Commonly reported side effects of tretinoin include: pleural effusion, dyspnea, edema, fever, hypotension, leukocytosis, weight gain, headache, hypercholesterolemia, hypertriglyceridemia, increased liver enzymes, nausea, visual disturbance, and vomiting. Other side effects include: pulmonary infiltrates. See below for a comprehensive list of adverse effects.
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.
Along with its needed effects, tretinoin 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:
Check with your doctor as soon as possible if any of the following side effects occur while taking tretinoin:
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:
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.
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
Very common (10% or more): Hemorrhage (60%), disseminated intravascular coagulation (26%)
Frequency not reported: Thrombocytosis, leukocytosis, basophilia
Very common (10% or more): Transaminases increased
Common (1% to 10%): Hepatosplenomegaly, hepatitis, unspecified liver disorder
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)
Very common (10% or more): Bone pain (77%), myalgia (14%)
Common (1% to 10%): Bone inflammation, flank pain
Frequency not reported: Myositis
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
Very common (10% or more): Visual disturbances/ocular disorders (17%), conjunctival disorders
Common (1% to 10%): Changed visual acuity, visual field defects
Very common (10% or more): Injection site reactions (17%)
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
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
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
Common (1% to 10%): Dysuria, micturition frequency, enlarged prostate
Frequency not reported: Genital ulceration
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
Very common (10% or more): Anxiety (17%), insomnia (14%), depression (14%), confusion (11%)
Common (1% to 10%): Agitation, hallucination, dementia, forgetfulness, somnolence
Very common (10% or more): Renal insufficiency (11%)
Frequency not reported: Renal infarct
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Tretinoin Microsphere