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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
This is a report of a 71-year-old patient (weight: NA) from ES, suffering from the following 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). The consumer presented with:
  • Neurotoxicity
  • Muscular Weakness
  • Guillain-barre Syndrome
  • Sepsis
which developed 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.

Blood Stem Cell Harvest Failure, Pyrexia
This report suggests a potential Bendamustine Blood Stem Cell Harvest Failure, Pyrexia 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. Soon after starting Bendamustine the patient began experiencing various side effects, including:
  • Blood Stem Cell Harvest Failure
  • Pyrexia
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.

Syncope, Dizziness, Loss Of Consciousness, Fall, Head Injury, Hypovolaemia
This Syncope, Dizziness, Loss Of Consciousness, Fall, Head Injury, Hypovolaemia 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 commencing Bendamustine Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Syncope
  • Dizziness
  • Loss Of Consciousness
  • Fall
  • Head Injury
  • Hypovolaemia
Although 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.

Nosocomial Infection, Upper Limb Fracture
This is a report of a 82-year-old female patient (weight: NA) from ES. The patient developed the following symptoms/conditions: plasma cell myeloma and was treated with Bendamustine (dosage: Cyclic) starting Sep 30, 2011. Concurrently used drugs:
  • Prednisone
  • Cyclophosphamide
  • Aciclovir
Soon after that, the consumer experienced the following side effects:
  • Nosocomial Infection
  • Upper Limb Fracture
The patient was hospitalized. This opens a possibility that Bendamustine treatment could cause the above reactions, including nosocomial infection, and some female subjects may be more susceptible.


Elective Procedure
A 74-year-old female patient (weight: NA) from IL with the following symptoms/conditions: chronic lymphocytic leukaemia started Bendamustine treatment (dosage: NA) on Jun 04, 2013. Soon after starting Bendamustine treatment, the subject experienced various side effects, including:
  • Elective Procedure
Concurrently used drugs:
  • Rituximab (Frequency: Once A Month For 6 Time)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Bendamustine.

Epilepsy, Leukopenia, Urinary Tract Infection, Pneumonia, Enteritis
A 72-year-old male patient from DE (weight: NA) experienced symptoms, such as: non-hodgkin^s lymphoma and was treated with Bendamustine Hcl(dosage: 180 Milligram Daily;). The treatment was initiated on Apr 15, 2011. After that a consumer reported the following side effect(s):
  • Epilepsy
  • Leukopenia
  • Urinary Tract Infection
  • Pneumonia
  • Enteritis
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Bendamustine Hcl efficacy:
  • Rituximab (750 Milligram Daily;)
  • Topiramate
  • Valproinsaure
The patient was hospitalized.

Hepatitis B
In this report, Bendamustine was administered for the following condition: waldenstrom^s macroglobulinaemia.A 68-year-old male consumer from JP (weight: NA) started Bendamustine treatment (dosage: NA) on 200912.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Hepatitis B
A possible interaction with other drugs could have contributed to this reaction:
  • Fludarabine
  • Rituximab
  • Rituximab
  • Rituximab
  • Cladribine
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Bendamustine treatment could be related to the listed above side effect(s).

Syncope, Dizziness, Loss Of Consciousness, Head Injury, Fall
This is a report of the following Bendamustine Hydrochloride side effect(s):
  • Syncope
  • Dizziness
  • Loss Of Consciousness
  • Head Injury
  • Fall
A 57-year-old male patient from US (weight: NA) presented with the following condition: NA and received a treatment with Bendamustine Hydrochloride (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Rituximab (moab C2b8 Anti Cd20, Chimeric)
The patient was hospitalized.This report suggests that a Bendamustine Hydrochloride treatment could be associated with the listed above side effect(s).

Listeriosis
This Bendamustine report was submitted by a 70-year-old male consumer from US (weight: NA). The patient was diagnosed with: mantle cell lymphoma and Bendamustine was administered (dosage: Cyclic) starting: Feb 17, 2014. The consumer developed a set of symptoms:
  • Listeriosis
Other drugs used simultaneously:
  • Rituximab (Total Dose)
  • Rituximab (Total Dose)
The patient was hospitalized.Those unexpected symptoms could be linked to a Bendamustine treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Confusional State
This is a report of a possible correlation between Bendamustine Hydrochloride use and the following symptoms/side effect(s):
  • Confusional State
which could contribute to an assessment of Bendamustine Hydrochloride risk profile.A 77-year-old female consumer from US (weight: NA) was suffering from NA and was treated with Bendamustine Hydrochloride (dosage: 90 Mg/m2/dse Of Benda Days 1 And 4 Of Cycle) starting NS.Other concurrent medications:
  • Velcade
  • Rituximab
The patient was hospitalized.

Anaphylactic Reaction, Blood Pressure Decreased, Circulatory Collapse, Procalcitonin Increased, Loss Of Consciousness
A 79-year-old female patient from DE (weight: NA) presented with the following symptoms: non-hodgkin^s lymphoma and after a treatment with Bendamustine (dosage: NA) experienced the following side effect(s):
  • Anaphylactic Reaction
  • Blood Pressure Decreased
  • Circulatory Collapse
  • Procalcitonin Increased
  • Loss Of Consciousness
The treatment was started on Jan 08, 2014. Bendamustine was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Bendamustine consumers.

Mood Altered, Syncope, Decreased Appetite, Vomiting, Nausea, Malaise, Diarrhoea
In this report, a 67-year-old female patient from PL (weight: NA) was affected by a possible Bendamustine side effect.The patient was diagnosed with mantle cell lymphoma. After a treatment with Bendamustine (dosage: Frequency: Day 1 And 2 Every 28 Days; Cyclic, start date: Feb 05, 2014), the patient experienced the following side effect(s):
  • Mood Altered
  • Syncope
  • Decreased Appetite
  • Vomiting
  • Nausea
  • Malaise
  • Diarrhoea
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Bendamustine treatment.

Febrile Neutropenia, Pharyngeal Abscess
This is a report of a 65-year-old male patient from SE (weight: NA), who used Bendamustine (dosage: NA) for a treatment of chronic lymphocytic leukaemia. After starting a treatment on Jan 16, 2014, the patient experienced the following side effect(s):
  • Febrile Neutropenia
  • Pharyngeal Abscess
The following drugs could possibly have interacted with the Bendamustine treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Bendamustine treatment could be related to side effect(s), such as Febrile Neutropenia, Pharyngeal Abscess.

Angina Pectoris, Tachycardia, Hyperventilation
This angina pectoris side effect was reported by a physician from DE. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: lymphocytic leukaemia. The patient was prescribed Bendamustine (dosage: 4 Weeks, Up To 6 Cycles), which was started on Jan 17, 2014. Concurrently used drugs:
  • Rituximab (4 Weeks, Up To 6 Cycles)
  • Ciprofloxacin (1000 Daily;)
  • Granocyte
When starting to take Bendamustine the consumer reported the following symptoms:
  • Angina Pectoris
  • Tachycardia
  • Hyperventilation
The patient was hospitalized. These side effects may potentially be related to Bendamustine.

Left Ventricular Dysfunction
This is a Bendamustine side effect report of a 72-year-old male patient (weight:NA) from CA, suffering from the following symptoms/conditions: non-hodgkin^s lymphoma, who was treated with Bendamustine (dosage:NA, start time: Oct 01, 2013), combined with: NA., and developed a serious reaction and a left ventricular dysfunction side effect. The patient presented with:
  • Left Ventricular Dysfunction
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Bendamustine treatment in male patients suffering from non-hodgkin^s lymphoma, resulting in left ventricular dysfunction.

Device Malfunction, Device Dislocation, Device Kink, Pain In Extremity, Tenderness, Erythema, Deep Vein Thrombosis, Thrombophlebitis Superficial, Musculoskeletal Pain
This report suggests a potential Bendamustine Hydrochloride device malfunction side effect(s) that can have serious consequences. A 50-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Bendamustine Hydrochloride (dosage: NA) starting NS. Soon after starting Bendamustine Hydrochloride the patient began experiencing various side effects, including:
  • Device Malfunction
  • Device Dislocation
  • Device Kink
  • Pain In Extremity
  • Tenderness
  • Erythema
  • Deep Vein Thrombosis
  • Thrombophlebitis Superficial
  • Musculoskeletal Pain
Drugs used concurrently:
  • Rituximab (moab C2b8 Anti Cd20, Chimeric)
The patient was hospitalized. Although Bendamustine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as device malfunction, may still occur.

Anaemia, Melaena
This anaemia problem was reported by a physician from IT. A 76-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Dec 05, 2013 a consumer started treatment with Bendamustine (dosage: NA). The following drugs/medications were being taken at the same time:
  • Granulocyte Colony-stimulating Factor Nos
  • Erythropoietin
  • Zelitrex
  • Chlorhexidine
  • Nystatin
  • Pantoprazolo
  • Ondansetron
  • Dapsone
When commencing Bendamustine, the patient experienced the following unwanted symptoms /side effects:
  • Anaemia
  • Melaena
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as anaemia, may become evident only after a product is in use by the general population.

Excessive Granulation Tissue
This is a Bendamustine side effect report of a 60-year-old female patient (weight: NA) from AR. The patient developed the following symptoms/conditions: chronic lymphocytic leukaemia,lymphocytic lymphoma and was treated with Bendamustine (dosage: NA) starting Jan 09, 2014. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Excessive Granulation Tissue
The patient was hospitalized. This opens a possibility that Bendamustine could cause excessive granulation tissue and that some female patients may be more susceptible.

Pancytopenia, Neutropenic Sepsis
A 69-year-old male patient (weight: NA) from ZA with the following symptoms: chronic lymphocytic leukaemia started Bendamustine treatment (dosage: Cycle 1) on Dec 14, 2013. Soon after starting Bendamustine treatment, the consumer experienced several side effects, including:
  • Pancytopenia
  • Neutropenic Sepsis
. Concurrently used drugs:
  • Prednisone
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Bendamustine side effects, such as pancytopenia.

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 (dosage: Cyclic), which was started on Jan 21, 2014. Concurrently used drugs:
  • Rituximab (Cyclic)
.When starting to take Bendamustine the consumer reported symptoms, such as:
  • Scleral Disorder
These side effects may potentially be related to Bendamustine. The patient was hospitalized.

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 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). The consumer presented with:
  • White Blood Cell Count Decreased
  • Jaundice
  • Hepatic Function Abnormal
which developed 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.

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. Soon after starting Bendamustine the patient began experiencing various side effects, including:
  • Cerebral Ischaemia
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.

Vomiting, Tremor, Feeling Cold, Pyrexia, Dysphagia, Anaemia, Lymphoma, Neutropenia, Blood Potassium Decreased
This Vomiting, Tremor, Feeling Cold, Pyrexia, Dysphagia, Anaemia, Lymphoma, Neutropenia, Blood Potassium Decreased 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 commencing Bendamustine Hydrochloride, the patient experienced the following unwanted symptoms/side effects:
  • Vomiting
  • Tremor
  • Feeling Cold
  • Pyrexia
  • Dysphagia
  • Anaemia
  • Lymphoma
  • Neutropenia
  • Blood Potassium Decreased
The 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.

Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Neutropenia, Anaemia, Lymphoma
This is a report of a 69-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Bendamustine Hydrochloride (dosage: NA) starting NS. Concurrently used drugs:
  • Ps-341 (bortezomib; Velcade)
  • Rituximab
  • Ambien
  • Bethamethasone Valerate
  • Ddavp
  • Diovan Hct
  • Ditropan Xl
  • Ergocalciferol
Soon after that, the consumer experienced the following side effects:
  • Vomiting
  • Tremor
  • Feeling Cold
  • Pyrexia
  • Dehydration
  • Dysphagia
  • Neutropenia
  • Anaemia
  • Lymphoma
The patient was hospitalized. This opens a possibility that Bendamustine Hydrochloride treatment could cause the above reactions, including vomiting, and some female subjects may be more susceptible.

Vomiting, Tremor, Feeling Cold, Pyrexia, Dehydration, Dysphagia, Anaemia, Lymphoma, Neutropenia
A 69-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: NA started Bendamustine Hydrochloride treatment (dosage: NA) on NS. Soon after starting Bendamustine Hydrochloride treatment, the subject experienced various side effects, including:
  • Vomiting
  • Tremor
  • Feeling Cold
  • Pyrexia
  • Dehydration
  • Dysphagia
  • Anaemia
  • Lymphoma
  • Neutropenia
Concurrently used drugs:
  • Ps-341 (bortezombid Velcade
This finding indicates that some female patients could be more vulnerable to Bendamustine Hydrochloride.

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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

    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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    How Effective is Bendamustine for You?

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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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