ZOLEDRONIC

Zoledronic Adverse Events Reported to the FDA Over Time

How are Zoledronic adverse event reports trending over time?

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

Most Common Zoledronic Adverse Events Reported to the FDA

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

Osteonecrosis	1151 (6.81%)
Tooth Extraction	387 (2.29%)
Bone Disorder	344 (2.04%)
Pain	335 (1.98%)
Pain In Jaw	243 (1.44%)
Death	219 (1.3%)
Pyrexia	195 (1.15%)
Fall	172 (1.02%)
Osteomyelitis	172 (1.02%)
Arthralgia	150 (.89%)
Nausea	148 (.88%)
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Infection	146 (.86%)
Impaired Healing	145 (.86%)
Dyspnoea	142 (.84%)
Surgery	134 (.79%)
Swelling	121 (.72%)
Vomiting	112 (.66%)
Hypocalcaemia	107 (.63%)
Sequestrectomy	101 (.6%)
Asthenia	98 (.58%)
Myalgia	97 (.57%)
Erythema	96 (.57%)
Fatigue	96 (.57%)
Headache	96 (.57%)
Bone Pain	94 (.56%)
Malaise	89 (.53%)
Diarrhoea	83 (.49%)
Oral Pain	82 (.49%)
Renal Failure Acute	82 (.49%)
Blood Creatinine Increased	81 (.48%)
Pain In Extremity	80 (.47%)
Femur Fracture	78 (.46%)
Malignant Neoplasm Progression	76 (.45%)
Neoplasm Malignant	75 (.44%)
Bone Debridement	73 (.43%)
General Physical Health Deteriorati...	72 (.43%)
Chest Pain	70 (.41%)
Dehydration	70 (.41%)
Pneumonia	70 (.41%)
Back Pain	69 (.41%)
Debridement	65 (.38%)
Gingival Infection	65 (.38%)
Oedema Peripheral	63 (.37%)
Primary Sequestrum	63 (.37%)
Bone Lesion	62 (.37%)
Disease Progression	62 (.37%)
Anaemia	60 (.36%)
Dizziness	59 (.35%)
Hypotension	58 (.34%)
Purulent Discharge	58 (.34%)
Syncope	58 (.34%)
Toothache	58 (.34%)
Chills	57 (.34%)
Influenza Like Illness	55 (.33%)
Osteotomy	55 (.33%)
Jaw Disorder	54 (.32%)
Renal Failure	54 (.32%)
Inflammation	52 (.31%)
Abdominal Pain	51 (.3%)
Renal Impairment	50 (.3%)
Weight Decreased	48 (.28%)
Concomitant Disease Progression	47 (.28%)
Periodontitis	47 (.28%)
Tooth Loss	47 (.28%)
Decreased Appetite	46 (.27%)
Jaw Operation	46 (.27%)
Mouth Ulceration	46 (.27%)
Sepsis	46 (.27%)
Neoplasm Progression	45 (.27%)
Tooth Disorder	45 (.27%)
Wound Closure	45 (.27%)
Atrial Fibrillation	44 (.26%)
Drug Ineffective	44 (.26%)
Fistula	44 (.26%)
Gait Disturbance	44 (.26%)
Gingivitis	44 (.26%)
Urinary Tract Infection	43 (.25%)
Bacterial Infection	41 (.24%)
Dental Caries	41 (.24%)
Hypertension	41 (.24%)
Tooth Abscess	41 (.24%)
Oral Surgery	40 (.24%)
Hip Arthroplasty	39 (.23%)
Osteitis	38 (.22%)
Confusional State	37 (.22%)
Eye Pain	37 (.22%)
Haemoglobin Decreased	37 (.22%)
Osteomyelitis Chronic	37 (.22%)
Loss Of Consciousness	36 (.21%)
Osteolysis	36 (.21%)
Palpitations	36 (.21%)
Paraesthesia	36 (.21%)
Feeling Abnormal	35 (.21%)
Metastases To Bone	35 (.21%)
Musculoskeletal Pain	35 (.21%)
Abscess	34 (.2%)
Blood Urea Increased	34 (.2%)
Hypoaesthesia	34 (.2%)
Soft Tissue Infection	34 (.2%)
Actinomycosis	33 (.2%)
Myocardial Infarction	33 (.2%)

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

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

Bone Disorders	2206 (13.06%)
Infections - Pathogen Unspecified	1107 (6.55%)
Head And Neck Therapeutic Procedure...	584 (3.46%)
Bone And Joint Injuries	483 (2.86%)
Neurological	455 (2.69%)
Dental And Gingival Conditions	450 (2.66%)
Gastrointestinal Signs	419 (2.48%)
Bone And Joint Therapeutic Procedur...	392 (2.32%)
Therapeutic Procedures And Supporti...	336 (1.99%)
Musculoskeletal And Connective Tiss...	319 (1.89%)
Respiratory	314 (1.86%)
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Oral Soft Tissue Conditions	299 (1.77%)
Epidermal And Dermal Conditions	290 (1.72%)
Injuries	286 (1.69%)
Joint	282 (1.67%)
Renal Disorders	236 (1.4%)
Fatal Outcomes	225 (1.33%)
Miscellaneous And Site Unspecified ...	210 (1.24%)
Muscle	210 (1.24%)
Tissue	205 (1.21%)
Body Temperature Conditions	203 (1.2%)
Renal And Urinary Tract Investigati...	195 (1.15%)
Bacterial Infectious	194 (1.15%)
Cardiac Arrhythmias	187 (1.11%)
Hematology Investigations	177 (1.05%)
Bone, Calcium, Magnesium And Phosph...	171 (1.01%)
Electrolyte And Fluid Balance Condi...	148 (.88%)
Gastrointestinal Motility And Defec...	128 (.76%)
Cardiac And Vascular Investigations	126 (.75%)
Metastases	120 (.71%)
Ocular Infections, Irritations And ...	108 (.64%)
Headaches	104 (.62%)
Urinary Tract Signs	103 (.61%)
Anemias Nonhemolytic And Marrow Dep...	98 (.58%)
Water, Electrolyte And Mineral	97 (.57%)
Coronary Artery	93 (.55%)
Appetite And General Nutritional	90 (.53%)
Physical Examination Topics	85 (.5%)
Movement Disorders	83 (.49%)
Central Nervous System Vascular	78 (.46%)
Musculoskeletal And Soft Tissue Inv...	78 (.46%)
Vision	77 (.46%)
Decreased And Nonspecific Blood Pre...	74 (.44%)
Therapeutic And Nontherapeutic Effe...	73 (.43%)
Eye	69 (.41%)
Lifestyle Issues	67 (.4%)
Cardiac Disorder Signs	62 (.37%)
Hepatobiliary	60 (.36%)
Hepatic And Hepatobiliary	57 (.34%)
White Blood Cell	57 (.34%)
Procedural And Device Related Injur...	55 (.33%)
Gastrointestinal Conditions	52 (.31%)
Deliria	49 (.29%)
Lower Respiratory Tract Disorders	48 (.28%)
Heart Failures	47 (.28%)
Investigations, Imaging And Histopa...	47 (.28%)
Respiratory Tract Therapeutic Proce...	46 (.27%)
Skin And Subcutaneous Tissue	46 (.27%)
Skin Appendage Conditions	46 (.27%)
Metabolic, Nutritional And Blood Ga...	44 (.26%)
Vascular Hypertensive	44 (.26%)
Enzyme	43 (.25%)
Vascular	43 (.25%)
Vascular Hemorrhagic	42 (.25%)
Fractures	41 (.24%)
Glucose Metabolism Disorders	41 (.24%)
Viral Infectious	41 (.24%)
Myocardial	40 (.24%)
Nephropathies	39 (.23%)
Endocrine Investigations	38 (.22%)
Gastrointestinal Inflammatory Condi...	35 (.21%)
Platelet	35 (.21%)
Arteriosclerosis, Stenosis, Vascula...	34 (.2%)
Anxiety Disorders	33 (.2%)
Peripheral Neuropathies	32 (.19%)
Pulmonary Vascular	32 (.19%)
Upper Respiratory Tract Disorders	32 (.19%)
Fungal Infectious	31 (.18%)
Pleural	31 (.18%)
Sleep Disorders	31 (.18%)
Mental Impairment	30 (.18%)
Musculoskeletal And Connective Tiss...	30 (.18%)
Bronchial Disorders	29 (.17%)
Inner Ear And Viiith Cranial Nerve	29 (.17%)
Breast Neoplasms Malignant And Unsp...	28 (.17%)
Coagulopathies And Bleeding Diathes...	28 (.17%)
Protein And Chemistry Analyses	28 (.17%)
Seizures	28 (.17%)
Gastrointestinal Hemorrhages	27 (.16%)
Cranial Nerve Disorders	25 (.15%)
Cardiac Valve	24 (.14%)
Gastrointestinal Neoplasms Malignan...	24 (.14%)
Tendon, Ligament And Cartilage	24 (.14%)
Acid-base	23 (.14%)
Administration Site Reactions	23 (.14%)
Allergic Conditions	22 (.13%)
Psychiatric	22 (.13%)
Embolism And Thrombosis	21 (.12%)
Gallbladder	21 (.12%)
Exocrine Pancreas Conditions	20 (.12%)
Ocular Structural Change, Deposit A...	20 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Zoledronic, 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 Zoledronic 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.