Trisenox Side Effects
Generic Name: arsenic trioxide
Note: This document contains side effect information about arsenic trioxide. Some of the dosage forms listed on this page may not apply to the brand name Trisenox.
Some side effects of Trisenox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to arsenic trioxide: intravenous solution
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
- convulsions (seizures)
- decreased urine output
- dry mouth
- eye pain
- general feeling of illness
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in hands, feet, or lips
- shortness of breath or trouble breathing
- sore throat
- unusual tiredness or weakness
- Abdominal or stomach cramps
- black, tarry stools
- bluish lips or skin
- blurred vision
- chest pain
- dizziness or lightheadedness
- flushed, dry skin
- fruit-like breath odor
- high or low blood pressure
- increased hunger
- increased urine output
- irregular or pounding heartbeat or pulse
- painful or difficult urination
- sores, ulcers, or white spots on lips or in mouth
- swollen glands
- unexplained weight loss
- unusual bleeding or bruising
- unusual weight gain
- behavior changes similar to drunkenness
- blood in urine or stools
- bluish fingernails, palms, or nailbeds
- cloudy urine
- cold sweats
- cool pale skin
- large hives
- persistent bleeding or oozing from puncture sites, mouth, or nose
- severe nausea
- sore mouth or tongue
- swelling of eyelids, lips, or face
- vomiting of blood or material that looks like coffee grounds
- white patches in mouth and/or on tongue
Get emergency help immediately if any of the following symptoms of overdose occur while taking arsenic trioxide:Symptoms of Overdose
- 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
- Acid or sour stomach
- back pain
- bloating or swelling of face, hands, lower legs, or feet
- bone pain
- heavy nonmenstrual vaginal bleeding
- injection site pain, redness, or swelling
- itchy, red skin
- joint or muscle pain
- limb pain
- loss of appetite
- mental depression
- neck pain
- pale skin
- shivering chills
- trouble sleeping or getting to sleep
- weight gain
- blisters inside the mouth
- coughing or spitting up blood
- 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 abdominal or stomach area
- swelling or puffiness of face or eyelids
- swollen, painful, or tender lymph glands in neck, armpit, or groin
For Healthcare Professionals
Applies to arsenic trioxide: compounding powder, intravenous solution
Cardiovascular side effects can include QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. Tachycardia (up to 55%), ECG QT corrected interval prolonged > 500 msec (up to 38%), palpitations (up to 10%), and ECG abnormalities other than QT interval prolongation (up to 7%) have been reported. One patient (also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with arsenic trioxide (the active ingredient contained in Trisenox)
The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia
The management of the syndrome has not been fully studied, but high-dose steroids have been used at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously BID) should be immediately initiated, irrespective of the leukocyte count, and continued for at least 3 days or longer until signs and symptoms have abated. The majority of patients do not require termination of arsenic trioxide (the active ingredient contained in Trisenox) therapy during treatment of the APL differentiation syndrome.
Other side effects similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome have been reported. This syndrome is characterized by fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions (with or without leukocytosis). The syndrome can be fatal.
General side effects including fatigue (up to 63%), fever (up to 63%), edema (up to 40%), rigors (up to 38%), chest pain (up to 25% ), pain (up to 15%), weight gain (up to 13%), weakness (up to 10%), weight loss (up to 8%) and hemorrhage (up to 8%) have been reported.
Local side effects including injection site pain (up to 20%), injection site erythema (up to 13%), and injection site edema (up to 10%) have been reported.
Hypersensitivity side effects have been reported in up to 5% of treated patients.
Gastrointestinal side effects including nausea (up to 75%), vomiting (up to 58%), abdominal pain (up to 58%), diarrhea (up to 53%), sore throat (up to 40%), constipation (up to 28%), anorexia (up to 23%), decreased appetite (up to 15%), loose stools (up to 10%), dyspepsia (up to 10%), oral blistering (up to 8%), fecal incontinence (up to 8%), gastrointestinal hemorrhage (up to 8%), dry mouth (up to 8%), abdominal tenderness (up to 8%), hemorrhagic diarrhea (up to 8%), and abdominal distension (up to 8%) have been reported.
Metabolic side effects including hypokalemia (up to 50%), hypomagnesemia (up to 45%), hyperglycemia (up to 45%), hyperkalemia (up to 18%), hypocalcemia (up to 10%), hypoglycemia (up to 8%) and acidosis (up to 5%) have been reported.
Hepatic side effects including increased ALT (up to 20%) and increased AST (up to 13%) have been reported.
Nervous system side effects including headache (up to 60%), insomnia (up to 43%), paresthesia (up to 33%), dizziness (up to 23%), tremor (up to 13%), convulsion (up to 8%), somnolence (up to 8%), and coma (up to 5%) have been reported.
Respiratory side effects including cough (up to 65%), dyspnea (up to 53%), epistaxis (up to 25%), hypoxia (up to 23%), pleural effusion (up to 20%), post nasal drip (up to 13%), wheezing (up to 13%), decreased breath sounds (up to 10%), crepitations (up to 10%), rales (up to 10%), hemoptysis (up to 8%), tachypnea (up to 8%), and rhonchi (up to 8%) have been reported.
Dermatologic side effects including dermatitis (up to 43%), pruritus (up to 33%), ecchymosis (up to 20%), dry skin (up to 13%), erythema (up to 10%), increased sweating (up to 10%), facial edema (up to 8%), night sweats (up to 8%), petechiae (up to 8%), hyperpigmentation (up to 8%), skin lesions (up to 8%), urticaria (up to 8%), local exfoliation (up to 5%), and eyelid edema have been reported. A case of iatrogenic arsenic induced Mees' lines has also been reported.
Musculoskeletal side effects including arthralgia (up to 33%), myalgia (up to 25%), bone pain (up to 23%), back pain (up to 18%), neck pain (up to 13%), and pain in a limb (up to 13%) have been reported.
Hematologic side effects including leukocytosis (up to 50%), anemia (up to 14%), thrombocytopenia (up to 19%), febrile neutropenia (up to 13%), neutropenia (up to 10%), disseminated intravascular coagulation (up to 8%), and lymphadenopathy (up to 8%) have been reported.
Vascular side effects including hypotension (up to 25%), flushing (up to 10%), hypertension (up to 10%), and pallor (up to 10%) have been reported.
Psychiatric side effects including anxiety (up to 30%), depression (up to 20%), agitation (up to 5%), and confusion (up to 5%) have been reported.
Ocular side effects including eye irritation (up to 10%), blurred vision (up to 10%), dry eye (up to 8%), and painful red eye (up to 5%) have been reported.
Renal side effects including renal failure (up to 8%), renal impairment (up to 8%), oliguria (up to 5%), and incontinence (up to 5%) have been reported.
Genitourinary side effects including vaginal hemorrhage (up to 13%) and intermenstrual bleeding (up to 8%) have been reported.
Otic side effects including earache (up to 8%) and tinnitus (up to 5%) have been reported.
Infections reported in patients receiving arsenic trioxide include sinusitis (up to 20%), herpes simplex (up to 13%), upper respiratory tract infection (up to 13%), nonspecific bacterial infection (up to 8%), herpes zoster (up to 8%), nasopharyngitis (up to 5%), oral candidiasis (up to 5%), and sepsis (up to 5%).
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