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Arsenic trioxide Side 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
  • Chills
  • convulsions (seizures)
  • 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 or vomiting
  • numbness or tingling in hands, feet, or lips
  • sore throat
  • trouble breathing
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach cramps
  • 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
  • stomachache
  • sweating
  • swollen glands
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual weight gain
Rare
  • 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
  • headache
  • 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
  • white patches in the mouth or on the tongue

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

Symptoms of overdose
  • Confusion
  • convulsions (seizures)
  • 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
  • Diarrhea
Less common
  • Acid or sour stomach
  • back pain
  • belching
  • bloating or swelling of the face, hands, lower legs, or feet
  • bone pain
  • constipation
  • flushing
  • heartburn
  • heavy non-menstrual vaginal bleeding
  • indigestion
  • injection site pain, redness, or swelling
  • itching
  • itchy, red skin
  • joint or muscle pain
  • limb pain
  • loss of appetite
  • mental depression
  • neck pain
  • nosebleeds
  • pale skin
  • shivering chills
  • trouble sleeping or getting to sleep
  • weight gain
Rare
  • 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 skin
  • swelling of the abdominal or stomach area
  • swelling or puffiness of the face or eyelids
  • 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. "UK Summary of Product Characteristics." O 0

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

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

Some side effects of arsenic trioxide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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