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ZOMETA

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Zometa Adverse Events Reported to the FDA Over Time

How are Zometa adverse event reports trending over time?

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

Most Common Zometa Adverse Events Reported to the FDA

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

Osteonecrosis
10303 (2.88%)
Pain
7190 (2.01%)
Anxiety
5259 (1.47%)
Bone Disorder
4852 (1.36%)
Tooth Extraction
4266 (1.19%)
Pain In Jaw
3549 (.99%)
Injury
3501 (.98%)
Osteomyelitis
3369 (.94%)
Death
2692 (.75%)
Back Pain
2540 (.71%)
General Physical Health Deteriorati...
2492 (.7%)
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Dyspnoea
2403 (.67%)
Impaired Healing
2349 (.66%)
Anaemia
2330 (.65%)
Infection
2236 (.62%)
Anhedonia
2204 (.62%)
Arthralgia
2065 (.58%)
Metastases To Bone
2064 (.58%)
Fatigue
2059 (.58%)
Osteoarthritis
1956 (.55%)
Neoplasm Malignant
1934 (.54%)
Emotional Distress
1903 (.53%)
Pyrexia
1882 (.53%)
Deformity
1835 (.51%)
Fall
1789 (.5%)
Depression
1728 (.48%)
Spinal Osteoarthritis
1645 (.46%)
Nausea
1612 (.45%)
Swelling
1581 (.44%)
Hypoaesthesia
1555 (.43%)
Oedema Peripheral
1530 (.43%)
Asthenia
1521 (.42%)
Bone Pain
1513 (.42%)
Constipation
1498 (.42%)
Hypertension
1491 (.42%)
Toothache
1474 (.41%)
Pleural Effusion
1469 (.41%)
Diarrhoea
1468 (.41%)
Pneumonia
1446 (.4%)
Bone Lesion
1431 (.4%)
Decreased Interest
1431 (.4%)
Pain In Extremity
1387 (.39%)
Atelectasis
1348 (.38%)
Chest Pain
1338 (.37%)
Intervertebral Disc Degeneration
1322 (.37%)
Primary Sequestrum
1312 (.37%)
Neuropathy Peripheral
1292 (.36%)
Dizziness
1284 (.36%)
Weight Decreased
1255 (.35%)
Gastrooesophageal Reflux Disease
1250 (.35%)
Vomiting
1226 (.34%)
Tooth Disorder
1180 (.33%)
Haemoglobin Decreased
1173 (.33%)
Abdominal Pain
1162 (.32%)
Osteopenia
1146 (.32%)
Headache
1136 (.32%)
Dental Caries
1115 (.31%)
Tooth Loss
1105 (.31%)
Tooth Abscess
1046 (.29%)
Paraesthesia
1022 (.29%)
Gait Disturbance
1019 (.28%)
Malaise
1018 (.28%)
Sinusitis
1012 (.28%)
Intervertebral Disc Protrusion
994 (.28%)
Cellulitis
987 (.28%)
Neoplasm Progression
985 (.28%)
Jaw Disorder
971 (.27%)
Dysphagia
959 (.27%)
Erythema
956 (.27%)
Purulent Discharge
956 (.27%)
Malignant Neoplasm Progression
953 (.27%)
Chronic Obstructive Pulmonary Disea...
949 (.27%)
Osteoporosis
949 (.27%)
Disability
947 (.26%)
Loose Tooth
897 (.25%)
Urinary Tract Infection
886 (.25%)
Lymphadenopathy
884 (.25%)
Decreased Appetite
882 (.25%)
Cough
864 (.24%)
Insomnia
854 (.24%)
Blood Creatinine Increased
850 (.24%)
Metastases To Liver
849 (.24%)
Physical Disability
838 (.23%)
Dehydration
829 (.23%)
Osteolysis
829 (.23%)
Cardiac Failure Congestive
812 (.23%)
Oral Pain
799 (.22%)
Multiple Myeloma
788 (.22%)
Musculoskeletal Pain
781 (.22%)
Renal Failure
774 (.22%)
Cardiomegaly
771 (.22%)
Hypokalaemia
764 (.21%)
Hypophagia
763 (.21%)
Mastication Disorder
762 (.21%)
Bronchitis
761 (.21%)
Thrombocytopenia
761 (.21%)
Mitral Valve Incompetence
749 (.21%)
Deep Vein Thrombosis
744 (.21%)
Osteitis
741 (.21%)
Arthritis
727 (.2%)
Hiatus Hernia
722 (.2%)

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

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

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

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

Metastases To Bone
8052
Multiple Myeloma
4336
Breast Cancer
1786
Breast Cancer Metastatic
1493
Prostate Cancer
1187
Prostate Cancer Metastatic
1018
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Osteoporosis
936
Neoplasm Malignant
467
Drug Use For Unknown Indication
431
Bone Disorder
364
Prophylaxis
327
Hypercalcaemia
311
Hypercalcaemia Of Malignancy
256
Product Used For Unknown Indication
208
Bone Lesion
200
Renal Cell Carcinoma
142
Lung Neoplasm Malignant
135
Bone Neoplasm Malignant
133
Bone Loss
124
Plasmacytoma
122
Metastasis
121
Lung Cancer Metastatic
106
Bone Density Decreased
106
Bone Pain
86
Metastatic Renal Cell Carcinoma
85
Osteoporosis Prophylaxis
83
Osteolysis
73
Resorption Bone Increased
72
Osteopenia
71
Breast Cancer Female
65
Metastases To Spine
59
Renal Cancer
51
Metastatic Neoplasm
49
Bone Density Abnormal
39
Calcium Deficiency
33
Renal Cell Carcinoma Stage Unspecif...
30
Metastases To Lung
28
Prostate Cancer Stage Iv
27
Metastases To Prostate
24
Bone Cancer Metastatic
24
Osteitis Deformans
24
Non-hodgkins Lymphoma
22
Metastases To Breast
20
Breast Cancer Stage Iv
20
Non-small Cell Lung Cancer
19
Renal Cancer Metastatic
19
Lymphoma
18
Ill-defined Disorder
18
Spinal Fracture
17
Leiomyosarcoma
16
Cancer Pain
15

Drug Labels

LabelLabelerEffective
ZometaNovartis Pharmaceuticals Corporation11-NOV-12

Zometa Case Reports

What Zometa 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 Zometa. 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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