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Treanda (Bendamustine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Treanda (Bendamustine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (756)
Death (63)
Life Threatening Events (49)
Disability (15)

Reports by Reaction Type

Pyrexia (67)Rash (63)White Blood Cell Count Decreased (38)Platelet Count Decreased (33)Neutrophil Count Decreased (32)Pancytopenia (30)Neutropenia (30)Pneumonia (29)Nausea (29)Fatigue (28)Dyspnoea (24)Lymphocyte Count Decreased (23)

Below are a few examples of reports where side effects / adverse reactions may be related to Treanda (Bendamustine). For a complete list or a specific selection of reports, please use the links above.

Possible Treanda side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Myalgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab

Treanda
    Indication: Chronic Lymphocytic Leukaemia



Possible Treanda side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 55 year old male

Reactions: Rash Generalised, Multi-Organ Failure, Lung Disorder, Heart Rate Increased, Bone Marrow Failure, Neutropenia, Gastrointestinal Tract Irritation, Thrombocytopenia, Stevens-Johnson Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Allopurinol; Rituximab



Possible Treanda side effects in 68 year old female

Reported by a physician from United States on 2012-08-23

Patient: 68 year old female, weighing 104.8 kg (230.7 pounds)

Reactions: Hypotension, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab
    Dosage: day 1 of each 28 day cycle,
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-03-27
    End date: 2012-03-27

Treanda
    Dosage: day 1 and 2 of each 28 day cycle
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-03-27
    End date: 2012-03-28

Other drugs received by patient: Sertraline Hydrochloride; Ondansetron; Allopurinol; Colecalciferol; Genistein; Lactobacillus Acidophilus; Acyclovir; Furosemide; Omeprazole; Loperamide; Metoprolol Succinate; Genesa; Ibuprofen; Potassium Chloride; Tylox; Lorazepam; Zinc Sulfate; Prochlorperazine Maleate; Levothyroxine Sodium



Possible Treanda side effects in male

Reported by a physician from United Kingdom on 2012-08-23

Patient: male

Reactions: Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 2.8571 milligram daily;
    Administration route: Oral
    Start date: 2012-03-30
    End date: 2012-05-28

Thalidomide
    Dosage: 100 milligram daily;
    Administration route: Oral
    Start date: 2012-03-30
    End date: 2012-05-28

Treanda
    Dosage: 8 milligram daily;
    Start date: 2012-03-30
    End date: 2012-05-25



Possible Treanda side effects in female

Reported by a physician from France on 2012-08-22

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab
    Start date: 2012-06-06

Treanda
    Start date: 2012-06-06

Other drugs received by patient: Aspirin; Praxada; Minisintrom



Possible Treanda side effects in female

Reported by a physician from France on 2012-08-21

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Dyspnoea, Pleural Effusion, Pyrexia, Generalised Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bortezomib
    Dosage: 1.82 milligram daily;
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-02

Dexamethasone
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-02

Rituximab
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-01

Treanda
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-01

Other drugs received by patient: Pegfilgrastim



Possible Treanda side effects in female

Reported by a physician from France on 2012-08-21

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab
    Start date: 2012-06-06

Treanda
    Start date: 2012-06-06



Possible Treanda side effects in

Reported by a physician from Netherlands on 2012-08-21

Patient:

Reactions: Diarrhoea, Skin Exfoliation, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lenalidomide
    Start date: 2012-04-20

Rituximab
    Start date: 2012-04-20

Treanda
    Start date: 2012-04-20



Possible Treanda side effects in female

Reported by a physician from France on 2012-08-21

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Dyspnoea, Pleural Effusion, Pyrexia, Generalised Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bortezomib
    Dosage: 1.82 milligram daily;
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-02

Dexamethasone
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-02

Rituximab
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-01

Treanda
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-01

Other drugs received by patient: Pegfilgrastim



Possible Treanda side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female

Reactions: Aplasia Pure RED Cell

Drug(s) suspected as cause:
Rituximab

Treanda



Possible Treanda side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: male

Reactions: Aplasia Pure RED Cell

Drug(s) suspected as cause:
Rituximab

Treanda



Possible Treanda side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male, weighing 54.0 kg (118.9 pounds)

Reactions: Tachycardia, Pneumothorax, Hypertension, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Velcade



Possible Treanda side effects in 48 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-17

Patient: 48 year old male

Reactions: Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Rituximab



Possible Treanda side effects in female

Reported by a physician from France on 2012-08-17

Patient: female, weighing 58.7 kg (129.1 pounds)

Reactions: Hypoglycaemia, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 40 milligram daily;
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-15

Mabthera
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-14

Treanda
    Dosage: 147.6 milligram daily;
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-14
    End date: 2012-06-15

Velcade
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-14

Other drugs received by patient: Sotalol HCL; Bactrim; Valacyclovir Hydrochloride; Glimepiride; Atorvastatin; Zolpidem; Potassium Chloride; Trandolapril; Glucophage



Possible Treanda side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male

Reactions: White Blood Cell Count Decreased, Rash, Aplasia Pure RED Cell, Haemolytic Anaemia

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Allopurinol



Possible Treanda side effects in female

Reported by a physician from France on 2012-08-17

Patient: female, weighing 62.0 kg (136.4 pounds)

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rituximab
    Start date: 2012-06-06

Treanda
    Start date: 2012-06-06



Possible Treanda side effects in male

Reported by a physician from Japan on 2012-08-16

Patient: male

Reactions: Haemolytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Treanda



Possible Treanda side effects in female

Reported by a physician from United Kingdom on 2012-08-16

Patient: female, weighing 72.6 kg (159.7 pounds)

Reactions: Psoriasis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ofatumumab
    Dosage: unknown/d
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-04

Treanda
    Indication: Chronic Lymphocytic Leukaemia
    Start date: 2012-07-04

Other drugs received by patient: Furosemide; Loratadine; Omeprazole; Amiloride Hydrochloride



Possible Treanda side effects in male

Reported by a physician from Japan on 2012-08-16

Patient: male

Reactions: Hyponatraemia, Full Blood Count Decreased, Hepatosplenomegaly, Pneumonia Cytomegaloviral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Allopurinol; Prednisolone; Tamsulosin Hydrochloride; Mecobalamin; Rituximab; Sulfamethoxazole and Trimethoprim; Amikacin Sulfate; Prednisolone Sodium Succinate INJ; Betamethasone Plus D-Chlorpheniramine Maleate



Possible Treanda side effects in male

Reported by a physician from Germany on 2012-08-15

Patient: male

Reactions: Gastrointestinal Infection

Drug(s) suspected as cause:
Treanda



Possible Treanda side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: 74 year old male, weighing 66.1 kg (145.5 pounds)

Reactions: Pneumonia, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Treanda



Possible Treanda side effects in 66 year old male

Reported by a physician from Japan on 2012-08-14

Patient: 66 year old male

Reactions: Interstitial Lung Disease

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Rituximab



Possible Treanda side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-13

Patient:

Reactions: Hypercalcaemia

Drug(s) suspected as cause:
Treanda



Possible Treanda side effects in male

Reported by a physician from Germany on 2012-08-13

Patient: male, weighing 80.8 kg (177.8 pounds)

Reactions: Drug Eruption, Systemic Inflammatory Response Syndrome, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Treanda

Other drugs received by patient: Diovan; Rituximab; Aspirin; Bisoprolol



Possible Treanda side effects in 70 year old male

Reported by a pharmacist from United States on 2012-08-13

Patient: 70 year old male

Reactions: Histiocytosis Haematophagic, Bacteraemia, Pancytopenia, Aspergillosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Rituximab

Treanda
    Indication: Lymphoma
    Start date: 2012-05-14
    End date: 2012-05-15



Possible Treanda side effects in male

Reported by a physician from Italy on 2012-08-13

Patient: male

Reactions: Pyrexia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 500 mg/m2, cyclic
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-25

Rituximab
    Dosage: 375 mg/m2, cyclic
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-25

Treanda
    Dosage: 70 mg/m2, cyclic
    Indication: Mantle Cell Lymphoma
    Start date: 2012-06-26

Other drugs received by patient: Fluconazole; Allopurinol; Tetracosactide; Sulfamethoxazole and Trimethoprim; Darbepoetin Alfa; Pegfilgastrim; Amoxicillin and Clavulanate Potassium



Possible Treanda side effects in male

Reported by a individual with unspecified qualification from France on 2012-08-13

Patient: male, weighing 96.0 kg (211.2 pounds)

Reactions: Ileus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mabthera
    Dosage: uid/qd
    Indication: Mantle Cell Lymphoma
    Start date: 2012-07-09

Treanda
    Dosage: uid/qd
    Indication: Mantle Cell Lymphoma
    Start date: 2012-07-09

Velcade
    Dosage: uid/qd
    Indication: Mantle Cell Lymphoma
    Start date: 2012-07-09

Other drugs received by patient: Lyrica; Gliclazide; Plavix; Prazosin HCL



Possible Treanda side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-13

Patient:

Reactions: Cardiotoxicity

Drug(s) suspected as cause:
Treanda



Possible Treanda side effects in male

Reported by a physician from France on 2012-08-13

Patient: male, weighing 180.0 kg (396.0 pounds)

Reactions: Oral Candidiasis, Nausea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bortezomib
    Start date: 2012-05-25

Bortezomib
    Start date: 2012-03-30

Bortezomib
    Indication: Mantle Cell Lymphoma
    Start date: 2012-03-02

Bortezomib
    Start date: 2012-04-27
    End date: 2012-05-04

Dexamethasone
    Dosage: uid/qd
    Start date: 2012-04-28
    End date: 2012-04-28

Dexamethasone
    Start date: 2012-05-25

Dexamethasone
    Indication: Mantle Cell Lymphoma
    Start date: 2012-03-02

Dexamethasone
    Start date: 2012-03-30

Rituximab
    Dosage: uid/qd
    Start date: 2012-04-27
    End date: 2012-04-27

Rituximab
    Indication: Mantle Cell Lymphoma
    Start date: 2012-05-02

Rituximab
    Start date: 2012-03-30

Rituximab
    Start date: 2012-05-25

Treanda
    Start date: 2012-05-25

Treanda
    Indication: Mantle Cell Lymphoma
    Start date: 2012-03-02

Treanda
    Dosage: uid/qd
    Start date: 2012-04-27
    End date: 2012-04-28

Treanda
    Start date: 2012-03-30

Other drugs received by patient: Valacyclovir Hydrochloride; Lederfoldine; Previscan



Possible Treanda side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-13

Patient:

Reactions: Thrombosis

Drug(s) suspected as cause:
Treanda

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