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Aredia Adverse Events Reported to the FDA Over Time

How are Aredia adverse event reports trending over time?

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

Most Common Aredia Adverse Events Reported to the FDA

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

Osteonecrosis
3663 (2.22%)
Pain
3506 (2.13%)
Anxiety
2783 (1.69%)
Bone Disorder
2119 (1.29%)
Injury
1801 (1.09%)
Tooth Extraction
1749 (1.06%)
Osteomyelitis
1568 (.95%)
Pain In Jaw
1373 (.83%)
Anhedonia
1224 (.74%)
Anaemia
1195 (.73%)
Back Pain
1178 (.71%)
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Infection
1171 (.71%)
Dyspnoea
1105 (.67%)
Osteoarthritis
1050 (.64%)
Arthralgia
1032 (.63%)
Impaired Healing
982 (.6%)
Deformity
965 (.59%)
Emotional Distress
960 (.58%)
General Physical Health Deteriorati...
954 (.58%)
Spinal Osteoarthritis
892 (.54%)
Oedema Peripheral
891 (.54%)
Fall
864 (.52%)
Depression
835 (.51%)
Fatigue
805 (.49%)
Decreased Interest
792 (.48%)
Nausea
785 (.48%)
Disability
752 (.46%)
Neuropathy Peripheral
727 (.44%)
Metastases To Bone
723 (.44%)
Hypertension
722 (.44%)
Hypoaesthesia
701 (.43%)
Bone Pain
695 (.42%)
Diarrhoea
690 (.42%)
Swelling
689 (.42%)
Gastrooesophageal Reflux Disease
687 (.42%)
Osteopenia
679 (.41%)
Pyrexia
676 (.41%)
Pneumonia
673 (.41%)
Atelectasis
672 (.41%)
Pleural Effusion
662 (.4%)
Osteoporosis
641 (.39%)
Asthenia
640 (.39%)
Constipation
640 (.39%)
Bone Lesion
625 (.38%)
Chest Pain
622 (.38%)
Intervertebral Disc Degeneration
597 (.36%)
Weight Decreased
596 (.36%)
Intervertebral Disc Protrusion
592 (.36%)
Vomiting
592 (.36%)
Pain In Extremity
581 (.35%)
Headache
578 (.35%)
Neoplasm Malignant
556 (.34%)
Sinusitis
553 (.34%)
Dizziness
552 (.33%)
Abdominal Pain
531 (.32%)
Primary Sequestrum
529 (.32%)
Cellulitis
520 (.32%)
Toothache
509 (.31%)
Dysphagia
505 (.31%)
Chronic Obstructive Pulmonary Disea...
502 (.3%)
Multiple Myeloma
495 (.3%)
Paraesthesia
491 (.3%)
Urinary Tract Infection
477 (.29%)
Dental Caries
474 (.29%)
Tooth Loss
468 (.28%)
Bronchitis
464 (.28%)
Hiatus Hernia
448 (.27%)
Arthritis
446 (.27%)
Tooth Abscess
440 (.27%)
Death
439 (.27%)
Gait Disturbance
432 (.26%)
Insomnia
423 (.26%)
Decreased Appetite
412 (.25%)
Diverticulum
411 (.25%)
Tooth Disorder
409 (.25%)
Haemorrhoids
408 (.25%)
Cataract
407 (.25%)
Sequestrectomy
405 (.25%)
Musculoskeletal Pain
403 (.24%)
Pancytopenia
400 (.24%)
Cardiac Failure Congestive
399 (.24%)
Cardiomegaly
396 (.24%)
Hyperlipidaemia
392 (.24%)
Physical Disability
391 (.24%)
Lymphadenopathy
386 (.23%)
Thrombocytopenia
386 (.23%)
Pathological Fracture
385 (.23%)
Mitral Valve Incompetence
381 (.23%)
Osteolysis
381 (.23%)
Rib Fracture
381 (.23%)
Oral Pain
380 (.23%)
Compression Fracture
378 (.23%)
Erythema
377 (.23%)
Renal Failure
376 (.23%)
Scoliosis
366 (.22%)
Neck Pain
364 (.22%)
Jaw Disorder
363 (.22%)
Upper Respiratory Tract Infection
360 (.22%)
Loose Tooth
357 (.22%)
Lung Neoplasm
353 (.21%)
Dehydration
349 (.21%)

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

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

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

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

Multiple Myeloma
2148
Metastases To Bone
2136
Osteoporosis
560
Breast Cancer
506
Breast Cancer Metastatic
323
Hypercalcaemia
251
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Drug Use For Unknown Indication
235
Product Used For Unknown Indication
235
Hypercalcaemia Of Malignancy
103
Osteogenesis Imperfecta
98
Bone Loss
94
Prophylaxis
91
Neoplasm Malignant
90
Bone Disorder
89
Bone Density Decreased
79
Plasmacytoma
75
Osteitis Deformans
69
Resorption Bone Increased
56
Osteolysis
55
Prostate Cancer
50
Bone Pain
47
Prostate Cancer Metastatic
47
Bone Lesion
39
Osteoporosis Prophylaxis
38
Bone Neoplasm Malignant
28
Complex Regional Pain Syndrome
27
Breast Cancer Female
22
Spinal Fracture
21
Metastasis
20
Lung Neoplasm Malignant
18
Sarcoidosis
18
Bone Cancer Metastatic
17
Hypogonadism
17
Osteopenia
16
Light Chain Analysis Increased
13
Breast Cancer Recurrent
11
Mastocytosis
11
Colon Cancer Metastatic
11
Fibrous Dysplasia Of Bone
10
Pain
10
Blood Calcium Increased
8
Hypergammaglobulinaemia Benign Mono...
8
Renal Cancer
7
Osteonecrosis
7
Supportive Care
7
Metastases To Bone Marrow
7
Metastatic Neoplasm
7
Osteoarthritis
7
Ankylosing Spondylitis
6
Breast Cancer Stage Iv
6
Lung Cancer Metastatic
6

Aredia Case Reports

What Aredia 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 Aredia. 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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