IBANDRONATE SODIUM

Ibandronate Sodium Adverse Events Reported to the FDA Over Time

How are Ibandronate Sodium adverse event reports trending over time?

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

Most Common Ibandronate Sodium Adverse Events Reported to the FDA

What are the most common Ibandronate Sodium adverse events reported to the FDA?

Death	84 (8.79%)
Femur Fracture	84 (8.79%)
Osteonecrosis	34 (3.56%)
Bone Disorder	32 (3.35%)
Stress Fracture	22 (2.3%)
Pain	18 (1.88%)
Impaired Healing	15 (1.57%)
Low Turnover Osteopathy	15 (1.57%)
Diarrhoea	12 (1.26%)
Pain In Extremity	11 (1.15%)
Arthralgia	10 (1.05%)
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Headache	10 (1.05%)
Fatigue	9 (.94%)
Tooth Extraction	9 (.94%)
Abscess Jaw	8 (.84%)
Dyspnoea	8 (.84%)
Infection	8 (.84%)
Neoplasm Malignant	8 (.84%)
Vomiting	8 (.84%)
Anxiety	7 (.73%)
Atrial Fibrillation	7 (.73%)
Back Pain	7 (.73%)
Fall	7 (.73%)
Gait Disturbance	7 (.73%)
Bone Pain	6 (.63%)
Drug Ineffective	6 (.63%)
Hip Fracture	6 (.63%)
Nausea	6 (.63%)
Osteoporosis	6 (.63%)
Asthenia	5 (.52%)
Chills	5 (.52%)
Influenza Like Illness	5 (.52%)
Myalgia	5 (.52%)
Myoclonus	5 (.52%)
Neoplasm Progression	5 (.52%)
Weight Decreased	5 (.52%)
Anaphylactic Reaction	4 (.42%)
Cerebral Thrombosis	4 (.42%)
Depression	4 (.42%)
Dizziness	4 (.42%)
Emotional Distress	4 (.42%)
Infected Neoplasm	4 (.42%)
Mouth Ulceration	4 (.42%)
Osteomyelitis	4 (.42%)
Renal Failure Acute	4 (.42%)
Toothache	4 (.42%)
Abdominal Pain	3 (.31%)
Anaemia	3 (.31%)
Anorexia	3 (.31%)
Aphagia	3 (.31%)
Blood Pressure Systolic Increased	3 (.31%)
Cardio-respiratory Arrest	3 (.31%)
Cyst	3 (.31%)
Dehydration	3 (.31%)
Disease Progression	3 (.31%)
Drug Interaction	3 (.31%)
Dyspepsia	3 (.31%)
Dysphagia	3 (.31%)
Epistaxis	3 (.31%)
Fibrosis	3 (.31%)
Goitre	3 (.31%)
Hypertension	3 (.31%)
Hypoaesthesia	3 (.31%)
Joint Swelling	3 (.31%)
Multiple Injuries	3 (.31%)
Oligohydramnios	3 (.31%)
Oroantral Fistula	3 (.31%)
Osteogenesis Imperfecta	3 (.31%)
Paraesthesia	3 (.31%)
Pruritus	3 (.31%)
Swelling	3 (.31%)
Tachycardia	3 (.31%)
Tremor	3 (.31%)
Abdominal Pain Upper	2 (.21%)
Abscess	2 (.21%)
Actinomycosis	2 (.21%)
Arnold-chiari Malformation	2 (.21%)
Arrhythmia	2 (.21%)
Arthritis	2 (.21%)
Atrial Flutter	2 (.21%)
Blindness	2 (.21%)
Body Height Decreased	2 (.21%)
Bone Debridement	2 (.21%)
Bone Lesion Excision	2 (.21%)
Bone Metabolism Disorder	2 (.21%)
Breast Cancer	2 (.21%)
Cardiac Failure Congestive	2 (.21%)
Cardiac Flutter	2 (.21%)
Cardiotoxicity	2 (.21%)
Cerebral Haemorrhage	2 (.21%)
Chest Pain	2 (.21%)
Chronic Obstructive Pulmonary Disea...	2 (.21%)
Confusional State	2 (.21%)
Coordination Abnormal	2 (.21%)
Decubitus Ulcer	2 (.21%)
Dementia	2 (.21%)
Facial Pain	2 (.21%)
Faecal Incontinence	2 (.21%)
Fear Of Disease	2 (.21%)
Fistula	2 (.21%)
Fracture	2 (.21%)

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

What are the most common Ibandronate Sodium adverse events reported to the FDA?

Bone And Joint Injuries	122 (12.76%)
Bone Disorders	105 (10.98%)
Fatal Outcomes	84 (8.79%)
Infections - Pathogen Unspecified	36 (3.77%)
Gastrointestinal Signs	34 (3.56%)
Musculoskeletal And Connective Tiss...	26 (2.72%)
Tissue	25 (2.62%)
Cardiac Arrhythmias	23 (2.41%)
Neurological	22 (2.3%)
Joint	16 (1.67%)
Injuries	15 (1.57%)
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Miscellaneous And Site Unspecified ...	13 (1.36%)
Gastrointestinal Motility And Defec...	12 (1.26%)
Head And Neck Therapeutic Procedure...	12 (1.26%)
Respiratory	12 (1.26%)
Epidermal And Dermal Conditions	11 (1.15%)
Headaches	11 (1.15%)
Anxiety Disorders	10 (1.05%)
Dental And Gingival Conditions	10 (1.05%)
Muscle	10 (1.05%)
Physical Examination Topics	9 (.94%)
Renal Disorders	9 (.94%)
Therapeutic And Nontherapeutic Effe...	9 (.94%)
Upper Respiratory Tract Disorders	9 (.94%)
Gastrointestinal Conditions	8 (.84%)
Allergic Conditions	7 (.73%)
Depressed Mood Disorders	7 (.73%)
Oral Soft Tissue Conditions	7 (.73%)
Central Nervous System Vascular	6 (.63%)
Gastrointestinal Ulceration And Per...	6 (.63%)
Mood Disorders	6 (.63%)
Movement Disorders	6 (.63%)
Urinary Tract Signs	6 (.63%)
Bone And Joint Therapeutic Procedur...	5 (.52%)
Cardiac And Vascular Investigations	5 (.52%)
Coronary Artery	5 (.52%)
Medication Errors	5 (.52%)
Metastases	5 (.52%)
Therapeutic Procedures And Supporti...	5 (.52%)
Thyroid Gland	5 (.52%)
Bacterial Infectious	4 (.42%)
Breast Neoplasms Malignant And Unsp...	4 (.42%)
Cardiac Disorder Signs	4 (.42%)
Hematology Investigations	4 (.42%)
Mental Impairment	4 (.42%)
Neoplasm Related Morbidities	4 (.42%)
Product Quality Issues	4 (.42%)
Administration Site Reactions	3 (.31%)
Anemias Nonhemolytic And Marrow Dep...	3 (.31%)
Appetite And General Nutritional	3 (.31%)
Cardiac Valve	3 (.31%)
Deliria	3 (.31%)
Electrolyte And Fluid Balance Condi...	3 (.31%)
Gastrointestinal Stenosis And Obstr...	3 (.31%)
Musculoskeletal And Connective Tiss...	3 (.31%)
Myocardial	3 (.31%)
Peripheral Neuropathies	3 (.31%)
Placental, Amniotic And Cavity Diso...	3 (.31%)
Procedural And Device Related Injur...	3 (.31%)
Skin Appendage Conditions	3 (.31%)
Vascular Hypertensive	3 (.31%)
Viral Infectious	3 (.31%)
Vision	3 (.31%)
Angiedema And Urticaria	2 (.21%)
Body Temperature Conditions	2 (.21%)
Bronchial Disorders	2 (.21%)
Connective Tissue Disorders	2 (.21%)
Embolism And Thrombosis	2 (.21%)
Endocrine Neoplasms Malignant And U...	2 (.21%)
Fractures	2 (.21%)
Gastrointestinal Hemorrhages	2 (.21%)
Gastrointestinal Inflammatory Condi...	2 (.21%)
Heart Failures	2 (.21%)
Inner Ear And Viiith Cranial Nerve	2 (.21%)
Investigations, Imaging And Histopa...	2 (.21%)
Neurological Disorders Congenital	2 (.21%)
Ocular Infections, Irritations And ...	2 (.21%)
Ocular Structural Change, Deposit A...	2 (.21%)
Psychiatric	2 (.21%)
Pulmonary Vascular	2 (.21%)
Spleen, Lymphatic And Reticulendoth...	2 (.21%)
Anal And Rectal Conditions	1 (.1%)
Anterior Eye Structural Change, Dep...	1 (.1%)
Bone, Calcium, Magnesium And Phosph...	1 (.1%)
Breast	1 (.1%)
Chemical Injury And Poisoning	1 (.1%)
Eye	1 (.1%)
Gallbladder	1 (.1%)
Gastrointestinal Neoplasms Malignan...	1 (.1%)
Hematological And Lymphoid Tissue T...	1 (.1%)
Hepatic And Hepatobiliary	1 (.1%)
Immunology And Allergy	1 (.1%)
Lifestyle Issues	1 (.1%)
Lipid Analyses	1 (.1%)
Lymphomas Non-hodgkins T-cell	1 (.1%)
Maternal Complications Of Labour An...	1 (.1%)
Microbiology And Serology	1 (.1%)
Neonatal And Perinatal Conditions	1 (.1%)
Nervous System Neoplasms Benign	1 (.1%)
Nervous System, Skull And Spine The...	1 (.1%)
Obstetric And Gynecological Therape...	1 (.1%)

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