ISOTRETINOIN-ORAL (cont.)
SIDE EFFECTS: May cause dry lips and mouth, minor swelling of the eyelids or lips, crusty skin, nosebleeds, indigestion, or thinning of hair. If these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately 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 sensation of the skin, sun sensitivity ("sunburn" effect), back, joint, or muscle pain, fever or other signs of infection, painful swallowing. Isotretinoin may infrequently cause pancreatic disease (pancreatitis), which rarely can be fatal. Stop taking this medication and tell your doctor immediately if you develop: severe stomach pain, severe or persistent nausea/vomiting. Stop taking this medication and tell your doctor immediately if you develop these unlikely but serious side effects: severe headache, vision changes, ringing in the ears or hearing loss, dark urine or yellowing eyes and skin, severe diarrhea, rectal bleeding. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before using this drug, tell your doctor or pharmacist your medical history, including: diabetes, family or personal history of high blood fats (triglycerides), family or personal history of psychiatric disorders, liver disease, pancreatitis, bone loss conditions (e.g., osteoporosis/osteomalacia, decreased bone density), any allergies. Do not donate blood while you take isotretinoin and for at least one month after you stop taking it. Avoid exposure to the sun and sunlamps. Use a sunscreen and wear protective clothing when you are exposed to direct sunlight. Isotretinoin can affect your night vision. Be cautious when driving or operating any machinery after dark. If you wear contact lenses, you may not tolerate them as well as usual while using this medication. Do not have cosmetic procedures to smooth your skin (e.g., waxing, laser, or dermabrasion) during and for six months after isotretinoin therapy. Skin scarring may occur. Avoid the use of alcohol while taking this medication, as it may worsen drug side effects (e.g., pancreatitis risk). Limited information suggests isotretinoin may cause some bone loss effects. Therefore, playing impact sports (e.g., football) may result in bone problems, including an increased risk of fractures. 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 children because they may be more sensitive to its effects, especially back, joint, or muscle pain. 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 immediately. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug should not be used by those who may become pregnant during treatment. Consult your doctor (see also Warning section). It is not known if this drug passes into breast milk. Due to the potential risks to an infant, do not breast-feed while using this medication. Use two reliable forms of birth control together, starting one month before treatment, during and at least one month after stopping the drug.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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