Note: This document contains side effect information about arsenic trioxide. Some dosage forms listed on this page may not apply to the brand name Trisenox.
Summary
Common side effects of Trisenox include: pleural effusion, dyspnea, fever, leukocytosis, palpitations, prolonged qt interval on ecg, tachycardia, and weight gain. Other side effects include: cardiac arrhythmia. Continue reading for a comprehensive list of adverse effects.
Applies to arsenic trioxide: intravenous solution.
Warning
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 Trisenox
Along with its needed effects, arsenic trioxide (the active ingredient contained in Trisenox) 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
- 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
- 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 Trisenox
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
- 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
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]
