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Arsenic trioxide Side Effects

In Summary

Commonly reported side effects of arsenic trioxide include: pleural effusion, dyspnea, fever, leukocytosis, palpitations, prolonged qt interval on ecg, tachycardia, and weight gain. Other side effects include: cardiac arrhythmia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to arsenic trioxide: intravenous solution

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

Less Common

  • 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

  • Anxiety
  • behavior changes similar to drunkenness
  • bleeding
  • blood in the urine or stools
  • bluish fingernails, palms, or nailbeds
  • bruising
  • cloudy urine
  • cold sweats
  • cool, pale skin
  • drowsiness
  • large hives or rash
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • severe nausea
  • shakiness
  • sore mouth or tongue
  • swelling of the eyelids, lips, or face
  • vomiting of blood or material that looks like coffee grounds

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

Symptoms of Overdose

  • Confusion
  • muscle weakness, severe

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:

More Common

Less Common

Incidence Not Known

  • Agitation
  • blisters inside the mouth
  • coughing or spitting up blood
  • earache
  • eye dryness, redness, or pain
  • loss of bowel or bladder control
  • night sweats
  • rapid, shallow breathing
  • ringing in the ears
  • small red or purple spots on the skin
  • swelling of the abdominal or stomach area
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

For Healthcare Professionals

Applies to arsenic trioxide: compounding powder, intravenous solution

Gastrointestinal

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Trisenox (arsenic trioxide)" Cephalon Inc, West Chester, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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