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Trisenox (Arsenic Trioxide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Trisenox (Arsenic Trioxide) 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 (47)
Death (4)
Life Threatening Events (2)
Disability (3)

Reports by Reaction Type

Electrocardiogram QT Prolonged (4)Pancytopenia (4)Acute Promyelocytic Leukaemia Differentiation Syndrome (3)Gamma-Glutamyltransferase Increased (3)Alanine Aminotransferase Increased (3)Febrile Neutropenia (3)Abdominal Pain (2)Femur Fracture (2)Pyrexia (2)Polyneuropathy (2)Myalgia (2)Chest Pain (2)

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

Possible Trisenox side effects in 53 year old female

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

Patient: 53 year old female, weighing 62.1 kg (136.6 pounds)

Reactions: Femur Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in 53 year old female

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

Patient: 53 year old female, weighing 62.1 kg (136.6 pounds)

Reactions: Femur Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in

Reported by a physician from Japan on 2012-08-07

Patient:

Reactions: Renal Impairment, Disseminated Intravascular Coagulation, Pyrexia

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in female

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

Patient: female

Reactions: Acute Psychosis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lestaurtinib

Atracurium Besylate

Trisenox
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-21
    End date: 2012-03-03



Possible Trisenox side effects in male

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

Patient: male

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Hypotension, Sudden Death, Respiratory Distress, Haemodialysis, Hypoxic-Ischaemic Encephalopathy, Renal Failure, Sepsis, Cardiac Arrest

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

Drug(s) suspected as cause:
Trisenox
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-15
    End date: 2012-05-16

Atracurium Besylate
    Start date: 2012-05-15
    End date: 2012-05-16

Lestaurtinib
    Dosage: lestaurtinib (cep-701) or placebo



Possible Trisenox side effects in male

Reported by a physician from Germany on 2012-07-06

Patient: male, weighing 125.0 kg (275.0 pounds)

Reactions: Acute Promyelocytic Leukaemia Differentiation Syndrome, Hepatotoxicity

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Trisenox
    Dosage: 17.7 milligram;
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2012-05-22
    End date: 2012-06-06

Vesanoid
    Dosage: 120 milligram;
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2012-05-22
    End date: 2012-06-06



Possible Trisenox side effects in 72 year old male

Reported by a physician from United States on 2012-06-20

Patient: 72 year old male, weighing 191.6 kg (421.5 pounds)

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemtuzumab Ozogamicin
    Dosage: 9 mg/m2
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2012-03-07

Trisenox
    Dosage: 0.15 mg/kg
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2012-03-07
    End date: 2012-03-18

Atracurium Besylate
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2012-03-07
    End date: 2012-03-18



Possible Trisenox side effects in 5 year old female

Reported by a physician from United States on 2012-05-29

Patient: 5 year old female, weighing 21.4 kg (47.1 pounds)

Reactions: White Blood Cell Count Decreased, Bacterial Infection, Febrile Neutropenia, Endocarditis, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mitoxantrone
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-12-19

Trisenox
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2012-04-13

Cytarabine
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-12-19

Cytarabine
    Dosage: high dose
    Start date: 2012-04-25

Tretinoin
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-12-19



Possible Trisenox side effects in male

Reported by a physician from United States on 2012-05-25

Patient: male

Reactions: Syncope

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox
    Dosage: biweekly for 7 weeks
    Indication: Glioblastoma Multiforme
    Start date: 2012-01-23
    End date: 2012-03-08

Temozolomide
    Dosage: daily x 5days q 28 days
    Indication: Glioblastoma Multiforme
    Start date: 2012-01-23

Other drugs received by patient: Fentanyl-100; Levetiracetam; Clonazepam; Vicodin; Duloxetine Hydrochloride; Temazepam; Gabapentin; Citalopram Hydrobromide; Escitalopram Oxalate; Methylphenidate HCL



Possible Trisenox side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-18

Patient:

Reactions: Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in male

Reported by a physician from Italy on 2012-05-14

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Aspartate Aminotransferase Increased, Transaminases Increased, White Blood Cell Count Increased

Drug(s) suspected as cause:
Trisenox
    Start date: 2011-12-29

Trisenox
    Dosage: 5 milligram;
    Start date: 2011-11-05
    End date: 2011-11-13

Atracurium Besylate
    Administration route: Oral
    Start date: 2011-12-01

Atracurium Besylate
    Administration route: Oral
    Start date: 2011-11-05
    End date: 2011-11-12



Possible Trisenox side effects in

Reported by a physician from United Kingdom on 2012-05-14

Patient:

Reactions: Osteonecrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-24

Atracurium Besylate
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-24

Lestaurtinib

Other drugs received by patient: Glicazide



Possible Trisenox side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: female

Reactions: Multi-Organ Failure

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in female

Reported by a physician from United Kingdom on 2012-05-10

Patient: female

Reactions: Acute Psychosis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lestaurtinib

Trisenox
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-21
    End date: 2012-03-03

Atracurium Besylate



Possible Trisenox side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21

Patient: 72 year old male, weighing 77.2 kg (169.8 pounds)

Reactions: Cardiac Arrest, Fall

Adverse event resulted in: death

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in female

Reported by a physician from Switzerland on 2012-02-20

Patient: female

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox
    Start date: 2009-04-08

Methotrexate
    Start date: 2009-06-18
    End date: 2009-08-18

Atracurium Besylate
    Start date: 2009-06-18
    End date: 2009-08-18

Mercaptopurine
    Start date: 2009-06-18
    End date: 2009-08-18

Trisenox
    Start date: 2009-01-29

Other drugs received by patient: Norvasc; Neupogen; Metoprolol Tartrate and Hydrochlorothiazide; Hydrocortone; Torsemide



Possible Trisenox side effects in female

Reported by a physician from Switzerland on 2012-02-20

Patient: female

Reactions: Pancytopenia, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox
    Start date: 2009-01-29

Atracurium Besylate
    Administration route: Oral
    Start date: 2009-06-18
    End date: 2009-07-02

Trisenox
    Start date: 2009-04-08

Methotrexate
    Administration route: Oral
    Start date: 2009-06-18
    End date: 2009-07-09

Mercaptopurine
    Administration route: Oral
    Start date: 2009-06-18
    End date: 2009-07-11

Other drugs received by patient: Amikin; Levofloxacin; Nopil Forte; Cefepime; Cefepime; Nopil Forte; Cefepime; Bactrim DS; Levofloxacin



Possible Trisenox side effects in 55 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-17

Patient: 55 year old male, weighing 84.8 kg (186.6 pounds)

Reactions: Refusal of Treatment by Patient, Chest Pain

Adverse event resulted in: death

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-30

Patient: 25 year old female

Reactions: Mitral Valve Incompetence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Start date: 2005-10-01
    End date: 2007-03-01

Trisenox
    Dosage: unk
    Start date: 2007-10-09
    End date: 2008-04-04

Vesanoid
    Dosage: unk
    Administration route: Oral
    Start date: 2005-10-01
    End date: 2007-03-01

Other drugs received by patient: Procoralan; Cordarone



Possible Trisenox side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-30

Patient: 25 year old female

Reactions: Mitral Valve Incompetence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vesanoid
    Administration route: Oral
    Start date: 2005-10-01
    End date: 2007-03-01

Trisenox
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2007-10-01

Cytarabine
    Start date: 2005-10-01
    End date: 2007-03-01

Other drugs received by patient: Cordarone; Procoralan



Possible Trisenox side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-23

Patient: 52 year old male

Reactions: Deafness

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Vesanoid
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-10-05

Trisenox
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-10-17

Other drugs received by patient: Pravastatin; Cordarone; Previscan; Myolastan; Lioresa



Possible Trisenox side effects in female

Reported by a physician from United States on 2011-12-28

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Febrile Neutropenia, Escherichia Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox
    Start date: 2011-09-12
    End date: 2011-10-14

Cytarabine

Mitoxantrone Hydrochloride

Cytarabine

Tretinoin

Trisenox
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-07-27
    End date: 2011-08-26



Possible Trisenox side effects in female

Reported by a physician from United Kingdom on 2011-12-22

Patient: female

Reactions: Intracranial Pressure Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atracurium Besylate
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2010-06-28
    End date: 2011-03-11

Trisenox
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2010-06-30
    End date: 2010-08-03

Other drugs received by patient: Cyclizine; Omeprazole; Paracetamol+codein; Tretinoin



Possible Trisenox side effects in

Reported by a pharmacist from Canada on 2011-12-16

Patient:

Reactions: Bradycardia

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in female

Reported by a physician from United States on 2011-11-30

Patient: female

Reactions: Neuropathy Peripheral

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in male

Reported by a physician from United States on 2011-11-30

Patient: male

Reactions: Abdominal Pain, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Trisenox
    Dosage: 10 mg (10 mg,1 in 1 d),intravenous drip ; 5 mg (5 mg,1 in 1 d),intravenous drip
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2010-09-13
    End date: 2010-09-24

Trisenox
    Dosage: 10 mg (10 mg,1 in 1 d),intravenous drip ; 5 mg (5 mg,1 in 1 d),intravenous drip
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2010-10-04



Possible Trisenox side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-30

Patient: 50 year old female, weighing 66.2 kg (145.7 pounds)

Reactions: Electrocardiogram QT Prolonged, Dyspnoea, Chest Pain

Drug(s) suspected as cause:
Adriamycin PFS
    Indication: Acute Promyelocytic Leukaemia

Trisenox
    Dosage: 910 mg,cyclical),intravenous (not otherwise specified)
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2010-10-04



Possible Trisenox side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-30

Patient: female

Reactions: Bone Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in 20 year old female

Reported by a physician from United States on 2011-11-30

Patient: 20 year old female, weighing 93.0 kg (204.6 pounds)

Reactions: Abdominal Pain, Vomiting, Nausea, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trisenox



Possible Trisenox side effects in 44 year old male

Reported by a physician from United States on 2011-11-30

Patient: 44 year old male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Trisenox

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