DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Velcade (Bortezomib) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Velcade (Bortezomib) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (2770)
Death (827)
Life Threatening Events (290)
Disability (77)

Reports by Reaction Type

Death (419)Neuropathy Peripheral (150)Diarrhoea (149)Pneumonia (124)Pyrexia (110)Hypotension (108)Dyspnoea (106)Thrombocytopenia (100)Multiple Myeloma (89)Fatigue (87)Asthenia (80)Renal Failure Acute (79)

Below are a few examples of reports where side effects / adverse reactions may be related to Velcade (Bortezomib). For a complete list or a specific selection of reports, please use the links above.

Possible Velcade side effects in 75 year old male

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

Patient: 75 year old male, weighing 97.0 kg (213.4 pounds)

Reactions: Anaphylactic Reaction, Atrial Fibrillation, Hyperthyroidism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bendamustine Hydrochloride
    Dosage: 90 mg/m2, cyclic
    Indication: Lymphoma
    Start date: 2012-08-02
    End date: 2012-08-06

Velcade
    Dosage: 1.6 mg/m2, cyclic
    Indication: Lymphoma
    End date: 2012-08-06

Ofatumumab
    Dosage: 300 mg, cyclic
    Indication: Lymphoma
    Start date: 2012-08-02
    End date: 2012-08-06



Possible Velcade side effects in

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

Patient:

Reactions: Death, Arthralgia, Radiotherapy

Adverse event resulted in: death

Drug(s) suspected as cause:
Velcade



Possible Velcade side effects in male

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

Patient: male

Reactions: Abscess Neck

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: unk
    Indication: Multiple Myeloma
    End date: 2011-06-21

Cisplatin
    Dosage: unk
    Indication: Multiple Myeloma
    End date: 2011-06-21

Doxorubicin Hydrochloride
    Dosage: unk
    Indication: Multiple Myeloma
    End date: 2011-06-21

Cyclophosphamide
    Dosage: unk
    Indication: Multiple Myeloma
    End date: 2011-06-21

Etoposide
    Dosage: unk
    Indication: Multiple Myeloma
    End date: 2011-06-21



Possible Velcade side effects in

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

Patient:

Reactions: Hypotension

Adverse event resulted in: death

Drug(s) suspected as cause:
Thalidomide
    Dosage: 50 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-06
    End date: 2012-08-09

Velcade
    Dosage: 1 mg/m2, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-06
    End date: 2012-08-09

Other drugs received by patient: Dexamethasone



Possible Velcade side effects in male

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

Patient: male, weighing 93.4 kg (205.5 pounds)

Reactions: Confusional State, Fatigue, Pseudomembranous Colitis, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 2.95 mg, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-02-07
    End date: 2011-03-03

Decadron
    Dosage: unk
    Indication: Multiple Myeloma

Other drugs received by patient: Zofran; Cipro / 00042702 /; Duragesic-100; Armodafinil; Xanax; Morphine Sulfate; Miralax; Valtrex



Possible Velcade side effects in male

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

Patient: male

Reactions: Portal Hypertension, Pain, Thrombocytopenia, Epistaxis, Decreased Appetite, Renal Failure Acute, Bronchopulmonary Aspergillosis, Pseudomonas Infection, Anaemia, Hyperviscosity Syndrome, Rash, Haemangioma of Spleen, Pulmonary Sepsis, Syncope, Respiratory Failure, Visual Impairment, Leukopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Velcade
    Indication: Multiple Myeloma
    Start date: 2012-04-17
    End date: 2012-04-28

Dexamethasone Sodium Phosphate
    Indication: Multiple Myeloma
    Start date: 2012-03-21
    End date: 2012-04-01

Doxorubicin HCL
    Indication: Multiple Myeloma
    Start date: 2012-03-21
    End date: 2012-04-01

Dexamethasone Sodium Phosphate
    Start date: 2012-03-01
    End date: 2012-03-12

Lenalidomide
    Indication: Multiple Myeloma
    Start date: 2012-05-21
    End date: 2012-06-10

Cotrim DS
    Indication: Product Used FOR Unknown Indication

Doxorubicin HCL
    Start date: 2012-04-17
    End date: 2012-04-28

Velcade
    Start date: 2012-03-21
    End date: 2012-04-01

Dexamethasone Sodium Phosphate
    Start date: 2012-05-21
    End date: 2012-06-10

Velcade
    Start date: 2012-03-01
    End date: 2012-03-12

Dexamethasone Sodium Phosphate
    Start date: 2012-04-17
    End date: 2012-04-28

Other drugs received by patient: Acyclovir



Possible Velcade side effects in 69 year old female

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

Patient: 69 year old female, weighing 71.8 kg (158.0 pounds)

Reactions: Blood Culture Positive, Bacterial Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temsirolimus
    Dosage: 25 mg, weekly, iv
    Start date: 2012-04-25
    End date: 2012-08-22

Velcade
    Dosage: 1.6 mg/m2, weekly iv
    Start date: 2012-04-25
    End date: 2012-08-22

Other drugs received by patient: Acyclovir; Hydrodiuril; Potassium Chloride; Diovan



Possible Velcade side effects in male

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

Patient: male, weighing 103.1 kg (226.8 pounds)

Reactions: Plasmacytosis, Pneumonia, Mouth Haemorrhage, Pseudomonas Infection, Headache, Disease Progression, Death, Mucosal Inflammation, Pleural Effusion, Depressed Level of Consciousness, Abscess, Lethargy, RIB Fracture

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Indication: Multiple Myeloma

Thalidomide
    Indication: Multiple Myeloma

Etoposide
    Indication: Multiple Myeloma

Radiation Therapy NOS
    Indication: Multiple Myeloma

Cyclophosphamide
    Indication: Multiple Myeloma

Velcade
    Indication: Multiple Myeloma

Revlimid
    Indication: Multiple Myeloma

Dexamethasone
    Indication: Multiple Myeloma

Cisplatin
    Indication: Multiple Myeloma

Other drugs received by patient: Bendamustine Hydrochloride; Lenalidomide



Possible Velcade side effects in

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

Patient:

Reactions: Hyperkalaemia, Interstitial Lung Disease, Multiple Myeloma

Adverse event resulted in: death

Drug(s) suspected as cause:
Velcade

Other drugs received by patient: Dexamethasone; Methylprednisolone Sodium Succinate; Glucose



Possible Velcade side effects in

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

Patient:

Reactions: Malocclusion, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bendamustine Hydrochloride
    Dosage: 180 mg, unk
    Indication: Mantle Cell Lymphoma
    Start date: 2012-04-17
    End date: 2012-07-10

Mabthera
    Dosage: 750 mg, unk
    Indication: Mantle Cell Lymphoma
    Start date: 2012-04-17
    End date: 2012-07-09

Velcade
    Dosage: 2.6 mg, unk
    Indication: Mantle Cell Lymphoma
    Start date: 2012-04-17
    End date: 2012-07-16

Other drugs received by patient: Gliclazide; Plavix; Alpresin; Lyrica



Possible Velcade side effects in

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

Patient:

Reactions: Neurogenic Bladder, Neuropathy Peripheral, Syncope, Diarrhoea, Interstitial Lung Disease, Dizziness, Toxic Skin Eruption, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 2.4 mg, unk
    Indication: Multiple Myeloma
    Start date: 2011-11-14
    End date: 2011-11-24

Piperacillin Tazobactam
    Indication: Infection

Other drugs received by patient: Mecobalamin; Lansoprazole; Uralyt / 01779901 /; Goshajinkigan; Acecol; Olopatadine HCL; Oxinorm / 00547301 /; Dexamethasone; Losartan Potassium



Possible Velcade side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Chalazion

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

Cyclophosphamide
    Indication: Multiple Myeloma

Dexamethasone
    Indication: Multiple Myeloma

Velcade
    Dosage: 2 mg, 1/week
    Indication: Multiple Myeloma
    Start date: 2008-11-13

Other drugs received by patient: Synthroid; Bisphosphonates



Possible Velcade side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: female, weighing 77.6 kg (170.6 pounds)

Reactions: Chest Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab
    Dosage: 375 mg/m2, cyclic
    Indication: Renal Transplant
    Start date: 2012-01-24
    End date: 2012-01-24

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Renal Transplant
    Start date: 2012-01-31
    End date: 2012-02-21

Other drugs received by patient: Pantoprazole; Nephrocaps; Estraderm; Gabapentin; Metoprolol Tartrate; Calcium Acetate; Epoetin; Nasonex



Possible Velcade side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 61 year old male, weighing 92.5 kg (203.5 pounds)

Reactions: Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 2.6 mg,d1,4,8,11 q 3 weeks
    Indication: Multiple Myeloma
    Start date: 2011-03-07
    End date: 2012-04-28

Adriamycin PFS
    Dosage: 20 mg, d1 and d3 q 3 weeks
    Indication: Multiple Myeloma
    Start date: 2011-03-07
    End date: 2011-04-25

Pamidronate Disodium
    Dosage: 90 mg,d1 q 3 weeks
    Indication: Osteolysis
    Start date: 2011-03-07
    End date: 2011-04-18



Possible Velcade side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Chalazion

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

Lenalidomide
    Indication: Multiple Myeloma

Velcade
    Dosage: 2 mg, 1/week
    Indication: Multiple Myeloma
    Start date: 2010-09-13

Dexamethasone
    Indication: Multiple Myeloma

Other drugs received by patient: Bisphosphonates; Doxazosin Mesylate



Possible Velcade side effects in

Reported by a physician from France on 2012-08-23

Patient:

Reactions: Back Pain, Electrocardiogram QT Prolonged, Dyspnoea, Hypotension, Thrombocytopenia

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

Drug(s) suspected as cause:
Velcade
    Dosage: 2.1 mg, unk
    Indication: Multiple Myeloma
    Start date: 2012-05-22
    End date: 2012-05-29

JNJ-26481585
    Dosage: 12 mg, unk
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-05-21
    End date: 2012-05-31

Dexamethasone
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2012-05-22
    End date: 2012-05-29

Other drugs received by patient: Ceftriaxone; Primperan / 00041901 /; Acetaminophen; Zelitrex / 01269701 /; Fentanyl; Atracurium Besylate; Kardegic / 00002703 /; Oxycontin; Oxygen; Tranxene; Primperan / 00041901 /; Bumetanide; Crestor; Primperan / 00041901 /; Hydrocortisone; Ondansetron; Ondansetron; Ondansetron; Importal; Tramadol HCL; Noradrenaline / 00127501 /; Tramadol HCL; Morphine; Furosemide; Midazolam; Tramadol HCL



Possible Velcade side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Neuropathy Peripheral, Pneumonia, Post Herpetic Neuralgia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 40 mg, cyclic
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-10-01

Velcade
    Dosage: 3.4 mg, cyclic
    Indication: Multiple Myeloma
    Start date: 2011-10-06
    End date: 2012-02-02

Other drugs received by patient: Simvastin-Mepha; Enalapril Maleate; Aspirin; Doxazosin Mesylate; Amlodipine; Dyazide



Possible Velcade side effects in female

Reported by a pharmacist from United States on 2012-08-23

Patient: female

Reactions: Blood Parathyroid Hormone Increased

Drug(s) suspected as cause:
Velcade



Possible Velcade side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Chalazion

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

Velcade
    Dosage: 2 mg, 1/week
    Indication: Multiple Myeloma
    Start date: 2009-04-01
    End date: 2011-02-10

Cyclophosphamide
    Indication: Multiple Myeloma

Lenalidomide
    Indication: Multiple Myeloma

Other drugs received by patient: Zocor; Aredia; Actonel; Bisphosphonates; Lasix; Multi Vitamin and Mineral + Selenium; Comadin



Possible Velcade side effects in

Reported by a physician from Canada on 2012-08-23

Patient:

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Velcade

Other drugs received by patient: Decadron; Cyclophosphamide



Possible Velcade side effects in 17 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 17 year old male, weighing 89.9 kg (197.8 pounds)

Reactions: Pharyngeal Inflammation, Hypoxia, Caecitis, Rash Maculo-Papular, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-28

Cefepime
    Indication: Acute Myeloid Leukaemia

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-22

Daunorubicin HCL
    Dosage: 50 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-22

Cytarabine
    Dosage: unk
    Start date: 2012-05-18
    End date: 2012-05-18

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-26



Possible Velcade side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male

Reactions: Death, Chalazion

Adverse event resulted in: death

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

Dexamethasone
    Indication: Multiple Myeloma

Velcade
    Dosage: 2 mg, 1/week
    Indication: Multiple Myeloma
    Start date: 2009-08-13
    End date: 2012-01-03

Cyclophosphamide
    Indication: Multiple Myeloma

Other drugs received by patient: Bisphosphonates; Travoprost



Possible Velcade side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-08-23

Patient:

Reactions: Off Label Use, Glossodynia, Neuropathy Peripheral, Skin Sensitisation

Drug(s) suspected as cause:
Velcade



Possible Velcade side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Velcade



Possible Velcade side effects in

Reported by a physician from France on 2012-08-22

Patient:

Reactions: Lung Disorder

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Bendamustine Hydrochloride
    Dosage: 180 mg, qd
    Indication: Mantle Cell Lymphoma
    Start date: 2012-05-29
    End date: 2012-05-30

Mabthera
    Dosage: 750 mg, unk
    Indication: Mantle Cell Lymphoma
    Start date: 2012-05-29
    End date: 2012-05-29

Velcade
    Dosage: 2.6 mg, qd
    Indication: Mantle Cell Lymphoma
    Start date: 2012-05-29
    End date: 2012-06-08

Dexamethasone
    Dosage: 40 mg, unk
    Indication: Mantle Cell Lymphoma

Other drugs received by patient: Rocephin; Glucophage; Fasturtec; Lasix; Duphalac; Colchicine; Actrapid / 00030501 /; Xanax; Ventolin; Albumin; Atarax; Nexium; Zelitrex / 01269701 /; Tranxene; Bactrim; Imovane; Magnesium Sulfate; Ramipril; Citalopram Hydrobromide; Folic Acid; Oxazepam; Pentoxifylline; Lasix



Possible Velcade side effects in

Reported by a physician from Netherlands on 2012-08-22

Patient:

Reactions: Pneumonia, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: Multiple Myeloma
    Start date: 2011-12-23
    End date: 2012-01-03

Cyclophosphamide
    Dosage: 4000 mg/m2, unk
    Start date: 2012-02-03
    End date: 2012-02-03

Velcade
    Dosage: 1.3 mg/m2, unk
    Indication: Multiple Myeloma
    Start date: 2011-12-23
    End date: 2012-01-02

Cyclophosphamide
    Dosage: 500 mg/m2, unk
    Indication: Multiple Myeloma
    Start date: 2011-12-23
    End date: 2011-12-30

Other drugs received by patient: Tramal / 00599201 /; Acetaminophen; Ascal / 00002702 /; Oxycodone HCL; Fluconazole; Gabapentin; Persantine; Haldol; Omeprazole; Butrans; Fragmin; Esomeprazole Sodium; Pregabalin; Cotrim; Valaciclovir; Hydrochlorothiazide



Possible Velcade side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male

Reactions: Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade



Possible Velcade side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 70 year old male, weighing 104.3 kg (229.5 pounds)

Reactions: Pneumonia, Thrombocytopenia, Groin Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 3.6 mg d1, d8 iv
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-30
    End date: 2012-08-06

Torisel
    Dosage: 25 mg d1, d8 iv
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-30
    End date: 2012-08-06



Possible Velcade side effects in

Reported by a consumer/non-health professional from Singapore on 2012-08-22

Patient:

Reactions: Incorrect Route of Drug Administration, Myalgia, Tumour Lysis Syndrome, Rhabdomyolysis, Demyelination

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: unk mg/m2, unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-06-21
    End date: 2012-07-26

Carboplatin
    Dosage: unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-06-21
    End date: 2012-07-26

Ifosfamide
    Dosage: unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-06-21
    End date: 2012-07-26

Rituximab
    Dosage: unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-06-21
    End date: 2012-07-26

Etoposide
    Dosage: unk
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-06-21
    End date: 2012-07-26

Velcade
    Dosage: unk
    Start date: 2012-07-31

Other drugs received by patient: Methotrexate; Lamivudine; Acyclovir; Pentamidine; Omeprazole



Possible Velcade side effects in 59 year old female

Reported by a physician from United States on 2012-08-22

Patient: 59 year old female, weighing 67.8 kg (149.1 pounds)

Reactions: Embolism, Muscular Weakness, Gastric Haemorrhage, Cardiac Arrest

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

Drug(s) suspected as cause:
Melphalan Hydrochloride
    Dosage: 0.22 mg/kg, cyclic
    Administration route: Oral
    Indication: Amyloidosis
    Start date: 2012-07-09
    End date: 2012-08-09

Dexamethasone
    Dosage: 40 mg, cyclic
    Administration route: Oral
    Indication: Amyloidosis
    Start date: 2012-07-09
    End date: 2012-08-09

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Amyloidosis
    Start date: 2012-07-09
    End date: 2012-08-09

Velcade
    Dosage: 1.3 mg/m2, cyclic

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012