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Bendamustine Side Effects

Report Bendamustine Side Effects

If you experienced any harmful or unwanted effects of Bendamustine, please share your experience. This could help to raise awareness about Bendamustine side effects, identify uknown risks and inform health professionals and patients taking Bendamustine.

Examples: headache, dizziness


The most commonly reported Bendamustine side effects are:
Abdominal Distention (17 reports)
Bloating (13 reports)
Bone Pain (8 reports)
Interstitial Lung Disease (8 reports)
Abdominal Distention And Bloating (7 reports)
Extreme Fatigue (7 reports)
Abdominal Distention Bloating (5 reports)
Itchy Hives (2 reports)
Pain In Left Eye (2 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Bendamustine side effects . You can also compare Bendamustine side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Blood Stem Cell Harvest Failure
on Feb 07, 2014 Male from ES , 60 years of age, weighting 194.0 lb, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: blood stem cell harvest failure. Bendamustine dosage: Cyclic.
Associated medications used:
  • Velcade (Cyclic)
  • Prednisone (Cyclic)


Blood Stem Cell Harvest Failure
Patient was taking Bendamustine. Patient felt the following Bendamustine side effects: blood stem cell harvest failure on Feb 25, 2014 from ES Additional patient health information: Male , 64 years of age, weighting 160.9 lb, was diagnosed with and. Bendamustine dosage: Cyclic.

Gastric Ulcer
Adverse event was reported on Jan 24, 2014 by a Female taking Bendamustine (Dosage: 120 Mg/m2) was diagnosed with and. Location: US , 70 years of age, After Bendamustine was administered, patient encountered several Bendamustine side effects: gastric ulcer. Patient was hospitalized.

Brain Natriuretic Peptide Increased
on Jan 23, 2014 Female from DE , 72 years of age, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: brain natriuretic peptide increased. Bendamustine dosage: N/A.


Blood Stem Cell Harvest Failure
on Jan 23, 2014 Male from ES , 64 years of age, was treated with Bendamustine. Patient felt the following Bendamustine side effects: blood stem cell harvest failure. Bendamustine dosage: Cyclic.
Multiple prescriptions taken:

Atrial Fibrillation, Pyrexia, Immunosuppression, Chest Pain, Bone Marrow Failure
Patient was taking Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: atrial fibrillation, pyrexia, immunosuppression, chest pain, bone marrow failure on Jan 22, 2014 from FR Additional patient health information: Male , 60 years of age, weighting 205.0 lb, was diagnosed with and. Bendamustine dosage: N/A. Patient was hospitalized.

Cardiac Failure, Blood Creatine Phosphokinase Increased
Adverse event was reported on Mar 26, 2014 by a Male taking Bendamustine (Dosage: Cyclic) was diagnosed with and. Location: JP , 68 years of age, Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: cardiac failure, blood creatine phosphokinase increased.


on Jan 07, 2014 Male from TR , 65 years of age, was diagnosed with and was treated with Bendamustine Hydrochloride. . Bendamustine Hydrochloride dosage: N/A.
Multiple prescriptions taken:

Hypersensitivity Vasculitis, Multi-organ Failure, Pneumonia, Hepatitis Toxic, Hyperuricaemia, Oral Candidiasis
on Feb 14, 2014 Female from UA , 61 years of age, weighting 180.8 lb, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: hypersensitivity vasculitis, multi-organ failure, pneumonia, hepatitis toxic, hyperuricaemia, oral candidiasis. Bendamustine dosage: Once Every Four Weeks. Patient was hospitalized.

Dizziness, Back Pain
Patient was taking Bendamustine Hydrochloride. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: dizziness, back pain on Feb 28, 2014 from AU Additional patient health information: Female , 82 years of age, was diagnosed with and. Bendamustine Hydrochloride dosage: 3.75 Milligram Daily;. Patient was hospitalized.

Polyneuropathy
Adverse event was reported on Feb 28, 2014 by a Male taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: DE , 79 years of age, weighting 194.0 lb, Patient felt the following Bendamustine side effects: polyneuropathy. Patient was hospitalized.

Hallucination
on Dec 30, 2013 Male from US , 63 years of age, weighting 179.5 lb, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: hallucination. Bendamustine dosage: Qdx2 Days. Patient was hospitalized.

Atrial Fibrillation
on Feb 17, 2014 Male from US , 65 years of age, weighting 231.9 lb, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: atrial fibrillation. Bendamustine dosage: N/A.
Associated medications used: Patient was hospitalized.

Blood Stem Cell Harvest Failure
Patient was taking Bendamustine. Patient felt the following Bendamustine side effects: blood stem cell harvest failure on Jan 23, 2014 from ES Additional patient health information: Female , 64 years of age, weighting 132.3 lb, was diagnosed with and. Bendamustine dosage: N/A.

Progressive Multifocal Leukoencephalopathy, Fall
Adverse event was reported on Jan 07, 2014 by a Female taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: IL , 74 years of age, After Bendamustine was administered, patient encountered several Bendamustine side effects: progressive multifocal leukoencephalopathy, fall. Patient was hospitalized and became disabled.

Pneumonia
on Mar 17, 2014 Female from FR , 77 years of age, weighting 116.8 lb, was diagnosed with and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pneumonia. Bendamustine dosage: N/A.
Associated medications used: Patient was hospitalized.

Myelodysplastic Syndrome
on Dec 27, 2013 Male from JP , 81 years of age, was diagnosed with and was treated with Bendamustine. Patient felt the following Bendamustine side effects: myelodysplastic syndrome. Bendamustine dosage: N/A.
Multiple prescriptions taken:
  • Fludarabine
  • Rituximab
  • Rituximab
  • Rituximab
  • Rituximab
  • Rituximab
  • Cyclophosphamide Hydrate
  • Doxorubicin
Patient was hospitalized.

Blood Stem Cell Harvest Failure
Patient was taking Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: blood stem cell harvest failure on Jan 03, 2014 from ES Additional patient health information: Male , 51 years of age, weighting 156.5 lb, was diagnosed with and. Bendamustine dosage: N/A.
Multiple concurrent drugs taken:

Atrial Fibrillation
Adverse event was reported on Jan 30, 2014 by a Female taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: US , 69 years of age, weighting 237.0 lb, Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: atrial fibrillation. Patient was hospitalized.

Epilepsy
on Dec 31, 2013 Male from DE , 74 years of age, weighting 189.6 lb, was treated with Bendamustine. Patient felt the following Bendamustine side effects: epilepsy. Bendamustine dosage: N/A.
Multiple prescriptions taken: Patient was hospitalized.

Swelling Face, Haemorrhoids, Weight Increased, Pneumonia, Pyrexia
on Jan 21, 2014 Female from CA , 75 years of age, weighting 127.9 lb, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: swelling face, haemorrhoids, weight increased, pneumonia, pyrexia. Bendamustine dosage: N/A. Patient was hospitalized.

Blood Stem Cell Harvest Failure
Patient was taking Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: blood stem cell harvest failure on Jan 03, 2014 from ES Additional patient health information: Male , 60 years of age, weighting 174.2 lb, was diagnosed with and. Bendamustine dosage: N/A.
Associated medications used:

Blood Stem Cell Harvest Failure
Adverse event was reported on Jan 03, 2014 by a Female taking Bendamustine (Dosage: N/A) was diagnosed with and. Location: ES , 60 years of age, weighting 125.7 lb, Patient felt the following Bendamustine side effects: blood stem cell harvest failure.
Multiple prescriptions taken:

Anaphylactic Shock
on Dec 23, 2013 Female from DE , 84 years of age, weighting 158.7 lb, was diagnosed with and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: anaphylactic shock. Bendamustine dosage: N/A.
Multiple concurrent drugs taken: Patient was hospitalized.

Pancytopenia, Pyrexia
on Dec 23, 2013 Female from IT , 61 years of age, was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pancytopenia, pyrexia. Bendamustine dosage: N/A.
Associated medications used:
  • Solosa
  • Deltacortene
  • Metformin Hydrochloride
  • Human Monsulin
Patient was hospitalized.

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

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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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