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 liquid filled
Along with its needed effects, tretinoin (the active ingredient contained in Vesanoid) 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 immediately if any of the following side effects occur while taking tretinoin:More common
- Black, tarry stools
- bloody stools
- bone pain
- difficulty in moving
- discomfort or pain in chest
- enlarged heart
- feeling of pressure
- joint pain
- paleness of skin
- shortness of breath, troubled breathing, tightness in chest, or wheezing
- sweating increased
- swollen joints
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- warmness at site
- weight gain (occurring together with any of the other symptoms listed before)
- Blue lips and fingernails
- convulsions (seizures)
- difficulty in speaking, slow speech, or inability to speak
- feeling of heaviness in chest
- headache (severe)
- inability to move arms, legs, or muscles of the face
- nausea and vomiting (occurring together with a headache)
- no blood pressure or pulse
- pain in back or left arm
- painful, red lumps under the skin, mostly on the legs
- prominent superficial veins over affected area
- stopping of heart
- vision problems (occurring together with a headache)
Check with your doctor as soon as possible if any of the following side effects occur while taking tretinoin:More common
- Any change in vision (not occurring with a headache)
- coughing, sneezing, sore throat, and stuffy or runny nose
- cracked lips
- crusting, redness, pain, or sores in mouth or nose
- decreased urination
- earache or feeling of fullness in the ear
- increase or decrease in blood pressure
- irregular heartbeat
- mental depression
- pain in stomach, side, abdomen or back
- pain and swelling in leg or foot
- skin rash
- swelling of abdomen (stomach area)
- swelling of face, fingers, hands, feet, or lower legs
- Bone swelling
- cramping or pain in stomach (severe)
- difficult or painful urination
- drowsiness (very severe and continuing)
- hallucinations (seeing, hearing, or feeling things that are not there)
- hearing loss
- heartburn, indigestion, or nausea (severe and continuing)
- mood, mental, or personality changes
- pain in lower back or side
- swollen area that feels sore and tender
- yellow eyes or skin
Some side effects of tretinoin 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
- blurred vision
- burning, crawling, or tingling feeling in the skin
- darkened urine
- dryness of skin, mouth, or nose
- fast heartbeat
- general feeling of discomfort or illness
- hair loss
- headache (mild and not occurring together with other side effects)
- itching of skin
- loss of appetite
- mood or mental changes
- muscle pain
- nausea and vomiting (not occurring together with a headache)
- trouble sleeping
- weight loss
- Anxiety and restlessness (occurring together)
- clumsiness or unsteadiness when walking
- difficulty sleeping
- frequent urination
- low body temperature
- redness, soreness or itching skin
- sores, welting or blisters
- sores on genitals
- swelling of feet or lower legs
- trembling, sometimes with a flapping movement
- weak or feeble pulse
- weakness in legs
For Healthcare Professionals
Applies to tretinoin: compounding powder, oral capsule
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 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.
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.
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 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 side effects including bone pain (77%) and bone inflammation (3%) have been reported. Isolated cases of myositis have also been reported.
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 side effects including visual disturbances (17%), ocular disorders (17%), changed visual acuity (6%), and visual field defects (3%) have been reported.
Local side effects including injection site reactions (17%) have been reported.
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.
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 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 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 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 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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