Accutane (Isotretinoin) is primarily used as a treatment for severe acne. The most common adverse effects are a transient worsening of acne (lasting 2–3 weeks), dry lips (cheilitis), dry and fragile skin, and an increased susceptibility to sunburn. Uncommon and rare side effects include: muscle aches and pains (myalgias), and headaches. Isotretinoin is known to cause birth defects due to in utero exposure because of the molecule’s close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development.
This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring. OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Read the Medication Guide provided by your pharmacist before you start using isotretinoin and each time you get a refill. Read and sign a Patient Information/Informed Consent form before you start taking this medication. If you have any questions about isotretinoin, consult your doctor or pharmacist before taking the medication. Swallow capsules whole. Do not crush or chew them. Isotretinoin is usually taken twice daily for 15-20 weeks, or as directed by your doctor. Directions for most generic forms of isotretinoin state that it should be taken with meals. However, the FDA has indicated that the Absorica brand may be taken with or without food. Food helps increase absorption of this drug into your bloodstream. Ask your doctor or pharmacist for more information. Take this drug with a full glass of water, and do not lie down for 10 minutes after taking it. The dosage is based on your medical condition, weight, and response to treatment. Your acne may worsen during the first few days of taking this drug, and it may take up to 1-2 months before you notice the full benefit of this medication. If severe acne returns, a second course of treatment may be started after you have stopped taking the drug for 2 months. The manufacturer does not recommend long-term use of isotretinoin. Do not take more than the recommended dose. 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.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using isotretinoin and call your doctor at once if you have any of these serious side effects: depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself; sudden numbness or weakness, especially on one side of the body; blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting; hearing problems, hearing loss, or ringing in your ears; seizure (convulsions); severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); severe diarrhea, rectal bleeding, black, bloody, or tarry stools; fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; severe blistering, peeling, and red skin rash; or joint stiffness, bone pain or fracture. Less serious side effects may include: joint pain, back pain; feeling dizzy, drowsy, or nervous; dryness of the lips, mouth, nose, or skin; or cracking or peeling skin, itching, rash, changes in your fingernails or toenails. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
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.