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Tretinoin Side Effects

In Summary

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.

For the Consumer

Applies to tretinoin: oral capsule liquid filled

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:

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

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

General

-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]

Other

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]

Hematologic

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

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

Hepatic

Very common (10% or more): Transaminases increased

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

Dermatologic

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]

Musculoskeletal

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

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

Frequency not reported: Myositis[Ref]

Gastrointestinal

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]

Ocular

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

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

Local

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

Respiratory

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]

Cardiovascular

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]

Genitourinary

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

Frequency not reported: Genital ulceration[Ref]

Metabolic

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]

Psychiatric

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

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

Renal

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

Frequency not reported: Renal infarct[Ref]

References

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

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.

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