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Zometa (Zoledronic Acid) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (5187)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zometa (Zoledronic Acid) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 5187   Next >>

Possible Zometa side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 86.6 kg (190.6 pounds)

Reactions: Diabetes Mellitus, Hot Flush, Ovarian Mass, Peroneal Nerve Palsy, Iron Deficiency Anaemia, Postmenopausal Haemorrhage, Back Pain, Spinal Fracture, Pancytopenia, Lumbar Radiculopathy, Emotional Distress, Staphylococcal Infection, Compression Fracture, Gastrointestinal Disorder, Abscess, Metastases To Meninges, Osteoporosis, Mental Status Changes, Kyphosis, Hypercholesterolaemia, Chest Pain, Bone Disorder, Candidiasis, Decreased Appetite, Tooth Fracture, Cataract, Paraesthesia Oral, Mass, Lung Neoplasm, Muscular Weakness, Arrhythmia, Impaired Healing, Oral Pain, Arthralgia, Sepsis, JAW Disorder, Weight Decreased, Primary Sequestrum, Asthma, Bone Fragmentation, Diabetic Foot, Sciatica, Urinary Incontinence, Osteomyelitis, Pyrexia, Headache, Joint Effusion, Cellulitis, Pain in Extremity, Anaemia, General Physical Health Deterioration, Gingival Disorder, Lymph Gland Infection, Osteomalacia, Eating Disorder, Cholelithiasis, Oesophageal Disorder, Insomnia, Dehydration, Colitis, Atelectasis, Haemorrhage, Pain, Enthesopathy, Conjunctivitis, Periodontitis, Hypokalaemia, Tinea Pedis, Diplopia, Dyspnoea Exertional, Dizziness, Gastrooesophageal Reflux Disease, Swelling Face, Urinary Tract Infection, Synovitis, Onychomycosis, Deformity, Anxiety, Osteoarthritis, Mucosal Inflammation, Osteonecrosis of JAW, Diarrhoea, Dysuria, Hypophagia, Bronchitis, Spinal Osteoarthritis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Antibiotics

Aredia
    Indication: Metastases To Bone

Zometa
    Indication: Breast Cancer

Other drugs received by patient: Taxotere; Enalapril Maleate; Dexamethasone; Tylenol PM; Calcium with Vitamin D; Zofran; Oxycontin; Potassium; Effexor; Cortisone Acetate; Lipitor; Vicodin; Acetaminophen PM; Amoxicillin; Lasix; Celebrex; Amitriptyline Hydrochloride; Diclofenac Sodium; Toradol; Nexium; Dexamethasone; Aspirin; Arimidex; Zyrtec; Synthroid; Effexor XR; Multi-Vitamins; Zocor; Coumadin; Atenolol; Percocet



Possible Zometa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Diverticulitis, Oral Cavity Fistula, Implant Site Infection, Tricuspid Valve Incompetence, Walking AID User, Hot Flush, Mood Disorder DUE To A General Medical Condition, Malaise, Oesophagitis, Mood Swings, Gallbladder Disorder, Back Pain, Pancytopenia, Cervical Dysplasia, Radiation Associated Pain, Emotional Distress, HIP Fracture, Neutropenia, Neuritis, Mental Status Changes, Respiratory Depression, Dermatitis Contact, Hypercholesterolaemia, Salivary Gland Enlargement, Oedema, Depression, Injury, Bone Disorder, Emphysema, Vomiting, Dyspnoea, Trismus, Musculoskeletal Pain, Lung Neoplasm, Discomfort, Dysarthria, Arthralgia, Mitral Valve Incompetence, Gait Disturbance, Memory Impairment, Physical Disability, Pulmonary Hypertension, Osteomyelitis, Clostridium Difficile Colitis, Pyrexia, Delusion, Fracture, Radiculopathy, Muscle Spasms, Intervertebral Disc Protrusion, Hiatus Hernia, Dystonia, Gingival Disorder, Sacroiliitis, Hypoaesthesia, Human Papilloma Virus Test Positive, Genital Neoplasm Malignant Female, Paraesthesia, Rash Erythematous, Dehydration, Mesenteric Vascular Insufficiency, Hemiplegia, Sleep Apnoea Syndrome, Scar, Spinal Column Stenosis, Neuralgia, Pain, Dyskinesia, JAW Fracture, Periodontitis, Gastritis, Suicidal Ideation, Viith Nerve Paralysis, Weight Increased, Fatigue, Neuropathy Peripheral, Bone Loss, Intervertebral Disc Disorder, Dizziness, Intervertebral Disc Degeneration, Pancreatitis Chronic, Toothache, Hallucination, Gastrooesophageal Reflux Disease, Cervix Carcinoma, Pain in JAW, Swelling Face, Hordeolum, Dental Caries, Radicular Pain, Facial Pain, Deformity, Anxiety, Osteoarthritis, Osteonecrosis of JAW, Neoplasm Malignant, Diarrhoea, Hypophagia, Spinal Osteoarthritis, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zometa

Other drugs received by patient: Tylenol; Neulasta; Pravastatin; Skelaxin; Morphine; Taxol; Calcium; Oral Contraceptive NOS; Zantac; Sodium Chloride; Tobrex; Fluticasone Propionate; Trastuzumab; Hydrocodone Bitartrate; Pamelor; Amitriptyline Hydrochloride; Klor-CON; Calcium with Vitamin D; Taxotere; Benadryl ^ache^; Ferrous Gluconate; Zyprexa; Albuterol; Dexamethasone; Oxymorphone Hydrochloride; Remeron; Multivitamin ^lappe^; Carboplatin; Paxil; Fenofibrate; Darvocet-N 50; Ritalin; Dexedrine ^medeva^; Ativan; Arimidex; Pravachol; Dalmane; Morphine Sulfate; Decadron; Chantix; Tamoxifen Citrate; Oxycodone HCL; Methylprednisolone; Herceptin; Neupogen; Wellbutrin SR; Celexa; Oxycontin; Aranesp; Procrit / 00909301 /; Gabapentin; Flonase; Desoxyn; Arimidex; Spiriva; Compazine; Nolvadex



Possible Zometa side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-27

Patient: female, weighing 35.0 kg (77.0 pounds)

Reactions: Tooth Loss, Exposed Bone in JAW, Bone Pain, Periodontitis, Oral Herpes, Dyslalia, Cheilitis, Oral Candidiasis, Osteolysis, Wound Complication, Eating Disorder, Dysarthria, Osteonecrosis of JAW, Oral Mucosal Erythema, Poor Personal Hygiene, Swelling, Gingival Infection, Loose Tooth

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zometa
    Dosage: unk ukn, unk
    Start date: 2012-07-01

Zometa
    Dosage: unk ukn, unk
    Indication: Breast Cancer
    Start date: 2010-07-01
    End date: 2011-08-01

Other drugs received by patient: Lyrica; Antibiotics; Aromasin; Aricept; Gramalil



Possible Zometa side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 61 year old female

Reactions: Agitation, Confusional State, Acute Pulmonary Oedema, Metastatic Pain, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 g, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, 1x/day
    Administration route: Oral

Atorvastatin
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Bisoprolol Fumarate
    Dosage: 3.75 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 mg, 1x/day
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, 1x/day
    Administration route: Oral

Nitroglycerin
    Dosage: 5 mg, 1x/day
    End date: 2012-07-26

Plavix
    Dosage: 75 mg, 1x/day
    Administration route: Oral

Ramipril
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, single
    Indication: Hypercalcaemia
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Zometa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Tooth Loss, Fractured Sacrum, Diabetes Mellitus, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Cerebral Ventricle Dilatation, Cardiac Disorder, Cardiomegaly, Arteriosclerosis, Back Pain, Pancytopenia, Coronary Artery Disease, Osteopenia, Respiratory Tract Congestion, Rhinitis Allergic, Intervertebral Disc Space Narrowing, Sleep Disorder, Swelling, Acrochordon, Hypoventilation, Exposed Bone in JAW, Osteoporosis, Mental Status Changes, Multiple Myeloma, Oroantral Fistula, Hypercholesterolaemia, Anhedonia, Chest Pain, Obesity, Bone Disorder, Injury, Exostosis, Cataract, Dyspnoea, Diastolic Dysfunction, Carotid Artery Stenosis, Syncope, Impaired Healing, Mitral Valve Incompetence, Sinus Disorder, Hypothyroidism, Aortic Dilatation, Hypogammaglobulinaemia, Disability, Weight Decreased, Dermoid Cyst, Gastrointestinal Haemorrhage, Goitre, Urinary Incontinence, Pericardial Effusion, Cerebral Ischaemia, Proteinuria, Pathological Fracture, Aneurysm, Cough, Intervertebral Disc Protrusion, Pneumonia, Hiatus Hernia, Aortic Calcification, Anaemia, Eating Disorder, Convulsion, Chondrocalcinosis, Colitis, Mastication Disorder, Impaired Gastric Emptying, Rash Maculo-Papular, Neuralgia, Spinal Column Stenosis, Atelectasis, Pain, Gastritis, Myalgia, Death, Neuropathy Peripheral, Intervertebral Disc Degeneration, Bone Marrow Failure, Hair Follicle Tumour Benign, Cholecystitis, Sinusitis, Lymphoedema, Urinary Tract Infection, Cerebral Atrophy, Osteolysis, Renal Failure Chronic, Anxiety, Hyperlipidaemia, Osteoarthritis, Gastrointestinal Pain, Renal Impairment, Respiratory Failure, Diarrhoea, Osteonecrosis of JAW, Diabetic Retinopathy, Bone Neoplasm, Spinal Osteoarthritis, Bronchitis, Hypertension, Deep Vein Thrombosis, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg, qmo
    Indication: Multiple Myeloma
    Start date: 2001-01-01
    End date: 2007-08-01

Zometa
    Dosage: 4 mg, qmo
    Start date: 2001-01-01
    End date: 2007-08-01

Other drugs received by patient: Augmentin '125'; Vitamin E; Lisinopril; Steroids NOS; Aspirin; Darvocet-N 50; Aspirin; Amlodipine; Acetaminophen; Colestid; Vicodin; Ativan; Megace; Reglan; Chlorpromazine HCL; Prednisone TAB; Decadron Phosphate; Lantus; Aranesp; Norco; Procrit; Velcade; Alavert; Melphalan Hydrochloride; Glycolax; Avandia; Actos; Insulin; Accupril; Heparin Sodium; Starlix; Lexapro; Warfarin Sodium; Nexium; Humalog; Timentin; Cardizem; Zocor; Calcium Carbonate; Esomeprazole Magnesium; Chemotherapeutics; Keppra; Levetiracetam; Tylenol



Possible Zometa side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 70.3 kg (154.6 pounds)

Reactions: Abdominal Pain, Contusion, Oedema Peripheral, Vasodilatation, Gallbladder Disorder, Cervical Spinal Stenosis, Hypovolaemia, Blood Iron Decreased, Retinal Haemorrhage, Diverticulum Intestinal, Emotional Distress, Alpha Haemolytic Streptococcal Infection, Diabetic Neuropathy, Limb Injury, Arteriosclerosis Coronary Artery, Thyroid Neoplasm, Pulmonary Mass, Fall, Serum Ferritin Increased, Abdominal Pain Upper, Vitreous Floaters, Chest Pain, Onychoclasis, Oedema, Exostosis, Renal Failure Acute, Ligament Sprain, Vomiting, Dyspnoea, Lung Neoplasm, Carotid Bruit, Lung Consolidation, Syncope, Life Expectancy Shortened, Gait Disturbance, Bladder Disorder, Lung Infiltration, Asthenia, Vitamin D Deficiency, Thrombosis, Hyperkalaemia, Goitre, Osteomyelitis, Visual Acuity Reduced, Erythema, Photopsia, Faecaloma, Arthropathy, Tracheal Deviation, Cardiac Failure Congestive, Pneumonia, Visual Field Defect, Aortic Calcification, General Physical Health Deterioration, Decreased Interest, Cholelithiasis, Bronchitis Chronic, Staphyloma, Dehydration, Spinal Column Injury, Atelectasis, Sinus Polyp, Glaucoma, Pain, Hepatic Lesion, Hepatitis, Constipation, Hypokalaemia, Myalgia, Bone Loss, Vertebral Artery Occlusion, Dizziness, Pleural Effusion, Toothache, Cholecystitis, Azotaemia, Gastrooesophageal Reflux Disease, RIB Fracture, Scoliosis, Renal Disorder, Spondylolisthesis, Supraventricular Extrasystoles, Nausea, Urinary Tract Infection, Nephrogenic Anaemia, Peripheral Vascular Disorder, Varicose Vein, Musculoskeletal Chest Pain, Onychomycosis, Deformity, Anxiety, Hyperlipidaemia, Mucosal Inflammation, Osteoarthritis, Mucosal Ulceration, Osteonecrosis of JAW, Pigmentation Disorder, Oral Disorder, Hypophagia, Diabetic Retinopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aredia
    Start date: 1999-01-01
    End date: 2001-01-01

Zometa
    Start date: 2001-01-01
    End date: 2005-01-01

Other drugs received by patient: Neurontin; Lisinopril; Aranesp; Latanoprost; Enalapril Maleate; Avandia; Dilaudid; Morphine; Alphagan P; Methadone HCL; Cyclobenzaprine; Coreg; Byetta; Claritin; Aldactone; Plavix; Taxol; Morphine; Morphine Sulfate; Compazine; Nitro-BID; Actos; Vancomycin; Lantus; Glipizide; Taxotere; Morphine; Loratadine; Oxycontin; Moxifloxacin; Combivent; Docusate; Lasix; Klor-CON; Spironolactone; Gabapentin; Amaryl; Bimatoprost; Diamox SRC; Hydrocodone Bitartrate; Nystatin; Novolog; Insulin; Tylenol; Percocet; Epinephrine; Econopred



Possible Zometa side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zometa
    Dosage: 4mg/100ml , once per 28 days
    Start date: 2012-07-17

Zometa
    Dosage: 4mg/100ml , once per 28 days
    Start date: 2012-01-12

Zometa
    Dosage: 4mg/100ml , once per 28 days
    Indication: Prostate Cancer Metastatic

Zometa
    Dosage: 4mg/100ml , once per 28 days
    Start date: 2012-06-19



Possible Zometa side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 71.0 kg (156.2 pounds)

Reactions: Abdominal Pain, Tinnitus, Hyperhidrosis, Neoplasm, C-Reactive Protein Increased, Accident AT Work, Oedema Peripheral, Cervical Spinal Stenosis, Fistula, Left Ventricular Hypertrophy, Rhinitis, Bursitis, Diverticulum Intestinal, Ulcer, Alpha Haemolytic Streptococcal Infection, Sleep Disorder, Hepatic Cyst, Swelling, Platelet Count Decreased, Periodontal Disease, Onychalgia, Liver Function Test Abnormal, Lung Neoplasm Malignant, Chest Pain, Aortic Arteriosclerosis, Bone Disorder, Injury, Exostosis, Ligament Rupture, White Blood Cell Count Decreased, Vomiting, Dyspnoea, Paraesthesia Oral, Heart Valve Incompetence, Foreign Body, Haematochezia, Agranulocytosis, Arthralgia, Oral Pain, Impaired Healing, Gait Disturbance, Asthenia, Primary Sequestrum, Gastrointestinal Haemorrhage, Lumbar Spinal Stenosis, Hypoaesthesia Oral, Oedema Mucosal, Eyelid Ptosis, Tenderness, Bone Density Decreased, Carpal Tunnel Syndrome, Tendonitis, Radiculopathy, Intervertebral Disc Protrusion, Blood Alkaline Phosphatase Increased, Gingival Bleeding, Pain in Extremity, Hypoaesthesia, Stomatocytes Present, Paraesthesia, Cholelithiasis, Osteosclerosis, Epicondylitis, Oral Mucosal Erythema, Colitis, Arthroscopy, Stress Fracture, QRS Axis Abnormal, Purulent Discharge, Soft Tissue Disorder, Enthesopathy, Synovial Cyst, Neuropathy Peripheral, Neck Pain, Chronic Sinusitis, Bacterial Infection, Blood Glucose Increased, RIB Fracture, Pain in JAW, Nausea, Synovitis, Radicular Pain, Osteolysis, Multiple Fractures, Onychomycosis, Tenosynovitis, Osteoarthritis, Radiculitis, Osteonecrosis of JAW, Cutis Laxa, Gallbladder Polyp, Spinal Osteoarthritis, Arthritis, Tooth Disorder, Post Laminectomy Syndrome, Deep Vein Thrombosis, Atrophy, Ovarian Cancer, Inflammation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg, qmo
    Indication: Breast Cancer Metastatic
    Start date: 1996-06-03
    End date: 2002-01-01

Fosamax

Zometa
    Dosage: 4 mg q3-4 wks
    Start date: 2002-06-04
    End date: 2004-09-15

Other drugs received by patient: Armodafinil; Neurontin; Compazine; Dilantin; Ativan; Carboplatin; Carboplatin; Arimidex; Epogen; Mitoxantrone Hydrochloride; Nasacort AQ; Avelox; Duragesic; Ambien; Ultram; Cimetidine; Etodolac; Primadex; Adriamycin PFS; Methotrexate; Alprazolam; Megestrol Acetate; MS Contin; Amifostine; Restoril; Sumatriptan; Carboplatin; Chemotherapeutics,other; Kytril; Lomotil; Taxol; Neupogen; Megace; Decadron Phosphate; Fluid / Electrolyte Replacement Therapy; Torecan; Flagyl; Toradol; Claritin; Fluorouracil; Anzemet; Maxalt-MLT; Celebrex; Penicillin VK; Darvocet-N 50; Atenolol; Tamoxifen Citrate; Taxotere; Benadryl; Tagamet; Levaquin; Aspirin



Possible Zometa side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female, weighing 74.8 kg (164.6 pounds)

Reactions: Lymphadenopathy, Oral Cavity Fistula, Face Oedema, Lymph Node Pain, Dermatitis, Melanocytic Naevus, Gastritis Atrophic, Back Pain, Magnesium Deficiency, Osteitis, Ulcer, Diverticulum, Swelling, Macule, Bunion, Change of Bowel Habit, Abdominal Pain Upper, Haematemesis, Hypercholesterolaemia, Hyperparathyroidism, Oedema, Erosive Oesophagitis, Bone Disorder, Depression, Arteriovenous Fistula Site Complication, Facial Asymmetry, Decreased Appetite, Renal Failure Acute, Excoriation, Haemorrhoids, Blood Potassium Increased, Discomfort, Blood Glucose Decreased, Dysgeusia, Loose Tooth, Foot Deformity, Vitamin D Deficiency, Urinary Incontinence, Arteriovenous Graft Aneurysm, Device Related Infection, Headache, Erythema, Colonic Polyp, Gallbladder Cholesterolosis, Hypoaesthesia Oral, Tongue Disorder, Dyspepsia, Cough, Oropharyngeal Plaque, Hiatus Hernia, Cellulitis, Anaemia, General Physical Health Deterioration, Paraesthesia, Decreased Interest, Impaired Gastric Emptying, Purulent Discharge, Tooth Abscess, Acute Leukaemia, Pain, JAW Fracture, Constipation, Gastritis, Blood Calcium Decreased, Intra-Abdominal Pressure Increased, Skin Lesion, Dizziness, Cholecystitis, Arteriovenous Fistula Thrombosis, Azotaemia, Gastrooesophageal Reflux Disease, Pain in JAW, Dental Caries, Post Herpetic Neuralgia, Hypercalcaemia, Anxiety, Barrett's Oesophagus, Gingival Recession, Osteonecrosis of JAW, Diarrhoea, Neoplasm Malignant, Oral Disorder, Arthritis, Infection, Influenza Like Illness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aredia

Zometa

Other drugs received by patient: Renagel; Omeprazole; Methadone HCL; Miralax; Lidocaine; Topral XL; Calcium Carbonate; Rocaltrol; Prograf; Bactrim; Lortab; Mycophenolate Mofetil (Cellcept); Thalidomide; Diovan; Lipitor; Prednisone TAB; Sensipar; Lyrica; Metoprolol Tartrate; Prevident; Epinephrine; Amoxicillin; Kayexalate; Nephro-Vite; Minoxidil; PEN-VEE K; Prilocaine Hydrochloride; MAG-OX; Norvasc; Chemotherapeutics NOS; Metoclopramide; Sodium Polystyrene Sulfonate; Oxycontin; Steroids NOS; Celexa; Magnesium; Mycelex; Chlorhexidine Gluconate; Augmentin '125'



Possible Zometa side effects in

Reported by a physician from United Kingdom on 2012-08-27

Patient:

Reactions: Femur Fracture

Drug(s) suspected as cause:
Zometa



Possible Zometa side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 72.6 kg (159.6 pounds)

Reactions: Haemoptysis, Lung Cancer Metastatic, Pulmonary Embolism, Pneumothorax

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zometa

Other drugs received by patient: Carbo Medicinalis; Lavsol



Possible Zometa side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 61 year old female

Reactions: Confusional State, Agitation, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Aspirin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bisoprolol Fumarate
    Dosage: 2.5-0-1.25
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Duragesic-100
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Nexium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Nitroglycerin
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-27

Plavix
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ramipril
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-07-26

Zometa
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Zometa side effects in male

Reported by a physician from Japan on 2012-08-27

Patient: male

Reactions: Osteonecrosis of JAW, Neoplasm Malignant, Neoplasm Progression, Osteomyelitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Metastatic Renal Cell Carcinoma
    Start date: 2011-03-18
    End date: 2011-07-01

Afinitor
    Dosage: 10 mg, daily
    Administration route: Oral
    Start date: 2011-09-05
    End date: 2012-01-12

Afinitor
    Dosage: 5 mg, daily
    Administration route: Oral
    Start date: 2011-08-05
    End date: 2011-09-04

Zometa
    Dosage: 4 mg, unk
    Indication: Metastases To Bone
    Start date: 2009-05-26
    End date: 2009-05-26

Zometa
    Dosage: 4 mg, unk
    Start date: 2011-01-31
    End date: 2011-01-31

Other drugs received by patient: Sorafenib Tosilate; Famotidine; Lyrica; Tramadol Hydrochloride; Oxycontin; Prochlorperazine; Hachiazule; Sunitinib Malate; Acetaminophen; Neurotropin; Clarithromycin; Onealfa



Possible Zometa side effects in male

Reported by a lawyer from United States on 2012-08-27

Patient: male

Reactions: Vitamin D Deficiency, Osteomyelitis, Headache, Nocturia, Pyrexia, Erectile Dysfunction, Dyspepsia, Proteinuria, Subcutaneous Abscess, Haemophilia, Hypoaesthesia, Osteopenia, Abscess JAW, Paraesthesia, Emotional Distress, Diabetic Neuropathy, Compression Fracture, Prostatomegaly, Vision Blurred, Mastication Disorder, Impaired Gastric Emptying, Arteriosclerosis Coronary Artery, Mobility Decreased, Lactose Intolerance, Exposed Bone in JAW, Osteoporosis, Haemorrhage, Restless Legs Syndrome, Periodontal Disease, Pain, Polyuria, Constipation, Kyphosis, Fatigue, Anhedonia, Interstitial Lung Disease, Obesity, Chest Pain, Benign Neoplasm of Adrenal Gland, Depression, Injury, Loss of Libido, Gastrooesophageal Reflux Disease, Umbilical Hernia, Scoliosis, Tooth Fracture, Dyspnoea, Type 2 Diabetes Mellitus, Soft Tissue Inflammation, Musculoskeletal Pain, Dental Caries, Osteolysis, DRY Skin, Deformity, Discomfort, Osteoarthritis, Hyperlipidaemia, Anxiety, Skin Papilloma, Osteonecrosis of JAW, Sinus Disorder, Life Expectancy Shortened, Hypertension

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aredia
    Indication: Multiple Myeloma

Aredia
    Dosage: 90 mg, qmo
    Indication: Neoplasm Malignant
    Start date: 1998-11-25
    End date: 2008-10-01

Zometa
    Indication: Multiple Myeloma

Other drugs received by patient: Lamictal; Wellbutrin SR; Synthroid; Aspirin; Flonase; Zoloft; Gabapentin; Thalidomide; Omeprazole



Possible Zometa side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-27

Patient: male

Reactions: Hypercholesterolaemia, Diabetes Mellitus

Drug(s) suspected as cause:
Zometa
    Dosage: 4 mg/100ml, 1x per 28 days
    Start date: 2012-07-23

Zometa
    Dosage: 4 mg/100ml, 1x per 28 days
    Indication: Prostate Cancer Metastatic
    Start date: 2011-02-10

Zometa
    Dosage: 4 mg/100ml, 1x per 28 days
    Start date: 2012-08-21

Other drugs received by patient: Firmagon



Possible Zometa side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 175.0 kg (385.0 pounds)

Reactions: Primary Sequestrum, Dementia, Deafness, Osteomyelitis, Cyst, Loss of Consciousness, Bone Density Decreased, Arteriosclerosis, Cough, Culture, Fistula, Peptic Ulcer, Anaemia, Coronary Artery Disease, Pancytopenia, Osteopenia, Diverticulum Intestinal, Biopsy Bone Abnormal, Insomnia, Swelling, Areflexia, Purulent Discharge, Atelectasis, Oesophagitis Ulcerative, Mental Status Changes, Fall, Gastritis, Oedema, Bone Disorder, Toothache, Nuclear Magnetic Resonance Imaging Brain, Pain in JAW, Scoliosis, Blood Pressure Increased, Urinary Tract Infection, Cognitive Disorder, Cerebrovascular Accident, Amnesia, Hyperlipidaemia, Osteonecrosis of JAW, Sepsis, Spinal Osteoarthritis, Lung Infiltration, Atrophy, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zometa

Other drugs received by patient: Lovaza; Plavix; Atenolol; Folic Acid; Flomax; Lipitor; Vitamin B-12; Xanax; Vesicare; Aspirin



Possible Zometa side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-27

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Malaise, Bronchopneumonia, Septic Shock, Immunosuppression, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zometa

Other drugs received by patient possibly interacting with the suspect drug:
Remicade
    Dosage: 5 mg/kg, 1/8 weeks
    Indication: Crohn's Disease
    Start date: 2011-01-11

Other drugs received by patient: Azathioprine Sodium; Prednisolone



Possible Zometa side effects in

Reported by a physician from Japan on 2012-08-27

Patient:

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zometa



Possible Zometa side effects in female

Reported by a physician from France on 2012-08-27

Patient: female

Reactions: Confusional State, Acute Pulmonary Oedema, Agitation, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Administration route: Oral

Atorvastatin
    Administration route: Oral

Bisoprolol Fumarate
    Dosage: 2.5 mg in the morning and 1.25 mg in the evening
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Administration route: Oral

Nitroglycerin
    End date: 2012-07-26

Plavix
    Administration route: Oral

Ramipril
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Start date: 2012-07-19
    End date: 2012-07-19



Possible Zometa side effects in 71 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 71 year old female

Reactions: Osteonecrosis

Drug(s) suspected as cause:
Zometa



Possible Zometa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Zometa



Possible Zometa side effects in 73 year old male

Reported by a pharmacist from Japan on 2012-08-27

Patient: 73 year old male

Reactions: Osteonecrosis of JAW

Drug(s) suspected as cause:
Zometa



Possible Zometa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female, weighing 80.3 kg (176.6 pounds)

Reactions: Oropharyngeal Pain, Tricuspid Valve Incompetence, Cardiomegaly, Metastases To Bone Marrow, C-Reactive Protein Increased, Upper Respiratory Tract Infection, Oedema Peripheral, Cardiotoxicity, Blood Creatinine Increased, Back Pain, Bone Swelling, Bursitis, Osteopenia, Hyperplasia, Heart Rate Decreased, Foreign Body Reaction, Hepatic Cyst, Swelling, Compression Fracture, Metastases To Spine, Left Atrial Dilatation, Ejection Fraction Abnormal, Bone Abscess, Fall, Kyphosis, Computerised Tomogram Coronary Artery Abnormal, Hypercholesterolaemia, Aortic Arteriosclerosis, Obesity, Rotator Cuff Syndrome, Bone Disorder, Exostosis, Vomiting, Trismus, Haemorrhoids, Diastolic Dysfunction, Pulmonary Valve Incompetence, Impaired Healing, Mitral Valve Incompetence, Depressed Mood, Metastases To Bone, Gliosis, RED Blood Cell Sedimentation Rate Increased, Primary Sequestrum, Vitamin D Deficiency, Pulmonary Hypertension, Osteomyelitis, Erythema, Pericardial Effusion, Implant Site Thrombosis, Fibrosis, Device Malfunction, Pathological Fracture, Dysphagia, Pain in Extremity, Family Stress, Anaemia, Gingival Disorder, Glomerular Filtration Rate Abnormal, Metastases To Pleura, Atelectasis, Ventricular Hypokinesia, Haemorrhage, Osteitis Deformans, Pain, Liver Disorder, Capillary Leak Syndrome, Dyspnoea Exertional, Pleural Effusion, Intervertebral Disc Degeneration, Gastrooesophageal Reflux Disease, Sinusitis, Pain in JAW, Metastases To Lung, Nausea, Bone Lesion, Renal Failure Chronic, Osteoarthritis, Anxiety, Gingival Recession, Osteonecrosis of JAW, Neoplasm Malignant, Diarrhoea, Oral Disorder, Tooth Disorder, Sinus Tachycardia, Infection, Inflammation

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg, unk
    Indication: Metastases To Bone
    Start date: 2000-04-21
    End date: 2002-02-16

Zometa
    Dosage: 4 mg, qmo
    Indication: Metastases To Bone
    Start date: 2001-01-01

Zometa
    Dosage: 4 mg, qw
    Start date: 2003-01-29

Zometa
    Dosage: 4 mg, q3w
    Start date: 2004-02-25
    End date: 2005-04-13

Zometa
    Dosage: unk ukn, qw3
    Start date: 2004-08-01

Other drugs received by patient: Fluticasone Propionate; Radiation Therapy; Ascorbic Acid; Hydrocodone Bitartrate; Prevacid; Celexa; Femara; Herceptin; Cimetidine; Herceptin; Minerals NOS; Metronidazole; Promethazine; Coumadin; Chemotherapeutics; Vitamin B Complex CAP; Trazodone Hydrochloride; Acetaminophen and Hydrocodone Bitartrate; Dyazide; Calcium W / Vitamin D NOS; Vicoprofen; Potassium Chloride (KV / 24); Herceptin; Xanax; Prednisone TAB; Benadryl; Vaccine Breast Cancer Protocol; Zyban; Levaquin; Cymbalta; Simvastatin; Cytoxan; Oxycontin; Tylenol W / Codeine; Albuterol; Bupropion HCL; Lotensin; Taxol; Lisinopril; Keflex; Cephalexin; Warfarin Sodium; Faslodex; Compazine; Lasix; Taxotere; Celebrex; Dexamethasone; Heparin; Navelbine; Chlorhexidine Gluconate; Kytril; Adriamycin PFS



Possible Zometa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Lymphadenopathy, Chronic Obstructive Pulmonary Disease, Rheumatoid Arthritis, Symbolic Dysfunction, Biliary Dilatation, DRY Mouth, Gallbladder Disorder, Immunosuppression, Back Pain, Osteopenia, Delirium, Secretion Discharge, Hepatic Steatosis, Breast Cancer Metastatic, Arteriosclerosis Coronary Artery, Muscle Disorder, Metastases To Meninges, Exposed Bone in JAW, Osteoporosis, Mental Status Changes, Bile Duct Cancer, Lymphadenitis, Paraparesis, Postoperative Wound Infection, Obesity, Exostosis, Stevens-Johnson Syndrome, Vomiting, Lung Neoplasm, Ligament Disorder, Gait Disturbance, Metastases To Bone, Weight Decreased, Metastases To Liver, Urinary Incontinence, Osteomyelitis, Headache, Device Related Infection, Erythema, Taeniasis, Spinal Compression Fracture, Arthropathy, Herpes Simplex, Ingrowing Nail, Intervertebral Disc Protrusion, Bladder Dysfunction, Paranoia, General Physical Health Deterioration, Gingival Disorder, Abnormal Behaviour, Faecal Incontinence, Hypoaesthesia, Renal Cyst, Abscess JAW, Lung Hyperinflation, Decreased Interest, Cholelithiasis, Insomnia, Fistula Discharge, Spinal Column Stenosis, Atelectasis, Glaucoma, Mouth Ulceration, Pain, Central Nervous System Lesion, Hepatic Lesion, Constipation, Fungal Paronychia, Bone Fistula, Dyspnoea Exertional, Bloody Discharge, Swelling Face, Type 2 Diabetes Mellitus, Urinary Tract Infection, Onychomycosis, Hyperlipidaemia, Anxiety, Neoplasm Malignant, Osteonecrosis of JAW, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Chemotherapeutics NOS
    Indication: Breast Cancer Metastatic

Zometa
    Start date: 2004-01-01

Other drugs received by patient: Triamterene; Ambien; Valtrex; Extra Strength Tylenol; Prinivil; Latanoprost; Aromasin; Lipitor; Lorazepam; Prilosec; Reglan; Levofloxacin; Vicodin; Bacitracin; Ampicillin; Paroxetine; Calcium; Oxycontin; Ferrous Sulfate TAB; Vitamin B6; Glucosamine; Paxil; Milk OF Magnesia TAB; Dilaudid; Xeloda; Nadolol; Decadron Phosphate; Cefazolin; Femara; Premarin; Dexamethasone; Olanzapine; Travatan; Zofran; Percocet; Lisinopril; Temazepam; Hydromorphone Hydrochloride



Possible Zometa side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Abdominal Pain, Lymphadenopathy, Tricuspid Valve Incompetence, Rheumatoid Arthritis, Monoclonal Gammopathy, Oesophagitis, Bronchial Disorder, Deafness Unilateral, Vertebral Foraminal Stenosis, Back Pain, Fistula, Phlebolith, Osteopenia, Hepatic Cyst, Exposed Bone in JAW, Osteoporosis, HIP Dysplasia, Gastric Ulcer, Kyphosis, Chest Pain, Injury, Exostosis, Injection Site Nodule, Renal Failure Acute, Kyphoscoliosis, Vomiting, Gingival Pain, Arthralgia, Mitral Valve Incompetence, Gait Disturbance, Sensitivity of Teeth, Weight Decreased, Soft Tissue Mass, Osteomyelitis, Pericardial Effusion, Spinal Compression Fracture, Pathological Fracture, Intervertebral Disc Protrusion, Hiatus Hernia, Gingival Bleeding, Cellulitis, Plasmacytoma, Peptic Ulcer, Pain in Extremity, Aortic Calcification, Anaemia, Hypoaesthesia, Abscess JAW, Cachexia, Osteosclerosis, Vertebral Wedging, Dehydration, Otitis Media, Mastication Disorder, Haemorrhage, Gastritis, Nephrolithiasis, Neuropathy Peripheral, Chronic Sinusitis, Gastrooesophageal Reflux Disease, Spinal Deformity, Swelling Face, Bone Lesion, Soft Tissue Inflammation, Neck Mass, Calcinosis, Barrett's Oesophagus, Osteonecrosis of JAW, Diarrhoea, Dysuria, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg,
    Indication: Hypercalcaemia

Revlimid

Thalidomide

Zometa
    Indication: Multiple Myeloma
    Start date: 2009-01-01
    End date: 2009-04-01

Other drugs received by patient: Nexium; Amoxicillin; Darvocet-N 50; Morphine; Vicodin; Tylenol; Chemotherapeutics NOS; Radiation Therapy



Possible Zometa side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Nephrolithiasis, Agitation, Confusional State, Acute Pulmonary Oedema, Dyspnoea, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 mg, unk
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, unk

Atorvastatin
    Dosage: 10 mg, qd

Bisoprolol Fumarate
    Dosage: 3.75 mg, daily (2.5 mg in the morning and 1.25 mg in the evening)
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, qd
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 ug, daily
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, qd
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, bid
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, qd
    End date: 2012-07-26

Nitroglycerin
    Dosage: 5 mg, daily
    End date: 2012-07-27

Plavix
    Dosage: 75 mg, qd
    End date: 2012-07-26

Ramipril
    Dosage: 10 mg, qd
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, in 15 min
    Indication: Hypercalcaemia
    Start date: 2012-07-19



Possible Zometa side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Agitation, Confusional State, Acute Pulmonary Oedema, Nephrolithiasis, Dyspnoea, Hypercalcaemia, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 mg, unk
    End date: 2012-07-26

Aspirin
    Dosage: 75 mg, unk

Atorvastatin
    Dosage: 10 mg, qd

Bisoprolol Fumarate
    Dosage: 3.75 mg, daily (2.5 mg in the morning and 1.25 mg in the evening)
    End date: 2012-07-27

Cymbalta
    Dosage: 60 mg, qd
    End date: 2012-07-26

Duragesic-100
    Dosage: 50 ug, daily
    End date: 2012-07-26

Lercanidipine
    Dosage: 10 mg, qd
    End date: 2012-07-26

Lyrica
    Dosage: 75 mg, bid
    End date: 2012-07-26

Nexium
    Dosage: 20 mg, qd
    End date: 2012-07-26

Nitroglycerin
    Dosage: 5 mg, daily
    End date: 2012-07-27

Plavix
    Dosage: 75 mg, qd
    End date: 2012-07-26

Ramipril
    Dosage: 10 mg, qd
    End date: 2012-07-26

Zometa
    Dosage: 4 mg, in 15 min
    Indication: Hypercalcaemia
    Start date: 2012-07-19



Possible Zometa side effects in male

Reported by a consumer/non-health professional from Australia on 2012-08-24

Patient: male

Reactions: Respiratory Failure, Osteonecrosis of JAW, Pain, Swelling, Gingival Infection, Lower Respiratory Tract Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Zometa



Possible Zometa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Basedow's Disease, Foot Deformity, Wound, Tachycardia, Palpitations, Back Pain, Pneumonia, Pain in Extremity, Bursitis, Tremor, Emotional Distress, Periorbital Oedema, Insomnia, Dyslipidaemia, Exposed Bone in JAW, Haemorrhage, Pain, Mania, Bone Loss, Fatigue, Injury, Depression, Eye Disorder, Exostosis, Exophthalmos, Gingival Ulceration, Deformity, Anxiety, Osteonecrosis of JAW, Impaired Healing, Typhoid Fever, Hypothyroidism, Memory Impairment, Hyperthyroidism, Physical Disability, Infection, Inflammation

Drug(s) suspected as cause:
Aredia
    Indication: Multiple Myeloma

Zometa
    Indication: Multiple Myeloma

Other drugs received by patient: Atenolol; Effexor; Wellbutrin SR; Ativan; Tapazole



Possible Zometa side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: female

Reactions: Agitation, Confusional State, Renal Failure Acute

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Administration route: Oral
    End date: 2012-07-26

Aspirin
    Administration route: Oral

Atorvastatin
    Administration route: Oral

Bisoprolol Fumarate
    Administration route: Oral
    End date: 2012-07-27

Cymbalta
    Administration route: Oral
    End date: 2012-07-26

Duragesic-100
    End date: 2012-07-26

Lercanidipine
    Administration route: Oral
    End date: 2012-07-26

Lyrica
    Administration route: Oral
    End date: 2012-07-26

Nexium
    Administration route: Oral

Nitroglycerin
    End date: 2012-07-27

Plavix
    Administration route: Oral

Ramipril
    Administration route: Oral
    End date: 2012-07-26

Zometa
    Start date: 2012-07-19
    End date: 2012-07-19



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