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Mesna (Mesna) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mesna 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 (163)
Death (29)
Life Threatening Events (23)

Reports by Reaction Type

Febrile Neutropenia (34)Mucosal Inflammation (23)Epistaxis (21)Candida Test Positive (18)Hypotension (17)Off Label Use (15)Fatigue (14)Infection (13)Pyrexia (13)Pneumonia (11)Encephalopathy (11)Hepatotoxicity (9)

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

Possible Mesna side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 59 year old female

Reactions: Encephalopathy

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Carboplatin
    Start date: 2012-07-20
    End date: 2012-07-20

Etoposide
    Start date: 2012-07-19
    End date: 2012-07-21

Ifosfamide
    Start date: 2012-07-20
    End date: 2012-07-21

Mabthera
    Start date: 2012-07-19
    End date: 2012-07-19

Mesna
    Start date: 2012-07-20
    End date: 2012-07-21

Other drugs received by patient: Solu-Medrol; Acetaminophen; Polaramine



Possible Mesna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: female, weighing 87.8 kg (193.2 pounds)

Reactions: Neuropathy Peripheral, Upper Respiratory Tract Infection, Urinary Tract Infection, Pleural Effusion, Pyrexia, Leukocytosis, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Mantle Cell Lymphoma

Cytarabine
    Dosage: 1.87 g, cyclic
    Indication: Mantle Cell Lymphoma

Dexamethasone
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: Mantle Cell Lymphoma

Doxorubicin Hydrochloride
    Dosage: 50 mg/m2, unk
    Indication: Mantle Cell Lymphoma

Mesna
    Dosage: 600 mg/m2, unk
    Indication: Mantle Cell Lymphoma

Methotrexate
    Indication: Mantle Cell Lymphoma

Rituximab
    Dosage: 1 mg/m2, cyclic
    Indication: Mantle Cell Lymphoma

Velcade
    Dosage: 0.7 mg/m2, cyclic
    Start date: 2012-03-19

Velcade
    Dosage: 2.77 mg, cyclic
    Indication: Mantle Cell Lymphoma
    Start date: 2011-12-31

Velcade
    Dosage: 0.7 mg/m2, cyclic

Velcade
    Dosage: 0.7 mg/m2, cyclic
    Start date: 2012-02-26

Vincristine
    Dosage: 2 mg, cyclic
    Indication: Mantle Cell Lymphoma

Other drugs received by patient: Sennosides A+B; Nystatin; Diphenhydramine Hydrochloride; Neupogen; Fluconazole; Zofran; Valtrex; Sodium Chloride; Meperidine HCL; Potassium Chloride; Leucovorin Calcium; Zofran; Sodium Chloride; Sodium Chloride; Sodium Chloride; Heparin; Leucovorin Calcium; Allopurinol; Lovenox; Morphine; Senokot; Cipro / 00042702 /; Lovenox; Prednisolone Acetate; Stomatologicals, Mouth Preparations; Tramadol; Sodium Bicarbonate



Possible Mesna side effects in 41 year old male

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

Patient: 41 year old male

Reactions: Photodermatosis

Drug(s) suspected as cause:
Mesna



Possible Mesna side effects in 41 year old male

Reported by a physician from NEW Zealand on 2012-08-13

Patient: 41 year old male

Reactions: Pancytopenia, Normochromic Normocytic Anaemia, Photodermatosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 150mg daily
    Indication: Wegener's Granulomatosis

Mesna
    Indication: Cystitis Haemorrhagic

Other drugs received by patient: Prednisone TAB; Calcium



Possible Mesna side effects in female

Reported by a physician from Israel on 2012-08-08

Patient: female, weighing 73.5 kg (161.7 pounds)

Reactions: General Physical Health Deterioration

Adverse event resulted in: death

Drug(s) suspected as cause:
Cisplatin
    Dosage: 100mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-18

Cytarabine
    Dosage: 4mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-19

Dexamethasone
    Dosage: 40mg every 3 weeks
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-18

Etoposide
    Dosage: 90mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Ifosfamide
    Dosage: 1200mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Mesna
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Methotrexate
    Dosage: 30mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-17



Possible Mesna side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-07

Patient: female

Reactions: Encephalopathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ifosfamide
    Start date: 2012-04-05
    End date: 2012-04-06

Ifosfamide
    Indication: Breast Cancer
    Start date: 2012-02-23

Ifosfamide
    Start date: 2012-03-15

Mesna
    Start date: 2012-03-15

Mesna
    Indication: Breast Cancer
    Start date: 2012-02-23

Mesna
    Start date: 2012-04-05



Possible Mesna side effects in female

Reported by a physician from Israel on 2012-08-06

Patient: female, weighing 73.5 kg (161.7 pounds)

Reactions: Encephalopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 100mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-18
    End date: 2012-06-18

Cytarabine
    Dosage: 4gm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-19

Dexamethasone
    Dosage: 40mg every 3 weeks
    Administration route: Oral
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-18
    End date: 2012-06-21

Etoposide
    Dosage: 90mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Ifosfamide
    Dosage: 1200mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Mesna
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Methotrexate
    Dosage: 30mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-07-17

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-17



Possible Mesna side effects in 51 year old female

Reported by a physician from United States on 2012-08-02

Patient: 51 year old female

Reactions: Subdural Haematoma, Pleural Effusion, Purpura, Hydropneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-04-08

Cytarabine
    Dosage: 16540 mg, total
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-15

Dexamethasone
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-04-17

Doxorubicin HCL
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-04-08

Filgrastim
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-04-24

Leucovorin Calcium
    Dosage: 140 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-14

Mesna
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Methotrexate Sodium
    Dosage: 1382 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-11

Methylprednisolone
    Dosage: 300 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-14

Sprycel
    Dosage: 700 mg, total
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-21

Vincristine Sulfate
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-04-15



Possible Mesna side effects in female

Reported by a physician from United States on 2012-08-01

Patient: female, weighing 87.8 kg (193.2 pounds)

Reactions: Neuropathy Peripheral, Upper Respiratory Tract Infection, Urinary Tract Infection, Pleural Effusion, Sinusitis, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Mantle Cell Lymphoma

Cytarabine
    Indication: Mantle Cell Lymphoma

Dexamethasone
    Dosage: on days 2-5 and days 12-15
    Administration route: Oral
    Indication: Mantle Cell Lymphoma

Doxorubicin Hydrochloride
    Dosage: 94 mg over 15 minutes for 1 dose on day 5
    Indication: Mantle Cell Lymphoma

Mesna
    Dosage: 1122mg in normal saline 2000 ml over 24 hours daily for 3 days on days 2-4
    Indication: Mantle Cell Lymphoma

Methotrexate
    Indication: Mantle Cell Lymphoma

Rituximab
    Indication: Mantle Cell Lymphoma

Velcade
    Indication: Mantle Cell Lymphoma
    Start date: 2012-02-26

Velcade

Velcade
    Dosage: push over 3-5 seconds
    Start date: 2012-03-19
    End date: 2012-03-19

Velcade
    Start date: 2011-12-31

Vincristine
    Dosage: on day 5 and day 12
    Indication: Mantle Cell Lymphoma

Other drugs received by patient: Sodium Chloride; Tramadol HCL; Leucovorin Calcium; Leucovorin Calcium; Unknown Medication; Morphine Sulfate; Sodium Chloride; Neupogen; Zofran; Sennosides-Docusate Sodium; Ondansetron HCL; Potassium Chloride; Sodium Chloride; Heparin; Zofran; Sodium Bicarbonate; Meperidine HCL; Diphenhydramine HCL; Nystatin; Lovenox; Sodium Chloride; Senokot; Allopurinol; Ciprofloxacin HCL; Fluconazole; Lovenox; Prednisolone Acetate; Stomatologicals, Mouth Preparations; Valtrex; Ondansetron HCL



Possible Mesna side effects in 24 year old female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: 24 year old female, weighing 51.0 kg (112.2 pounds)

Reactions: Abdominal Pain, Hyperkalaemia, Disseminated Intravascular Coagulation, Gastrointestinal Necrosis, Acidosis, Nephrolithiasis, Skin Discolouration, Ecchymosis, Clostridial Infection, Emphysema, White Blood Cell Count Decreased, Hypotension, Anaemia, Condition Aggravated, Soft Tissue Infection, Sepsis, Flank Pain, Colitis, Cardiac Arrest, Sinus Tachycardia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: last dose on 16jun12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Cytarabine
    Dosage: last dose:17jun12 route:intra ommya
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Dexamethasone
    Dosage: last dose:16jun12
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Doxorubicin HCL
    Dosage: last dose:17jun12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Filgrastim
    Dosage: last dose:18jun12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17
    End date: 2012-01-01

Leucovorin Calcium
    Dosage: last dose :21may12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Mesna
    Dosage: last dose:17jun12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Methotrexate
    Dosage: last dose:13jun12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Methylprednisolone
    Dosage: last dose:21may12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Sprycel
    Dosage: last dose on 26jun12
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17

Vincristine Sulfate
    Dosage: last dose:17jun12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-17



Possible Mesna side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27

Patient: male

Reactions: Angioedema, Dystonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25

Etoposide
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25

Ifosfamide
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25
    End date: 2012-06-27

Mesna
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25
    End date: 2012-06-27

Primperan TAB
    Dosage: 2 vials
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25
    End date: 2012-06-27

Vincristine
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25

Other drugs received by patient: Polyethylene Glycol; Oxycodone HCL; Paroxetine HCL; Acetaminophen; Lovenox; Esomeprazole; Xanax



Possible Mesna side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25

Patient: male

Reactions: Angioedema, Dystonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxorubicin Hydrochloride
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25

Etoposide
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25

Ifosfamide
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25
    End date: 2012-06-27

Mesna
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25
    End date: 2012-06-27

Primperan TAB
    Dosage: 2 vials
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25
    End date: 2012-06-27

Vincristine
    Indication: Ewing's Sarcoma
    Start date: 2012-06-25

Other drugs received by patient: Acetaminophen; Xanax; Polyethylene Glycol; Paroxetine HCL; Oxycodone HCL; Esomeprazole; Lovenox



Possible Mesna side effects in 46 year old female

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-07-20

Patient: 46 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Neutropenia, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Epirubicin
    Start date: 2012-05-17
    End date: 2012-05-18

Epirubicin
    Start date: 2012-05-17
    End date: 2012-05-18

Epirubicin
    Start date: 2012-05-17
    End date: 2012-05-18

Ifosfamide
    Start date: 2012-05-17
    End date: 2012-05-18

Mesna
    Start date: 2012-05-17
    End date: 2012-05-18



Possible Mesna side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20

Patient: 51 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Subdural Haematoma, Pleural Effusion, Purpura, Hydropneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: last dose on 8apr2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Cytarabine
    Dosage: last dose on 15may2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Dexamethasone
    Dosage: last dose on 17apr2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Doxorubicin HCL
    Dosage: last dose on 08apr12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Filgrastim
    Dosage: last dose on 24apr2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Leucovorin Calcium
    Dosage: last dose:14may2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Mesna
    Dosage: last dose on 7apr2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Methotrexate
    Dosage: last dose on 11may2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05

Methylprednisolone
    Dosage: last dose on 14may12
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-14

Sprycel
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05
    End date: 2012-05-21

Vincristine Sulfate
    Dosage: last dose :15apr2012
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-05



Possible Mesna side effects in male

Reported by a consumer/non-health professional from South Africa on 2012-07-20

Patient: male

Reactions: Haematuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Chemotherapy

Holoxan Vial 2G
    Indication: Synovial Sarcoma

Mesna
    Indication: Synovial Sarcoma



Possible Mesna side effects in female

Reported by a physician from United Kingdom on 2012-07-18

Patient: female, weighing 13.1 kg (28.8 pounds)

Reactions: Mucosal Inflammation, Candida Test Positive, Febrile Neutropenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: frequency: day 1, last dose prior to sae: 20/jun/2012
    Indication: Sarcoma Metastatic

Cyclophosphamide
    Dosage: last dose prior to sae 23/jun/2012
    Administration route: Oral
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Dactinomycin
    Dosage: frequency: day 1 of cycle dosage: 1.5 mg/m2 last dose prior to sae was taken on 30 aug 2011
    Indication: Sarcoma Metastatic

Dactinomycin
    Dosage: date of last dose prior to onset of sae: 11 oct 2011

Dactinomycin
    Dosage: dosage: 1-5 mg/m2, day 1, date of last dose prior to sae: 23 nov 2011
    Start date: 2011-07-12

Doxorubicin Hydrochloride
    Dosage: frequency: days 1 and 2 dosage: 30 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Ifosfamide
    Dosage: frequency: days 1 and 2. dosage form:3g/m2 last dose prior to sae was taken on 24 nov 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: frequency: days 1 and 2 dosage form: 3600 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: date of last dose prior to sae: 21 sep 2011

Mesna
    Dosage: frequency: od, dosage form: 3600 mg/m2

Vincristine
    Dosage: dosage cumm: 1.5 mg/m2, frequency days 1,8 and 15 of cyclelast doseprior to sae: 23 nov 2011
    Indication: Sarcoma Metastatic

Vinorelbine Tartrate
    Dosage: last dose prior to sae:20/jun/2012
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Other drugs received by patient: Ondansetron; Levomepromazine; Moviprep; Fluconazole; Levomepromazine; Cotrim; Docusate; Ondansetron; Gentamicin; Morphine; Moviprep; Neupogen; Neupogen; Dihydrocodeine Bitartrate INJ; Acetaminophen; Ondansetron; Docusate; Docusate; Piperacillin and Tazobactam; Moviprep; Emollient Cream (Unk Ingredients); Ondansetron



Possible Mesna side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female, weighing 12.4 kg (27.3 pounds)

Reactions: Dyspnoea, Unresponsive To Stimuli, Anaphylactic Reaction, Mental Status Changes, Acute Respiratory Distress Syndrome, Pleural Effusion, Apnoea, Cough, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 36 mg

Doxorubicin Hydrochloride
    Dosage: 27 mg

Mesna
    Dosage: 145 mg

Vincristine Sulfate
    Dosage: .9 mg



Possible Mesna side effects in female

Reported by a physician from United Kingdom on 2012-07-13

Patient: female, weighing 12.9 kg (28.4 pounds)

Reactions: Candida Test Positive, Mucosal Inflammation, Febrile Neutropenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: frequency: day 1, last dose prior to sae: 20/jun/2012
    Indication: Sarcoma Metastatic

Cyclophosphamide
    Dosage: last dose prior to sae 23/jun/2012
    Administration route: Oral
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Dactinomycin
    Dosage: dosage: 1-5 mg/m2, day 1, date of last dose prior to sae: 23 nov 2011
    Start date: 2011-07-12

Dactinomycin
    Dosage: date of last dose prior to onset of sae: 11 oct 2011

Dactinomycin
    Dosage: frequency: day 1 of cycle dosage: 1.5 mg/m2 last dose prior to sae was taken on 30 aug 2011
    Indication: Sarcoma Metastatic

Doxorubicin HCL
    Dosage: frequency: days 1 and 2 dosage: 30 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Ifosfamide
    Dosage: frequency: days 1 and 2. dosage form:3g/m2 last dose prior to sae was taken on 24 nov 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: date of last dose prior to sae: 21 sep 2011

Mesna
    Dosage: frequency: od, dosage form: 3600 mg/m2

Mesna
    Dosage: frequency: days 1 and 2 dosage form: 3600 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Vincristine and Vincristine
    Dosage: dosage cumm: 1.5 mg/m2, frequency days 1,8 and 15 of cyclelast doseprior to sae: 23 nov 2011
    Indication: Sarcoma Metastatic

Vinorelbine Tartrate
    Dosage: last dose prior to sae:20/jun/2012
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Other drugs received by patient: Ondansetron; Ondansetron; Gentamicin; Moviprep; Moviprep; Levomepromazine; Moviprep; Docusate; Cotrim; Docusate; Neupogen; Acetaminophen; Levomepromazine; Neupogen; Ondansetron; Piperacillin and Tazobactam; Dihydrocodeine Bitartrate INJ; Ondansetron; Fluconazole; Docusate; Morphine; Emollient Cream (Unk Ingredients)



Possible Mesna side effects in 46 year old male

Reported by a physician from United States on 2012-07-12

Patient: 46 year old male

Reactions: Febrile Neutropenia, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 446 mg, unk

Cyclophosphamide
    Dosage: 630 mg, q12h
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17
    End date: 2012-02-22

Dexamethasone
    Dosage: 40 mg, unk
    Administration route: Oral
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17

Doxorubicin HCL
    Dosage: 56.5 mg, unk
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17
    End date: 2012-02-22

Doxorubicin HCL
    Dosage: 37 mg, unk

Mesna
    Dosage: 1116 mg, unk
    Indication: non-Hodgkin's Lymphoma

Pegfilgrastim
    Dosage: 6 mg, unk
    Indication: non-Hodgkin's Lymphoma

Rituxan
    Dosage: 698 mg, unk
    Start date: 2012-05-02

Rituxan
    Dosage: 787.5 mg, unk
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17
    End date: 2012-02-22

Vincristine Sulfate
    Dosage: 2 mg, unk
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17

Other drugs received by patient: MS Contin; Valtrex; Omeprazole; Ciprofloxacin; Morphine Sulfate; Enoxaparin / 01708202 /; Compazine; Fluconazole; Metoprolol Tartrate



Possible Mesna side effects in 46 year old male

Reported by a physician from United States on 2012-07-09

Patient: 46 year old male

Reactions: Febrile Neutropenia, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17
    End date: 2012-02-22

Cyclophosphamide

Dexamethasone
    Administration route: Oral

Dexamethasone
    Administration route: Oral
    Indication: non-Hodgkin's Lymphoma

Doxorubicin HCL
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17
    End date: 2012-02-22

Doxorubicin HCL

Mabthera
    Start date: 2012-05-02

Mabthera
    Indication: non-Hodgkin's Lymphoma
    Start date: 2012-02-17
    End date: 2012-02-22

Mesna

Mesna
    Indication: non-Hodgkin's Lymphoma

Neulasta

Neulasta
    Indication: non-Hodgkin's Lymphoma

Vincristine

Vincristine
    Indication: non-Hodgkin's Lymphoma

Other drugs received by patient: Valtrex; Omeprazole; Fluconazole; Metoprolol; Morphine; Ciprofloxacin; MS Contin; Enoxaparin; Compazine



Possible Mesna side effects in female

Reported by a physician from United Kingdom on 2012-07-06

Patient: female, weighing 12.9 kg (28.4 pounds)

Reactions: Candida Test Positive, Mucosal Inflammation, Febrile Neutropenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: frequency: day 1, last dose prior to sae: 20/jun/2012
    Indication: Sarcoma Metastatic

Cyclophosphamide
    Dosage: last dose prior to sae 23/jun/2012
    Administration route: Oral
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Dactinomycin
    Dosage: frequency: day 1 of cycle dosage: 1.5 mg/m2 last dose prior to sae was taken on 30 aug 2011
    Indication: Sarcoma Metastatic

Dactinomycin
    Dosage: dosage: 1-5 mg/m2, day 1, date of last dose prior to sae: 23 nov 2011
    Start date: 2011-07-12

Dactinomycin
    Dosage: date of last dose prior to onset of sae: 11 oct 2011

Doxorubicin HCL
    Dosage: frequency: days 1 and 2 dosage: 30 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Ifosfamide
    Dosage: frequency: days 1 and 2. dosage form:3g/m2 last dose prior to sae was taken on 24 nov 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: frequency: days 1 and 2 dosage form: 3600 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: frequency: od, dosage form: 3600 mg/m2

Mesna
    Dosage: date of last dose prior to sae: 21 sep 2011

Vincristine
    Dosage: dosage cumm: 1.5 mg/m2, frequency days 1,8 and 15 of cyclelast doseprior to sae: 23 nov 2011
    Indication: Sarcoma Metastatic

Vinorelbine Tartrate
    Dosage: last dose prior to sae:20/jun/2012
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Other drugs received by patient: Ondansetron; Neupogen; Dihydrocodeine Bitartrate INJ; Ondansetron; Fluconazole; Levomepromazine; Docusate; Piperacillin and Tazobactam; Cotrim; Gentamicin; Ondansetron; Morphine; Moviprep; Emollient Cream (Unk Ingredients); Ondansetron; Docusate; Moviprep; Neupogen; Acetaminophen; Levomepromazine; Moviprep; Docusate



Possible Mesna side effects in female

Reported by a physician from United Kingdom on 2012-07-02

Patient: female, weighing 12.9 kg (28.4 pounds)

Reactions: Candida Test Positive, Mucosal Inflammation, Febrile Neutropenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Avastin
    Dosage: frequency: day 1, last dose prior to sae: 21/05/2012
    Indication: Sarcoma Metastatic

Cyclophosphamide
    Dosage: last dose prior to sae 06/06/2012
    Administration route: Oral
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Dactinomycin
    Dosage: dosage: 1-5 mg/m2, day 1, date of last dose prior to sae: 23 nov 2011
    Start date: 2011-07-12

Dactinomycin
    Dosage: frequency: day 1 of cycle dosage: 1.5 mg/m2 last dose prior to sae was taken on 30 aug 2011
    Indication: Sarcoma Metastatic

Dactinomycin
    Dosage: date of last dose prior to onset of sae: 11 oct 2011

Doxorubicin HCL
    Dosage: frequency: days 1 and 2 dosage: 30 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Ifosfamide
    Dosage: frequency: days 1 and 2. dosage form:3g/m2 last dose prior to sae was taken on 24 nov 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: frequency: days 1 and 2 dosage form: 3600 mg/m2 last dose prior to sae was taken on 31 aug 2011
    Indication: Sarcoma Metastatic

Mesna
    Dosage: frequency: od, dosage form: 3600 mg/m2

Mesna
    Dosage: date of last dose prior to sae: 21 sep 2011

Vincristine
    Dosage: dosage cumm: 1.5 mg/m2, frequency days 1,8 and 15 of cyclelast doseprior to sae: 23 nov 2011
    Indication: Sarcoma Metastatic

Vinorelbine Tartrate
    Dosage: last dose prior to sae 08/may/2012
    Indication: Rhabdomyosarcoma
    Start date: 2012-03-01

Other drugs received by patient: Ondansetron; Levomepromazine; Moviprep; Moviprep; Cotrim; Morphine; Docusate; Docusate; Gentamicin; Moviprep; Emollient Cream (Unk Ingredients); Acetaminophen; Ondansetron; Ondansetron; Fluconazole; Levomepromazine; Piperacillin and Tazobactam; Ondansetron; Neupogen; Dihydrocodeine Bitartrate INJ; Docusate; Neupogen



Possible Mesna side effects in male

Reported by a pharmacist from United States on 2012-06-29

Patient: male, weighing 21.3 kg (46.9 pounds)

Reactions: B-Cell Lymphoma, Hypotension, Alanine Aminotransferase Increased, Pancytopenia, Roseolovirus Test Positive, Aspartate Aminotransferase Increased, Venoocclusive Liver Disease, Acute Respiratory Distress Syndrome, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Product Used FOR Unknown Indication

Fludarabine Phosphate
    Indication: Product Used FOR Unknown Indication

Mesna
    Indication: Product Used FOR Unknown Indication

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: B-Cell Lymphoma
    Start date: 2011-12-27
    End date: 2012-01-16



Possible Mesna side effects in male

Reported by a physician from Poland on 2012-06-22

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Pneumonia, Circulatory Collapse, Altered State of Consciousness

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cytosar-U
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-17

Etoposide
    Dosage: 96mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ifosfamide
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Mesna
    Dosage: 128mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16

Other drugs received by patient: Zokzid; Metronidazole; Albuminar-20; Sodium Chloride 0.9%; Diflucan; Meropenem; 5% Glucose; Furosemide



Possible Mesna side effects in male

Reported by a physician from Poland on 2012-06-19

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Pneumonia, Circulatory Collapse, Altered State of Consciousness

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cytosar-U
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-17

Etoposide
    Dosage: 96mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ifosfamide
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Mesna
    Dosage: 128mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16

Other drugs received by patient: Furosemide; Albuminar-20; Zokzid; Diflucan; 5% Glucose; Meropenem; Metronidazole; Sodium Chloride 0.9%



Possible Mesna side effects in male

Reported by a physician from Poland on 2012-06-15

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Pneumonia, Blood PH Decreased, Haemoglobin Decreased, Haematocrit Decreased, Gamma-Glutamyltransferase Increased, RED Blood Cell Count Decreased, Circulatory Collapse, Platelet Count Decreased, Altered State of Consciousness

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cytosar-U
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-17

Etoposide
    Dosage: 96mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ifosfamide
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Mesna
    Dosage: 128mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16

Other drugs received by patient: Diflucan; Albuminar-20; Metronidazole; Zokzid; Meropenem; 5% Glucose; Furosemide; Sodium Chloride 0.9%



Possible Mesna side effects in male

Reported by a physician from Poland on 2012-06-14

Patient: male, weighing 58.0 kg (127.6 pounds)

Reactions: Pneumonia, Circulatory Collapse, Altered State of Consciousness

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cytosar-U
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-17

Etoposide
    Dosage: 96mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ifosfamide
    Dosage: 1600mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Mesna
    Dosage: 128mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16
    End date: 2012-05-20

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma
    Start date: 2012-05-16

Other drugs received by patient: Metronidazole; Meropenem; Furosemide; Zokzid; Diflucan; Sodium Chloride 0.9%; Albuminar-20; 5% Glucose



Possible Mesna side effects in

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-06-12

Patient:

Reactions: Mucosal Inflammation, Multi-Organ Failure, Tumour Lysis Syndrome, Condition Aggravated, Febrile Neutropenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Cyclophosphamide
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Cytarabine
    Dosage: on days 4, 5
    Indication: Burkitt's Leukaemia

Cytarabine
    Dosage: on days 4, 5
    Indication: Burkitt's Lymphoma

Cytarabine
    Indication: Prophylaxis

Dexamethasone
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Dexamethasone
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Doxorubicin HCL
    Dosage: on days 4, 5
    Indication: Burkitt's Leukaemia

Doxorubicin HCL
    Dosage: on days 4, 5
    Indication: Burkitt's Lymphoma

Etoposide
    Dosage: days 4, 5
    Indication: Burkitt's Leukaemia

Etoposide
    Dosage: days 4, 5
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Ifosfamide
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Leucovorin Calcium
    Indication: Burkitt's Lymphoma

Leucovorin Calcium
    Indication: Burkitt's Leukaemia

Mesna
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Mesna
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Methotrexate
    Dosage: on day 1 with folinic acid rescue
    Indication: Burkitt's Leukaemia

Methotrexate
    Dosage: on day 1 with folinic acid rescue
    Indication: Burkitt's Lymphoma

Methotrexate
    Indication: Prophylaxis

Methylprednisolone
    Indication: Prophylaxis

Prednisone TAB
    Dosage: days 1-5
    Indication: Burkitt's Leukaemia

Prednisone TAB
    Dosage: days 1-5
    Indication: Burkitt's Lymphoma

Radiation Therapy NOS
    Dosage: 30-36 gy
    Indication: Burkitt's Leukaemia

Radiation Therapy NOS
    Dosage: 30-36 gy
    Indication: Burkitt's Lymphoma

Rituximab
    Indication: Burkitt's Leukaemia

Rituximab
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: on day 1
    Indication: Burkitt's Leukaemia

Vincristine
    Dosage: on day 1
    Indication: Burkitt's Lymphoma

Other drugs received by patient: Blood Products; Acyclovir; Antibiotics; Neupogen



Possible Mesna side effects in

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-06-08

Patient:

Reactions: Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Cyclophosphamide
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Cytarabine
    Dosage: on days 4, 5
    Indication: Burkitt's Leukaemia

Cytarabine
    Indication: Prophylaxis

Cytarabine
    Dosage: on days 4, 5
    Indication: Burkitt's Lymphoma

Dexamethasone
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Dexamethasone
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Doxorubicin HCL
    Dosage: on days 4, 5
    Indication: Burkitt's Leukaemia

Doxorubicin HCL
    Dosage: on days 4, 5
    Indication: Burkitt's Lymphoma

Etoposide
    Dosage: days 4, 5
    Indication: Burkitt's Leukaemia

Etoposide
    Dosage: days 4, 5
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5
    Indication: Burkitt's Leukaemia

Leucovorin Calcium
    Indication: Burkitt's Leukaemia

Leucovorin Calcium
    Indication: Burkitt's Lymphoma

Mesna
    Indication: Burkitt's Leukaemia

Mesna
    Indication: Burkitt's Lymphoma

Methotrexate
    Dosage: on day 1 with folinic acid rescue
    Indication: Burkitt's Lymphoma

Methotrexate
    Indication: Prophylaxis

Methotrexate
    Dosage: on day 1 with folinic acid rescue
    Indication: Burkitt's Leukaemia

Methylprednisolone
    Indication: Prophylaxis

Prednisone
    Dosage: days 1-5
    Indication: Burkitt's Leukaemia

Prednisone
    Dosage: days 1-5
    Indication: Burkitt's Lymphoma

Radiation Therapy NOS
    Dosage: 30-36 gy
    Indication: Burkitt's Leukaemia

Radiation Therapy NOS
    Dosage: 30-36 gy
    Indication: Burkitt's Lymphoma

Rituximab
    Indication: Burkitt's Leukaemia

Rituximab
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: on day 1
    Indication: Burkitt's Leukaemia

Vincristine
    Dosage: on day 1
    Indication: Burkitt's Lymphoma

Other drugs received by patient: Neupogen; Blood Products; Acyclovir; Antibiotics



Possible Mesna side effects in

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-06-08

Patient:

Reactions: Multi-Organ Failure, Tumour Lysis Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Cytarabine
    Dosage: on days 4, 5
    Indication: Burkitt's Lymphoma

Cytarabine
    Indication: Prophylaxis

Dexamethasone
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Doxorubicin HCL
    Dosage: on days 4, 5
    Indication: Burkitt's Lymphoma

Etoposide
    Dosage: days 4, 5
    Indication: Burkitt's Lymphoma

Ifosfamide
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Leucovorin Calcium
    Indication: Burkitt's Lymphoma

Mesna
    Dosage: on days 1-5
    Indication: Burkitt's Lymphoma

Methotrexate
    Dosage: on day 1 with folinic acid rescue
    Indication: Burkitt's Lymphoma

Methotrexate
    Indication: Prophylaxis

Methylprednisolone
    Indication: Prophylaxis

Prednisone
    Dosage: days 1-5
    Indication: Burkitt's Lymphoma

Radiation Therapy NOS
    Dosage: 30-36 gy
    Indication: Burkitt's Lymphoma

Rituximab
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: on day 1
    Indication: Burkitt's Lymphoma

Other drugs received by patient: Neupogen; Blood Products; Acyclovir; Antibiotics

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