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Bendamustine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 470 

Pneumonia (8371425-7)
on May 15, 2012 Male from UNITED STATES , 72 years of age, was diagnosed with
  • b-cell lymphoma
and was treated with Bendamustine Hydrochloride. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pneumonia. Bendamustine Hydrochloride dosage: 90mgm2 Cyclic.
Associated medications used:
  • Ofatumumab (1000mg Cyclic)
Patient was hospitalized.

Hypoxia (8371424-5)
Patient was taking Bendamustine Hydrochloride. Patient felt the following Bendamustine side effects: hypoxia on May 15, 2012 from UNITED STATES Additional patient health information: Female , 65 years of age, weighting 110.9 lb, was diagnosed with
  • b-cell lymphoma
and. Bendamustine Hydrochloride dosage: 90mgm2 Cyclic.
Multiple prescriptions taken:
  • Bortezomib (1.6mgm2 Cyclic)
  • Ofatumumab (300mg Cyclic)
Patient was hospitalized.

Pulmonary Mycosis, Lung Infiltration (8367002-4)
Adverse event was reported on Apr 10, 2012 by a Male taking Bendamustine Hydrochloride (Dosage: N/A) was diagnosed with
  • chronic lymphocytic leukaemia
  • non-hodgkin's lymphoma
and. Location: GERMANY , 67 years of age, After Bendamustine was administered, patient encountered several Bendamustine side effects: pulmonary mycosis, lung infiltration. Patient was hospitalized.

Pneumonia (8350518-4)
on May 07, 2012 Male from UNITED STATES , 72 years of age, was diagnosed with
  • b-cell lymphoma
and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pneumonia. Bendamustine dosage: 90mgm2 Cyclic.
Associated medications used:
  • Ofatumumab (1000mg Cyclic)
Patient was hospitalized.


Bronchospasm, Pulmonary Embolism (8344750-3)
on Apr 25, 2012 Male from FRANCE , weighting 224.9 lb, was diagnosed with
  • b-cell lymphoma
and was treated with Bendamustine. Patient felt the following Bendamustine side effects: bronchospasm, pulmonary embolism. Bendamustine dosage: Date Of Last Dose Prior To Sae 23/mar/2012.
Multiple prescriptions taken:
  • Mabthera (Date Of Last Dose Prior To Sae 23/mar/2012)
  • Acebutolol
  • Mabthera
Patient was hospitalized.

Neutropenia, Pyrexia (8344197-X)
Patient was taking Bendamustine Hydrochloride. After Bendamustine was administered, patient encountered several Bendamustine side effects: neutropenia, pyrexia on Mar 16, 2011 from UNITED STATES Additional patient health information: Male , 71 years of age, weighting 149.1 lb, was diagnosed with
  • chronic lymphocytic leukaemia
and. Bendamustine Hydrochloride dosage: N/A. Patient was hospitalized.

Neutropenia, Pyrexia (8344186-5)
Adverse event was reported on Feb 28, 2011 by a Male taking Bendamustine Hydrochloride (Dosage: N/A) was diagnosed with
  • chronic lymphocytic leukaemia
and. Location: UNITED STATES , 71 years of age, weighting 149.1 lb, Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: neutropenia, pyrexia. Patient was hospitalized.

Pyrexia, Respiratory Failure, Asthenia (8337727-5)
on Apr 26, 2012 Male from UNITED STATES , 72 years of age, was diagnosed with
  • b-cell lymphoma
and was treated with Bendamustine. Patient felt the following Bendamustine side effects: pyrexia, respiratory failure, asthenia. Bendamustine dosage: 90mgm2 Cyclic.
Multiple prescriptions taken:
  • Ofatumumab (1000mg Cyclic)
Patient was hospitalized.

Pulmonary Embolism (8329939-1)
on Apr 17, 2012 Male from FRANCE , weighting 224.9 lb, was diagnosed with
  • b-cell lymphoma
and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: pulmonary embolism. Bendamustine dosage: Date Of Last Dose Prior To Sae 23/mar/2012.
Multiple concurrent drugs taken:
  • Mabthera (Date Of Last Dose Prior To Sae 23/mar/2012)
Patient was hospitalized.

Blood Creatinine Increased, Renal Failure Acute, Pyrexia (8308198-X)
Patient was taking Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: blood creatinine increased, renal failure acute, pyrexia on Apr 18, 2012 from GERMANY Additional patient health information: Male , 70 years of age, was diagnosed with
  • lymphoplasmacytoid lymphoma/immunocytoma
and. Bendamustine dosage: N/A.
Associated medications used:
  • Ondansetron
  • Mabthera
  • Levothyroxine Sodium (Thyronajod 75)
  • Acetaminophen
  • Bisoprolol Fumarate
  • Allopurin (Allopurinol 100)


Neutrophil Count Decreased (8307856-0)
Adverse event was reported on Apr 18, 2012 by a Female taking Bendamustine Hcl (Dosage: N/A) . Location: JAPAN , 69 years of age, Patient felt the following Bendamustine side effects: neutrophil count decreased.

Platelet Count Decreased, Lymphocyte Count Decreased, Hypokalaemia, Neutrophil Count Decreased, Upper Respiratory Tract Inflammation, Weight Decreased, Cytomegalovirus Chorioretinitis, Febrile Neutropenia, Pneumonia (8307851-1)
on Apr 18, 2012 Female from JAPAN , weighting 103.6 lb, was treated with Bendamustine Hydrochloride. After Bendamustine was administered, patient encountered several Bendamustine side effects: platelet count decreased, lymphocyte count decreased, hypokalaemia, neutrophil count decreased, upper respiratory tract inflammation, weight decreased, cytomegalovirus chorioretinitis, febrile neutropenia, pneumonia. Bendamustine Hydrochloride dosage: N/A.
Multiple concurrent drugs taken:
  • Allopurinol
Patient was hospitalized.

Pancytopenia (8298631-4)
on Apr 12, 2012 Female from JAPAN , 69 years of age, was treated with Bendamustine Hcl. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pancytopenia. Bendamustine Hcl dosage: N/A.

Vasculitis, White Blood Cell Count Decreased, Lymphocyte Count Decreased, Neutrophil Count Decreased, Febrile Neutropenia (8290036-5)
Patient was taking Bendamustine Hcl. Patient felt the following Bendamustine side effects: vasculitis, white blood cell count decreased, lymphocyte count decreased, neutrophil count decreased, febrile neutropenia on Apr 06, 2012 from JAPAN Additional patient health information: Female , weighting 100.8 lb, . Bendamustine Hcl dosage: 90 Mg/m2;.
Multiple prescriptions taken:
  • Brotizolam


Cytomegalovirus Chorioretinitis, White Blood Cell Count Decreased, Cytomegalovirus Infection (8288251-X)
Adverse event was reported on Mar 05, 2012 by a Male taking Bendamustine (Dosage: 150 Dosage Forms;) . Location: JAPAN , weighting 150.1 lb, After Bendamustine was administered, patient encountered several Bendamustine side effects: cytomegalovirus chorioretinitis, white blood cell count decreased, cytomegalovirus infection.
Multiple concurrent drugs taken:
  • Lansoprazole (1 Tablet;)
  • Allopurinol (3 Tablet;)
  • Rebamipide (3 Tablets)


Tremor (8282935-5)
on Mar 30, 2012 Male from FRANCE , weighting 153.7 lb, was diagnosed with
  • chronic lymphocytic leukaemia
and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: tremor. Bendamustine dosage: Dosage Form: 90 Mg/m2. Last Dose Prior To Sae: 11 Jan 2011..
Associated medications used:
  • Trospium Chloride
  • Diltiazem Hcl
  • Zofran
  • Bricanyl (Tdd: 3 Inh.)
  • Atrovent (Tdd: 3 Inh.)
  • Pravastatin
  • Piascledine (france)
  • Mabthera (Dosage Form: 500 Mg/m2. Last Dose Prior Sae: 10 Jan 2011.)
Patient was hospitalized.

Febrile Neutropenia (8271520-7)
on Mar 28, 2012 Male from GREECE , weighting 185.2 lb, was diagnosed with
  • non-hodgkin's lymphoma
and was treated with Bendamustine. Patient felt the following Bendamustine side effects: febrile neutropenia. Bendamustine dosage: 90mgm2 Cyclic.
Multiple prescriptions taken:
  • Ofatumumab (1000mg Cyclic)
Patient was hospitalized.

Lymphopenia (8271160-X)
Patient was taking Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: lymphopenia on Mar 29, 2012 from GERMANY Additional patient health information: Male , 73 years of age, weighting 143.3 lb, . Bendamustine dosage: 161.10 Mg, Unk.
Multiple concurrent drugs taken:
  • Temsirolimus (75 Mg, Unk)
  • Rituximab (671.25 Mg, Unk)


Peripheral Motor Neuropathy (8269375-X)
Adverse event was reported on Mar 27, 2012 by a Male taking Bendamustine (Dosage: Dast Dose Prior To Sae 19/aug/2011) was diagnosed with
  • chronic lymphocytic leukaemia
and. Location: SWITZERLAND , 59 years of age, weighting 156.5 lb, Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: peripheral motor neuropathy.
Associated medications used:
  • Mabthera (Last Dose Prior To Sae 18/aug/2011)
Patient was hospitalized.

Pyrexia, Renal Failure, Blood Creatinine Increased (8256114-1)
on Mar 29, 2012 Male from GERMANY , 70 years of age, was diagnosed with
  • lymphoplasmacytoid lymphoma/immunocytoma
and was treated with Bendamustine. Patient felt the following Bendamustine side effects: pyrexia, renal failure, blood creatinine increased. Bendamustine dosage: N/A.
Multiple prescriptions taken:
  • Mabthera


Confusional State (8247479-5)
on Mar 22, 2012 Male from CANADA , weighting 174.8 lb, was diagnosed with
  • non-hodgkin's lymphoma
and was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: confusional state. Bendamustine dosage: 90mgm2 Cyclic.
Multiple concurrent drugs taken:
  • Ofatumumab (1000mg Cyclic)
Patient was hospitalized.

Joint Effusion (8235494-7)
Patient was taking Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: joint effusion on Mar 26, 2012 from GERMANY Additional patient health information: Male , weighting 169.8 lb, was diagnosed with
  • mantle cell lymphoma
  • b-cell lymphoma
and. Bendamustine dosage: Date Of Last Dose Prior Event: 20/jan/2010.
Associated medications used:
  • Mabthera (Date Of Last Dose Prior Event: 03/jan/2012)
Patient was hospitalized.

Pyoderma Gangrenosum (8233359-8)
Adverse event was reported on Mar 20, 2012 by a Male taking Bendamustine (Dosage: Unk) was diagnosed with
  • chronic lymphocytic leukaemia
  • hypertension
and. Location: UNITED STATES , 60 years of age, weighting 284.4 lb, Patient felt the following Bendamustine side effects: pyoderma gangrenosum.
Multiple prescriptions taken:
  • Avapro
  • Neulasta (6 Mg, One Time Dose)
  • Norvasc
Patient was hospitalized.

Platelet Count Decreased, Granulocyte Count Decreased, Haemolytic Anaemia, Phlebitis, Lymphocyte Count Decreased, Lymphopenia (8231002-5)
on Mar 13, 2012 Female from JAPAN , weighting 97.89 lb, was treated with Bendamustine. After Bendamustine was administered, patient encountered several Bendamustine side effects: platelet count decreased, granulocyte count decreased, haemolytic anaemia, phlebitis, lymphocyte count decreased, lymphopenia. Bendamustine dosage: N/A.

Pulmonary Embolism, Venous Thrombosis Limb, Malignant Ascites (8225882-7)
on Mar 14, 2012 Female from GERMANY , 59 years of age, weighting 196.2 lb, was diagnosed with
  • chronic lymphocytic leukaemia
  • prophylaxis of nausea and vomiting
and was treated with Bendamustine. Directly after, patient experienced the unwanted or unexpected Bendamustine side effects: pulmonary embolism, venous thrombosis limb, malignant ascites. Bendamustine dosage: N/A.
Associated medications used:
  • Prednisolone
  • Mabthera
  • Granisetron
  • Prednisolone
Patient was hospitalized.

Showing 1-25 of 470 

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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.

Bendamustine Information

More About Bendamustine

Side Effects reported to FDA: 470. View Bendamustine Adverse Reports

Bendamustine safety alerts: 2012

Reported deaths: 52

Reported hospitalizations: 172

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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