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Review Bortezomib Safety Reports submitted to FDA

Total Bortezomib reports: 34.
Bortezomib FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 23.
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FDA Reported Bortezomib Side Effects: febrile neutropenia, pain in extremity, disease progression, herpes zoster, disease recurrence, pleural effusion, atelectasis, neuropathy peripheral, hypotension, mental status changes, dyspnoea.
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Bortezomib Side Effects Report #5674896-X
Pharmacist from UNITED STATES reported BORTEZOMIB problem on Mar 19, 2008. Male patient, weighting 156.5 lb, was diagnosed with t-cell lymphoma recurrent and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: gallbladder disorder, hepatic infection fungal, mucormycosis. BORTEZOMIB dosage: 2.4MG IV. Patient recovered.

Bortezomib Side Effects Report #5677214-6
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Mar 21, 2008. Male patient, weighting 143.3 lb, was diagnosed with lung neoplasm malignant and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: aortic thrombosis, platelet count increased. BORTEZOMIB dosage: 2.8 MG WK 1 + 2 OF 3 WKS IV BOLUS. During the same period patient was treated with BEVACIZUMAB, ASPIRIN, NEXIUM, COUMADIN, ZOFRAN, SPIRIVA, MIRACLE MOUTHWASH, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5624263-X
Health Professional from UNITED STATES reported BORTEZOMIB problem on Feb 08, 2008. Male patient, 48 years of age, weighting 282.2 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: catheter related complication, deep vein thrombosis, embolism. BORTEZOMIB dosage: B=3.1 MG; B=D1+4; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXAN, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient recovered.

Bortezomib Side Effects Report #5598138-9
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Jan 17, 2008. Male patient, 60 years of age, weighting 116.4 lb, was diagnosed with renal cell carcinoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: abdominal pain, blood creatinine increased. BORTEZOMIB dosage: 1.6 MG/M2 DAYS 1+8 IV. During the same period patient was treated with BEVACIZUMAB, ATENOLOL. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5608920-7
Health Professional from UNITED STATES reported BORTEZOMIB problem on Jan 29, 2008. Male patient, 60 years of age, weighting 116.4 lb, was diagnosed with renal cell carcinoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea, nausea, vomiting. BORTEZOMIB dosage: 1.6 MG/M2 DAYS 1+8. During the same period patient was treated with BEVACIZUMAB, ATENOLOL. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5542046-6
BORTEZOMIB problem was reported by a Physician from TURKEY on Dec 04, 2007. Female patient, 45 years of age, weighting 178.6 lb, was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: excessive granulation tissue, osteonecrosis, tooth extraction. BORTEZOMIB dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

Bortezomib Side Effects Report #5546752-9
Health Professional from UNITED STATES reported BORTEZOMIB problem on Dec 07, 2007. Male patient, 61 years of age, weighting 203.9 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia, haemoglobin abnormal, platelet count abnormal, rhinitis, sinusitis. BORTEZOMIB dosage: 2.7MG D1+4 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXIMAB, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5578808-9
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Dec 28, 2007. Male patient, 54 years of age, weighting 191.6 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. BORTEZOMIB dosage: B-2.6MG B=D1+4 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXAN, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient recovered.

Bortezomib Side Effects Report #5506009-9
Pharmacist from UNITED STATES reported BORTEZOMIB problem on Nov 01, 2007. Female patient, weighting 158.7 lb, was diagnosed with acute lymphocytic leukaemia and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: blood phosphorus decreased, chills, hypotension, incontinence, loss of consciousness, pain, rhabdomyolysis. BORTEZOMIB dosage: 2.3MG ONCE IV. During the same period patient was treated with DOXORUBICIN. Patient recovered.

Bortezomib Side Effects Report #5506421-8
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Nov 01, 2007. Male patient was diagnosed with non-small cell lung cancer and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: asthenia, disease progression, pain, wheelchair user. BORTEZOMIB dosage: 1.3 MG/M2 Q 3 WEEKS IV. Patient died on 09/21/2007.

Bortezomib Side Effects Report #5509747-7
Physician from UNITED STATES reported BORTEZOMIB problem on Nov 07, 2007. Male patient, 70 years of age, weighting 215.2 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: furuncle, perirectal abscess. BORTEZOMIB dosage: 1.3MG/M2 ON DAYS 1 + 4. During the same period patient was treated with RITUXAN, ATIVAN, AUGMENTIN, PREDNISONE, TYLENOL #, ZOFRAN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5509922-1
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Nov 07, 2007. Male patient, 63 years of age, weighting 61.40 lb, was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: nasopharyngitis. BORTEZOMIB dosage: 1.6 MG/M2 DAYS 1+8 IV. During the same period patient was treated with BEVACIZUMAB, COLACE, NORVASC, GLYBURIDE. Patient died on 10/26/2007.

Bortezomib Side Effects Report #5503966-1
Consumer or non-health professional from UNITED STATES reported BORTEZOMIB problem on Oct 30, 2007. Male patient, 58 years of age, was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: abdominal pain, adverse reaction, asthenia, blood potassium decreased, discomfort, dizziness, gout, hypokalaemia, nausea. BORTEZOMIB dosage: 2.6MG OTHER IV. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5455781-5
BORTEZOMIB problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 13, 2007. Male patient was diagnosed with multiple myeloma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: disease recurrence, herpes zoster. BORTEZOMIB dosage: 1.95 MG X1 (DAYS 1,4,8,11) IV PUSH. During the same period patient was treated with OMEPRAZOLE, POTASSIUM CHLORIDE, OXYCODONE, ACETAMINOPHEN AND HYDROCODONE BITARTRATE, CEPHALEXIN, FUROSEMIDE, INSULIN AASPART, METOPROLOL SUCCINATE. Patient recovered.

Bortezomib Side Effects Report #5455782-7
Consumer or non-health professional from UNITED STATES reported BORTEZOMIB problem on Sept 13, 2007. Male patient, weighting 181.3 lb, was diagnosed with multiple myeloma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: disease recurrence, herpes zoster. BORTEZOMIB dosage: 2.6MG X1 (DAYS 1,4,8,11) IV PUSH. During the same period patient was treated with MORPHINE SULPHATE, CYCLOBENZAPRINE, WARFARIN, SERTRALINE, SIMVASTATIN, CYPROHEPTADINE, DOCUSATE, RANITIDINE. Patient recovered.

Bortezomib Side Effects Report #5389375-7
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on July 13, 2007. Male patient, weighting 185.6 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. BORTEZOMIB dosage: unknown. During the same period patient was treated with RITUXAN, CYTOXAN, DOXORUBICIN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5389398-8
Health Professional from UNITED STATES reported BORTEZOMIB problem on July 13, 2007. Male patient, 57 years of age, weighting 230.0 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: chills, febrile neutropenia, leukopenia, malaise, pain in jaw. BORTEZOMIB dosage: 2.9MG DAY 1+4 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXIMAB, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5393395-6
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on July 17, 2007. Female patient, weighting 182.5 lb, was diagnosed with non-small cell lung cancer and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: atelectasis, pleural effusion. BORTEZOMIB dosage: 0.7 MG/M2 IV DAY 1,4,8,11. During the same period patient was treated with CARBOPLATIN, DOCETAXEL, MOTRIN, DECADRON, VICODIN, KYTRIL, COMPAZINE, ZOFRAN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5399138-4
Health Professional from UNITED STATES reported BORTEZOMIB problem on July 25, 2007. Female patient, weighting 182.5 lb, was diagnosed with non-small cell lung cancer and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: atelectasis, chest discomfort, disease progression, dyspnoea, neoplasm malignant, pleural effusion. BORTEZOMIB dosage: 0.7 MG/M2 IV DAY 1, 4, 8,11. During the same period patient was treated with CARBOPLATIN, DOCETAXEL, MOTRIN, VICODIN, COMPAZINE, DECADRON, KYTRIL, ZOFRAN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5389375-7
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on July 13, 2007. Male patient, weighting 185.6 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. BORTEZOMIB dosage: unknown. During the same period patient was treated with RITUXAN, CYTOXAN, DOXORUBICIN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5389398-8
Health Professional from UNITED STATES reported BORTEZOMIB problem on July 13, 2007. Male patient, 57 years of age, weighting 230.0 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: chills, febrile neutropenia, leukopenia, malaise, pain in jaw. BORTEZOMIB dosage: 2.9MG DAY 1+4 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXIMAB, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5393395-6
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on July 17, 2007. Female patient, weighting 182.5 lb, was diagnosed with non-small cell lung cancer and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: atelectasis, pleural effusion. BORTEZOMIB dosage: 0.7 MG/M2 IV DAY 1,4,8,11. During the same period patient was treated with CARBOPLATIN, DOCETAXEL, MOTRIN, DECADRON, VICODIN, KYTRIL, COMPAZINE, ZOFRAN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5399138-4
Health Professional from UNITED STATES reported BORTEZOMIB problem on July 25, 2007. Female patient, weighting 182.5 lb, was diagnosed with non-small cell lung cancer and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: atelectasis, chest discomfort, disease progression, dyspnoea, neoplasm malignant, pleural effusion. BORTEZOMIB dosage: 0.7 MG/M2 IV DAY 1, 4, 8,11. During the same period patient was treated with CARBOPLATIN, DOCETAXEL, MOTRIN, VICODIN, COMPAZINE, DECADRON, KYTRIL, ZOFRAN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5758380-0
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on June 02, 2008. Male patient, 74 years of age, weighting 155.9 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, renal injury. BORTEZOMIB dosage: 2.4MG D1+4 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXAN, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5782965-9
Health Professional from UNITED STATES reported BORTEZOMIB problem on June 19, 2008. Male patient, weighting 170.0 lb, was diagnosed with non-hodgkin's lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: diarrhoea, ileus paralytic, pyrexia, vomiting. BORTEZOMIB dosage: 1.3 MG/M3 DAY 1, 4, 8, 11 IV. During the same period patient was treated with BENDAMUSTINE, RITUXIMAB. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5793070-X
BORTEZOMIB problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2008. Male patient, weighting 50.30 lb, was diagnosed with neuroblastoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: bacillus infection, blood culture positive, pyrexia. BORTEZOMIB dosage: 1.04 MG D1, 4, 8, 11 IV. During the same period patient was treated with IRINOTECAN. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5731776-9
Physician from UNITED STATES reported BORTEZOMIB problem on May 06, 2008. Female patient, weighting 100.5 lb, was diagnosed with acute lymphocytic leukaemia and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: alpha haemolytic streptococcal infection, bacteraemia, herpes simplex. BORTEZOMIB dosage: 1.3MG/M2/DAY DAYS 1, 4, 8, 11 IV. During the same period patient was treated with FLUCONAZOLE, NORETHINDRONE, CETIRIZINE, ESOMEPRAZOLE, LEVOFLOXACIN, ACETAMINOPHEN, DIPHENHYDRAMINE, BACTRIM. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5749576-2
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on May 20, 2008. Male patient, 74 years of age, weighting 167.0 lb, was diagnosed with mantle cell lymphoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: cardiac failure, dyspnoea at rest, dyspnoea exertional, ejection fraction decreased, pleural effusion, pneumonia, pulmonary oedema, pyrexia. BORTEZOMIB dosage: 2.4MG D1+4 IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, RITUXAN, DOXORUBICIN, DEXAMETHASONE, VINCRISTINE. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5752700-9
Health Professional from UNITED STATES reported BORTEZOMIB problem on May 27, 2008. Male patient, 66 years of age, weighting 239.2 lb, was diagnosed with multiple myeloma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: chronic obstructive pulmonary disease, condition aggravated, dyspnoea, platelet count decreased, pneumonia. BORTEZOMIB dosage: 2.3 MG ONCE EVERY 2 WEEKS IV. During the same period patient was treated with CNTO. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5723400-6
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Apr 29, 2008. Female patient, 69 years of age, weighting 225.0 lb, was diagnosed with multiple myeloma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: constipation, decreased appetite, epistaxis, nasopharyngitis, thrombocytopenia. BORTEZOMIB dosage: 2.6MG OTHER IV. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5345329-8
Health Professional from UNITED STATES reported BORTEZOMIB problem on June 01, 2007. Female patient, 60 years of age, weighting 111.0 lb, was diagnosed with squamous cell carcinoma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: diarrhoea, hypotension. BORTEZOMIB dosage: 1.6MG/M2 IV DAYS 1+8. During the same period patient was treated with DOCETAXEL, PREVACID, PREMARIN, SYNTHROID, LEXAPRO, MEGACE, PHENERGAN, KYTRIL. Patient was hospitalized. Patient recovered.

Bortezomib Side Effects Report #5316774-1
BORTEZOMIB problem was reported by a Pharmacist from UNITED STATES on May 01, 2007. Male patient, 74 years of age, was diagnosed with multiple myeloma and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: back pain, muscle spasms, myalgia. BORTEZOMIB dosage: 2MG OTHER IV. Patient recovered.

Bortezomib Side Effects Report #5317427-6
Health Professional from UNITED STATES reported BORTEZOMIB problem on May 03, 2007. Male patient, weighting 128.0 lb, was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: ascites, blood glucose abnormal, blood glucose decreased, disease progression, glasgow coma scale abnormal, haemoglobin decreased, metabolic acidosis, metastases to liver, no therapeutic response. BORTEZOMIB dosage: 1.3 MG/M2 IVP. During the same period patient was treated with BEVACIZUMAB, MS CONTIN, VICODIN. Patient died on 09/14/2006.

Bortezomib Side Effects Report #5295735-5
BORTEZOMIB problem was reported by a Health Professional from UNITED STATES on Apr 10, 2007. Male patient, 38 years of age, was diagnosed with pharyngeal cancer recurrent and was treated with BORTEZOMIB. After drug was administered, patient experienced the following problems/side effects: convulsion. BORTEZOMIB dosage: 2.56MG,WEEKLY,IV. During the same period patient was treated with DOCETAXEL. Patient was hospitalized. Patient recovered.


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gallbladder disorder, hepatic infection fungal, mucormycosis, aortic thrombosis, platelet count increased, , was diagnosed with t-cell lymphoma recurrent and was diagnosed with lung neoplasm malignant and was diagnosed with mantle cell lymphoma and