Arsenic trioxide Side Effects

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.

For the Consumer

Applies to arsenic trioxide: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking arsenic trioxide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Arsenic trioxide can cause a serious and sometimes fatal complication by changing the way your immune system works. Call your doctor at once if you have any signs of this condition, including:

• fever, weight gain, feeling weak or tired;

• swelling in your ankles or feet;

• cough, pain when you breathe, rapid heart rate, feeling short of breath; or

• feeling like you might pass out.

Also call your doctor right away if you have:

• pale skin, easy bruising or bleeding;

• cough, sore throat;

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Common side effects may include:

• stomach pain, nausea, vomiting;

• constipation, diarrhea;

• headache, dizziness, anxiety, numbness or tingly feeling;

• joint or muscle pain, tired feeling, trouble sleeping; or

• mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to arsenic trioxide: compounding powder, intravenous solution

Cardiovascular

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 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

Other

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 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

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

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

Hypersensitivity side effects have been reported in up to 5% of treated patients.

Gastrointestinal

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

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

Hepatic side effects including increased ALT (up to 20%) and increased AST (up to 13%) have been reported.

Nervous system

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

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

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

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

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.

Other

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

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

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

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

Genitourinary side effects including vaginal hemorrhage (up to 13%) and intermenstrual bleeding (up to 8%) have been reported.

Other

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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