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Arsenic Side Effects

Report Arsenic Side Effects

Examples: headache, dizziness


The most commonly reported Arsenic side effects are:
Dark Colored Blood (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Arsenic side effects or compare Arsenic side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.
Red Blood Cell Abnormality
on Feb 05, 2009 Male from UNITED KINGDOM , 65 years of age, weighting 167.6 lb, was diagnosed with and was treated with Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: red blood cell abnormality. Arsenic Trioxide dosage: 0.3 Mg/kg Day 1-5 Week 1: Twice/weekly Weeks 2-4 Cyclical Intravenous.
Associated medications used:
  • Magnesium Glycerophosphate
  • Slow-k
  • Tramadol Hcl
  • Paracetamol
  • Atra


Dysplasia, Red Blood Cell Abnormality
Patient was taking Arsenic Trioxide. Patient felt the following Arsenic side effects: dysplasia, red blood cell abnormality on Jan 27, 2009 from UNITED KINGDOM Additional patient health information: Male , 65 years of age, weighting 167.6 lb, was diagnosed with and. Arsenic Trioxide dosage: 0.3 Mg/kg Day 1-5 Week 1: Twice/weekly Weeks 2-4 Cyclical Intravenous.
Multiple prescriptions taken:
  • Magnesium Glycerophosphate
  • Slow-k
  • Tramadol Hcl
  • Paracetamol
  • Atra


Epistaxis, Fall, Gingival Bleeding, Haematemesis, Haematoma, Lower Gastrointestinal Haemorrhage, Pulmonary Haemorrhage, Pyrexia, Renal Failure Acute
Adverse event was reported on Jan 12, 2009 by a Male taking Arsenic Trioxide (Dosage: 0.1 Mg/kg Days 1-5 Q Wk Intravenous Drip) was diagnosed with and. Location: UNITED STATES , 73 years of age, weighting 149.9 lb, After Arsenic was administered, patient encountered several Arsenic side effects: epistaxis, fall, gingival bleeding, haematemesis, haematoma, lower gastrointestinal haemorrhage, pulmonary haemorrhage, pyrexia, renal failure acute.
Multiple concurrent drugs taken:
  • Decitabine (20 Mg/m2 Days 1-5 Intravenous)
  • Ascorbic Acid (1000 Mg Days 1-5 Q Wk Intravenous)
  • Lyrica
  • Metoprolol
  • Lisinopril
  • Zetia
  • Flomax /01280302/
  • Allopurinol
Patient was hospitalized.

Haematemesis, Lower Gastrointestinal Haemorrhage, Melaena, Pulmonary Haemorrhage, Red Blood Cell Count Decreased, Respiratory Tract Haemorrhage, Thrombocytopenia, White Blood Cell Count Increased
on Jan 02, 2009 Male from UNITED STATES , weighting 149.9 lb, was diagnosed with and was treated with Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: haematemesis, lower gastrointestinal haemorrhage, melaena, pulmonary haemorrhage, red blood cell count decreased, respiratory tract haemorrhage, thrombocytopenia, white blood cell count increased. Arsenic Trioxide dosage: 0.1 Mg/kg Days 1-5 Q Wk Intravenous Drip.
Associated medications used:
  • Decitabine (20 Mg/m2 Days 1-5 Intravenous)
  • Ascorbic Acid (1000 Mg Days 1-5 Q Wk Intravenous)
  • Lyrica
  • Metoprolol Tartrate
  • Lisinopril
  • Zetia
  • Flomax /01280302/
  • Allopurinol
Patient was hospitalized.


Alanine Aminotransferase Increased, Anaemia, Blood Lactate Dehydrogenase Increased, Cardiac Failure, Dyspnoea, Pco2 Decreased, Platelet Count Decreased, Po2 Decreased, Sinus Tachycardia
on Dec 04, 2008 Male from ITALY , 74 years of age, weighting 185.2 lb, was diagnosed with and was treated with Arsenic Trioxide. Patient felt the following Arsenic side effects: alanine aminotransferase increased, anaemia, blood lactate dehydrogenase increased, cardiac failure, dyspnoea, pco2 decreased, platelet count decreased, po2 decreased, sinus tachycardia. Arsenic Trioxide dosage: 25.2 Mg Cycle 1 Intravenous Drip.
Multiple prescriptions taken:
  • Clorfenamina Maleato
  • Irbesartan
  • Metformin Hcl
  • Lenograstim
  • Ascorbic Acid
  • Potassium Chloride
Patient was hospitalized.

Febrile Neutropenia, Muscular Weakness
Patient was taking Arsenic Trioxide. After Arsenic was administered, patient encountered several Arsenic side effects: febrile neutropenia, muscular weakness on Nov 17, 2008 from UNITED STATES Additional patient health information: Male , 69 years of age, was diagnosed with and. Arsenic Trioxide dosage: 10.4 Mg Qwkly Days 1, 8, 15, And 22 Intravenous Drip.
Multiple concurrent drugs taken:
  • Decitabine (20 Mg/m2 Daily Days 1-5 Intravenous)
  • Ascorbic Acid (1000 Mg Qwkly Days 1, 8, 15, And 22 Intravenous)
Patient was hospitalized.

Bronchopneumonia
Adverse event was reported on Oct 27, 2008 by a Male taking Arsenic Trioxide (Dosage: 15 Mg Two Times Per Week (3 Cycles); Intravenous Drip) was diagnosed with and. Location: ITALY , 67 years of age, weighting 136.7 lb, Directly after, patient experienced the unwanted or unexpected Arsenic side effects: bronchopneumonia. Patient was hospitalized.

Anaphylactic Reaction
on Oct 23, 2008 Male from UNITED STATES , 69 years of age, weighting 235.0 lb, was diagnosed with and was treated with Arsenic Trioxide. Patient felt the following Arsenic side effects: anaphylactic reaction. Arsenic Trioxide dosage: 0.1 Mg/kg Days 1-5 Cycle 1 Qd Intravenous. Patient was hospitalized.

Bronchopneumonia, Chlamydia Identification Test Positive, Haemoglobin Decreased, Neutrophil Percentage Decreased, Platelet Count Decreased, Pneumocystis Jiroveci Infection, Respiratory Depression, Sputum Culture Positive, White Blood Cell Count Decreased
on Oct 01, 2008 Male from ITALY , 67 years of age, weighting 136.7 lb, was diagnosed with and was treated with Arsenic Trioxide. After Arsenic was administered, patient encountered several Arsenic side effects: bronchopneumonia, chlamydia identification test positive, haemoglobin decreased, neutrophil percentage decreased, platelet count decreased, pneumocystis jiroveci infection, respiratory depression, sputum culture positive, white blood cell count decreased. Arsenic Trioxide dosage: 15 Mg Two Times Per Week (3 Cycles) Intravenous Drip. Patient was hospitalized.

Alanine Aminotransferase Increased, Anaemia, Blood Lactate Dehydrogenase Increased, Cardiac Failure, Electrocardiogram Repolarisation Abnormality, Hypoxia, Pco2 Decreased, Platelet Count Decreased, Sinus Tachycardia
Patient was taking Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: alanine aminotransferase increased, anaemia, blood lactate dehydrogenase increased, cardiac failure, electrocardiogram repolarisation abnormality, hypoxia, pco2 decreased, platelet count decreased, sinus tachycardia on Oct 01, 2008 from ITALY Additional patient health information: Male , 75 years of age, weighting 185.2 lb, was diagnosed with and. Arsenic Trioxide dosage: 25.2 Mg Cycle 1 Intravenous Drip.
Associated medications used:
  • Clorfenamina Maleato
  • Irbesartan
  • Metformin Hydrochloride
  • Lenogastrim
  • Ascorbic Acid
  • Potassium Chloride
Patient was hospitalized.

Bronchopneumonia, Obstructive Airways Disorder, Respiratory Depression
Adverse event was reported on Oct 01, 2008 by a Male taking Arsenic Trioxide (Dosage: 15 Mg Two Times Per Week (3 Cycles) Intravenous Drip) was diagnosed with and. Location: ITALY , 67 years of age, weighting 136.7 lb, Patient felt the following Arsenic side effects: bronchopneumonia, obstructive airways disorder, respiratory depression. Patient was hospitalized.

Asthenia, Dysarthria, Fatigue, Gait Disturbance, Metastases To Central Nervous System, Nausea, Nuclear Magnetic Resonance Imaging Brain Abnormal, Psychomotor Retardation, Vomiting
on Oct 16, 2008 Female from UNITED STATES , 57 years of age, was treated with Arsenic Trioxide. After Arsenic was administered, patient encountered several Arsenic side effects: asthenia, dysarthria, fatigue, gait disturbance, metastases to central nervous system, nausea, nuclear magnetic resonance imaging brain abnormal, psychomotor retardation, vomiting. Arsenic Trioxide dosage: N/A. Patient was hospitalized.

Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Cardiac Failure, Dyspnoea, Electrocardiogram Repolarisation Abnormality, Hypoxia, Sinus Tachycardia
on Oct 01, 2008 Male from ITALY , 74 years of age, weighting 185.2 lb, was diagnosed with and was treated with Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: alanine aminotransferase increased, blood lactate dehydrogenase increased, cardiac failure, dyspnoea, electrocardiogram repolarisation abnormality, hypoxia, sinus tachycardia. Arsenic Trioxide dosage: 25.2 Mg Cycle 1 Intravenous Drip.
Associated medications used:
  • Clorfenamina Maleato
  • Irbesartan
  • Metformin
  • Lenograstim
  • Ascorbic Acid
  • Potassium Chloride
Patient was hospitalized.

Bronchopneumonia, Haemoglobin Decreased, Neutrophil Percentage Decreased, Platelet Count Decreased, Respiratory Depression, White Blood Cell Count Decreased
Patient was taking Arsenic Trioxide. Patient felt the following Arsenic side effects: bronchopneumonia, haemoglobin decreased, neutrophil percentage decreased, platelet count decreased, respiratory depression, white blood cell count decreased on Sep 22, 2008 from ITALY Additional patient health information: Male , 67 years of age, weighting 136.7 lb, was diagnosed with and. Arsenic Trioxide dosage: 15 Mg Two Times Per Week (3 Cycles) Intravenous Drip. Patient was hospitalized.

Aeromona Infection, Blood Culture Positive, Chills, Nausea
Adverse event was reported on Sep 04, 2008 by a Male taking Arsenic Trioxide (Dosage: 0.1 Mg/kg Days 1-5; 8, 15, 22 Qd Intravenous) was diagnosed with and. Location: UNITED STATES , 69 years of age, weighting 235.0 lb, After Arsenic was administered, patient encountered several Arsenic side effects: aeromona infection, blood culture positive, chills, nausea.
Multiple concurrent drugs taken:
  • Decitabine (20 Mg/m2 Days 1-5 Qd)
  • Ascorbic Acid (100 Mg On Days 1-5, 8, 15, And 22 Qd)
  • Nexium
  • Paxil
  • Glyburide
  • Acyclovir
Patient was hospitalized.

Anaphylactic Reaction
on Sep 04, 2008 Male from UNITED STATES , 69 years of age, weighting 235.0 lb, was diagnosed with and was treated with Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: anaphylactic reaction. Arsenic Trioxide dosage: 0.1 Mg/kg Qd Intravenous.
Associated medications used:
  • Decitabine (20 Mg/m2 Qd)
  • Ascorbic Acid (100 Mg Qd)
  • Nexium
  • Paxil
  • Glyburide
  • Acyclovir
Patient was hospitalized.

Bronchopneumonia, Respiratory Depression
on Sep 08, 2008 Male from ITALY , 67 years of age, weighting 136.7 lb, was diagnosed with and was treated with Arsenic Trioxide. Patient felt the following Arsenic side effects: bronchopneumonia, respiratory depression. Arsenic Trioxide dosage: 3rd Cycle Intravenous Drip.
Multiple prescriptions taken:
  • Zelitrex
  • Potassium Chloride
Patient was hospitalized.

Atrial Fibrillation, Cardiac Failure Congestive, Malaise
Patient was taking Arsenic Trioxide. After Arsenic was administered, patient encountered several Arsenic side effects: atrial fibrillation, cardiac failure congestive, malaise on Apr 29, 2008 from ITALY Additional patient health information: Female , 72 years of age, weighting 143.3 lb, was diagnosed with and. Arsenic Trioxide dosage: Unk Intravenous Drip.
Multiple concurrent drugs taken:
  • Norvasc
  • Pantorc
Patient was hospitalized.

Acute Abdomen, Chest Pain, Deep Vein Thrombosis, Disseminated Intravascular Coagulation, Pericardial Haemorrhage, Pseudomonal Sepsis, Renal Ischaemia
Adverse event was reported on Dec 06, 2007 by a Male taking Arsenic Trioxide (Dosage: Unk Intravenous Drip) was diagnosed with and. Location: ITALY , 65 years of age, Directly after, patient experienced the unwanted or unexpected Arsenic side effects: acute abdomen, chest pain, deep vein thrombosis, disseminated intravascular coagulation, pericardial haemorrhage, pseudomonal sepsis, renal ischaemia.
Associated medications used:
  • Furosemide
  • Pantoprazole
  • Metronidazole
  • Pipericillin
  • Tazobactam
  • Seleparina


Alanine Aminotransferase Increased, Anaemia, Blood Lactate Dehydrogenase Increased, Cardiac Failure, Dyspnoea, Pco2 Decreased, Platelet Count Decreased, Po2 Decreased
on Jan 23, 2008 Male from ITALY , 74 years of age, weighting 185.2 lb, was diagnosed with and was treated with Arsenic Trioxide. Patient felt the following Arsenic side effects: alanine aminotransferase increased, anaemia, blood lactate dehydrogenase increased, cardiac failure, dyspnoea, pco2 decreased, platelet count decreased, po2 decreased. Arsenic Trioxide dosage: 25.2 Mg Cycle 1 Intravenous Drip.
Multiple prescriptions taken:
  • Clorfenamina Maleato
  • Irbesartan
  • Metformin Hcl
  • Lenogastrim
Patient was hospitalized.

Abdominal Pain Upper, Acute Abdomen, Hepatic Neoplasm, Liver Disorder, Rectal Haemorrhage
on Nov 27, 2007 Male from ITALY , 65 years of age, was diagnosed with and was treated with Arsenic Trioxide. After Arsenic was administered, patient encountered several Arsenic side effects: abdominal pain upper, acute abdomen, hepatic neoplasm, liver disorder, rectal haemorrhage. Arsenic Trioxide dosage: Intravenous Drip.
Multiple concurrent drugs taken:
  • Furosemide
  • Pantoprazole Sodium
  • Magnesium Sulfate
  • Potassium Chloride
Patient was hospitalized.

Gastrointestinal Haemorrhage, Haemoptysis, Myelodysplastic Syndrome, Pleural Effusion, Pneumonia, Renal Failure
Patient was taking Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: gastrointestinal haemorrhage, haemoptysis, myelodysplastic syndrome, pleural effusion, pneumonia, renal failure on Jul 29, 2008 from UNITED STATES Additional patient health information: Male , 83 years of age, was diagnosed with and. Arsenic Trioxide dosage: 17 Mg Days 1-5 And 8-12 Qd Intravenous.
Associated medications used:
  • Cytarabine
Patient was hospitalized.

Aortic Stenosis, Aortic Valve Incompetence, Atrial Fibrillation, Cardiac Failure Congestive, Cardiomegaly, Hydropneumothorax, Left Ventricular Hypertrophy, Mitral Valve Incompetence, Neutropenic Sepsis
Adverse event was reported on Jul 18, 2008 by a Male taking Arsenic Trioxide (Dosage: Intravenous Drip) was diagnosed with and. Location: UNITED KINGDOM , 81 years of age, Patient felt the following Arsenic side effects: aortic stenosis, aortic valve incompetence, atrial fibrillation, cardiac failure congestive, cardiomegaly, hydropneumothorax, left ventricular hypertrophy, mitral valve incompetence, neutropenic sepsis. Patient was hospitalized.

Chest X-ray Abnormal, Gastrointestinal Haemorrhage, Haemoptysis, Lung Consolidation, Lung Disorder, Myelodysplastic Syndrome, Pneumonia, Renal Failure
on Jun 23, 2008 Male from UNITED STATES , 83 years of age, was diagnosed with and was treated with Arsenic Trioxide. After Arsenic was administered, patient encountered several Arsenic side effects: chest x-ray abnormal, gastrointestinal haemorrhage, haemoptysis, lung consolidation, lung disorder, myelodysplastic syndrome, pneumonia, renal failure. Arsenic Trioxide dosage: 17 Mg Days 1-5 And 8-12 Qd Intravenous.
Multiple concurrent drugs taken:
  • Cytarabine
Patient was hospitalized.

Asthenia, Atrioventricular Block First Degree, Blood Alkaline Phosphatase Increased, Enterococcal Bacteraemia, Feeling Abnormal, Pancytopenia, Supraventricular Extrasystoles
on Jun 26, 2008 Male from UNITED STATES , 75 years of age, weighting 206.1 lb, was diagnosed with and was treated with Arsenic Trioxide. Directly after, patient experienced the unwanted or unexpected Arsenic side effects: asthenia, atrioventricular block first degree, blood alkaline phosphatase increased, enterococcal bacteraemia, feeling abnormal, pancytopenia, supraventricular extrasystoles. Arsenic Trioxide dosage: 23 Mgqd For 5 Days Each Week Times 2 Weeks Intravenous.
Associated medications used:
  • Cytarabine
  • Norvasc
  • Acyclovir
  • Voriconazole
  • Levaquin
  • K-dur
Patient was hospitalized.

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative ARSENIC Names:ACNE ADDASECT ANIMAL ANTIGENS ANX ANX HP ANXIETY ANXIETY HP ANXIOLIX ASTH ASTHMA ASTHMA HP ASTHMA RX ASTHMA THERAPY BLOOD AND KIDNEY DE CATARACTS CHEMOCLENZ CHILDRENS COUGH AND CHILDRENS EARACHE R CHRON SINO COLD SORES COMPULSIN CONNECTIVE TISSUE CONSTIPATION COUGH COUGH HP DEPRESSION COMPLEX DIARRHEA ECZEMA ECZEMA HP EDOMETRIOSIS FEMALE FIBROIDS FLU-LIKE SYMPTOMS GALLBLADDER LIVER GALLBLADDER LIVER M GUNA-PMS HANG OVER RELIEF HEADACHE COUGH HEART SMALL INTESTI HERPES SORES HOMEOPATHIC ACNE FO HOMEOPATHIC SHINGLE INSOMNIA INSOMNIA HP INSOMNIA PLUS LIVER DETOX LYM D MET-TOX MOLD ANTIGENS MOLD MIX ANTIGENS NAUSEA VOMITING HP NOBACCO REMEDY WATE OSTEOPOROSIS HP PROGENA PSORIASIS RAD HP RESTULEX ROSACEA SCIATIC AIDE SINUCHRON SINUCHRON HP SINUS RESCUE SINUSITIS SKIN IRRITATION SLEEP RELIEF SMOKE-X STOMACH DISTRESS STOMACH FLU FIGHTER STOMACH SPLEEN MERI TOBACCO WITHDRAWAL TOTAL FLU-CLD 1 TRISENOX V V HP VIRAL HP VIRAL PLUS VIREX VITAL HP VITILIGO WEIGHT MANAGEMENT H WHEEZING HP

    Active Ingredient: ACONITUM ACTIVATED ALLYLTHIO ALTERNARI ANAMIRTA ANAS PLAT APIS MELL ARABICA C ARSENIC ARSENIC T

    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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