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Review Ibandronate Safety Reports submitted to FDA

Total Ibandronate reports: 28.
Ibandronate FDA safety alerts: 2007 .
Reported deaths: 6    Reported hospitalizations: 12.
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FDA Reported Ibandronate Side Effects: osteonecrosis, mouth ulceration, impaired healing, spinal osteoarthritis, breast tenderness, tooth abscess, oesophagitis ulcerative, nephrolithiasis.
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Ibandronate Side Effects Report #5639083-X
Health Professional from GERMANY reported IBANDRONATE problem on Feb 18, 2008. Male patient, 66 years of age, was diagnosed with metastases to bone and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis, sequestrectomy, tooth extraction, wound treatment. IBANDRONATE dosage: unknown. During the same period patient was treated with ZOLEDRONAT. Patient recovered.

Ibandronate Side Effects Report #5506628-X
IBANDRONATE problem was reported by a Physician from DENMARK on Oct 25, 2007. Female patient, 83 years of age, weighting 130.5 lb, was diagnosed with osteoporosis postmenopausal and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: cerebral thrombosis. IBANDRONATE dosage: unknown. During the same period patient was treated with CENTYL K, NIZAX, ASPIRIN AND DIPYRIDAMOLE, SIMVASTATIN, RAMIPRIL, CALCIUM, VITAMIN D. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5514179-1
Physician from UNITED KINGDOM reported IBANDRONATE problem on Nov 05, 2007. Female patient, 60 years of age, was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: lower respiratory tract infection, renal failure. IBANDRONATE dosage: TAKEN WITH 180 - 240 ML OF PLAIN WATER. TEMPORARILY INTERRUPTED.. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5519279-8
IBANDRONATE problem was reported by a Physician from GERMANY on Nov 08, 2007. Female patient, 69 years of age, weighting 154.3 lb, was diagnosed with osteoporosis postmenopausal, analgesia and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: oedema, visual disturbance. IBANDRONATE dosage: unknown. During the same period patient was treated with VOLTAREN. Patient recovered.


Ibandronate Side Effects Report #5523563-1
Physician from UNITED KINGDOM reported IBANDRONATE problem on Nov 07, 2007. Male patient, 48 years of age, was diagnosed with pain and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: sinus tachycardia. IBANDRONATE dosage: unknown. During the same period patient was treated with TRAMADOL, DEXAMETHASONE, COVERSYL. Patient recovered.

Ibandronate Side Effects Report #5479513-X
IBANDRONATE problem was reported by a Physician from BELGIUM on Sept 27, 2007. Female patient, 75 years of age, weighting 167.6 lb, was diagnosed with osteoporosis postmenopausal and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, myocardial ischaemia. IBANDRONATE dosage: unknown. During the same period patient was treated with MS CONTIN, DAKAR, PREDNISONE, INDAPAMIDE, MIXTARD. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5480371-8
Physician from GERMANY reported IBANDRONATE problem on Sept 27, 2007. Female patient, 71 years of age, weighting 136.7 lb, was diagnosed with osteoporosis postmenopausal and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: tachyarrhythmia. IBANDRONATE dosage: unknown. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5499662-X
IBANDRONATE problem was reported by a Health Professional from GREECE on Oct 12, 2007. Female patient was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, PAMIDRONATE DI, ZOLEDRONIC ACID. Patient recovered.

Ibandronate Side Effects Report #5499663-1
Health Professional from GREECE reported IBANDRONATE problem on Oct 12, 2007. Female patient was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, ZOLEDRONIC ACID. Patient recovered.


Ibandronate Side Effects Report #5499672-2
IBANDRONATE problem was reported by a Health Professional from GREECE on Oct 12, 2007. Female patient was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, ZOLEDRONIC ACID. Patient recovered.

Ibandronate Side Effects Report #5500767-5
Physician from DENMARK reported IBANDRONATE problem on Oct 16, 2007. Female patient, 83 years of age, weighting 130.5 lb, was diagnosed with osteoporosis postmenopausal and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: cerebral thrombosis. IBANDRONATE dosage: unknown. During the same period patient was treated with CENTYL K, NIZAX, ASPIRIN AND DIPYRIDAMOLE, SIMVASTATIN, RAMIPRIL. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5502099-8
IBANDRONATE problem was reported by a Health Professional from GREECE on Oct 12, 2007. Female patient was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, ZOLEDRONIC ACID. Patient recovered.

Ibandronate Side Effects Report #5502100-1
Health Professional from GREECE reported IBANDRONATE problem on Oct 12, 2007. Female patient was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, PAMIDRONATE DI, ZOLEDRONIC ACID. Patient recovered.

Ibandronate Side Effects Report #5502103-7
IBANDRONATE problem was reported by a Health Professional from GREECE on Oct 12, 2007. Female patient was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, ZOLEDRONIC ACID. Patient recovered.


Ibandronate Side Effects Report #5503028-3
Physician from GERMANY reported IBANDRONATE problem on Oct 25, 2007. Female patient, 77 years of age, weighting 141.1 lb, was diagnosed with breast cancer and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: herpes zoster. IBANDRONATE dosage: unknown. During the same period patient was treated with CAPECITABINE, ASPIRIN, PLASTULEN, CALCIUM, ARTHROTEC. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5503047-7
IBANDRONATE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 19, 2007. Female patient, 65 years of age, was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: vertebroplasty. IBANDRONATE dosage: unknown. During the same period patient was treated with NEXIUM, METHADONE, VICODIN, MELOXICAM, LORAZEPAM, SINGULAIR, ARICEPT, NAMENDA. Patient recovered.

Ibandronate Side Effects Report #5503053-2
Physician from GERMANY reported IBANDRONATE problem on Oct 19, 2007. Female patient, 69 years of age, was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. Patient recovered.

Ibandronate Side Effects Report #5461114-0
IBANDRONATE problem was reported by a Physician from PHILIPPINES on Sept 13, 2007. Male patient, 58 years of age, weighting 145.5 lb, was diagnosed with metastases to bone and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: impaired healing, mouth ulceration, osteonecrosis, tooth abscess. IBANDRONATE dosage: unknown. During the same period patient was treated with SUTENT, ZOMETA. Patient recovered.

Ibandronate Side Effects Report #5468397-1
Health Professional from UNITED KINGDOM reported IBANDRONATE problem on Sept 14, 2007. Female patient, 58 years of age, was diagnosed with osteopenia and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: breast tenderness. IBANDRONATE dosage: unknown. During the same period patient was treated with ADCAL D, ESTRADERM. Patient recovered.


Ibandronate Side Effects Report #5471137-3
IBANDRONATE problem was reported by a Health Professional from UNITED KINGDOM on Sept 17, 2007. Female patient, 75 years of age, weighting 168.2 lb, was diagnosed with osteoporosis and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with PAMIDRONATE DI, BUMETANIDE, CALCIUM, CODEINE PHOSPHATE, FLUOXETINE, GABAPENTIN, IMDUR, NICORANDIL. Patient recovered.

Ibandronate Side Effects Report #5419280-9
Physician from PHILIPPINES reported IBANDRONATE problem on Aug 13, 2007. Male patient, 58 years of age, was diagnosed with metastases to bone and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: impaired healing, mouth ulceration, osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with SUNITINIB MALATE, ZOMETA. Patient recovered.

Ibandronate Side Effects Report #5419649-2
IBANDRONATE problem was reported by a Physician from PHILIPPINES on Aug 13, 2007. Male patient, 58 years of age, was diagnosed with metastases to bone and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: impaired healing, mouth ulceration, osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with SUNITINIB MALATE, ZOMETA. Patient recovered.

Ibandronate Side Effects Report #5419722-9
Physician from PHILIPPINES reported IBANDRONATE problem on Aug 13, 2007. Male patient, 58 years of age, was diagnosed with metastases to bone and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: impaired healing, mouth ulceration, osteonecrosis. IBANDRONATE dosage: unknown. During the same period patient was treated with SUNITINIB MALATE, ZOMETA. Patient recovered.

Ibandronate Side Effects Report #5321052-0
IBANDRONATE problem was reported by a Physician from CANADA on May 07, 2007. Female patient was diagnosed with osteoporosis and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: spinal osteoarthritis. IBANDRONATE dosage: unknown. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5287805-2
Consumer or non-health professional from UNITED STATES reported IBANDRONATE problem on Apr 02, 2007. Female patient, weighting 231.5 lb, was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: nephrolithiasis. IBANDRONATE dosage: 650 MG. During the same period patient was treated with CALCIUM, VITAMIN D. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5287814-3
IBANDRONATE problem was reported by a Physician from CANADA on Apr 02, 2007. Female patient was diagnosed with osteoporosis and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: spinal osteoarthritis. IBANDRONATE dosage: unknown. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5295792-6
Consumer or non-health professional from UNITED STATES reported IBANDRONATE problem on Apr 10, 2007. Female patient, weighting 189.4 lb, was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: oesophagitis ulcerative. IBANDRONATE dosage: 1400 MG. During the same period patient was treated with BUSPIRONE, COMPAZINE, COUMADIN, FEXOFENADINE, FUROSEMIDE, LEVOTHYROXINE, LEXAPRO, LISINOPRIL. Patient was hospitalized. Patient recovered.

Ibandronate Side Effects Report #5309361-2
IBANDRONATE problem was reported by a Physician from CANADA on Apr 25, 2007. Female patient was diagnosed with osteoporosis and was treated with IBANDRONATE. After drug was administered, patient experienced the following problems/side effects: spinal osteoarthritis. IBANDRONATE dosage: unknown. Patient was hospitalized. Patient recovered.


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