SIDE EFFECTS: 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 persist or worsen, 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 your doctor has prescribed this medication because he or she 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 of these unlikely but serious side effects: mental/mood changes (e.g., depression, aggressive or violent behavior, and in rare cases, thoughts of suicide), tingling feeling in the skin, back/joint/muscle pain, signs of infection (e.g., fever, persistent sore throat), 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, severe or persistent nausea/vomiting. Stop taking this medication and tell your doctor right away if you develop these unlikely but very serious side effects: 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, seek immediate medical attention 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.

PRECAUTIONS: Before taking isotretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as tretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as soybean, parabens), which can cause allergic reactions or other problems. Some people who are allergic to peanuts may also be allergic to soy. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders (including depression), liver disease, obesity, eating disorders (e.g., anorexia nervosa), alcohol abuse, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density). Do not donate blood while you are taking isotretinoin and for at least 1 month after you stop taking it. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Isotretinoin can affect your night vision. Do not drive, use machinery, or do any activity that requires clear vision after dark until you are sure you can perform such activities safely. If you wear contact lenses, you may not tolerate them as well as usual while using this medication. Contact your doctor for more information. Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, dermabrasion) during and for 6 months after isotretinoin therapy. Skin scarring may occur. Avoid the use of alcohol while taking this medication because it may increase the risk of certain side effects (e.g., pancreatitis). Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing contact or repetitive impact sports (e.g., football, basketball, soccer, tennis) may result in bone problems, including an increased risk of broken bones. Limited information also suggests isotretinoin may stop normal growth in some children (epiphyseal plate closure). Consult your doctor for more details. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on bones. Caution is advised when using this drug in children because they may be more sensitive to its effects, especially back/joint/muscle pain. This drug must not be used during pregnancy or by those who may become pregnant during treatment. If you become pregnant or think you may be pregnant, inform your doctor right away. See also Warning section. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules. You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor right away. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: tetracyclines (e.g., minocycline, tetracycline), vitamin A-type drugs (e.g., acitretin, bexarotene), vitamin A, drugs that cause bone loss (e.g., 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 additional reliable 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. (See also Warning section.) This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, stomach pain, facial flushing, headache, loss of balance.