Absorica

Retinoids

ISOTRETINOIN treats severe acne that has not responded to other therapy like antibiotics.

Side effects of Absorica

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.

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:

More common

Bone or joint pain

burning, redness, itching, or other signs of eye inflammation

difficulty moving

nosebleeds

scaling, redness, burning, pain, or other signs of inflammation of the lips

skin infection or rash

Rare

Abdominal or stomach pain (severe)

attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)

back pain

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)

diarrhea (severe)

headache (severe or continuing)

mental depression

nausea and vomiting

pain or tenderness of the eyes

pain, tenderness, or stiffness in the muscles (long-term treatment)

rectal bleeding

yellow eyes or skin

Incidence not known

Black, tarry stools

bloating

bloody cough

bloody or cloudy urine

bone pain, tenderness, or aching

burning or stinging of the skin

chest pain

confusion

constipation

convulsions

cough or hoarseness

dark-colored urine

decrease in height

difficulty breathing

difficulty speaking

difficulty swallowing

discharge from the eyes

dizziness

double vision

ear pain

excessive tearing

fainting

fast, irregular, pounding, or racing heartbeat or pulse

fever with or without chills

fractures and/or delayed healing

heartburn

high blood pressure

hives

inability to move the arms, legs, or facial muscles

inability to speak

indigestion

inflamed tissue from infection

irregular yellow patch or lump on the skin

irritation

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

pale skin

pinpoint red spots on the skin

redness or soreness around the fingernails

redness, soreness, or itching skin

sensitivity of the eyes to sunlight

shortness of breath

skin rash

sneezing

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 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

wheezing

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:

More common

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

headache (mild)

increased sensitivity of the skin to sunlight

peeling of the skin on palms of the hands or soles of the feet

stomach upset

thinning of the hair (may continue after treatment is stopped)

Incidence not known

Abnormal menstruation

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

dandruff

darkening of the skin

flushing

hair abnormalities

hair loss

increased hair growth, especially on the face

lightening of normal skin color

lightening of treated areas of dark skin

nervousness

oily skin

redness of the face

severe sunburn

skin rash, encrusted, scaly and oozing

stomach burning

sweating

trouble sleeping

unable to sleep

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusually warm skin of the face

voice changes

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.

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