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Vesanoid Side Effects

Generic name: tretinoin

Medically reviewed by Last updated on Aug 19, 2020.

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.

For the Consumer

Applies to tretinoin: oral capsule liquid filled


Oral route (Capsule, Liquid Filled)

Patients with acute promyelocytic leukemia (APL) can have severe adverse reactions to tretinoin including retinoic acid-APL (RA-APL) 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. High-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. Patients can also develop rapidly evolving leukocytosis during therapy which can lead to an increased risk of life-threatening complications. There is a high risk that a severely deformed infant will result if tretinoin is administered during pregnancy. Pregnancy testing is necessary prior to initiation of treatment in women of childbearing potential and the patient must be instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of tretinoin treatment.

Side effects requiring immediate medical attention

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
  • bleeding
  • blistering
  • bloody stools
  • bone pain
  • burning
  • coldness
  • difficulty in moving
  • discomfort or pain in chest
  • enlarged heart
  • feeling of pressure
  • fever
  • hives
  • infection
  • inflammation
  • joint pain
  • lumps
  • numbness
  • paleness of skin
  • rash
  • redness
  • scaring
  • seizures
  • shortness of breath, troubled breathing, tightness in chest, or wheezing
  • soreness
  • stinging
  • sweating increased
  • swelling
  • swollen joints
  • tenderness
  • tingling
  • ulceration
  • 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)

Less common

  • Blue lips and fingernails
  • convulsions (seizures)
  • difficulty in speaking, slow speech, or inability to speak
  • faintness
  • 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
  • unconsciousness
  • vision problems (occurring together with a headache)
  • warmth

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

Less common

  • 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

Side effects not requiring immediate medical attention

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
  • agitation
  • anxiety
  • belching
  • blurred vision
  • bloating
  • burning, crawling, or tingling feeling in the skin
  • chills
  • confusion
  • constipation
  • darkened urine
  • diarrhea
  • dizziness
  • dryness of skin, mouth, or nose
  • fast heartbeat
  • flushing
  • general feeling of discomfort or illness
  • hair loss
  • headache (mild and not occurring together with other side effects)
  • indigestion
  • irritability
  • itching of skin
  • loss of appetite
  • mood or mental changes
  • muscle pain
  • nausea and vomiting (not occurring together with a headache)
  • shivering
  • trouble sleeping
  • weakness
  • weight loss

Less common

  • Anxiety and restlessness (occurring together)
  • clumsiness or unsteadiness when walking
  • difficulty sleeping
  • disorientation
  • forgetfulness
  • frequent urination
  • lethargy
  • lightheadedness
  • low body temperature
  • redness, soreness or itching skin
  • sores, welting or blisters
  • sores on genitals
  • swelling of feet or lower legs
  • thirst
  • trembling, sometimes with a flapping movement
  • weak or feeble pulse
  • weakness in legs

For Healthcare Professionals

Applies to tretinoin: compounding powder, oral capsule


-The most frequent undesirable effects of this drug are consistent with signs of hypervitaminosis A syndrome (as for other retinoids).

-APL patients treated with this drug may experience 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 is sometimes accompanied by impaired myocardial contractility and episodic hypotension with or without concomitant leukocytosis.[Ref]


Very common (10% or more): Fever (83%), malaise (66%), peripheral edema (52%), earache/feeling of fullness in the ears (23%), edema (29%), shivering (63%), hearing impaired, chills, weakness, fatigue, chest pain

Common (1% to 10%): Face edema, hypothermia, hearing loss and other unspecified auricular disorders

Uncommon (0.1% to 1%): Irreversible hearing loss

Frequency not reported: Histamine level increased, teratogenicity[Ref]


Very common (10% or more): Hemorrhage (60%), disseminated intravascular coagulation (26%)

Frequency not reported: Thrombocytosis, leukocytosis, basophilia[Ref]


Very common (10% or more): Transaminases increased

Common (1% to 10%): Hepatosplenomegaly, hepatitis, unspecified liver disorder[Ref]


Very common (10% or more): Skin/mucous membrane dryness (77%), rash (54%), pruritus (20%), increased sweating (20%), alopecia (14%), skin changes (14%), erythema, hyperhidrosis

Frequency not reported: Erythema nodosum, acute febrile neutrophilic dermatosis (Sweet's syndrome)[Ref]


Very common (10% or more): Bone pain (77%), myalgia (14%)

Common (1% to 10%): Bone inflammation, flank pain

Frequency not reported: Myositis[Ref]


Very common (10% or more): Nausea/vomiting (57%), GI hemorrhage (34%), abdominal pain (31%), mucositis (26%), diarrhea (23%), constipation (17%), dyspepsia (14%), abdominal distension (11%)

Common (1% to 10%): Ascites, ulcer

Frequency not reported: Organomegaly, pancreatitis[Ref]


Very common (10% or more): Visual disturbances/ocular disorders (17%), conjunctival disorders

Common (1% to 10%): Changed visual acuity, visual field defects[Ref]


Very common (10% or more): Injection site reactions (17%)[Ref]


Very common (10% or more): Upper respiratory tract disorders (63%), dyspnea (60%), respiratory insufficiency (26%), pleural effusion (20%), pneumonia (14%), rales (14%), expiratory wheezing (14%), respiratory failure, nasal dryness, asthma

Common (1% to 10%): Lower respiratory tract disorders, pulmonary infiltration, pulmonary edema, larynx edema, unspecified pulmonary disease[Ref]


Very common (10% or more): Arrhythmia (23%), flushing (23%), hypotension (14%), hypertension (11%), phlebitis (11%)

Common (1% to 10%): Pallor, lymph disorders, cardiac failure, cardiac arrest, myocardial infarction, enlarged heart, heart murmur, ischemia, stroke, myocarditis, pericarditis, pulmonary hypertension, secondary cardiomyopathy

Frequency not reported: Arterial thrombosis, venous thrombosis involving various sites (e.g., cerebrovascular accident, renal infarct), vasculitis[Ref]

Nervous system

Very common (10% or more): Headache (86%), dizziness (20%), paresthesias (17%), intracranial pressure increased, pseudotumor cerebri

Common (1% to 10%): Cerebral hemorrhage, intracranial hypertension, 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, slow speech

Frequency not reported: Cerebrovascular accident[Ref]


Common (1% to 10%): Dysuria, micturition frequency, enlarged prostate

Frequency not reported: Genital ulceration[Ref]


Very common (10% or more): Anorexia (17%), weight loss (17%), decreased appetite, weight gain (23%), blood triglyceride increased, blood creatinine increased, blood cholesterol increased

Common (1% to 10%): Fluid imbalance, acidosis

Frequency not reported: Hypercalcemia[Ref]


Very common (10% or more): Anxiety (17%), insomnia (14%), depression (14%), confusion (11%)

Common (1% to 10%): Agitation, hallucination, dementia, forgetfulness, somnolence[Ref]


Very common (10% or more): Renal insufficiency (11%)

Frequency not reported: Renal infarct[Ref]


1. "Product Information. Tretinoin (tretinoin)." Par Pharmaceutical Inc, Chestnut Ridge, NY.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.