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Bendamustine Side Effects

Common Bendamustine Side Effects

The most commonly reported Bendamustine side effects (click to view or check a box to report):

Pyrexia (86)
Lymphocyte Count Decreased (65)
Neutrophil Count Decreased (63)
White Blood Cell Count Decreased (57)
Febrile Neutropenia (49)
Platelet Count Decreased (47)
Pneumonia (41)
Pancytopenia (39)
Cytomegalovirus Infection (37)
Anaemia (35)
Neutropenia (35)
Nausea (33)
Diarrhoea (30)
Leukopenia (27)
Dyspnoea (25)
Vomiting (24)
Thrombocytopenia (24)
Sepsis (23)
Rash (22)
Infection (20)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Bendamustine Side Effects Reported to FDA

The following Bendamustine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Bendamustine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Neurotoxicity, Muscular Weakness, Guillain-barre Syndrome, Sepsis
on Mar 11, 2014 Patient from ES , 71 years of age, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: neurotoxicity, muscular weakness, guillain-barre syndrome, sepsis. Bendamustine dosage: N/A.
Associated medications used:
  • Rituximab


Blood Stem Cell Harvest Failure, Pyrexia
Patient was taking Bendamustine. Patient felt the following Bendamustine side effects: blood stem cell harvest failure, pyrexia on Mar 19, 2014 from ES Additional patient health information: Female , 58 years of age, weighting 163.1 lb, was diagnosed with and. Bendamustine dosage: N/A.
Multiple prescriptions taken:
  • Velcade
  • Velcade (Cyclic)
  • Prednisone (Regimen 1)
  • Prednisone (Regimen 2 Cyclic)
  • Prednisolone
  • Granulocyte Colony-stimulating Factor Nos
  • Omeprazole
  • Tramadol


Syncope, Dizziness, Loss Of Consciousness, Fall, Head Injury, Hypovolaemia
Adverse event was reported on Feb 28, 2014 by a Male taking Bendamustine Hydrochloride (Dosage: N/A) . Location: COUNTRY NOT SPECIFIED , 57 years of age, weighting 212.7 lb, After Bendamustine was administered, patient encountered several Bendamustine side effects: syncope, dizziness, loss of consciousness, fall, head injury, hypovolaemia.
Multiple concurrent drugs taken:
  • Rituximab(moab C2b8 Anti Cd20, Chimeric)


Nosocomial Infection, Upper Limb Fracture
on Mar 03, 2014 Female from ES , 82 years of age, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: nosocomial infection, upper limb fracture. Bendamustine dosage: Cyclic.
Associated medications used:
  • Prednisone
  • Cyclophosphamide
  • Aciclovir
Patient was hospitalized.


Elective Procedure
on Mar 13, 2014 Female from IL , 74 years of age, weighting 112.4 lb, was diagnosed with and was treated with Bendamustine. Patient felt the following Bendamustine side effects: elective procedure. Bendamustine dosage: N/A.
Multiple prescriptions taken:
  • Rituximab (Frequency: Once A Month For 6 Time)
Patient was hospitalized.

Epilepsy, Leukopenia, Urinary Tract Infection, Pneumonia, Enteritis
Patient was taking Bendamustine Hcl. After Bendamustine was administered, patient encountered several Bendamustine side effects: epilepsy, leukopenia, urinary tract infection, pneumonia, enteritis on Feb 25, 2014 from DE Additional patient health information: Male , 72 years of age, weighting 176.1 lb, was diagnosed with and. Bendamustine Hcl dosage: 180 Milligram Daily;.
Multiple concurrent drugs taken:
  • Rituximab (750 Milligram Daily;)
  • Topiramate
  • Valproinsaure
Patient was hospitalized.

Hepatitis B
Adverse event was reported on Mar 05, 2014 by a Male taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: JP , 68 years of age, Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: hepatitis b.
Associated medications used:
  • Fludarabine
  • Rituximab
  • Rituximab
  • Rituximab
  • Cladribine


Syncope, Dizziness, Loss Of Consciousness, Head Injury, Fall
on Feb 20, 2014 Male from US , 57 years of age, weighting 212.7 lb, was treated with Bendamustine Hydrochloride. Patient felt the following Bendamustine side effects: syncope, dizziness, loss of consciousness, head injury, fall. Bendamustine Hydrochloride dosage: N/A.
Multiple prescriptions taken:
  • Rituximab (moab C2b8 Anti Cd20, Chimeric)
Patient was hospitalized.

Listeriosis
on Mar 03, 2014 Male from US , 70 years of age, weighting 179.9 lb, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: listeriosis. Bendamustine dosage: Cyclic.
Multiple concurrent drugs taken:
  • Rituximab (Total Dose)
  • Rituximab (Total Dose)
Patient was hospitalized.

Confusional State
Patient was taking Bendamustine Hydrochloride. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: confusional state on Feb 18, 2014 from US Additional patient health information: Female , 77 years of age, weighting 129.9 lb, . Bendamustine Hydrochloride dosage: 90 Mg/m2/dse Of Benda Days 1 And 4 Of Cycle.
Associated medications used:
  • Velcade
  • Rituximab
Patient was hospitalized.

Anaphylactic Reaction, Blood Pressure Decreased, Circulatory Collapse, Procalcitonin Increased, Loss Of Consciousness
Adverse event was reported on Feb 19, 2014 by a Female taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: DE , 79 years of age, weighting 114.6 lb, Patient felt the following Bendamustine side effects: anaphylactic reaction, blood pressure decreased, circulatory collapse, procalcitonin increased, loss of consciousness. Patient was hospitalized.

Mood Altered, Syncope, Decreased Appetite, Vomiting, Nausea, Malaise, Diarrhoea
on Feb 19, 2014 Female from PL , 67 years of age, weighting 128.5 lb, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: mood altered, syncope, decreased appetite, vomiting, nausea, malaise, diarrhoea. Bendamustine dosage: Frequency: Day 1 And 2 Every 28 Days; Cyclic. Patient was hospitalized.

Febrile Neutropenia, Pharyngeal Abscess
on Feb 14, 2014 Male from SE , 65 years of age, weighting 183.0 lb, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: febrile neutropenia, pharyngeal abscess. Bendamustine dosage: N/A. Patient was hospitalized.

Angina Pectoris, Tachycardia, Hyperventilation
Patient was taking Bendamustine. Patient felt the following Bendamustine side effects: angina pectoris, tachycardia, hyperventilation on Mar 17, 2014 from DE Additional patient health information: Female , 72 years of age, was diagnosed with and. Bendamustine dosage: 4 Weeks, Up To 6 Cycles.
Multiple prescriptions taken:
  • Rituximab (4 Weeks, Up To 6 Cycles)
  • Ciprofloxacin (1000 Daily;)
  • Granocyte
Patient was hospitalized.

Left Ventricular Dysfunction
Adverse event was reported on Mar 18, 2014 by a Male taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: CA , 72 years of age, After Bendamustine was administered, patient encountered several Bendamustine side effects: left ventricular dysfunction. Patient was hospitalized.

Device Malfunction, Device Dislocation, Device Kink, Pain In Extremity, Tenderness, Erythema, Deep Vein Thrombosis, Thrombophlebitis Superficial, Musculoskeletal Pain
on Feb 10, 2014 Male from US , 50 years of age, weighting 187.8 lb, was treated with Bendamustine Hydrochloride. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: device malfunction, device dislocation, device kink, pain in extremity, tenderness, erythema, deep vein thrombosis, thrombophlebitis superficial, musculoskeletal pain. Bendamustine Hydrochloride dosage: N/A.
Associated medications used:
  • Rituximab (moab C2b8 Anti Cd20, Chimeric)
Patient was hospitalized.

Anaemia, Melaena
on Mar 24, 2014 Male from IT , 76 years of age, was treated with Bendamustine. Patient felt the following Bendamustine side effects: anaemia, melaena. Bendamustine dosage: N/A.
Multiple prescriptions taken:
  • Granulocyte Colony-stimulating Factor Nos
  • Erythropoietin
  • Zelitrex
  • Chlorhexidine
  • Nystatin
  • Pantoprazolo
  • Ondansetron
  • Dapsone
Patient was hospitalized.

Excessive Granulation Tissue
Patient was taking Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: excessive granulation tissue on Feb 13, 2014 from AR Additional patient health information: Female , 60 years of age, was diagnosed with and. Bendamustine dosage: N/A. Patient was hospitalized.

Pancytopenia, Neutropenic Sepsis
Adverse event was reported on Mar 24, 2014 by a Male taking Bendamustine (Dosage: Cycle 1) was diagnosed with and. Location: ZA , 69 years of age, weighting 145.5 lb, Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pancytopenia, neutropenic sepsis.
Associated medications used:
  • Prednisone
Patient was hospitalized.

Scleral Disorder
on Feb 20, 2014 Female from CO , 58 years of age, weighting 123.5 lb, was diagnosed with and was treated with Bendamustine. Patient felt the following Bendamustine side effects: scleral disorder. Bendamustine dosage: Cyclic.
Multiple prescriptions taken:
  • Rituximab (Cyclic)
Patient was hospitalized.

White Blood Cell Count Decreased, Jaundice, Hepatic Function Abnormal
on Feb 14, 2014 Female from JP , 77 years of age, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: white blood cell count decreased, jaundice, hepatic function abnormal. Bendamustine dosage: N/A. Patient was hospitalized.

Cerebral Ischaemia
Patient was taking Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: cerebral ischaemia on Feb 05, 2014 from AR Additional patient health information: Male , 65 years of age, weighting 193.3 lb, was diagnosed with and. Bendamustine dosage: N/A. Patient was hospitalized.

Vomiting, Tremor, Feeling Cold, Pyrexia, Dysphagia, Anaemia, Lymphoma, Neutropenia, Blood Potassium Decreased
Adverse event was reported on Jan 27, 2014 by a Female taking Bendamustine Hydrochloride (Dosage: N/A) . Location: COUNTRY NOT SPECIFIED , 69 years of age, weighting 183.0 lb, Patient felt the following Bendamustine side effects: vomiting, tremor, feeling cold, pyrexia, dysphagia, anaemia, lymphoma, neutropenia, blood potassium decreased.
Multiple prescriptions taken:
  • Ps-341 (bortezomib; Velcade (681239)
  • Rituximab
Patient was hospitalized.

Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Neutropenia, Anaemia, Lymphoma
on Jan 27, 2014 Female from US , 69 years of age, weighting 183.0 lb, was treated with Bendamustine Hydrochloride. After Bendamustine was administered, patient encountered several Bendamustine side effects: vomiting, tremor, feeling cold, pyrexia, dehydration, dysphagia, neutropenia, anaemia, lymphoma. Bendamustine Hydrochloride dosage: N/A.
Multiple concurrent drugs taken:
  • Ps-341 (bortezomib; Velcade)
  • Rituximab
  • Ambien
  • Bethamethasone Valerate
  • Ddavp
  • Diovan Hct
  • Ditropan Xl
  • Ergocalciferol
Patient was hospitalized.

Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Anaemia, Lymphoma, Neutropenia
on Jan 27, 2014 Female from COUNTRY NOT SPECIFIED , 69 years of age, weighting 183.0 lb, was treated with Bendamustine Hydrochloride. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: vomiting, tremor, feeling cold, pyrexia, dehydration, dysphagia, anaemia, lymphoma, neutropenia. Bendamustine Hydrochloride dosage: N/A.
Associated medications used:
  • Ps-341 (bortezombid Velcade


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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Discuss Bendamustine Side Effects

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    Safety Alerts, Active Ingredients, Usage Information

    More About Bendamustine

    Side Effects reported to FDA: 806

    Bendamustine safety alerts: 2012

    Reported deaths: 67

    Reported hospitalizations: 304

    Treanda (bendamustine HCL): Recall - Particulate Matter in Vial

    [Posted 01/30/2012]

    AUDIENCE: Risk Manager, Oncology, Pharmacy

    ISSUE: Cephalon, Inc. notified healthcare professionals of a recall of Treanda (bendamustine HCL) for Injection 25mg/8mL, lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments. Potential adverse events after intravenous administration of solutions containing particulates may present as an emboli and result in disruption of blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, and the elderly, as well as patients with micro or macrovasular disease, such as cardiac and renal disease, who may be more at risk since their vasculature and end organs are already compromised.

    The affected Treanda lot is packaged in 8 mL vials and was distributed to wholesalers and distributors nationwide between March 22, 2011 and October 5, 2011.

    BACKGROUND: Treanda (bendamustine HCL) for Injection 25mg/8mL is indicated for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab-containing regimen.

    RECOMMENDATION: Recipients of the subject lot have been previously notified of this recall via overnight notification on 11/18/11. Wholesalers, retailers, hospitals and health care professionals who have lot TB30111 in their possession are instructed to immediately cease using the product and immediately quarantine product for return.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [01/27/2012 - Press Release - Cephalon, Inc.]

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