Arsenic Trioxide Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 7, 2024.

Applies to arsenic trioxide: intravenous solution.

Precautions

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

You should not receive this medicine if you are pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment with this medicine and for 3 months after the last dose. If you think you or your sexual partner have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Tell your doctor right away if you have chest pain or discomfort, chills, cough, difficulty with breathing, eye pain, fever, general feeling of illness, headache, sore throat, unusual tiredness or weakness, or weight gain while using this medicine. These may be symptoms of a serious condition called retinoic-acid-APL (RA-APL) or APL differentiation syndrome.

This medicine can cause serious heart rhythm problems, including arrhythmias. Your doctor will monitor you during treatment to assess for heart rhythm problems. Talk to your doctor if you have concerns about this.

This medicine may cause a brain disease called encephalopathy. It may also increase your risk for Wernicke’s encephalopathy, especially if you have vitamin B1 (thiamine) deficiency. This is more likely in patients who have been drinking alcohol for a long time, who also use a diuretic (eg, furosemide), or who have malabsorption and nutritional deficiency. Check with your doctor right away if you have blurred vision, loss of consciousness, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, a stiff neck, unusual tiredness or weakness, or vomiting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine may increase your risk of getting other cancers. Talk to your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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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