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Bendamustine Side Effects

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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.

Bendamustine Side Effects Reported to FDA



Bendamustine Side Effect Report#9996571
Neurotoxicity, Muscular Weakness, Guillain-barre Syndrome, Sepsis
This is a report of a 71-year-old patient (weight: NA) from ES, suffering from the following health symptoms/conditions: mantle cell lymphoma, who was treated with Bendamustine (dosage: NA, start time:
Jan 14, 2014), combined with:
  • Rituximab
and developed a serious reaction and side effect(s): Neurotoxicity, Muscular Weakness, Guillain-barre Syndrome, Sepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine treatment in patients, resulting in Neurotoxicity side effect.
Bendamustine Side Effect Report#9993457
Blood Stem Cell Harvest Failure, Pyrexia
This report suggests a potential Bendamustine Blood Stem Cell Harvest Failure side effect(s) that can have serious consequences. A 58-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: plasma cell myeloma and used Bendamustine (dosage: NA) starting
Jan 17, 2012. After starting Bendamustine the patient began experiencing various side effects, including: Blood Stem Cell Harvest Failure, PyrexiaAdditional drugs used concurrently:
  • Velcade
  • Velcade (Cyclic)
  • Prednisone (Regimen 1)
  • Prednisone (Regimen 2 Cyclic)
  • Prednisolone
  • Granulocyte Colony-stimulating Factor Nos
  • Omeprazole
  • Tramadol
Although Bendamustine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Stem Cell Harvest Failure, may still occur.
Bendamustine Side Effect Report#9959769
Syncope, Dizziness, Loss Of Consciousness, Fall, Head Injury, Hypovolaemia
This Syncope problem was reported by a consumer or non-health professional from Country Not Specified. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Bendamustine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Rituximab(moab C2b8 Anti Cd20, Chimeric)
When using Bendamustine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Syncope, Dizziness, Loss Of Consciousness, Fall, Head Injury, HypovolaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Bendamustine Side Effect Report#9941044
Nosocomial Infection, Upper Limb Fracture
This Nosocomial Infection side effect was reported by a physician from ES. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: plasma cell myeloma.The patient was prescribed Bendamustine (drug dosage: Cyclic), which was initiated on
Sep 30, 2011. Concurrently used drugs:
  • Prednisone
  • Cyclophosphamide
  • Aciclovir
.After starting to take Bendamustine the consumer reported adverse symptoms, such as: Nosocomial Infection, Upper Limb FractureThese side effects may potentially be related to Bendamustine. The patient was hospitalized.
Bendamustine Side Effect Report#9931015
Elective Procedure
This is a report of a 74-year-old female patient (weight: NA) from IL, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Bendamustine (dosage: NA, start time:
Jun 04, 2013), combined with:
  • Rituximab (Frequency: Once A Month For 6 Time)
and developed a serious reaction and side effect(s): Elective Procedure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine treatment in female patients, resulting in Elective Procedure side effect. The patient was hospitalized.
Bendamustine Side Effect Report#9922417
Epilepsy, Leukopenia, Urinary Tract Infection, Pneumonia, Enteritis
This report suggests a potential Bendamustine Hcl Epilepsy side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: non-hodgkin^s lymphoma and used Bendamustine Hcl (dosage: 180 Milligram Daily;) starting
Apr 15, 2011. After starting Bendamustine Hcl the patient began experiencing various side effects, including: Epilepsy, Leukopenia, Urinary Tract Infection, Pneumonia, EnteritisAdditional drugs used concurrently:
  • Rituximab (750 Milligram Daily;)
  • Topiramate
  • Valproinsaure
The patient was hospitalized. Although Bendamustine Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epilepsy, may still occur.
Bendamustine Side Effect Report#9919515
Hepatitis B
This Hepatitis B problem was reported by a physician from JP. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: waldenstrom^s macroglobulinaemia. On 200912 this consumer started treatment with Bendamustine (dosage: NA). The following drugs were being taken at the same time:
  • Fludarabine
  • Rituximab
  • Rituximab
  • Rituximab
  • Cladribine
When using Bendamustine, the patient experienced the following unwanted symptoms/side effects: Hepatitis BAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatitis B, may become evident only after a product is in use by the general population.
Bendamustine Side Effect Report#9915989
Syncope, Dizziness, Loss Of Consciousness, Head Injury, Fall
This Syncope side effect was reported by a health professional from US. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bendamustine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Rituximab (moab C2b8 Anti Cd20, Chimeric)
.After starting to take Bendamustine Hydrochloride the consumer reported adverse symptoms, such as: Syncope, Dizziness, Loss Of Consciousness, Head Injury, FallThese side effects may potentially be related to Bendamustine Hydrochloride. The patient was hospitalized.
Bendamustine Side Effect Report#9914610
Listeriosis
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: mantle cell lymphoma, who was treated with Bendamustine (dosage: Cyclic, start time:
Feb 17, 2014), combined with:
  • Rituximab (Total Dose)
  • Rituximab (Total Dose)
and developed a serious reaction and side effect(s): Listeriosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine treatment in male patients, resulting in Listeriosis side effect. The patient was hospitalized.
Bendamustine Side Effect Report#9912620
Confusional State
This report suggests a potential Bendamustine Hydrochloride Confusional State side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Bendamustine Hydrochloride (dosage: 90 Mg/m2/dse Of Benda Days 1 And 4 Of Cycle) starting NS. After starting Bendamustine Hydrochloride the patient began experiencing various side effects, including: Confusional StateAdditional drugs used concurrently:
  • Velcade
  • Rituximab
The patient was hospitalized. Although Bendamustine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Confusional State, may still occur.
Bendamustine Side Effect Report#9910448
Anaphylactic Reaction, Blood Pressure Decreased, Circulatory Collapse, Procalcitonin Increased, Loss Of Consciousness
This Anaphylactic Reaction problem was reported by a physician from DE. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-hodgkin^s lymphoma. On
Jan 08, 2014 this consumer started treatment with Bendamustine (dosage: NA). The following drugs were being taken at the same time: NA. When using Bendamustine, the patient experienced the following unwanted symptoms/side effects: Anaphylactic Reaction, Blood Pressure Decreased, Circulatory Collapse, Procalcitonin Increased, Loss Of ConsciousnessThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Reaction, may become evident only after a product is in use by the general population.
Bendamustine Side Effect Report#9909672
Mood Altered, Syncope, Decreased Appetite, Vomiting, Nausea, Malaise, Diarrhoea
This Mood Altered side effect was reported by a physician from PL. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: mantle cell lymphoma.The patient was prescribed Bendamustine (drug dosage: Frequency: Day 1 And 2 Every 28 Days; Cyclic), which was initiated on
Feb 05, 2014. Concurrently used drugs: NA..After starting to take Bendamustine the consumer reported adverse symptoms, such as: Mood Altered, Syncope, Decreased Appetite, Vomiting, Nausea, Malaise, DiarrhoeaThese side effects may potentially be related to Bendamustine. The patient was hospitalized.
Bendamustine Side Effect Report#9900116
Febrile Neutropenia, Pharyngeal Abscess
This is a report of a 65-year-old male patient (weight: NA) from SE, suffering from the following health symptoms/conditions: chronic lymphocytic leukaemia, who was treated with Bendamustine (dosage: NA, start time:
Jan 16, 2014), combined with: NA. and developed a serious reaction and side effect(s): Febrile Neutropenia, Pharyngeal Abscess after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine treatment in male patients, resulting in Febrile Neutropenia side effect. The patient was hospitalized.
Bendamustine Side Effect Report#9897250
Angina Pectoris, Tachycardia, Hyperventilation
This report suggests a potential Bendamustine Angina Pectoris side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: lymphocytic leukaemia and used Bendamustine (dosage: 4 Weeks, Up To 6 Cycles) starting
Jan 17, 2014. After starting Bendamustine the patient began experiencing various side effects, including: Angina Pectoris, Tachycardia, HyperventilationAdditional drugs used concurrently:
  • Rituximab (4 Weeks, Up To 6 Cycles)
  • Ciprofloxacin (1000 Daily;)
  • Granocyte
The patient was hospitalized. Although Bendamustine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Angina Pectoris, may still occur.
Bendamustine Side Effect Report#9893673
Left Ventricular Dysfunction
This Left Ventricular Dysfunction problem was reported by a physician from CA. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: non-hodgkin^s lymphoma. On
Oct 01, 2013 this consumer started treatment with Bendamustine (dosage: NA). The following drugs were being taken at the same time: NA. When using Bendamustine, the patient experienced the following unwanted symptoms/side effects: Left Ventricular DysfunctionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Left Ventricular Dysfunction, may become evident only after a product is in use by the general population.
Bendamustine Side Effect Report#9890664
Device Malfunction, Device Dislocation, Device Kink, Pain In Extremity, Tenderness, Erythema, Deep Vein Thrombosis, Thrombophlebitis Superficial, Musculoskeletal Pain
This Device Malfunction side effect was reported by a physician from US. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bendamustine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Rituximab (moab C2b8 Anti Cd20, Chimeric)
.After starting to take Bendamustine Hydrochloride the consumer reported adverse symptoms, such as: Device Malfunction, Device Dislocation, Device Kink, Pain In Extremity, Tenderness, Erythema, Deep Vein Thrombosis, Thrombophlebitis Superficial, Musculoskeletal PainThese side effects may potentially be related to Bendamustine Hydrochloride. The patient was hospitalized.
Bendamustine Side Effect Report#9888021
Anaemia, Melaena
This is a report of a 76-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Bendamustine (dosage: NA, start time:
Dec 05, 2013), combined with:
  • Granulocyte Colony-stimulating Factor Nos
  • Erythropoietin
  • Zelitrex
  • Chlorhexidine
  • Nystatin
  • Pantoprazolo
  • Ondansetron
  • Dapsone
and developed a serious reaction and side effect(s): Anaemia, Melaena after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine treatment in male patients, resulting in Anaemia side effect. The patient was hospitalized.
Bendamustine Side Effect Report#9879354
Excessive Granulation Tissue
This report suggests a potential Bendamustine Excessive Granulation Tissue side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from AR was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia,lymphocytic lymphoma and used Bendamustine (dosage: NA) starting
Jan 09, 2014. After starting Bendamustine the patient began experiencing various side effects, including: Excessive Granulation TissueAdditional drugs used concurrently: NA.The patient was hospitalized. Although Bendamustine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Excessive Granulation Tissue, may still occur.
Bendamustine Side Effect Report#9870457
Pancytopenia, Neutropenic Sepsis
This Pancytopenia problem was reported by a physician from ZA. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: chronic lymphocytic leukaemia. On
Dec 14, 2013 this consumer started treatment with Bendamustine (dosage: Cycle 1). The following drugs were being taken at the same time:
  • Prednisone
When using Bendamustine, the patient experienced the following unwanted symptoms/side effects: Pancytopenia, Neutropenic SepsisThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pancytopenia, may become evident only after a product is in use by the general population.
Bendamustine Side Effect Report#9869404
Scleral Disorder
This Scleral Disorder side effect was reported by a physician from CO. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: chronic lymphocytic leukaemia.The patient was prescribed Bendamustine (drug dosage: Cyclic), which was initiated on
Jan 21, 2014. Concurrently used drugs:
  • Rituximab (Cyclic)
.After starting to take Bendamustine the consumer reported adverse symptoms, such as: Scleral DisorderThese side effects may potentially be related to Bendamustine. The patient was hospitalized.
Bendamustine Side Effect Report#9856473
White Blood Cell Count Decreased, Jaundice, Hepatic Function Abnormal
This is a report of a 77-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: b-cell small lymphocytic lymphoma,chronic lymphocytic leukaemia,pyrexia,nausea,vomiting, who was treated with Bendamustine (dosage: NA, start time:
Nov 27, 2013), combined with: NA. and developed a serious reaction and side effect(s): White Blood Cell Count Decreased, Jaundice, Hepatic Function Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine treatment in female patients, resulting in White Blood Cell Count Decreased side effect. The patient was hospitalized.
Bendamustine Side Effect Report#9851116
Cerebral Ischaemia
This report suggests a potential Bendamustine Cerebral Ischaemia side effect(s) that can have serious consequences. A 65-year-old male patient (weight: NA) from AR was diagnosed with the following symptoms/conditions: lymphocytic lymphoma,chronic lymphocytic leukaemia and used Bendamustine (dosage: NA) starting
Aug 29, 2013. After starting Bendamustine the patient began experiencing various side effects, including: Cerebral IschaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Bendamustine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebral Ischaemia, may still occur.
Bendamustine Side Effect Report#9850086
Vomiting, Tremor, Feeling Cold, Pyrexia, Dysphagia, Anaemia, Lymphoma, Neutropenia, Blood Potassium Decreased
This Vomiting problem was reported by a physician from Country Not Specified. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Bendamustine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Ps-341 (bortezomib; Velcade (681239)
  • Rituximab
When using Bendamustine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Vomiting, Tremor, Feeling Cold, Pyrexia, Dysphagia, Anaemia, Lymphoma, Neutropenia, Blood Potassium DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vomiting, may become evident only after a product is in use by the general population.
Bendamustine Side Effect Report#9850052
Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Neutropenia, Anaemia, Lymphoma
This Vomiting side effect was reported by a physician from US. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Bendamustine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Ps-341 (bortezomib; Velcade)
  • Rituximab
  • Ambien
  • Bethamethasone Valerate
  • Ddavp
  • Diovan Hct
  • Ditropan Xl
  • Ergocalciferol
.After starting to take Bendamustine Hydrochloride the consumer reported adverse symptoms, such as: Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Neutropenia, Anaemia, LymphomaThese side effects may potentially be related to Bendamustine Hydrochloride. The patient was hospitalized.
Bendamustine Side Effect Report#9850041
Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Anaemia, Lymphoma, Neutropenia
This is a report of a 69-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Bendamustine Hydrochloride (dosage: NA, start time: NS), combined with:
  • Ps-341 (bortezombid Velcade
and developed a serious reaction and side effect(s): Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Anaemia, Lymphoma, Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Bendamustine Hydrochloride treatment in female patients, resulting in Vomiting side effect.

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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.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    Bendamustine 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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