8 (.28%)
Upper Respiratory Tract Infection
8 (.28%)
Weight Decreased
8 (.28%)
Wrong Drug Administered
8 (.28%)
Activities Of Daily Living Impaired
7 (.25%)
Blood Phosphorus Decreased
7 (.25%)
Blood Pressure Increased
7 (.25%)
Breast Cancer Metastatic
7 (.25%)
Cerebrovascular Accident
7 (.25%)
Chronic Obstructive Pulmonary Disea...
7 (.25%)
Deep Vein Thrombosis
7 (.25%)
Erythema
7 (.25%)
Eye Disorder
7 (.25%)
Injection Site Pain
7 (.25%)
Insomnia
7 (.25%)
Medication Error
7 (.25%)
Osteoarthritis
7 (.25%)
Respiratory Distress
7 (.25%)
Tooth Fracture
7 (.25%)
Abdominal Discomfort
6 (.21%)
Alopecia
6 (.21%)
Bacteraemia
6 (.21%)
Blood Creatinine Abnormal
6 (.21%)
Blood Urea Abnormal
6 (.21%)
Cardiac Disorder
6 (.21%)
Cellulitis
6 (.21%)
Chest Discomfort
6 (.21%)
Chest Pain
6 (.21%)
Constipation
6 (.21%)
Dehydration
6 (.21%)
Dental Care
6 (.21%)

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

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

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

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

Metastases To Bone
518
Product Used For Unknown Indication
300
Prophylaxis
73
Prostate Cancer
71
Breast Cancer
63
Breast Cancer Metastatic
61
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Prostate Cancer Metastatic
54
Osteoporosis Postmenopausal
14
Osteoporosis
12
Renal Cell Carcinoma
10
Bone Giant Cell Tumour
10
Neoplasm
9
Multiple Myeloma
8
Manipulation
7
Lung Cancer Metastatic
6
Neoplasm Malignant
6
Lung Neoplasm Malignant
6
Hypercalcaemia
5
Fibrous Dysplasia Of Bone
4
Bone Sarcoma
3
Bone Disorder
3
Small Cell Lung Cancer Metastatic
2
Renal Cancer
2
Bone Loss
2
Metastatic Malignant Melanoma
2
Bone Lesion
2
Prostatic Disorder
2
Metastases To Breast
2
Metastatic Neoplasm
2
Metastatic Carcinoma Of The Bladder
1
Transitional Cell Carcinoma
1
Osteoporosis Prophylaxis
1
Routine Health Maintenance
1
Bone Neoplasm Malignant
1
Bone Density Abnormal
1
Oestrogen Receptor Assay Positive
1
Osteonecrosis
1
Colorectal Cancer
1
Osteolysis
1
Breast Cancer Stage Iv
1
Lung Adenocarcinoma
1
Metastases To Bone Marrow
1
Bladder Cancer
1
Breast Disorder
1

Drug Labels

LabelLabelerEffective
XgevaAmgen Inc27-FEB-13

Xgeva Case Reports

What Xgeva 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 Xgeva. 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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