Women who are pregnant must not use isotretinoin. Women must avoid becoming pregnant while taking this medication. Serious (sometimes fatal) birth defects, miscarriages, and premature births have occurred when this drug has been used during pregnancy. For female patients, two effective forms of birth control (or complete avoidance of sexual intercourse) must be used for 1 month before starting isotretinoin, during use, and for 1 month after stopping this drug. You must also have monthly pregnancy-avoidance counseling from your doctor. Do not use minipills for birth control (non-estrogen-containing pills) since they may not work as well with isotretinoin. If you are late in having your period, or if you have sexual intercourse at any time without using two effective forms of birth control, stop taking this medication and contact your doctor right away. (See also the Precautions section.) To receive isotretinoin in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations. Talk with your doctor about the risks and benefits of using this medication.

Dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, upset stomach, or thinning of hair may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety, thoughts of suicide), tingling feeling in the skin, back/joint/muscle pain, signs of infection (such as sore throat that doesn't go away, fever), painful swallowing, peeling skin on palms/soles. Isotretinoin may rarely cause disease of the pancreas (pancreatitis) that may rarely be fatal. Stop taking this medication and tell your doctor right away if you develop: severe stomach pain, nausea/vomiting that is severe or doesn't stop. Stop taking this medication and tell your doctor right away if you have any very serious side effects, including: severe headache, vision changes, ringing in the ears, hearing loss, chest pain, yellowing eyes/skin, dark urine, severe diarrhea, rectal bleeding. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Some products that may interact with this drug are: tetracyclines (such as minocycline, tetracycline), vitamin A-type drugs (such as acitretin, bexarotene), vitamin A, drugs that cause bone loss (for example, anti-seizure drugs such as phenytoin, corticosteroids such as prednisone). Tell your doctor when you start any new drug, and discuss if you should use reliable backup birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. ()