Arsenic Trioxide Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 11, 2025.

Applies to arsenic trioxide: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Differentiation Syndrome, Cardiac Conduction Abnormalities, and Encephalopathy including Wernicke'sPatients with acute promyelocytic leukemia (APL) treated with arsenic trioxide have experienced symptoms of differentiation syndrome, which may be life-threatening or fatal.

If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution.

Temporarily withhold arsenic trioxide.Arsenic trioxide can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal.

Before administering arsenic trioxide, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval.

Do not administer arsenic trioxide to patients with ventricular arrhythmia or prolonged QTc interval.

Withhold arsenic trioxide until resolution and resume at reduced dose for QTc prolongation.Serious encephalopathy, including Wernicke’s, has occurred with arsenic trioxide.

If Wernicke’s encephalopathy is suspected, immediately interrupt arsenic trioxide and initiate parenteral thiamine.

Monitor until symptoms resolve or improve and thiamine levels normalize.

Serious side effects of arsenic trioxide

Along with its needed effects, arsenic trioxide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking arsenic trioxide:

More common side effects

• chills
• cough
• decreased urine output
• dry mouth
• eye pain
• general feeling of illness
• headache
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in hands, feet, or lips
• seizures
• sore throat
• trouble breathing
• unusual tiredness or weakness
• vomiting

Less common side effects

• black, tarry stools
• bluish lips or skin
• blurred vision
• chest pain
• dizziness or lightheadedness
• fever
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased urine output
• irregular or pounding heartbeat or pulse
• painful or difficult urination
• sores, ulcers, or white spots on the lips or in the mouth
• stomach ache or cramps
• sweating
• swollen glands
• unexplained weight loss
• unusual bleeding or bruising
• unusual weight gain

Incidence not known

• agitation
• anxiety
• back pain
• behavior changes similar to drunkenness
• bleeding
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bluish fingernails, palms, or nailbeds
• bruising
• change in size, shape, or color of existing mole
• cloudy urine
• cold sweats
• cool, pale skin
• confusion
• constipation
• coughing that sometimes produces a pink frothy sputum
• coughing or spitting up blood
• dark urine
• diarrhea
• difficult, fast, noisy breathing
• dilated neck veins
• drowsiness
• extreme tiredness or weakness
• fainting
• fast heartbeat
• high fever
• indigestion
• irregular heartbeat, recurrent
• irritability
• joint pain
• large hives, itching, or skin rash
• loss of consciousness
• mole that leaks fluid or bleeds new mole
• painful blisters on the trunk of the body
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• persistent bleeding or oozing from puncture sites, mouth, or nose
• rapid, shallow breathing
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• severe nausea
• shakiness
• stiff neck
• sudden weight gain
• tightness in the chest
• swelling of the eyelids, lips, face, fingers, or lower legs
• unsteadiness or awkwardness
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking arsenic trioxide:

Symptoms of overdose

• confusion
• muscle weakness, severe

Other side effects of arsenic trioxide

Some side effects of arsenic trioxide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

• belching
• bone pain
• feeling of warmth
• heartburn
• heavy non-menstrual vaginal bleeding
• injection site pain, redness, or swelling
• limb pain
• mental depression
• neck pain
• nosebleeds
• redness of the face, neck, arms, and occasionally, upper chest
• trouble sleeping or getting to sleep

Incidence not known

• deafness
• difficulty moving
• earache
• eye dryness, redness, or pain
• loss of bowel or bladder control
• night sweats
• ringing in the ears
• small red or purple spots on the skin
• swelling of the abdominal or stomach area

For healthcare professionals

Applies to arsenic trioxide: compounding powder, intravenous solution.

Gastrointestinal adverse events

• Very common (10% or more): Nausea (75%), upper and lower abdominal pain (58%), vomiting (58%), diarrhea (53%), constipation (28%), loose stools (10%), dyspepsia (10%)
• Common (1% to 10%): Oral blistering, fecal incontinence, gastrointestinal hemorrhage, dry mouth, abdominal tenderness, hemorrhagic diarrhea, abdominal distension, oral candidiasis
• Frequency not reported: Dysphagia, mucosal inflammation/stomatitis, oropharyngeal pain, cecitis^[Ref]

Respiratory

• Very common (10% or more): Cough (65%), dyspnea (53%), sore throat (35%), APL differentiation syndrome (26.9%), epistaxis (25%), hypoxia (23%), pleural effusion (20%), sinusitis (20%), post nasal drip (13%), upper respiratory tract infection (13%), wheezing (13%), decreased breath sounds (10%), crepitations (10%), rales (10%)
• Common (1% to 10%): Hemoptysis, tachypnea, rhonchi, nasopharyngitis, pleuritic pain, pulmonary alveolar hemorrhage
• Frequency not reported: Acute respiratory distress syndrome, lung infiltration, pneumonitis, pulmonary edema, respiratory distress, capillary leak syndrome, pneumonia^[Ref]

Other

• Very common (10% or more): Fatigue (63%), pyrexia (63%), non-specific edema (40%), rigors (38%), chest pain (25%), non-specific pain (15%), herpes simplex (13%), vaginal hemorrhage (13%), weakness (10%)
• Common (1% to 10%): Non-specific bacterial infection, herpes zoster, intermenstrual bleeding, sepsis, earache, tinnitus, chills
• Frequency not reported: Death^[Ref]

Nervous system

• Very common (10% or more): Headache (60%), neuropathy (44%), paresthesia (33%), dizziness (23%), tremor (13%)
• Common (1% to 10%): Convulsion, somnolence, coma, peripheral neuropathy, seizures
• Uncommon (0.1% to 1%): Cerebrovascular accident
• Frequency not reported: Neuralgia, cerebral hemorrhage^[Ref]

Cardiovascular

• Very common (10% or more): Tachycardia (55%), QT prolongation (40%), hypotension (25%), flushing (10%), hypertension (10%), pallor (10%), palpitations (10%), premature ventricular contractions (at least 10%)
• Common (1% to 10%): Torsade de pointes, abnormal ECG, ventricular extrasystoles and ventricular tachycardia (both in association with QT prolongation), pericardial effusion, vasculitis
• Frequency not reported: Complete heart block, cardiac failure^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (50%), hypomagnesemia (45%), hyperglycemia (45%), anorexia (23%), hyperkalemia (18%), decreased appetite (15%), weight gain (13%), hypocalcemia (10%)
• Common (1% to 10%): Weight loss, hypoglycemia, acidosis, hypernatremia, ketoacidosis, hypermagnesemia, increased blood creatinine
• Frequency not reported: Hyponatremia, hypoalbuminemia, hypophosphatemia, increased lipase, dehydration, fluid retention^[Ref]

Hematologic

• Very common (10% or more): Leukocytosis (50%), anemia (20%), thrombocytopenia (18%), febrile neutropenia (13%), neutropenia (10%)
• Common (1% to 10%): Disseminated intravascular coagulation, lymphadenopathy, hemorrhage, thrombosis, pancytopenia
• Uncommon (0.1% to 1%): Leucopenia vasculitis
• Frequency not reported: Hyperleukocytosis, lymphopenia^[Ref]

Dermatologic

• Very common (10% or more): Tachycardia (55%), QT prolongation (40%), hypotension (25%), flushing (10%), hypertension (10%), pallor (10%), palpitations (10%), premature ventricular contractions (at least 10%)
• Common (1% to 10%): Torsade de pointes, abnormal ECG, ventricular extrasystoles and ventricular tachycardia (both in association with QT prolongation), pericardial effusion, vasculitis
• Frequency not reported: Complete heart block, cardiac failure^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (43%), anxiety (30%), depression (20%)
• Common (1% to 10%): Agitation, confusion, mood alteration^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (33%), myalgia (25%), bone pain (23%), back pain (18%), limb pain (13%), neck pain (13%)
• Common (1% to 10%): Musculoskeletal pain^[Ref]

Hepatic

• Very common (10% or more): Increased ALT (20%), increased AST (13%), hepatotoxicity (at least 10%)
• Common (1% to 10%): Increased gamma-glutamyltransferase, liver dysfunction, hyperbilirubinemia^[Ref]

Local

• Very common (10% or more): Injection site pain (20%), injection site erythema (13%), injection site edema (10%)^[Ref]

Ocular

• Very common (10% or more): Eye irritation (10%), blurred vision (10%)
• Common (1% to 10%): Dry eye, painful red eye^[Ref]

Hypersensitivity

• Common (1% to 10%): Drug hypersensitivity^[Ref]

Renal

• Common (1% to 10%): Renal failure, renal impairment, oliguria, incontinence
• Frequency not reported: Enuresis^[Ref]

Further information

Arsenic trioxide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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