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Arsenic Side Effects

Common Arsenic Side Effects


The most commonly reported Arsenic side effects (click to view or check a box to report):

Hypotension (11)
Platelet Count Decreased (10)
Haemoglobin Decreased (10)
White Blood Cell Count Decreased (9)
Disseminated Intravascular Coagulation (8)
Dyspnoea (8)
Pyrexia (8)
Electrocardiogram Qt Prolonged (8)
Pneumonia (7)
Asthenia (7)
Alanine Aminotransferase Increased (7)
Blood Lactate Dehydrogenase Increased (6)
Cardiac Failure (6)
Cerebral Haemorrhage (6)
Nausea (5)
Convulsion (5)
Anaemia (5)
Bronchopneumonia (5)
Pleural Effusion (4)
Fluid Overload (4)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Arsenic Side Effects Reported to FDA

The following Arsenic reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Arsenic on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

This is a report of a 76-year-old patient (weight: NA) from US, suffering from the following symptoms/conditions: small cell lung cancer, who was treated with Arsenic Trioxide (dosage: 19.5 Bi Weekly Iv, start time: Jan 16, 2013), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
    which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in patients, resulting in death side effect. The patient was hospitalized.

    Dyspnoea
    This report suggests a potential Arsenic Trioxide Dyspnoea side effect(s) that can have serious consequences. A 76-year-old patient (weight: NA) from US was diagnosed with the following symptoms/conditions: small cell lung cancer and used Arsenic Trioxide (dosage: Bi Weekly) starting Jan 16, 2013. Soon after starting Arsenic Trioxide the patient began experiencing various side effects, including:
    • Dyspnoea
    Drugs used concurrently: NA.The patient was hospitalized. Although Arsenic Trioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dyspnoea, may still occur.

    Tubulointerstitial Nephritis, Peritonitis
    This Tubulointerstitial Nephritis, Peritonitis problem was reported by a physician from JP. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: acute promyelocytic leukaemia. On May 24, 2012 this consumer started treatment with Arsenic Trioxide (dosage: NA). The following drugs were being taken at the same time:
    • Vesanoid
    • Vesanoid
    When commencing Arsenic Trioxide, the patient experienced the following unwanted symptoms/side effects:
    • Tubulointerstitial Nephritis
    • Peritonitis
    Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as tubulointerstitial nephritis, may become evident only after a product is in use by the general population.

    Cerebral Haemorrhage
    This is a report of a male patient (weight: NA) from ITALY. The patient developed the following symptoms/conditions: NA and was treated with Arsenic Trioxide (dosage: 10 Milligram;) starting Jun 10, 2012. Concurrently used drugs:
    • Atracurium Besylate (80 Milligram;)
    • Methylprednisolone
    • Hydroxyurea (4 Milligram;)
    • Dexamethasone
    Soon after that, the consumer experienced the following side effects:
    • Cerebral Haemorrhage
    This opens a possibility that Arsenic Trioxide treatment could cause the above reactions, including cerebral haemorrhage, and some male subjects may be more susceptible.


    Oxygen Saturation Decreased, Dehydration, Bradycardia, Syncope, Renal Failure, Cold Sweat, Hypotension, Amnesia, Headache
    A 56-year-old male patient (weight: NA) from UNITED STATES with the following symptoms/conditions: glioblastoma multiforme started Arsenic Trioxide treatment (dosage: 18.2347 Mg Bid Weekly X 7 Wks Iv) on Jan 23, 2012. Soon after starting Arsenic Trioxide treatment, the subject experienced various side effects, including:
    • Oxygen Saturation Decreased
    • Dehydration
    • Bradycardia
    • Syncope
    • Renal Failure
    • Cold Sweat
    • Hypotension
    • Amnesia
    • Headache
    Concurrently used drugs:
    • 1-lidoderm Patch
    • 4-lexapro
    • 3-norco
    • Keppra
    • 5-celexa
    • Temozolomide (420 Mg Daily X5 Q 28days Po)
    The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Arsenic Trioxide.

    Hepatotoxicity
    A male patient from ITALY (weight: NA) experienced symptoms, such as: NA and was treated with Arsenic Trioxide(dosage: NA). The treatment was initiated on Mar 30, 2012. After that a consumer reported the following side effect(s):
    • Hepatotoxicity
    Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Arsenic Trioxide efficacy:
    • Transretinoic Acid
    The patient was hospitalized.

    Asthenia, Myocardial Infarction, Paraesthesia, Alopecia
    In this report, Arsenicum Album was administered for the following condition: NA.A 59-year-old male consumer from ITALY (weight: NA) started Arsenicum Album treatment (dosage: 10 Other) on Jan 28, 2009.Sometime after starting the treatment, the patient complained of the following side effect(s):
    • Asthenia
    • Myocardial Infarction
    • Paraesthesia
    • Alopecia
    A possible interaction with other drugs could have contributed to this reaction:
    • Doxorubicin Hcl (80 Milligram)
    • Sulfur (10 Drops)
    • Abraxane
    • T-melatonine (2 Tablet)
    • Madopar
    • Xanax (.25 Milligram)
    • Lenicalm (2 Tablet)
    • Seda K (20 Drops)
    Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Arsenicum Album treatment could be related to the listed above side effect(s).

    Condition Aggravated, Obsessive Thoughts, Electrocardiogram Qt Prolonged, Tremor, Anxiety, Laboratory Test Interference, Staphylococcus Test Positive, Agitation
    This is a report of the following Arsenic Trioxide side effect(s):
    • Condition Aggravated
    • Obsessive Thoughts
    • Electrocardiogram Qt Prolonged
    • Tremor
    • Anxiety
    • Laboratory Test Interference
    • Staphylococcus Test Positive
    • Agitation
    A 43-year-old male patient from UNITED STATES (weight: NA) presented with the following condition: acute promyelocytic leukaemia and received a treatment with Arsenic Trioxide (dosage: 0.15 Mg/kg;iv) starting: Oct 18, 2006.The following concurrently used drugs could have generated interactions:
    • Daunorubicin Hcl
    • Calcium Acetate
    • Fluticasone Propionate
    • Lorazepam
    • Allopurinol
    • Albuterol Sulfate And Ipratropium Bromide
    • Oxycodone Hcl
    • Verapamil
    The patient was hospitalized.This report suggests that a Arsenic Trioxide treatment could be associated with the listed above side effect(s).

    Tremor, Depression, Electrocardiogram Qt Prolonged, Hyperhidrosis, Anxiety, Chills, Obsessive Thoughts
    This Arsenic Trioxide report was submitted by a 43-year-old male consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Arsenic Trioxide was administered (dosage: 0.15 Mg/kg;iv) starting: Sep 29, 2006. The consumer developed a set of symptoms:
    • Tremor
    • Depression
    • Electrocardiogram Qt Prolonged
    • Hyperhidrosis
    • Anxiety
    • Chills
    • Obsessive Thoughts
    Other drugs used simultaneously:
    • Fluvoxamine Maleate (100 Mg;am)
    • Fluconazole
    The patient was hospitalized.Those unexpected symptoms could be linked to a Arsenic Trioxide treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

    Antiphospholipid Syndrome, Dyspnoea, Pneumonia
    This is a report of a possible correlation between Arsenic Trioxide use and the following symptoms/side effect(s):
    • Antiphospholipid Syndrome
    • Dyspnoea
    • Pneumonia
    which could contribute to an assessment of Arsenic Trioxide risk profile.A 73-year-old male consumer from UNITED STATES (weight: NA) was suffering from lung neoplasm malignant and was treated with Arsenic Trioxide (dosage: 30mg 4 Days A Week Iv) starting Dec 07, 2011.Other concurrent medications: NA.The patient was hospitalized.


    A 72-year-old male patient from UNITED STATES (weight: NA) presented with the following symptoms: NA and after a treatment with Arsenic Trioxide (dosage: 15 Mg Twice A Week) experienced the following side effect(s):
      The treatment was started on Sep 08, 2011. Arsenic Trioxide was used in combination with the following drugs: NA.This report could alert potential Arsenic Trioxide consumers.

      Neoplasm Progression, Confusional State, Pyrexia, Hypotension, Neutropenia
      In this report, a 51-year-old female patient from UNITED STATES (weight: NA) was affected by a possible Arsenic Trioxide side effect.The patient was diagnosed with NA. After a treatment with Arsenic Trioxide (dosage: 19.2 Mg, start date: Oct 05, 2011), the patient experienced the following side effect(s):
      • Neoplasm Progression
      • Confusional State
      • Pyrexia
      • Hypotension
      • Neutropenia
      The following simultaneously used drugs could have led to this reaction:
      • Hydrochlorothiazide
      • Oxycodone Hcl
      • Pantoprazole
      • Valsartan
      • Clonazepam
      • Docusate
      The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Arsenic Trioxide treatment.

      Herpes Zoster
      This is a report of a 72-year-old male patient from UNITED STATES (weight: NA), who used Arsenic Trioxide (dosage: 15mg Twice A Wk Iv) for a treatment of lung neoplasm malignant. After starting a treatment on Sep 08, 2011, the patient experienced the following side effect(s):
      • Herpes Zoster
      The following drugs could possibly have interacted with the Arsenic Trioxide treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Arsenic Trioxide treatment could be related to side effect(s), such as Herpes Zoster.

      Asthenia, Pleural Effusion
      This asthenia side effect was reported by a physician from UNITED STATES. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: lung neoplasm malignant. The patient was prescribed Arsenic Trioxide (dosage: 15mg Twice A Week Iv), which was started on Sep 08, 2011. Concurrently used drugs: NA. When starting to take Arsenic Trioxide the consumer reported the following symptoms:
      • Asthenia
      • Pleural Effusion
      The patient was hospitalized. These side effects may potentially be related to Arsenic Trioxide.

      Gait Disturbance, Amnesia
      This is a Arsenic Trioxide side effect report of a 51-year-old female patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: lung neoplasm malignant, who was treated with Arsenic Trioxide (dosage:0.25 Mg Twice A Week, start time: Oct 05, 2011), combined with:
      • See Attached
      , and developed a serious reaction and a gait disturbance side effect. The patient presented with:
      • Gait Disturbance
      • Amnesia
      which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Arsenic Trioxide treatment in female patients suffering from lung neoplasm malignant, resulting in gait disturbance.

      Hospitalisation
      This report suggests a potential Arsenic Trioxide hospitalisation side effect(s) that can have serious consequences. A 72-year-old male patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): lung neoplasm malignant and used Arsenic Trioxide (dosage: 15mg Twice A Week Iv) starting Sep 08, 2011. Soon after starting Arsenic Trioxide the patient began experiencing various side effects, including:
      • Hospitalisation
      Drugs used concurrently:NA. The patient was hospitalized. Although Arsenic Trioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hospitalisation, may still occur.

      Neutropenia
      This neutropenia problem was reported by a physician from ITALY. A 52-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): acute promyelocytic leukaemia.On NS a consumer started treatment with Arsenic Trioxide (dosage: 5 Courses Of Monthly Administration). The following drugs/medications were being taken at the same time:
      • Tretinoin (8 Courses Of Bi-weekly Administration)
      When commencing Arsenic Trioxide, the patient experienced the following unwanted symptoms /side effects:
      • Neutropenia
      Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as neutropenia, may become evident only after a product is in use by the general population.

      Hyperbilirubinaemia, Disease Progression
      This is a Arsenic Trioxide side effect report of a 59-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Arsenic Trioxide (dosage: 28.7mg Iv Twice A Week) starting Sep 18, 2011. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
      • Hyperbilirubinaemia
      • Disease Progression
      This opens a possibility that Arsenic Trioxide could cause hyperbilirubinaemia and that some female patients may be more susceptible.

      Biliary Dilatation, Bile Duct Obstruction, Blood Bilirubin Increased, Metastases To Liver
      A 59-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: non-small cell lung cancer started Arsenic Trioxide treatment (dosage: 28.7mg Iv Twice A Week) on Sep 18, 2011. Soon after starting Arsenic Trioxide treatment, the consumer experienced several side effects, including:
      • Biliary Dilatation
      • Bile Duct Obstruction
      • Blood Bilirubin Increased
      • Metastases To Liver
      . Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Arsenic Trioxide side effects, such as biliary dilatation.

      Bacteraemia, Sepsis, Respiratory Failure
      This bacteraemia side effect was reported by a physician from UNITED STATES. A male patient (weight:NA) experienced the following symptoms/conditions: myelofibrosis.The patient was prescribed Arsenic Trioxide (dosage: NA), which was started on Dec 29, 2010. Concurrently used drugs: NA..When starting to take Arsenic Trioxide the consumer reported symptoms, such as:
      • Bacteraemia
      • Sepsis
      • Respiratory Failure
      These side effects may potentially be related to Arsenic Trioxide. The patient was hospitalized.

      Mitochondrial Myopathy
      This is a report of a 65-year-old female patient (weight: NA) from FRANCE, suffering from the following symptoms/conditions: acute promyelocytic leukaemia, who was treated with Arsenic Trioxide (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
      • Mitochondrial Myopathy
      which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in female patients, resulting in mitochondrial myopathy side effect.

      Cerebral Infarction, Leukostasis, Leukocytosis, Disseminated Intravascular Coagulation
      This report suggests a potential Arsenic Trioxide Cerebral Infarction, Leukostasis, Leukocytosis, Disseminated Intravascular Coagulation side effect(s) that can have serious consequences. A 27-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: acute promyelocytic leukaemia and used Arsenic Trioxide (dosage: NA) starting NS. Soon after starting Arsenic Trioxide the patient began experiencing various side effects, including:
      • Cerebral Infarction
      • Leukostasis
      • Leukocytosis
      • Disseminated Intravascular Coagulation
      Drugs used concurrently: NA.The patient was hospitalized. Although Arsenic Trioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cerebral infarction, may still occur.

      Neoplasm Malignant, Bone Marrow Disorder, Lung Infection
      This Neoplasm Malignant, Bone Marrow Disorder, Lung Infection problem was reported by a consumer or non-health professional from GERMANY. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: mantle cell lymphoma. On Jan 01, 2006 this consumer started treatment with Arsenic (dosage: Unk). The following drugs were being taken at the same time:
      • Bortezomib (Unk)
      • Chlorambucil (Unk)
      • Doxorubicin (Unk)
      • Cyclophosphamide (Unk)
      • Prednisone (Unk)
      • Etoposide (Unk)
      • Ifosfamide (Unk)
      • Carboplatin (Unk)
      When commencing Arsenic, the patient experienced the following unwanted symptoms/side effects:
      • Neoplasm Malignant
      • Bone Marrow Disorder
      • Lung Infection
      Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as neoplasm malignant, may become evident only after a product is in use by the general population.

      Electrocardiogram Qt Prolonged
      This is a report of a 55-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Arsenic Trioxide (dosage: 15mg/kg/dose Iv Daily) starting NS. Concurrently used drugs:
      • Methadone (30mg Po Q12h)
      • Prochlorperazine
      • Hydromorphone
      • Oxybutynin Chloride
      • Temazepam
      • Baclofen
      • Lorazepam
      • Quinapril
      Soon after that, the consumer experienced the following side effects:
      • Electrocardiogram Qt Prolonged
      This opens a possibility that Arsenic Trioxide treatment could cause the above reactions, including electrocardiogram qt prolonged, and some female subjects may be more susceptible.

      Abdominal Pain Upper, Dehydration, Nausea, Vomiting
      A 63-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: acute myeloid leukaemia started Arsenic Trioxide treatment (dosage: 15.9 Mg Qd Intravenous) on Feb 16, 2009. Soon after starting Arsenic Trioxide treatment, the subject experienced various side effects, including:
      • Abdominal Pain Upper
      • Dehydration
      • Nausea
      • Vomiting
      Concurrently used drugs:
      • Ara-c
      • Pantoprazole Sodium
      • Metformin Hcl
      • Enalapril
      • Ciprofloxacin
      The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Arsenic Trioxide.

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      Medicine Name and Dosage:
      Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
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      Arsenic Safety Alerts, Active Ingredients, Usage Information

      NDC10191-1989
      TypeHUMAN OTC DRUG
      Proprietary NameARSENICUM ALBUM
      NameARSENIC TRIOXIDE
      Dosage FormPELLET
      RouteSUBLINGUAL
      On market since20040712
      LabelerRemedy Makers
      Active Ingredient(s)ARSENIC TRIOXIDE
      Strength(s)30
      Unit(s)[hp_C]/1
      Pharma Class

      More About Arsenic

      Side Effects reported to FDA: 113

      Arsenic safety alerts: 2001

      Reported deaths: 29

      Reported hospitalizations: 75

      Arsenic trioxide

      Healthcare providers reminded to closely monitor patients on arsenic trioxide

      CTI has issued a "Dear Health Care Provider" letter reminding clinicians that QTc prolongation with torsade de pointes arrhythmia and sudden death have been associated with the use of arsenic trioxide. An article published recently in Blood (Unnikrishnan, et al, 1 March 2001;97:1514‚??1516) describes prolonged QT interval and torsade de pointes in 3 patients being treated with arsenic trioxide for acute myeloid leukemia (AML). The arsenic trioxide used in the reported study was not Cell Therapeutics‚?? Trisenox‚?Ę (arsenic trioxide) injection. The current Trisenox label emphasizes the importance of ECG and electrolyte monitoring prior to and during therapy in patients given arsenic trioxide.

      [March 19, 2001 - Letter - Cell Therapeutics, Inc.]

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