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Review Aredia Safety Reports submitted to FDA

Total Aredia reports: 560.
Aredia FDA safety alerts: 2005 2007 2008 .
Reported deaths: 41    Reported hospitalizations: 152.
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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 #5398849-4
Consumer or non-health professional from GERMANY reported AREDIA problem on July 24, 2007. Female patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw operation, osteitis, osteonecrosis, periodontitis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, METOPROLOL SUCCINATE, DEKRISTOL, DIGITOXIN, VESDIL, CLINDAMYCIN. Patient died on 03/01/2005.

Aredia Side Effects Report #5398861-5
AREDIA problem was reported by a Health Professional from GERMANY on July 24, 2007. Female patient was diagnosed with plasmacytoma, multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw disorder, oral surgery, osteomyelitis, osteonecrosis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, CAPTOHEXAL, INSULIN, XALATAN, TRUSOPT. Patient died on 09/01/2005.

Aredia Side Effects Report #5398862-7
Consumer or non-health professional from GREECE reported AREDIA problem on July 24, 2007. Female patient, 66 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: biopsy, localised oedema, osteonecrosis, purulent discharge, squamous cell carcinoma. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5399339-5
AREDIA problem was reported by a Consumer or non-health professional from GERMANY on July 24, 2007. Female patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw operation, osteitis, osteonecrosis, periodontitis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, METOPROLOL SUCCINATE, DEKRISTOL, DIGITOXIN, VESDIL, CLINDAMYCIN. Patient died on 03/01/2005.

Aredia Side Effects Report #5399343-7
Consumer or non-health professional from GERMANY reported AREDIA problem on July 24, 2007. Female patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw operation, osteitis, osteonecrosis, periodontitis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, METOPROLOL SUCCINATE, DEKRISTOL, DIGITOXIN, VESDIL, CLINDAMYCIN. Patient died on 03/01/2005.

Aredia Side Effects Report #5401162-X
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on July 25, 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: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5401397-6
Consumer or non-health professional from JAPAN reported AREDIA problem on July 25, 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: osteonecrosis. AREDIA dosage: unknown. 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, THALIDOMIDE, NEXIUM, CYMBALTA, VIOXX, OXYCONTIN. Patient was hospitalized. Patient died on 04/04/2007.

Aredia Side Effects Report #5387334-1
Physician from GERMANY reported AREDIA problem on July 06, 2007. Female patient, 75 years of age, weighting 136.7 lb, was diagnosed with osteonecrosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, biopsy gingival, oral surgery, osteonecrosis, plastic surgery. AREDIA dosage: 90 MG, QMO. Patient recovered.

Aredia Side Effects Report #5388912-6
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on July 06, 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 #5388917-5
Pharmacist from UNITED STATES reported AREDIA problem on July 09, 2007. Male 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: abnormal sensation in eye, chills, eye pain, infusion site reaction, infusion site swelling, optic ischaemic neuropathy, pyrexia, visual disturbance. AREDIA dosage: 90MG QMOS. Patient recovered.

Aredia Side Effects Report #5388982-5
AREDIA problem was reported by a Health Professional from GERMANY on July 09, 2007. Male patient was diagnosed with plasmacytoma, multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone cyst, cyst removal, dental prosthesis user, loose tooth, necrotising ulcerative periodontitis, sequestrectomy, soft tissue inflammation, tooth extraction. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, LIPID MODIFYING AGENTS. Patient recovered.

Aredia Side Effects Report #5388993-X
Consumer or non-health professional from UNITED STATES reported AREDIA problem on July 09, 2007. Female patient, 41 years of age, weighting 244.0 lb, was diagnosed with osteitis deformans, thyroid disorder and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: arthralgia, dental caries, endodontic procedure, facial pain, hemiparesis, osteonecrosis, pain in jaw, swelling, tooth abscess. AREDIA dosage: 60 TO 90MG Q2MOS. During the same period patient was treated with CALCIUM CHLORIDE, LIPITOR, LEUCOVORIN CALCIUM, LEVOTHYROXINE, METHOTREXATE, PREVACID, ATIVAN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5389833-5
AREDIA problem was reported by a Consumer or non-health professional from ITALY on July 11, 2007. Female patient was diagnosed with osteoporosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: dental treatment, erythema, fistula, mastication disorder, osteonecrosis, pain, purulent discharge. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with CLASTEON, ADRONAT, DELTACORTENE. Patient recovered.

Aredia Side Effects Report #5391917-2
Physician from GERMANY reported AREDIA problem on July 16, 2007. Male patient, 68 years of age, weighting 227.1 lb, was diagnosed with plasmacytoma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: biopsy bone abnormal, bone disorder, bone lesion excision, oral surgery, osteomyelitis, osteonecrosis, tooth extraction. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5391927-5
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on July 11, 2007. Female patient, weighting 167.0 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: anxiety, bone disorder, bone operation, cataract operation, dental operation, gingival infection, haemorrhage. AREDIA dosage: 90 MG MONTHLY. During the same period patient was treated with ZOMETA, FOSAMAX, HERCEPTIN, NAVELBINE, TAXOL, LIPITOR, ARANESP. Patient recovered.

Aredia Side Effects Report #5391929-9
Consumer or non-health professional from UNITED STATES reported AREDIA problem on July 11, 2007. Female patient, 58 years of age, weighting 180.0 lb, was diagnosed with multiple myeloma, rheumatoid arthritis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, antinuclear antibody positive, arthralgia, bone debridement, bone lesion, endodontic procedure, intervertebral disc protrusion, mouth ulceration. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, VIOXX. Patient recovered.

Aredia Side Effects Report #5391949-4
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on July 11, 2007. Female patient, weighting 167.0 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: anxiety, bone disorder, bone operation, cataract operation, dental operation, gingival infection, haemorrhage. AREDIA dosage: 90 MG MONTHLY. During the same period patient was treated with ZOMETA, FOSAMAX, HERCEPTIN, NAVELBINE, TAXOL, LIPITOR, ARANESP. Patient recovered.

Aredia Side Effects Report #5391963-9
Consumer or non-health professional from JAPAN reported AREDIA problem on July 12, 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: cellulitis, osteonecrosis, periodontitis, primary sequestrum, tooth extraction. AREDIA dosage: unknown. During the same period patient was treated with TRASTUZUMAB, CYCLOPHOSPHAMIDE, DOXIFLURIDINE. Patient recovered.

Aredia Side Effects Report #5393270-7
AREDIA problem was reported by a Physician from GERMANY on July 18, 2007. Female patient, 83 years of age, was diagnosed with breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: 4 MG, QMO. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5393272-0
Physician from GERMANY reported AREDIA problem on July 18, 2007. Female patient, 83 years of age, was diagnosed with breast cancer and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. AREDIA dosage: 4 MG, QMO. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5393296-3
AREDIA problem was reported by a Physician from on July 16, 2007. Female patient 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, nuclear magnetic resonance imaging abnormal. AREDIA dosage: unknown. During the same period patient was treated with ASPIRIN. Patient recovered.

Aredia Side Effects Report #5393352-X
Pharmacist from GERMANY reported AREDIA problem on July 16, 2007. Female patient, 75 years of age, weighting 158.7 lb, was diagnosed with plasmacytoma, dialysis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: dental treatment, inflammation of wound, neurolysis surgical, osteomyelitis, osteonecrosis, sequestrectomy, tooth extraction. AREDIA dosage: 90 MG EVERY 6 WEEKS. During the same period patient was treated with DIALYSIS, PRAVASTATIN, PREDNISONE, ASPIRIN, TORSEMIDE, ERYPO. Patient recovered.

Aredia Side Effects Report #5393369-5
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on July 17, 2007. Female patient, 43 years of age, weighting 191.0 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: bone disorder, impaired healing, osteonecrosis, pain, positron emission tomogram abnormal, tooth extraction, wound debridement. AREDIA dosage: 90MG Q4WKS. During the same period patient was treated with TAXOTERE. Patient recovered.

Aredia Side Effects Report #5393371-3
Consumer or non-health professional from UNITED STATES reported AREDIA problem on July 17, 2007. Female patient, 43 years of age, weighting 191.0 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: bone disorder, impaired healing, osteonecrosis, pain, positron emission tomogram abnormal, tooth extraction, wound debridement. AREDIA dosage: 90MG Q4WKS. During the same period patient was treated with TAXOTERE. Patient recovered.

Aredia Side Effects Report #5397407-5
AREDIA problem was reported by a Consumer or non-health professional from GERMANY on July 24, 2007. Female patient, 69 years of age, was diagnosed with plasmacytoma, hypertension and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, dental prosthesis user, jaw operation, oral surgery, osteonecrosis, osteotomy, primary sequestrum, tooth extraction. AREDIA dosage: 80 MG, UNK. During the same period patient was treated with CARMEN, OMNIC. Patient recovered.

Aredia Side Effects Report #5398849-4
Consumer or non-health professional from GERMANY reported AREDIA problem on July 24, 2007. Female patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw operation, osteitis, osteonecrosis, periodontitis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, METOPROLOL SUCCINATE, DEKRISTOL, DIGITOXIN, VESDIL, CLINDAMYCIN. Patient died on 03/01/2005.

Aredia Side Effects Report #5398861-5
AREDIA problem was reported by a Health Professional from GERMANY on July 24, 2007. Female patient was diagnosed with plasmacytoma, multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw disorder, oral surgery, osteomyelitis, osteonecrosis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, CAPTOHEXAL, INSULIN, XALATAN, TRUSOPT. Patient died on 09/01/2005.

Aredia Side Effects Report #5398862-7
Consumer or non-health professional from GREECE reported AREDIA problem on July 24, 2007. Female patient, 66 years of age, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: biopsy, localised oedema, osteonecrosis, purulent discharge, squamous cell carcinoma. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5399339-5
AREDIA problem was reported by a Consumer or non-health professional from GERMANY on July 24, 2007. Female patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw operation, osteitis, osteonecrosis, periodontitis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, METOPROLOL SUCCINATE, DEKRISTOL, DIGITOXIN, VESDIL, CLINDAMYCIN. Patient died on 03/01/2005.

Aredia Side Effects Report #5399343-7
Consumer or non-health professional from GERMANY reported AREDIA problem on July 24, 2007. Female patient was diagnosed with multiple myeloma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess drainage, abscess jaw, actinomycosis, antibiotic prophylaxis, jaw operation, osteitis, osteonecrosis, periodontitis. AREDIA dosage: 90 MG, UNK. During the same period patient was treated with ZOMETA, ASPIRIN, METOPROLOL SUCCINATE, DEKRISTOL, DIGITOXIN, VESDIL, CLINDAMYCIN. Patient died on 03/01/2005.

Aredia Side Effects Report #5401162-X
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on July 25, 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: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5401397-6
Consumer or non-health professional from JAPAN reported AREDIA problem on July 25, 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: osteonecrosis. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5755786-0
AREDIA problem was reported by a Health Professional from JAPAN on May 21, 2008. 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: bone disorder, gingival swelling, oral discharge, osteomyelitis. AREDIA dosage: unknown. During the same period patient was treated with VINORELBINE, NAVELBINE. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5756567-4
Consumer or non-health professional from UNITED STATES reported AREDIA problem on May 30, 2008. Female patient, weighting 167.0 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: actinomycosis, anxiety, bone disorder, bone operation, breath odour, cataract operation, dental operation, dysgeusia, dysphonia. AREDIA dosage: 90 MG MONTHLY. During the same period patient was treated with ZOMETA, FOSAMAX, HERCEPTIN, NAVELBINE, TAXOL, LIPITOR, ARANESP. Patient recovered.

Aredia Side Effects Report #5757847-9
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on May 27, 2008. Female patient, weighting 142.0 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: back pain, computerised tomogram abnormal, deep vein thrombosis, depressive symptom, device related infection, face and mouth x-ray abnormal, failure of implant, fatigue, gingival infection. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ZOMETA, ARIMIDEX, FASLODEX, NAVELBINE, TAXOTERE, GEMZAR. Patient recovered.

Aredia Side Effects Report #5758897-9
Consumer or non-health professional from CANADA reported AREDIA problem on May 27, 2008. Female patient was diagnosed with osteoporosis, juvenile arthritis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: dizziness, fatigue, heart rate irregular, impaired work ability, insomnia, oedema peripheral, speech disorder. AREDIA dosage: 30 MG. During the same period patient was treated with CORTICOSTEROIDS, ESTROGENIC SUBSTANCE, PROGESTERONE, TESTOSTERONE. Patient recovered.

Aredia Side Effects Report #5758899-2
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on May 28, 2008. Female patient was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: deformity, infection, osteonecrosis, pain. AREDIA dosage: unknown. Patient recovered.

Aredia Side Effects Report #5759071-2
Health Professional from UNITED STATES reported AREDIA problem on May 28, 2008. Male patient was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, gingival disorder, impaired healing, osteonecrosis, tooth extraction. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5759861-6
AREDIA problem was reported by a Consumer or non-health professional from on May 29, 2008. Male patient was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: jaw disorder, mastication disorder, oral disorder, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5759873-2
Consumer or non-health professional from ITALY reported AREDIA problem on May 29, 2008. Female patient was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: jaw disorder, mastication disorder, oral disorder, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5764687-3
AREDIA problem was reported by a Physician from UNITED STATES on May 30, 2008. Male patient, weighting 198.4 lb, was diagnosed with metastatic renal cell carcinoma and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: impaired healing, osteonecrosis, surgery, toothache. AREDIA dosage: unknown. During the same period patient was treated with SUNITINIB MALATE. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5765622-4
Consumer or non-health professional from UNITED STATES reported AREDIA problem on May 30, 2008. Male patient, weighting 182.0 lb, was diagnosed with metastases to bone, hypercalcaemia, pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, alveoloplasty, anaemia, biopsy, bone debridement, bone disorder, cataract operation, compression fracture, dental fistula. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, VELCADE, OXYCONTIN, OXYCODONE, PRILOSEC, TYLENOL, THALOMID. Patient recovered.

Aredia Side Effects Report #5766811-5
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on May 30, 2008. Female patient, weighting 148.0 lb, was diagnosed with depression and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, aortic stenosis, arteriosclerosis, arthritis, asthenia, atelectasis, bacteria tissue specimen identified, biopsy bone abnormal, biopsy mucosa abnormal. AREDIA dosage: 90MG Q4WKS. During the same period patient was treated with ZOMETA, COUMADIN, LASIX, AMBIEN, SPIRONOLACTONE, PAXIL, LANOXIN. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5767842-1
Consumer or non-health professional from SPAIN reported AREDIA problem on June 05, 2008. Female patient, 75 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 was hospitalized. Patient recovered.

Aredia Side Effects Report #5772239-4
AREDIA problem was reported by a Physician from UNITED STATES on June 03, 2008. 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: bone disorder, jaw operation, pain. AREDIA dosage: 90 MG QMONTH. Patient recovered.

Aredia Side Effects Report #5772246-1
Physician from UNITED STATES reported AREDIA problem on June 03, 2008. Female patient, 66 years of age, was diagnosed with breast cancer metastatic and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, infection, jaw operation, pain. AREDIA dosage: 90MG Q MONTH. During the same period patient was treated with ZOMETA, XELODA, FEMARA, TAMOXIFEN CITRATE. Patient recovered.

Aredia Side Effects Report #5772264-3
AREDIA problem was reported by a Physician from GERMANY on June 03, 2008. Female patient was diagnosed with osteoporosis and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: calcinosis, condition aggravated. AREDIA dosage: 60 MG, EVERY 3 MONTH. Patient recovered.

Aredia Side Effects Report #5777329-8
Physician from BELGIUM reported AREDIA problem on June 10, 2008. Female patient was diagnosed with osteomalacia and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: arthralgia, disability, inflammation, myalgia, nail discolouration, nail discomfort, nail disorder, osteonecrosis, pain in extremity. AREDIA dosage: 45 MG. During the same period patient was treated with MS CONTIN, CALCIUM CARBONATE, BEFACT, STRONTIUM RANELATE. Patient recovered.

Aredia Side Effects Report #5788174-1
AREDIA problem was reported by a Consumer or non-health professional from UNITED STATES on June 13, 2008. Male patient was diagnosed with osteopenia and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, bone graft, dental implantation, loose tooth, oral disorder, oral surgery, osteonecrosis, tooth extraction. AREDIA dosage: 90 MG, QMONTH. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5792029-6
Consumer or non-health professional from UNITED STATES reported AREDIA problem on June 12, 2008. Female patient, 85 years of age, was diagnosed with breast cancer metastatic and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess oral, bacterial infection, bone debridement, bone disorder, bone erosion, bone pain, escherichia infection, gingival erythema, oral pain. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ARIMIDEX, MEGACE, XALATAN, COSOPT, PROCRIT, DIOVAN. Patient recovered.

Aredia Side Effects Report #5793530-1
AREDIA problem was reported by a Health Professional from SWEDEN on June 17, 2008. Female patient was diagnosed with breast cancer female and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: impaired healing, osteonecrosis. AREDIA dosage: unknown. During the same period patient was treated with PREDNISOLONE. Patient recovered.

Aredia Side Effects Report #5726019-6
Consumer or non-health professional from JAPAN reported AREDIA problem on Apr 25, 2008. Female patient, 72 years of age, weighting 103.6 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, bone disorder, c-reactive protein increased, erythema, fistula, metastasis, oral pruritus, osteonecrosis, pain in jaw. AREDIA dosage: 90 MG, EVERY 4 WEEKS. During the same period patient was treated with BISPHONAL. Patient died.

Aredia Side Effects Report #5734520-4
AREDIA problem was reported by a Physician from UNITED STATES on May 02, 2008. Female patient, 54 years of age, weighting 197.0 lb, was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, change of bowel habit, chest pain, chills, colonic polyp, colonoscopy abnormal, computerised tomogram abdomen abnormal, computerised tomogram thorax abnormal, constipation. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, LIPITOR, PREMARIN, HYDROCHLOROTHIAZIDE, XANAX, ANASTROZOLE, TAMOXIFEN CITRATE, POTASSIUM CHLORIDE. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5735070-1
Consumer or non-health professional from UNITED STATES reported AREDIA problem on May 02, 2008. Female 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: anxiety, decreased interest, dizziness, hyperhidrosis, osteonecrosis, pain, syncope, vertigo. AREDIA dosage: 90 MG Q4W. During the same period patient was treated with ZOMETA, FEMARA, DEXAMETHASONE. Patient recovered.

Aredia Side Effects Report #5738887-2
AREDIA problem was reported by a Consumer or non-health professional from ITALY on May 06, 2008. Female patient, 69 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 lesion excision, bone pain, oral cavity fistula, osteonecrosis. AREDIA dosage: 90 MG, QMO. Patient recovered.

Aredia Side Effects Report #5741013-7
Consumer or non-health professional from UNITED STATES reported AREDIA problem on May 09, 2008. Male patient, 57 years of age, weighting 193.0 lb, was diagnosed with metastases to bone, pain and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, alveolar osteitis, artificial crown procedure, aspiration pleural cavity, biopsy, blood creatinine increased, bone debridement, bone disorder, breath odour. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ZOMETA, TAXOTERE, TAXOL, DIFLUCAN, MS CONTIN, LOVENOX, MORPHINE SULPHATE, ZOLOFT. Patient was hospitalized. Patient recovered.

Aredia Side Effects Report #5744741-2
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on May 15, 2008. Female patient, 72 years of age, weighting 103.6 lb, was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: actinomycosis, bone disorder, c-reactive protein increased, dentofacial functional disorder, denture wearer, erythema, excessive granulation tissue, fistula, hypoaesthesia oral. AREDIA dosage: 90 MG, EVERY 4 WEEKS. During the same period patient was treated with BISPHONAL, CEFAZOLIN, CARBENIN, AMPICILLIN, POVIDONE IODINE. Patient was hospitalized. Patient died on 06/01/2007.

Aredia Side Effects Report #5746283-7
Consumer or non-health professional from UNITED STATES reported AREDIA problem on May 13, 2008. Male patient was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anhedonia, anxiety, injury, osteonecrosis, pain, physical disability. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Aredia Side Effects Report #5753510-9
AREDIA problem was reported by a Health Professional from JAPAN on May 21, 2008. Female patient was diagnosed with metastases to bone and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: bone disorder, gingival swelling, gingivitis, impaired healing, osteomyelitis, periodontitis, therapeutic procedure, tooth extraction. AREDIA dosage: unknown. During the same period patient was treated with TAMOXIFEN CITRATE. Patient recovered.

Aredia Side Effects Report #5754098-9
Health Professional from UNITED STATES reported AREDIA problem on May 26, 2008. Female patient, weighting 106.0 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 lesion, discomfort, gingival infection, impaired healing, oedema mouth, oral pain, osteomyelitis, osteonecrosis. AREDIA dosage: 90 MG, MONTHLY. During the same period patient was treated with ZOMETA, INTERFERON, VELCADE, INTRON A, DOXIL. Patient recovered.

Aredia Side Effects Report #5693213-2
AREDIA problem was reported by a Pharmacist from UNITED STATES on Mar 24, 2008. Female patient, 57 years of age, weighting 207.0 lb, was diagnosed with breast cancer metastatic and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: impaired healing, infection, osteonecrosis, pain, tooth extraction. AREDIA dosage: unknown. During the same period patient was treated with ZOMETA, FEMARA, EFFEXOR, COZAAR, POTASSIUM CHLORIDE, MOTRIN. Patient recovered.

Aredia Side Effects Report #5693267-3
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Mar 26, 2008. Female patient, 48 years of age, weighting 192.0 lb, was diagnosed with multiple myeloma, anaemia and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: abscess, anxiety, arthralgia, bone cyst, bone disorder, bone pain, condition aggravated, gastrointestinal disorder, gingival erosion. AREDIA dosage: 90 MG, QMO. During the same period patient was treated with ZOMETA, VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE, CYTOXAN, PROCRIT, MELPHALAN, ACYCLOVIR. Patient recovered.

Aredia Side Effects Report #5693715-9
AREDIA problem was reported by a Consumer or non-health professional from JAPAN on Mar 28, 2008. Female patient, 81 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 debridement, bone disorder, bone formation increased, denture wearer, malignant neoplasm progression, memory impairment, mouth haemorrhage, mouth ulceration, osteitis. AREDIA dosage: 45 MG. During the same period patient was treated with AROMASIN, ALPRAZOLAM. Patient recovered.

Aredia Side Effects Report #5694454-0
Consumer or non-health professional from UNITED STATES reported AREDIA problem on Mar 26, 2008. Female patient, 57 years of age, weighting 157.0 lb, was diagnosed with metastases to bone, breast cancer metastatic, depression and was treated with AREDIA. After drug was administered, patient experienced the following problems/side effects: anaemia, back pain,