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ZOLEDRONATE

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Zoledronate Adverse Events Reported to the FDA Over Time

How are Zoledronate adverse event reports trending over time?

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

Most Common Zoledronate Adverse Events Reported to the FDA

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

Osteonecrosis
297 (4.75%)
Tooth Extraction
157 (2.51%)
Bone Disorder
125 (2%)
Pain
114 (1.82%)
Impaired Healing
91 (1.46%)
Malignant Neoplasm Progression
83 (1.33%)
Pyrexia
74 (1.18%)
Osteomyelitis
72 (1.15%)
Fall
68 (1.09%)
Death
67 (1.07%)
Dyspnoea
65 (1.04%)
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Swelling
64 (1.02%)
Nausea
63 (1.01%)
Vomiting
61 (.98%)
Pain In Jaw
57 (.91%)
Hypocalcaemia
55 (.88%)
Sequestrectomy
55 (.88%)
Bone Debridement
45 (.72%)
Surgery
43 (.69%)
Erythema
42 (.67%)
Arthralgia
40 (.64%)
Asthenia
38 (.61%)
Blood Creatinine Increased
37 (.59%)
Bone Pain
37 (.59%)
Diarrhoea
32 (.51%)
Chest Pain
31 (.5%)
Concomitant Disease Progression
31 (.5%)
Jaw Disorder
31 (.5%)
Primary Sequestrum
31 (.5%)
Gingival Infection
30 (.48%)
Purulent Discharge
30 (.48%)
Fatigue
29 (.46%)
Toothache
29 (.46%)
Anaemia
28 (.45%)
Disease Progression
26 (.42%)
Headache
26 (.42%)
Abdominal Pain
25 (.4%)
Cellulitis
24 (.38%)
General Physical Health Deteriorati...
24 (.38%)
Infection
24 (.38%)
Loss Of Consciousness
24 (.38%)
Lymphadenopathy
24 (.38%)
Pneumonia
24 (.38%)
Sepsis
24 (.38%)
Urinary Tract Infection
24 (.38%)
Bone Lesion Excision
23 (.37%)
Osteitis
23 (.37%)
Blood Urea Increased
22 (.35%)
Hypotension
22 (.35%)
Osteolysis
22 (.35%)
Back Pain
21 (.34%)
Blood Calcium Decreased
21 (.34%)
Confusional State
21 (.34%)
Dehydration
21 (.34%)
Gingival Pain
21 (.34%)
Periodontal Disease
21 (.34%)
Syncope
21 (.34%)
Bone Lesion
20 (.32%)
Malaise
20 (.32%)
Neutropenia
20 (.32%)
Chills
19 (.3%)
Dental Operation
19 (.3%)
Tooth Disorder
19 (.3%)
Abdominal Pain Upper
18 (.29%)
Debridement
18 (.29%)
Fistula
18 (.29%)
Oral Pain
18 (.29%)
Osteomyelitis Chronic
18 (.29%)
Renal Impairment
18 (.29%)
Wound Closure
18 (.29%)
Blood Alkaline Phosphatase Increase...
17 (.27%)
Myalgia
17 (.27%)
Neoplasm Malignant
17 (.27%)
Pleural Effusion
17 (.27%)
Renal Failure Acute
17 (.27%)
Tooth Abscess
17 (.27%)
Wound Treatment
17 (.27%)
Dizziness
16 (.26%)
Drug Ineffective
16 (.26%)
White Blood Cell Count Decreased
16 (.26%)
C-reactive Protein Increased
15 (.24%)
Cerebrovascular Accident
15 (.24%)
Febrile Neutropenia
15 (.24%)
Gingival Swelling
15 (.24%)
Hypoaesthesia
15 (.24%)
Jaw Operation
15 (.24%)
Mucosal Inflammation
15 (.24%)
Oral Surgery
15 (.24%)
Rib Fracture
15 (.24%)
Soft Tissue Infection
15 (.24%)
Bone Fragmentation
14 (.22%)
Decreased Appetite
14 (.22%)
Dental Caries
14 (.22%)
Femur Fracture
14 (.22%)
Hip Arthroplasty
14 (.22%)
Metastases To Central Nervous Syste...
14 (.22%)
Oral Cavity Fistula
14 (.22%)
Tooth Loss
14 (.22%)
Vision Blurred
14 (.22%)
Wrist Fracture
14 (.22%)
Aspartate Aminotransferase Increase...
13 (.21%)

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

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

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

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

Metastases To Bone
439
Osteoporosis
142
Breast Cancer
126
Multiple Myeloma
124
Osteoporosis Postmenopausal
119
Prostate Cancer
47
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Bone Sarcoma
28
Prophylaxis
27
Breast Cancer Metastatic
19
Bone Disorder
16
Resorption Bone Increased
11
Prostate Cancer Metastatic
11
Osteonecrosis
9
Bone Density Decreased
9
Osteitis Deformans
8
Plasmacytoma
6
Hypercalcaemia Of Malignancy
4
Drug Use For Unknown Indication
4
Metastatic Renal Cell Carcinoma
4
Osteolysis
3
Lung Neoplasm Malignant
3
Metastasis
2
Fibrous Dysplasia Of Bone
2
Non-small Cell Lung Cancer
2
Osteoporosis Prophylaxis
2
Spinal Fracture
1
Renal Cell Carcinoma
1
Lung Adenocarcinoma Stage Iv
1
Product Used For Unknown Indication
1
Osteogenesis Imperfecta
1
Hypercalcaemia
1
Neoplasm Malignant
1
Osteoporotic Fracture
1
Bone Neoplasm Malignant
1
Bone Pain
1
Bone Lesion
1
Postmenopause
1
Organ Transplant
1

Zoledronate Case Reports

What Zoledronate 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 Zoledronate. 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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