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:
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 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 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 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
Possible Trisenox side effects in 52 year old female
Reported by a pharmacist from United States on 2011-11-30
Patient: 52 year old female
Reactions: Capsule Physical Issue, Accidental Exposure
Drug(s) suspected as cause:
Trisenox
Possible Trisenox side effects in 50 year old male
Reported by a physician from United States on 2011-11-30
Patient: 50 year old male
Reactions: Alanine Aminotransferase Increased
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: Pancytopenia
Drug(s) suspected as cause:
Trisenox
Possible Trisenox side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-30
Patient: 40 year old female, weighing 77.1 kg (169.6 pounds)
Reactions: Platelet Count Decreased
Drug(s) suspected as cause:
Trisenox
Possible Trisenox side effects in
Reported by a physician from United States on 2011-11-30
Patient:
Reactions: Electrocardiogram QT Prolonged
Drug(s) suspected as cause:
Trisenox
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