What should I watch for?
You may experience a flare in your acne during the initial treatment period. You will need to see your doctor or health care professional monthly to get a new prescription and to check on your progress and for side effects.
To receive this medicine, you, your doctor and your pharmacy must be registered in the iPLEDGE program. You may only receive up to a 30 day supply of this medicine at one time. You will need a new prescription for each refill. Your prescription must be filled within 7 days of your doctor's office visit.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females will need to have 2 negative pregnancy tests before starting this medicine and then monthly pregnancy tests during treatment, even if you are not sexually active. Use 2 reliable forms of birth control together for 1 month prior to, during, and for 1 month after stopping this medicine. Avoid using birth control pills that do not contain estrogen. They may not work while you are taking this medicine. If you become pregnant, miss a menstrual cycle, or stop using birth control, you must immediately stop taking this medicine. If you are pregnant, report it to FDA MedWatch at 1-800-FDA-1088 and the iPLEDGE pregnancy registry at 1-866-495-0654. Severe birth defects may occur even if just one dose is taken. Do not breast-feed while taking this medicine or for 1 month after stopping treatment.
Do not give blood while taking this medicine and for 30 days after completion of treatment to avoid exposing pregnant women to this medicine through the donated blood.
Some patients have become depressed or developed serious mental problems while taking this medicine or soon after stopping. Stop taking this medicine if you start feeling depressed or have thoughts of violence or suicide. Contact your doctor.
This medicine can increase cholesterol and triglyceride levels and decrease HDL (the good cholesterol) levels. Your health care provider will monitor these levels and recommend appropriate therapy, including changes in diet or prescription drugs, if necessary. Alcohol can increase the risk of developing high cholesterol or high blood lipids. Avoid alcoholic drinks while you are taking this medicine.
If you wear contact lenses, they may feel uncomfortable. If your eyes get dry, check with your eye doctor. This medicine may decrease your night vision or cause other changes in vision. If you experience any change in vision, stop taking this medicine and see an eye doctor.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Cosmetic procedures to smooth your skin including waxing, dermabrasion, or laser therapy should be avoided during therapy and for at least 6 months after you stop because of the possibility of scarring. Check with your health care provider for advice about when you can have cosmetic procedures.
This medicine may affect your blood sugar levels. If you have diabetes check with your doctor or health care professional if you notice any change in your blood sugar tests.
Common and Rare Side Effects
Along with its needed effects, a medicine 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:
Bone or joint pain
difficulty with moving
scaling, redness, burning, pain, or other signs of inflammation of the lips
skin infection or rash
Abdominal or stomach pain (severe)
attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
bleeding or inflammation of the gums
blurred vision or other changes in vision
changes in behavior
decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
headache (severe or continuing)
pain or tenderness of the eyes
pain, tenderness, or stiffness in the muscles (long-term treatment)
yellow eyes or skin
Incidence not known
Black, tarry stools
bloody or cloudy urine
bone pain, tenderness, or aching
burning or stinging of the skin
cough or hoarseness
decrease in height
discharge from the eyes
fast, irregular, pounding, or racing heartbeat or pulse
fever with or without chills
fractures and/or delayed healing
hives or skin rash
inability to move the arms, legs, or facial muscles
inability to speak
inflamed tissue from infection
irregular yellow patch or lump on the skin
joint pain, redness, stiffness, or swelling
lack or slowing of normal growth in children
loosening of the fingernails
loss of appetite
loss of bladder control
loss or change in hearing
muscle cramps, spasms, or weakness
pain in the ribs, arms, or legs
pain or burning in the throat
pain or tenderness around the eyes and cheekbones
painful cold sores or blisters on the lips, nose, eyes, or genitals
painful or difficult urination
pains in the chest, groin, or legs, especially calves of the legs
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on the skin
redness or soreness around the fingernails
redness, soreness, or itching skin
sensitivity of the eyes to sunlight
sores, ulcers, or white spots on the lips or tongue or inside the mouth
stuffy or runny nose
sudden loss of consciousness
sudden loss of coordination
sudden onset of severe acne on the chest and trunk
sudden onset of slurred speech
swelling of the eyelids, face, lips, hands, lower legs, or feet
swollen, painful or tender lymph glands in the neck, armpit, or groin
tightness in the chest
unusual bleeding or bruising
unusual weight gain or loss
use of extreme physical or emotional force
watery or bloody diarrhea
Some side effects 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:
Crusting of the skin
difficulty in wearing contact lenses (may continue after medicine is stopped)
dryness of the eyes (may continue after treatment is stopped)
dryness of the mouth or nose
dryness or itching of the skin
increased sensitivity of the skin to sunlight
peeling of the skin on palms of the hands or soles of the feet
thinning of the hair (may continue after treatment is stopped)
Incidence not known
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
changes in fingernails or toenails
continuing ringing or buzzing, or other unexplained noise in the ears
darkening of the skin
increased hair growth, especially on the face
lightening of normal skin color
lightening of treated areas of dark skin
redness of the face
skin rash, encrusted, scaly and oozing
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusually warm skin of the face
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.