Possible Side Effects of Tretinoin (Table Version Date: June 24, 2013)

COMMON, SOME MAY BE SERIOUS

In 100 people receiving Tretinoin, more than 20 and up to 100 may have:
 Blood clot which may cause bleeding
 Abnormal heartbeat
 Diarrhea, nausea, vomiting
 Dry mouth, skin
 Internal bleeding which may cause black tarry stool, blood in vomit
 Chills, fever
 Pain
 Swelling of the body
 Tiredness
 Infection
 Weight gain
 Headache
 Damage to organs which may cause shortness of breath
 Itching, rash, flushing
 Bleeding
 Retinoic Acid Syndrome or APL syndrome consisting of shortness of breath, fever, weight gain, and fluid
in the lung or heart
 Numbness and tingling of the skin
 Peeling of skin

OCCASIONAL, SOME MAY BE SERIOUS

In 100 people receiving Tretinoin, from 4 to 20 may have:
 Fluid around heart
 Heart failure which may cause shortness of breath, swelling of ankles, and tiredness
 Cloudiness of the eye, visual disturbances
 Constipation
 Reaction during or following infusion of the drug which may cause low blood pressure
 Liver damage which may cause yellowing of eyes and skin; enlarged liver and spleen
 Weight loss, loss of appetite
 Dizziness
 Feeling of "pins and needles" in arms and legs
 Restlessness
 Sensing things that are not there
 Worry
 Hair loss
 Painful urination
 Increased sweating
 Swelling of the brain which may cause headache, nausea, vomiting and visual disturbances

RARE, AND SERIOUS

In 100 people receiving Tretinoin, 3 or fewer may have:
 Heart attack which may cause chest pain
 Heart stops beating
 Stroke which may cause paralysis, weakness

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 RARE, AND SERIOUS
In 100 people receiving Tretinoin, 3 or fewer may have:
 Skin changes
 Blood clot which may cause swelling, pain or shortness of breath

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