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Review Aredia Safety Reports submitted to FDA

Total Aredia reports: 347.
Aredia FDA safety alerts: 2005 2007 2008 .
Reported deaths: 29    Reported hospitalizations: 98.
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FDA Reported Aredia Side Effects: osteonecrosis, bone disorder, tooth extraction, osteomyelitis, sequestrectomy, pain in jaw, impaired healing, actinomycosis, dental treatment, osteomyelitis acute, bone debridement.
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Aredia Side Effects Report #5477911-1
Consumer or non-health professional from JAPAN reported AREDIA problem on Sept 26, 2007. Female patient, 65 years of age, weighting 68.34 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bone disorder, discomfort, gingival swelling, incisional drainage, inflammation, loose tooth, lymphadenectomy, mastectomy. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with ANTINEOPLASTIC AGENTS, TAXOTERE, EPIRUBICIN. Patient was hospitalized and became disabled. Patient recovered.

Aredia Side Effects Report #5481307-6
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Oct 04, 2007. Female patient, 65 years of age, weighting 68.34 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bone disorder, discomfort, incisional drainage, inflammation, loose tooth, lymphadenectomy, mastectomy, osteomyelitis. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with ANTINEOPLASTIC AGENTS, TAXOTERE, EPIRUBICIN. Patient was hospitalized and became disabled. Patient recovered.

Aredia Side Effects Report #5483336-5
Pharmacist from UNITED KINGDOM reported AREDIA problem on Oct 05, 2007. Female patient, 13 years of age, was diagnosed with osteogenesis imperfecta and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: fracture. AREDIA dosage: unknown. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5485015-7
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 08, 2007. Female patient, 55 years of age, weighting 160.0 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess jaw, bone debridement, bone disorder, bone erosion, emotional distress, injury, lesion excision, oral disorder, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, TAMOXIFEN CITRATE, ARIMIDEX, FEMARA, PROZAC, BELLAMINE S. Patient recovered.

Aredia Side Effects Report #5485016-9
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Oct 08, 2007. Female patient, 47 years of age, weighting 156.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: emotional distress, injury, metastasis, osteonecrosis, pain, pain in jaw. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, DOCETAXEL, TRASTUZUMAB, ANASTROZOLE. Patient recovered.

Aredia Side Effects Report #5485025-X
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 08, 2007. Female patient, 68 years of age, weighting 154.0 lb, was diagnosed with metastases to bone, multiple myeloma, breast cancer, atrial fibrillation and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, bone swelling, breast cancer in situ, breast reconstruction, gingival pain, gingivitis, granuloma, infection, jaw fracture. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, THALIDOMIDE, TAMOXIFEN CITRATE, FLECAINIDE ACETATE. Patient recovered.

Aredia Side Effects Report #5485040-6
Physician from ITALY reported AREDIA problem on Oct 05, 2007. Male patient, 72 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis, sinus disorder. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, THALIDOMIDE, DEXAMETHASONE. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5486310-8
AREDIA problem was reported by a Health Professional from GERMANY on Oct 11, 2007. Female patient, weighting 132.3 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: biopsy, c-reactive protein increased, jaw operation, leukocytosis, osteonecrosis, surgery. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5486952-X
Consumer or non-health professional from JAPAN reported AREDIA problem on Oct 10, 2007. Female patient, 67 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with INCADRONIC ACID. Patient recovered.

Aredia Side Effects Report #5486954-3
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Oct 10, 2007. Female patient, 66 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with INCADRONIC ACID. Patient recovered.

Aredia Side Effects Report #5486955-5
Consumer or non-health professional from JAPAN reported AREDIA problem on Oct 10, 2007. Male patient, 60 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5488440-3
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Oct 10, 2007. Male patient, 49 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5489039-5
Consumer or non-health professional from FRANCE reported AREDIA problem on Oct 15, 2007. Male patient, weighting 7.28 lb, was diagnosed with osteogenesis imperfecta and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: blood pressure immeasurable, bronchospasm, hypercapnia, hyperthermia, respiratory disorder, skin discolouration, tachycardia, tachypnoea. AREDIA dosage: 1.5 MG, ONCE/SINGLE. Patient died on 07/30/2007.

Aredia Side Effects Report #5491528-4
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 16, 2007. Male patient, 42 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bone disorder, cellulitis, deep vein thrombosis, dental prosthesis placement, erythema, face oedema, gingival bleeding, gingival oedema. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, EFFEXOR, HYDROCODONE, MORPHINE SULPHATE, ALPRAZOLAM, SPIRONOLACTONE W. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5492734-5
Consumer or non-health professional from GERMANY reported AREDIA problem on Oct 16, 2007. Female patient, 75 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: antibiotic prophylaxis, osteitis, osteonecrosis, plastic surgery, primary sequestrum, sequestrectomy, tooth extraction. AREDIA dosage: 90 MG, QMO. Patient recovered.

Aredia Side Effects Report #5492751-5
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 16, 2007. Female patient, 74 years of age, weighting 191.0 lb, was diagnosed with metastases to bone, breast cancer, anxiety, bone pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess jaw, actinomycosis, anhedonia, anxiety, biopsy, bone disorder, deformity, dental caries, dental operation. AREDIA dosage: 90MG QMON IN 500CC OVER 1.5 TO 2 HOURS. During the same period patient was treated with ZOMETA, TAMOXIFEN CITRATE, ATIVAN, VIOXX, FOSAMAX, ARIMIDEX, CALCIUM, GLUCOSAMINE W. Patient recovered.

Aredia Side Effects Report #5494148-0
Physician from BELGIUM reported AREDIA problem on July 30, 2007. Female patient, 78 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5494176-5
AREDIA problem was reported by a Physician from UNITED STATES on Oct 16, 2007. Male patient, 71 years of age, weighting 178.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, biopsy, bone disorder, bone erosion, bone fragmentation, computerised tomogram abnormal, dental treatment, exostosis, fall. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, PROCRIT, IRON SUPPLEMENTS, NEURONTIN, FOLIC ACID, BUMEX, NAPROXEN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5494220-5
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Oct 16, 2007. Female patient, 51 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: chills, dyspnoea, osteonecrosis, pleural effusion, pneumonia, pneumothorax, pulmonary congestion, wheezing, x-ray abnormal. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, LIPITOR, PREMARIN, HYDROCHLOROTHIAZIDE, XANAX. Patient recovered.

Aredia Side Effects Report #5498545-9
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Oct 18, 2007. Female patient, 67 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with INCADRONIC ACID. Patient recovered.

Aredia Side Effects Report #5498547-2
Consumer or non-health professional from JAPAN reported AREDIA problem on Oct 18, 2007. Male patient, 60 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5498616-7
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Oct 18, 2007. Male patient, 49 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, INCADRONIC ACID. Patient recovered.

Aredia Side Effects Report #5498618-0
Consumer or non-health professional from JAPAN reported AREDIA problem on Oct 18, 2007. Female patient, 66 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with INCADRONIC ACID, DEXAMETHASONE. Patient recovered.

Aredia Side Effects Report #5501520-9
AREDIA problem was reported by a Consumer or non-health professional from GERMANY on Oct 24, 2007. Male patient was diagnosed with plasmacytoma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: gastrointestinal tube insertion, jaw disorder, jaw operation, osteonecrosis, pain in jaw, plastic surgery, sinusitis, tooth extraction. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5502583-7
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Oct 24, 2007. Male patient, 74 years of age, weighting 167.0 lb, was diagnosed with hypercalcaemia, neuropathy peripheral, arthritis, lipids increased and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anhedonia, anxiety, arthralgia, blood immunoglobulin a increased, bone disorder, burning sensation, erythema, haemorrhoids, herpes zoster. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, NITROGLYCERIN, KLONOPIN, NEURONTIN, CELEBREX, ZOCOR, PAXIL. Patient recovered.

Aredia Side Effects Report #5441355-9
AREDIA problem was reported by a Pharmacist from GERMANY on Aug 28, 2007. Female patient, 70 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis, tooth erosion, tooth extraction, tooth loss. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5441385-7
Physician from JAPAN reported AREDIA problem on Aug 27, 2007. Female patient, 46 years of age, weighting 119.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: dental operation, gingival swelling, osteonecrosis, pain in jaw, sequestrectomy. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, TAXOL, HERCEPTIN, TAMOXIFEN CITRATE, PROGESTON WYETH, FURTULON, DUROTEP JANSSEN, RITALIN. Patient recovered.

Aredia Side Effects Report #5443003-0
AREDIA problem was reported by a Health Professional from GERMANY on Aug 27, 2007. Female patient, weighting 145.5 lb, was diagnosed with plasmacytoma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, jaw operation, osteomyelitis, osteonecrosis. AREDIA dosage: 90 MG, ONCE/SINGLE. During the same period patient was treated with ZOMETA, ALDACTONE, CALCIUM, OXYGESIC, LASIX, NOVODIGAL, MOVICOL, PANTOPRAZOLE. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5444163-8
Pharmacist from UNITED STATES reported AREDIA problem on Sept 04, 2007. Female patient, 55 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5444240-1
AREDIA problem was reported by a Health Professional from UNITED STATES on Sept 04, 2007. Male patient, weighting 180.0 lb, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5445882-X
Physician from UNITED STATES reported AREDIA problem on Aug 31, 2007. Female patient, 55 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5448280-8
AREDIA problem was reported by a Physician from AUSTRALIA on Sept 06, 2007. Female patient, 80 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess, osteonecrosis, pain. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5455030-8
Physician from UNITED STATES reported AREDIA problem on Sept 12, 2007. Female patient, 55 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5455703-7
AREDIA problem was reported by a Physician from JAPAN on Sept 11, 2007. Male patient, 74 years of age, weighting 97.00 lb, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: fistula, inflammation, jaw operation, oral surgery, osteomyelitis, pain in jaw, primary sequestrum, sequestrectomy. AREDIA dosage: 45 MG/DAY. During the same period patient was treated with VINCRISTINE, DECADRON. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5458036-8
Consumer or non-health professional from AUSTRALIA reported AREDIA problem on Sept 17, 2007. Female patient, 80 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess, osteonecrosis, pain, swelling, wound secretion. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5458046-0
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2007. Female patient, 63 years of age, weighting 118.0 lb, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, diplopia, haemodialysis, paraesthesia, renal failure chronic, renal impairment, vision blurred. AREDIA dosage: unknown. During the same period patient was treated with THALOMID, VINCRISTINE, LISINOPRIL, LOVASTATIN, DILTIAZEM, LOPID. Patient recovered.

Aredia Side Effects Report #5459883-9
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Sept 11, 2007. Female patient, 54 years of age, was diagnosed with autoimmune thyroiditis, narcolepsy and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: arthralgia, autonomic neuropathy, bloody discharge, chest pain, dry eye, hypersensitivity, malignant neoplasm progression, pneumonia, pyrexia. AREDIA dosage: unknown. During the same period patient was treated with DILAUDID, FEXOFENADINE, ZOMETA, LEVOTHYROXINE, RITALIN, FEMARA, NEURONTIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5461106-1
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2007. Female patient, 54 years of age, was diagnosed with autoimmune thyroiditis, narcolepsy and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: arthralgia, autonomic neuropathy, bloody discharge, chest pain, dry eye, hypersensitivity, malignant neoplasm progression, pneumonia, pyrexia. AREDIA dosage: unknown. During the same period patient was treated with DILAUDID, FEXOFENADINE, ZOMETA, LEVOTHYROXINE, RITALIN, FEMARA, NEURONTIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5461112-7
Pharmacist from UNITED STATES reported AREDIA problem on Sept 12, 2007. Female patient, 62 years of age, weighting 120.0 lb, was diagnosed with breast cancer metastatic and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: cellulitis, conjunctivitis, dermatitis allergic, erythema, eye swelling. AREDIA dosage: 90MG Q4WKS. During the same period patient was treated with TAMOXIFEN CITRATE, LASIX, RANITIDINE, PROCRIT, LEVOTHYROXINE. Patient recovered.

Aredia Side Effects Report #5461117-6
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 15, 2007. Female patient, 47 years of age, was diagnosed with osteoporosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anhedonia, anxiety, emotional distress, endodontic procedure, gingival disorder, jaw disorder, life expectancy shortened, oral intake reduced, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with REMICADE. Patient recovered.

Aredia Side Effects Report #5463952-7
Consumer or non-health professional from JAPAN reported AREDIA problem on Sept 13, 2007. Male patient, child 9 years of age, was diagnosed with osteogenesis imperfecta and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: failure to thrive, inflammation, lower limb fracture, pyrexia, upper limb fracture. AREDIA dosage: 0.5MG/KG/DOSE X 3 DAYS. Patient recovered.

Aredia Side Effects Report #5466586-3
AREDIA problem was reported by a Physician from on Sept 19, 2007. Female patient, weighting 103.6 lb, was diagnosed with complex regional pain syndrome and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: metastases to bone, metastatic neoplasm, non-hodgkin's lymphoma, nuclear magnetic resonance imaging abnormal. AREDIA dosage: unknown. During the same period patient was treated with ASPIRIN. Patient recovered.

Aredia Side Effects Report #5466593-0
Physician from AUSTRALIA reported AREDIA problem on Sept 19, 2007. Male patient, 81 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5467806-1
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2007. Female patient, 54 years of age, was diagnosed with autoimmune thyroiditis, narcolepsy and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: arthralgia, autonomic neuropathy, chest pain, constipation, dry eye, dry mouth, flatulence, gait disturbance, haemorrhage. AREDIA dosage: unknown. During the same period patient was treated with DILAUDID, FEXOFENADINE, ZOMETA, LEVOTHYROXINE, RITALIN, FEMARA, NEURONTIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5469131-1
Consumer or non-health professional from FRANCE reported AREDIA problem on Sept 24, 2007. Male patient, weighting 7.28 lb, was diagnosed with osteogenesis imperfecta and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: blood pressure immeasurable, bronchospasm, hypercapnia, hyperthermia, respiratory disorder, skin discolouration, tachycardia, tachypnoea. AREDIA dosage: 1.5 MG, ONCE/SINGLE. Patient recovered.

Aredia Side Effects Report #5470566-1
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 20, 2007. Male patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anhedonia, anxiety, deformity, discomfort, emotional distress, injury, oral intake reduced, osteonecrosis, pain. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5403588-7
Physician from UNITED STATES reported AREDIA problem on July 27, 2007. Female patient, 35 years of age, was diagnosed with osteoporosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, haemoptysis, non-small cell lung cancer, oesophageal pain, pharyngeal haemorrhage, pharyngolaryngeal pain, pneumonia, throat irritation. AREDIA dosage: unknown. During the same period patient was treated with COLCHICINE, CUPRIMINE, MIRAPEX, ESOMEPRAZOLE MAGNESIUM, PREDNISONE, NORVASC, VYTORIN, PREMARIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5403594-2
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on July 24, 2007. Male patient was diagnosed with osteogenesis imperfecta and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: failure to thrive, inflammation, lower limb fracture, pyrexia, upper limb fracture. AREDIA dosage: 0.5MG/KG/DOSE X 3 DAYS. Patient recovered.

Aredia Side Effects Report #5403599-1
Physician from JAPAN reported AREDIA problem on July 26, 2007. Female patient, 65 years of age, weighting 68.34 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bone disorder, discomfort, incisional drainage, inflammation, loose tooth, lymphadenectomy, mastectomy, osteomyelitis. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with TAXOTERE, EPIRUBICIN. Patient was hospitalized and became disabled. Patient recovered.

Aredia Side Effects Report #5404821-8
AREDIA problem was reported by a Physician from JAPAN on July 26, 2007. Female patient, 65 years of age, weighting 68.34 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bone disorder, discomfort, incisional drainage, inflammation, loose tooth, lymphadenectomy, mastectomy, osteomyelitis. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with TAXOTERE, EPIRUBICIN. Patient was hospitalized and became disabled. Patient recovered.

Aredia Side Effects Report #5409278-9
Consumer or non-health professional from JAPAN reported AREDIA problem on Aug 02, 2007. Female patient, 63 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, oral pain, osteonecrosis, soft tissue inflammation. AREDIA dosage: 45 MG, QMO. Patient recovered.

Aredia Side Effects Report #5410851-2
AREDIA problem was reported by a Physician from JAPAN on Aug 03, 2007. Female patient, 46 years of age, weighting 119.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: dental operation, gingival swelling, osteonecrosis, pain in jaw. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, TAXOL, HERCEPTIN, TAMOXIFEN CITRATE, PROGESTON WYETH, FURTULON, DUROTEP JANSSEN, RITALIN. Patient recovered.

Aredia Side Effects Report #5410855-X
Consumer or non-health professional from SWITZERLAND reported AREDIA problem on Aug 03, 2007. Female patient was diagnosed with breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, impaired healing, osteonecrosis, tooth extraction. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE, FLUOROURACIL. Patient recovered.

Aredia Side Effects Report #5411709-5
AREDIA problem was reported by a Consumer or non-health professional from SWITZERLAND on Aug 03, 2007. Female patient was diagnosed with breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, impaired healing, osteonecrosis, tooth extraction. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE, FLUOROURACIL. Patient recovered.

Aredia Side Effects Report #5413212-5
Physician from BELGIUM reported AREDIA problem on Aug 08, 2007. Female patient, 14 years of age, was diagnosed with bone pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hyperbilirubinaemia, malaise, pallor, pneumonitis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5413215-0
AREDIA problem was reported by a Physician from BELGIUM on Aug 08, 2007. Female patient, 14 years of age, was diagnosed with bone pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, hyperbilirubinaemia, malaise, pallor, pneumonitis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5413227-7
Consumer or non-health professional from JAPAN reported AREDIA problem on Aug 10, 2007. Female patient, 63 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anorexia, bone disorder, hepatic failure, lip swelling, malignant neoplasm progression, metastases to liver, oral pain, osteonecrosis, soft tissue inflammation. AREDIA dosage: 45 MG, QMO. During the same period patient was treated with PACLITAXEL, HERCEPTIN, DOCETAXEL. Patient was hospitalized and became disabled. Patient died on 08/13/2006.

Aredia Side Effects Report #5414838-5
AREDIA problem was reported by a Consumer or non-health professional from GERMANY on Aug 10, 2007. Male patient, 53 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, histology abnormal, impaired healing, jaw disorder, oral surgery, osteomyelitis, osteonecrosis, tooth extraction, x-ray dental. AREDIA dosage: 90 MG/DAY. During the same period patient was treated with BONDRONAT, ACARBOSE. Patient recovered.

Aredia Side Effects Report #5416387-7
Consumer or non-health professional from GERMANY reported AREDIA problem on Aug 10, 2007. Female patient, 64 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, histology abnormal, jaw disorder, oral surgery, osteonecrosis, scintigraphy, tooth extraction, x-ray dental. AREDIA dosage: unknown. During the same period patient was treated with CLINDAMYCIN, ASPIRIN, LISIHEXAL, CALCILAC KT, MAREEN, PENTAERYTHRITOL TETRANITRATE, QUERTO. Patient recovered.

Aredia Side Effects Report #5418203-6
AREDIA problem was reported by a Physician from GERMANY on Aug 13, 2007. Female patient was diagnosed with metastases to bone, osteoarthritis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: albumin urine present, biopsy, biopsy kidney, blood creatinine increased, blood urea increased, creatine urine increased, creatinine renal clearance decreased, glomerulonephritis. AREDIA dosage: 75 MG, QMO. During the same period patient was treated with FEMARA, RAMIPRIL, PREDNISOLONE, AMLODIPINE, LOCOL, NSAID, ACEMETACIN. Patient recovered.

Aredia Side Effects Report #5419049-5
Physician from UNITED STATES reported AREDIA problem on Aug 14, 2007. Female patient, 54 years of age, weighting 130.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, fall, femur fracture, hip arthroplasty, oral surgery, osteonecrosis, periodontal disease, periodontitis, primary sequestrum. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, VITAMIN CAP, FEMARA, LASIX, PRINIVIL, COUMADIN, LORTAB, NAPROXEN. Patient recovered.

Aredia Side Effects Report #5419121-X
AREDIA problem was reported by a Consumer or non-health professional from GEORGIA on Aug 13, 2007. Female patient, child 11 years of age, weighting 63.93 lb, was diagnosed with osteogenesis imperfecta and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bronchospasm, chills, pyrexia. AREDIA dosage: 14.5 MG/DAY. During the same period patient was treated with CHLORIDE. Patient recovered.

Aredia Side Effects Report #5427166-9
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Aug 20, 2007. Female patient, 44 years of age, weighting 249.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, artificial crown procedure, bone lesion, breast cancer metastatic, dental caries, excessive granulation tissue, fistula, osteitis, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5427167-0
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 20, 2007. Male patient, 51 years of age, weighting 154.0 lb, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: biopsy bone abnormal, biopsy peripheral nerve, bone scan abnormal, edentulous, gingival erosion, gingival pain, hypoaesthesia. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ZOMETA, WARFARIN, FAMVIR, ALEVE, NEURONTIN. Patient recovered.

Aredia Side Effects Report #5427471-6
Consumer or non-health professional from JAPAN reported AREDIA problem on Aug 23, 2007. Female patient, 63 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anorexia, bone disorder, hepatic failure, lip swelling, malignant neoplasm progression, metastases to liver, oral pain, osteonecrosis, soft tissue inflammation. AREDIA dosage: 45 MG, QMO. During the same period patient was treated with PACLITAXEL, HERCEPTIN, DOCETAXEL. Patient was hospitalized and became disabled. Patient died on 08/13/2006.

Aredia Side Effects Report #5428767-4
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Aug 23, 2007. Female patient, 63 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anorexia, bone disorder, hepatic failure, lip swelling, malignant neoplasm progression, metastases to liver, oral pain, osteonecrosis, soft tissue inflammation. AREDIA dosage: 45 MG, QMO. During the same period patient was treated with PACLITAXEL, HERCEPTIN, DOCETAXEL. Patient was hospitalized and became disabled. Patient died on 08/13/2006.

Aredia Side Effects Report #5440787-2
Physician from JAPAN reported AREDIA problem on Aug 24, 2007. Female patient, 65 years of age, weighting 68.34 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bone disorder, discomfort, incisional drainage, inflammation, loose tooth, lymphadenectomy, mastectomy, osteomyelitis. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with TAXOTERE, EPIRUBICIN. Patient was hospitalized and became disabled. Patient recovered.

Aredia Side Effects Report #5375836-3
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2007. Female patient, 47 years of age, was diagnosed with osteoporosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anhedonia, anxiety, emotional distress, endodontic procedure, gingival disorder, jaw disorder, life expectancy shortened, oral intake reduced, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with REMICADE. Patient recovered.

Aredia Side Effects Report #5378112-8
Consumer or non-health professional from JAPAN reported AREDIA problem on June 25, 2007. Female patient, 54 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, osteonecrosis, tooth loss. AREDIA dosage: unknown. During the same period patient was treated with VINORELBINE, TRASTUZUMAB. Patient recovered.

Aredia Side Effects Report #5378165-7
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on June 27, 2007. Female patient, 65 years of age, weighting 105.8 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess jaw, bone swelling, dental caries, dental treatment, inflammation, osteomyelitis, osteonecrosis, purulent discharge, rash pustular. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, TAXOTERE. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5378167-0
Consumer or non-health professional from JAPAN reported AREDIA problem on June 27, 2007. Male patient, 75 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: biopsy skin abnormal, gastric cancer, induration, metastases to skin, subcutaneous nodule. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5379647-4
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on June 26, 2007. Female patient, 64 years of age, weighting 105.8 lb, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, bone trimming, osteomyelitis, osteonecrosis, pain in jaw, sequestrectomy, tooth disorder, tooth extraction, viith nerve paralysis. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with DECADRON, DIOVAN, OMEPRAL, AMLODIN. Patient recovered.

Aredia Side Effects Report #5379660-7
Consumer or non-health professional from JAPAN reported AREDIA problem on June 26, 2007. Female patient, 69 years of age, weighting 127.9 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, bone swelling, dysaesthesia, fistula, gingival swelling, gingivitis, granuloma, haematocrit abnormal, osteomyelitis. AREDIA dosage: 45 TO 90 MG/DAY. During the same period patient was treated with AROMASIN, EPIDOSIN, CYCLOPHOSPHAMIDE, TAXOL, HERCEPTIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5381510-X
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on July 02, 2007. Female patient, 62 years of age, was diagnosed with osteoporosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anxiety, osteonecrosis, pain. AREDIA dosage: unknown. During the same period patient was treated with FOSAMAX. Patient recovered.

Aredia Side Effects Report #5382594-5
Consumer or non-health professional from JAPAN reported AREDIA problem on July 03, 2007. Female patient, 64 years of age, weighting 105.8 lb, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, bone trimming, osteomyelitis, osteonecrosis, pain in jaw, sequestrectomy, tooth disorder, tooth extraction, viith nerve paralysis. AREDIA dosage: 45 MG, UNK. During the same period patient was treated with DECADRON, DIOVAN, OMEPRAL, AMLODIN. Patient recovered.

Aredia Side Effects Report #5385021-7
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Female patient, 69 years of age, weighting 127.9 lb, was diagnosed with metastases to bone, breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, bone swelling, dysaesthesia, fistula, gingival swelling, gingivitis, granuloma, haematocrit abnormal, osteomyelitis. AREDIA dosage: 45 TO 90 MG/DAY. During the same period patient was treated with AROMASIN, EPIDOSIN, CYCLOPHOSPHAMIDE, TAXOL, HERCEPTIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5385046-1
Consumer or non-health professional from ITALY reported AREDIA problem on July 02, 2007. Male patient, 69 years of age, was diagnosed with metastases to bone, multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, osteonecrosis. AREDIA dosage: 90 MG, CYCLIC. During the same period patient was treated with VELCADE, NAVOBAN, ARANESP, FLEBOCORTID, ZOMETA. Patient recovered.

Aredia Side Effects Report #5386224-8
AREDIA problem was reported by a Health Professional from ITALY on July 04, 2007. Male patient, 71 years of age, was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess, bone disorder, fistula, osteonecrosis, sequestrectomy. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ZOMETA, ALKERAN. Patient recovered.

Aredia Side Effects Report #5386225-X
Consumer or non-health professional from JAPAN reported AREDIA problem on July 04, 2007. Female patient, 63 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with TRASTUZUMAB, CYCLOPHOSPHAMIDE, DOXIFLURIDINE. Patient recovered.

Aredia Side Effects Report #5386276-5
AREDIA problem was reported by a Pharmacist from CANADA on July 04, 2007. Female patient, 69 years of age, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5387275-X
Physician from UNITED STATES reported AREDIA problem on July 11, 2007. Female patient, 62 years of age, weighting 125.7 lb, was diagnosed with metastases to bone, anaemia, multiple myeloma, pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, chronic obstructive pulmonary disease, dehydration, dialysis, erythema, malignant neoplasm progression, mental status changes, neuropathy peripheral, osteonecrosis. AREDIA dosage: 90MG Q4WKS. During the same period patient was treated with ZOMETA, PROCRIT, VELCADE, THALIDOMIDE, NEXIUM, CYMBALTA, VIOXX, OXYCONTIN. Patient was hospitalized. Patient died on 04/04/2007.

Aredia Side Effects Report #5387277-3
AREDIA problem was reported by a Physician from UNITED STATES on July 11, 2007. Female patient, 62 years of age, weighting 125.7 lb, was diagnosed with metastases to bone, anaemia, multiple myeloma, pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, chronic obstructive pulmonary disease, dehydration, dialysis, erythema, malignant neoplasm progression, mental status changes, neuropathy peripheral, osteonecrosis. AREDIA dosage: 90MG Q4WKS. During the same period patient was treated with ZOMETA, PROCRIT, VELCADE,