Vesanoid Side Effects

Generic name: tretinoin

Note: This document contains side effect information about tretinoin. Some of the dosage forms listed on this page may not apply to the brand name Vesanoid.

Some side effects of Vesanoid 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 tretinoin: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking tretinoin (the active ingredient contained in Vesanoid) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• fever, breathing problems, weight gain, swelling of your hands or feet;

• sudden and severe pain behind your eyes, with nausea, vomiting, and vision problems;

• black, bloody, or tarry stools; or

• vomit that looks like blood or coffee grounds.

Less serious side effects of tretinoin may include:

• feeling tired or weak;

• headache;

• fever;

• dry skin, mouth, or nose;

• bone pain;

• nausea and vomiting;

• rash or itching;

• white patches or sores inside your mouth or on your lips;

• increased sweating;

• vision problems; or

• hair loss or skin changes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to tretinoin: compounding powder, oral capsule

General

Headache, fever, weakness, and fatigue are seldom permanent and will not usually require any interruption in therapy.

In general, almost all patients experience some tretinoin related toxicity including headache (86%), fever (83%), weakness, and fatigue. General effects related to either tretinoin or to the disease condition acute promyelocytic leukemia (APL) have been reported to include malaise (66%), shivering (63%), hemorrhage (60%), infections (58%), peripheral edema (52%), pain (37%), chest discomfort (32%), edema (29%), weight increase (23%), weight decrease (17%), flank pain (9%), cellulitis (8%), facial edema (6%), fluid imbalance (6%), pallor (6%), lymph disorders (6%), acidosis (3%), hypothermia (3%), and ascites (3%).

Other

Other side effects include a retinoic-acid-APL (RA-APL) syndrome characterized by fever, dyspnea, weight gain, radiographic pulmonary infiltrates and pleural or pericardial effusions, which has been reported in approximately 25% of patients treated with tretinoin (the active ingredient contained in Vesanoid) Impaired myocardial contractility and episodic hypotension have been reported occasionally with this syndrome. Several fatalities have been reported due to multiorgan failure.

Pseudotumor cerebri has also been reported. Side effects including isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, and hypercalcemia have been reported rarely.

Due to progressive hypoxia which can occur with RA-APL syndrome, endotracheal intubation and mechanical ventilation have been required in some cases.

High dose steroids (dexamethasone 10 mg intravenously administered every twelve hours for three days or until the resolution of symptoms) given at the first signs suggestive of the RA-APL syndrome (unexplained fever, dyspnea, and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities) have been reported to appear to reduce morbidity and mortality. High dose steroids should be initiated immediately regardless of the leukocyte count. However, most patients do not require discontinuation of tretinoin therapy during treatment of the RA-APL syndrome.

Approximately 40% of patients develop a rapidly evolving leukocytosis. Rapidly evolving leukocytosis has been associated with a higher risk of life-threatening complications.

Early signs of pseudotumor cerebri have been reported to include papilledema, headache, nausea, vomiting, and visual disturbances.

Hematologic

Rapidly evolving leukocytosis has been associated with a higher risk of life-threatening complications.

Although hypercholesterolemia and/or hypertriglyceridemia have been reversible upon the completion of treatment, venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for these complications.

Hematologic side effects including a reversible hypercholesterolemia and/or hypertriglyceridemia (up to 60%), rapidly evolving leukocytosis (40%), and disseminated intravascular coagulation (26%) have been reported. Several cases of thrombocytosis have also been reported.

Hepatic

Liver function tests should be monitored closely during treatment. Temporary discontinuation of therapy may be appropriate if liver test results reach greater than five times the upper limit of normal values.

Hepatic side effects including elevated liver function tests (50% to 60%), hepatosplenomegaly (9%), hepatitis (3%), and unspecified liver disorder (3%) have been reported.

Dermatologic

Dermatologic side effects including skin/mucous membrane dryness (77%), rash (54%), pruritus (20%), increased sweating (20%), alopecia (14%), and skin changes (14%) have been reported.

Musculoskeletal

Musculoskeletal side effects including bone pain (77%) and bone inflammation (3%) have been reported. Isolated cases of myositis have also been reported.

Gastrointestinal

Gastrointestinal side effects including nausea/vomiting (57%), GI hemorrhage (34%), abdominal pain (31%), mucositis (26%), other gastrointestinal disorders (26%), diarrhea (23%), constipation (17%), dyspepsia (14%), anorexia (17%), abdominal distention (11%), and ulcer (3%) have been reported. Isolated cases of pancreatitis (including one case of fatal acute pancreatitis) have also been reported.

Ocular

Ocular side effects including visual disturbances (17%), ocular disorders (17%), changed visual acuity (6%), and visual field defects (3%) have been reported.

Local

Local side effects including injection site reactions (17%) have been reported.

Respiratory

The majority of respiratory side effects with the use of tretinoin (the active ingredient contained in Vesanoid) are symptoms of the retinoic-acid-APL (RA-APL) syndrome (25%). This syndrome is charactered by radiographic pulmonary infiltrates and pleural or pericardial effusions among other things. Respiratory system effects including 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%), and unspecified pulmonary disease (3%) have been reported.

Due to progressive hypoxia related to RA-APL, endotracheal intubation and mechanical ventilation have been required in some cases.

Other

Otic side effects (23%) have been reported. Hearing loss and other unspecified auricular disorders (6%) including irreversible hearing loss (less than 1%) have also been reported.

Cardiovascular

Cardiovascular side effects including arrhythmias (23%), flushing (23%), hypotension (14%), hypertension (11%), phlebitis (11%), cardiac failure (6%), cardiac arrest (3%), myocardial infarction (3%), enlarged heart (3%), heart murmur (3%), ischemia (3%), stroke (3%), myocarditis (3%), pericarditis (3%), pulmonary hypertension (3%), and secondary cardiomyopathy (3%) have been reported. Cases of thrombosis (both venous and arterial) involving various sites have been reported rarely. Several cases of vasculitis have also been reported.

Nervous system

Nervous system side effects including dizziness (20%), paresthesias (17%), anxiety (17%), insomnia (14%), depression (14%), confusion (11%), cerebral hemorrhage (9%), intracranial hypertension (9%), agitation (9%), hallucination (6%), abnormal gait (3%), agnosia (3%), aphasia (3%), asterixis (3%), cerebellar edema (3%), cerebellar disorders (3%), convulsions (3%), coma (3%), CNS depression (3%), dysarthria (3%), encephalopathy (3%), facial paralysis (3%), hemiplegia (3%), hyporeflexia (3%), hypotaxia (3%), no light reflux (3%), neurologic reaction (3%), spinal cord disorder (3%), tremor (3%), leg weakness (3%), unconsciousness (3%), dementia (3%), forgetfulness (3%), somnolence (3%), and slow speech (3%) have been reported.

Genitourinary

Genitourinary side effects including renal insufficiency (11%), dysuria (9%), acute renal failure (3%), micturition frequency (3%), renal tubular necrosis (3%), enlarged prostate (3%), and genital ulceration have been reported.

Oncologic

Oncologic side effects have been reported in animals. Animal studies have reported that tretinoin (the active ingredient contained in Vesanoid) increased the rate of diethylnitrosamine-induced liver adenomas and carcinomas.

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