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Arsenic Side Effects

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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.

Arsenic Side Effects Reported to FDA



Arsenic Side Effect Report#9167491
This is a report of a 76-year-old patient (weight: NA) from US, suffering from the following health 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): 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.
Arsenic Side Effect Report#9115386
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. After starting Arsenic Trioxide the patient began experiencing various side effects, including: DyspnoeaAdditional 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.
Arsenic Side Effect Report#8821405
Tubulointerstitial Nephritis, Peritonitis
This Tubulointerstitial Nephritis 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 using Arsenic Trioxide, the patient experienced the following unwanted symptoms/side effects: Tubulointerstitial Nephritis, PeritonitisAlthough 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.
Arsenic Side Effect Report#8469763-2
Cerebral Haemorrhage
This Cerebral Haemorrhage side effect was reported by a physician from Italy. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Arsenic Trioxide (drug dosage: 10 Milligram;), which was initiated on
Jun 10, 2012. Concurrently used drugs:
  • Atracurium Besylate (80 Milligram;)
  • Methylprednisolone
  • Hydroxyurea (4 Milligram;)
  • Dexamethasone
.After starting to take Arsenic Trioxide the consumer reported adverse symptoms, such as: Cerebral HaemorrhageThese side effects may potentially be related to Arsenic Trioxide.
Arsenic Side Effect Report#8362493-7
Oxygen Saturation Decreased, Dehydration, Bradycardia, Syncope, Renal Failure, Cold Sweat, Hypotension, Amnesia, Headache
This is a report of a 56-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: glioblastoma multiforme, who was treated with Arsenic Trioxide (dosage: 18.2347 Mg Bid Weekly X 7 Wks Iv, start time:
Jan 23, 2012), combined with:
  • 1-lidoderm Patch
  • 4-lexapro
  • 3-norco
  • Keppra
  • 5-celexa
  • Temozolomide (420 Mg Daily X5 Q 28days Po)
and developed a serious reaction and side effect(s): Oxygen Saturation Decreased, Dehydration, Bradycardia, Syncope, Renal Failure, Cold Sweat, Hypotension, Amnesia, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in male patients, resulting in Oxygen Saturation Decreased side effect. The patient was hospitalized.
Arsenic Side Effect Report#8327058-1
Hepatotoxicity
This report suggests a potential Arsenic Trioxide Hepatotoxicity side effect(s) that can have serious consequences. A male patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: NA and used Arsenic Trioxide (dosage: NA) starting
Mar 30, 2012. After starting Arsenic Trioxide the patient began experiencing various side effects, including: HepatotoxicityAdditional drugs used concurrently:
  • Transretinoic Acid
The patient was hospitalized. Although Arsenic Trioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatotoxicity, may still occur.
Arsenic Side Effect Report#8170644-2
Asthenia, Myocardial Infarction, Paraesthesia, Alopecia
This Asthenia problem was reported by a physician from Italy. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 28, 2009 this consumer started treatment with Arsenicum Album (dosage: 10 Other). The following drugs were being taken at the same time:
  • Doxorubicin Hcl (80 Milligram)
  • Sulfur (10 Drops)
  • Abraxane
  • T-melatonine (2 Tablet)
  • Madopar
  • Xanax (.25 Milligram)
  • Lenicalm (2 Tablet)
  • Seda K (20 Drops)
When using Arsenicum Album, the patient experienced the following unwanted symptoms/side effects: Asthenia, Myocardial Infarction, Paraesthesia, AlopeciaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Asthenia, may become evident only after a product is in use by the general population.
Arsenic Side Effect Report#8048528-X
Condition Aggravated, Obsessive Thoughts, Electrocardiogram Qt Prolonged, Tremor, Anxiety, Laboratory Test Interference, Staphylococcus Test Positive, Agitation
This Condition Aggravated side effect was reported by a health professional from United States. A 43-year-old male patient (weight:NA) experienced the following symptoms/conditions: acute promyelocytic leukaemia.The patient was prescribed Arsenic Trioxide (drug dosage: 0.15 Mg/kg;iv), which was initiated on
Oct 18, 2006. Concurrently used drugs:
  • Daunorubicin Hcl
  • Calcium Acetate
  • Fluticasone Propionate
  • Lorazepam
  • Allopurinol
  • Albuterol Sulfate And Ipratropium Bromide
  • Oxycodone Hcl
  • Verapamil
.After starting to take Arsenic Trioxide the consumer reported adverse symptoms, such as: Condition Aggravated, Obsessive Thoughts, Electrocardiogram Qt Prolonged, Tremor, Anxiety, Laboratory Test Interference, Staphylococcus Test Positive, AgitationThese side effects may potentially be related to Arsenic Trioxide. The patient was hospitalized.
Arsenic Side Effect Report#8022047-9
Tremor, Depression, Electrocardiogram Qt Prolonged, Hyperhidrosis, Anxiety, Chills, Obsessive Thoughts
This is a report of a 43-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Arsenic Trioxide (dosage: 0.15 Mg/kg;iv, start time:
Sep 29, 2006), combined with:
  • Fluvoxamine Maleate (100 Mg;am)
  • Fluconazole
and developed a serious reaction and side effect(s): Tremor, Depression, Electrocardiogram Qt Prolonged, Hyperhidrosis, Anxiety, Chills, Obsessive Thoughts after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in male patients, resulting in Tremor side effect. The patient was hospitalized.
Arsenic Side Effect Report#7982467-5
Antiphospholipid Syndrome, Dyspnoea, Pneumonia
This report suggests a potential Arsenic Trioxide Antiphospholipid Syndrome side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: lung neoplasm malignant and used Arsenic Trioxide (dosage: 30mg 4 Days A Week Iv) starting
Dec 07, 2011. After starting Arsenic Trioxide the patient began experiencing various side effects, including: Antiphospholipid Syndrome, Dyspnoea, PneumoniaAdditional 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 Antiphospholipid Syndrome, may still occur.
Arsenic Side Effect Report#7964963-X
This Death problem was reported by a physician from United States. A 72-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 08, 2011 this consumer started treatment with Arsenic Trioxide (dosage: 15 Mg Twice A Week). The following drugs were being taken at the same time: NA. When using Arsenic Trioxide, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Arsenic Side Effect Report#7945115-6
Neoplasm Progression, Confusional State, Pyrexia, Hypotension, Neutropenia
This Neoplasm Progression side effect was reported by a health professional from United States. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Arsenic Trioxide (drug dosage: 19.2 Mg), which was initiated on
Oct 05, 2011. Concurrently used drugs:
  • Hydrochlorothiazide
  • Oxycodone Hcl
  • Pantoprazole
  • Valsartan
  • Clonazepam
  • Docusate
.After starting to take Arsenic Trioxide the consumer reported adverse symptoms, such as: Neoplasm Progression, Confusional State, Pyrexia, Hypotension, NeutropeniaThese side effects may potentially be related to Arsenic Trioxide. The patient was hospitalized.
Arsenic Side Effect Report#7906983-7
Herpes Zoster
This is a report of a 72-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: lung neoplasm malignant, who was treated with Arsenic Trioxide (dosage: 15mg Twice A Wk Iv, start time:
Sep 08, 2011), combined with: NA. and developed a serious reaction and side effect(s): Herpes Zoster after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in male patients, resulting in Herpes Zoster side effect. The patient was hospitalized.
Arsenic Side Effect Report#7906830-3
Asthenia, Pleural Effusion
This report suggests a potential Arsenic Trioxide Asthenia side effect(s) that can have serious consequences. A 72-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: lung neoplasm malignant and used Arsenic Trioxide (dosage: 15mg Twice A Week Iv) starting
Sep 08, 2011. After starting Arsenic Trioxide the patient began experiencing various side effects, including: Asthenia, Pleural EffusionAdditional 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 Asthenia, may still occur.
Arsenic Side Effect Report#7896330-1
Gait Disturbance, Amnesia
This Gait Disturbance problem was reported by a consumer or non-health professional from United States. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: lung neoplasm malignant. On
Oct 05, 2011 this consumer started treatment with Arsenic Trioxide (dosage: 0.25 Mg Twice A Week). The following drugs were being taken at the same time:
  • See Attached
When using Arsenic Trioxide, the patient experienced the following unwanted symptoms/side effects: Gait Disturbance, AmnesiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gait Disturbance, may become evident only after a product is in use by the general population.
Arsenic Side Effect Report#7888779-8
Hospitalisation
This Hospitalisation side effect was reported by a consumer or non-health professional 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 (drug dosage: 15mg Twice A Week Iv), which was initiated on
Sep 08, 2011. Concurrently used drugs: NA..After starting to take Arsenic Trioxide the consumer reported adverse symptoms, such as: HospitalisationThese side effects may potentially be related to Arsenic Trioxide. The patient was hospitalized.
Arsenic Side Effect Report#7833618-4
Neutropenia
This is a report of a 52-year-old male patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: acute promyelocytic leukaemia, who was treated with Arsenic Trioxide (dosage: 5 Courses Of Monthly Administration, start time: NS), combined with:
  • Tretinoin (8 Courses Of Bi-weekly Administration)
and developed a serious reaction and side effect(s): Neutropenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in male patients, resulting in Neutropenia side effect.
Arsenic Side Effect Report#7808452-1
Hyperbilirubinaemia, Disease Progression
This report suggests a potential Arsenic Trioxide Hyperbilirubinaemia side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Arsenic Trioxide (dosage: 28.7mg Iv Twice A Week) starting
Sep 18, 2011. After starting Arsenic Trioxide the patient began experiencing various side effects, including: Hyperbilirubinaemia, Disease ProgressionAdditional drugs used concurrently: NA. Although Arsenic Trioxide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperbilirubinaemia, may still occur.
Arsenic Side Effect Report#7799018-0
Biliary Dilatation, Bile Duct Obstruction, Blood Bilirubin Increased, Metastases To Liver
This Biliary Dilatation problem was reported by a physician from United States. A 59-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: non-small cell lung cancer. On
Sep 18, 2011 this consumer started treatment with Arsenic Trioxide (dosage: 28.7mg Iv Twice A Week). The following drugs were being taken at the same time: NA. When using Arsenic Trioxide, the patient experienced the following unwanted symptoms/side effects: Biliary Dilatation, Bile Duct Obstruction, Blood Bilirubin Increased, Metastases To LiverThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Biliary Dilatation, may become evident only after a product is in use by the general population.
Arsenic Side Effect Report#7712982-0
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 (drug dosage: NA), which was initiated on
Dec 29, 2010. Concurrently used drugs: NA..After starting to take Arsenic Trioxide the consumer reported adverse symptoms, such as: Bacteraemia, Sepsis, Respiratory FailureThese side effects may potentially be related to Arsenic Trioxide. The patient was hospitalized.
Arsenic Side Effect Report#7535939-1
Mitochondrial Myopathy
This is a report of a 65-year-old female patient (weight: NA) from France, suffering from the following health 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): Mitochondrial Myopathy 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.
Arsenic Side Effect Report#7530415-4
Cerebral Infarction, Leukostasis, Leukocytosis, Disseminated Intravascular Coagulation
This report suggests a potential Arsenic Trioxide Cerebral Infarction 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. After starting Arsenic Trioxide the patient began experiencing various side effects, including: Cerebral Infarction, Leukostasis, Leukocytosis, Disseminated Intravascular CoagulationAdditional 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.
Arsenic Side Effect Report#7395193-0
Neoplasm Malignant, Bone Marrow Disorder, Lung Infection
This Neoplasm Malignant 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 using Arsenic, the patient experienced the following unwanted symptoms/side effects: Neoplasm Malignant, Bone Marrow Disorder, Lung InfectionAlthough 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.
Arsenic Side Effect Report#6248609-7
Electrocardiogram Qt Prolonged
This Electrocardiogram Qt Prolonged side effect was reported by a pharmacist from United States. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Arsenic Trioxide (drug dosage: 15mg/kg/dose Iv Daily), which was initiated on NS. Concurrently used drugs:
  • Methadone (30mg Po Q12h)
  • Prochlorperazine
  • Hydromorphone
  • Oxybutynin Chloride
  • Temazepam
  • Baclofen
  • Lorazepam
  • Quinapril
.After starting to take Arsenic Trioxide the consumer reported adverse symptoms, such as: Electrocardiogram Qt ProlongedThese side effects may potentially be related to Arsenic Trioxide.
Arsenic Side Effect Report#6104656-7
Abdominal Pain Upper, Dehydration, Nausea, Vomiting
This is a report of a 63-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: acute myeloid leukaemia, who was treated with Arsenic Trioxide (dosage: 15.9 Mg Qd Intravenous, start time:
Feb 16, 2009), combined with:
  • Ara-c
  • Pantoprazole Sodium
  • Metformin Hcl
  • Enalapril
  • Ciprofloxacin
and developed a serious reaction and side effect(s): Abdominal Pain Upper, Dehydration, Nausea, Vomiting after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arsenic Trioxide treatment in female patients, resulting in Abdominal Pain Upper side effect. The patient was hospitalized.


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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.

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Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    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.

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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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