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Vesanoid

Last reviewed on RxList: 11/15/2016
Vesanoid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/05/2016

Vesanoid (tretinoin) is a cancer medication used to treat acute promyelocytic leukemia (a type of blood cancer). The brand name Vesanoid is discontinued, but generic versions may be available. Common side effects of Vesanoid (tretinoin) include headache, dizziness, fever, weakness, tiredness, dry mouth or nose, dry skin, other skin changes, thinning hair or hair loss, nausea, vomiting, itching, bone pain, white patches or sores inside your mouth or on your lips, increased sweating, earache, rash or itching, or vision problems.

The recommended dose of Vesanoid is 45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Vesanoid may interact with vitamin A supplements, cimetidine, cyclosporine, troleandomycin, rifampin, phenobarbital, fluoxetine, fluvoxamine, steroids, itraconazole, ketoconazole, antibiotics, amiodarone, mibefradil, diltiazem, verapamil, or HIV medicines. Tell your doctor all medications and supplements you use. Vesanoid is not recommended for use during pregnancy due to the risk of birth defects and harm to a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Use two forms of birth control together to prevent pregnancy. Talk to your doctor about birth control. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Vesanoid (tretinoin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Vesanoid Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking tretinoin develop a life-threatening condition called retinoic acid-APL (RA-APL) syndrome. This syndrome can progress and cause failure of many organs in your body, such as the lungs, liver, or kidneys. Tell your doctor right away if you have early symptoms of RA-APL syndrome: fever, shortness of breath, feeling light-headed, and/or weight gain. RA-APL is treatable, but you may need to stop taking tretinoin for a short time. Follow your doctor's instructions carefully.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • mouth and throat ulcers, red or swollen gums, burning mouth pain, trouble swallowing;
  • increased pressure inside the skull--severe headaches, ringing in your ears, nausea, vision problems, pain behind your eyes;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
  • liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • lung problems--pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down);
  • signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg;
  • signs of infection--fever, chills, flu symptoms, easy bruising or bleeding, new or worsening cough, stabbing chest pain, wheezing, rapid and shallow breathing; or
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • headache, weakness, tiredness;
  • fever, chills, infections, not feeling well;
  • bleeding;
  • swelling in your hands or feet;
  • abnormal liver function tests;
  • flushing (sudden warmth, redness, or tingly feeling);
  • dry mouth, nose, or throat;
  • stomach pain, nausea, vomiting, diarrhea;
  • bone pain;
  • rash; or
  • mouth sores.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vesanoid (Tretinoin)

Vesanoid Professional Information

SIDE EFFECTS

Virtually all patients experience some drug-related toxicity, especially headache, fever, weakness, and fatigue. These adverse effects are seldom permanent or irreversible nor do they usually require interruption of therapy. Some of the adverse events are common in patients with APL, including hemorrhage, infections, gastrointestinal hemorrhage, disseminated intravascular coagulation, pneumonia, septicemia, and cerebral hemorrhage. The following describes the adverse events, regardless of drug relationship, that were observed in patients treated with VESANOID (tretinoin) .

Typical Retinoid Toxicity

The most frequently reported adverse events were similar to those described in patients taking high doses of vitamin A and included headache (86%), fever (83%), skin/mucous membrane dryness (77%), bone pain (77%), nausea/vomiting (57%), rash (54%), mucositis (26%), pruritus (20%), increased sweating (20%), visual disturbances (17%), ocular disorders (17%), alopecia (14%), skin changes (14%), changed visual acuity (6%), bone inflammation (3%), visual field defects (3%).

RA-APL Syndrome

APL patients treated with VESANOID (tretinoin) have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension and has been observed with or without concomitant leukocytosis. Some patients have expired due to progressive hypoxemia and multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of VESANOID (tretinoin) . The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first signs of the syndrome appear to reduce morbidity and mortality. Treatment with dexamethasone, 10 mg intravenously administered every 12 hours for 3 days or until resolution of symptoms, should be initiated without delay at the first suspicion of symptoms (one or more of the following: fever, dyspnea, weight gain, abnormal chest auscultatory findings or radiographic abnormalities). Sixty percent or more of patients treated with VESANOID (tretinoin) may require high-dose steroids because of these symptoms. The majority of patients do not require termination of VESANOID (tretinoin) therapy during treatment of the syndrome.

Body as a Whole

General disorders related to VESANOID (tretinoin) administration and/or associated with APL included malaise (66%), shivering (63%), hemorrhage (60%), infections (58%), peripheral edema (52%), pain (37%), chest discomfort (32%), edema (29%), disseminated intravascular coagulation (26%), weight increase (23%), injection site reactions (17%), anorexia (17%), weight decrease (17%), myalgia (14%), flank pain (9%), cellulitis (8%), face edema (6%), fluid imbalance (6%), pallor (6%), lymph disorders (6%), acidosis (3%), hypothermia (3%), ascites (3%).

Respiratory System Disorders

Respiratory system disorders were commonly reported in APL patients administered VESANOID (tretinoin) . The majority of these events are symptoms of the RA-APL syndrome (see boxed WARNINGS). Respiratory system adverse events included upper respiratory tract disorders (63%), dyspnea (60%), respiratory insufficiency (26%), pleural effusion (20%), pneumonia (14%), rales (14%), expiratory wheezing (14%), lower respiratory tract disorders (9%), pulmonary infiltration (6%), bronchial asthma (3%), pulmonary edema (3%), larynx edema (3%), unspecified pulmonary disease (3%).

Ear Disorders

Ear disorders were consistently reported, with earache or feeling of fullness in the ears reported by 23% of the patients. Hearing loss and other unspecified auricular disorders were observed in 6% of patients, with infrequent (<1%) reports of irreversible hearing loss.

Gastrointestinal Disorders

GI disorders included GI hemorrhage (34%), abdominal pain (31%), other gastrointestinal disorders (26%), diarrhea (23%), constipation (17%), dyspepsia (14%), abdominal distention (11%), hepatosplenomegaly (9%), hepatitis (3%), ulcer (3%), unspecified liver disorder (3%).

Cardiovascular and Heart Rate and Rhythm Disorders

Arrhythmias (23%), flushing (23%), hypotension (14%), hypertension (11%), phlebitis (11%), cardiac failure (6%) and for 3% of patients: cardiac arrest, myocardial infarction, enlarged heart, heart murmur, ischemia, stroke, myocarditis, pericarditis, pulmonary hypertension, secondary cardiomyopathy.

Central and Peripheral Nervous System Disorders and Psychiatric

Dizziness (20%), paresthesias (17%), anxiety (17%), insomnia (14%), depression (14%), confusion (11%), cerebral hemorrhage (9%), intracranial hypertension (9%), agitation (9%), hallucination (6%) and for 3% of patients: abnormal gait, agnosia, aphasia, asterixis, cerebellar edema, cerebellar disorders, convulsions, coma, CNS depression, dysarthria, encephalopathy, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, no light reflex, neurologic reaction, spinal cord disorder, tremor, leg weakness, unconsciousness, dementia, forgetfulness, somnolence, slow speech.

Urinary System Disorders

Renal insufficiency (11%), dysuria (9%), acute renal failure (3%), micturition frequency (3%), renal tubular necrosis (3%), enlarged prostate (3%).

Miscellaneous Adverse Events

Isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, hypercalcemia, pancreatitis and myositis have been reported.

Additional Adverse Reactions Reported With VESANOID (tretinoin)

Cardiovascular

Cases of thrombosis (both venous and arterial) involving various sites (eg, cerebrovascular accident, myocardial infarction, renal infarct) have been reported rarely (see PRECAUTIONS: General).

Hematologic

Rare cases of thrombocytosis have been reported.

Skin

Genital ulceration

Miscellaneous Adverse Events

Rare cases of vasculitis, predominantly involving the skin, have been reported.

Read the entire FDA prescribing information for Vesanoid (Tretinoin)

Related Resources for Vesanoid

© Vesanoid Patient Information is supplied by Cerner Multum, Inc. and Vesanoid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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