Isotretinoin (eye-soe-TRET-i-noin)

Treats severe acne.

Brand Name(s):

Absorica, Absorica LD, Accutane, Amnesteem, Claravis, Myorisan, Zenatane

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Liquid Filled Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take Accutane® capsules with food.
• Swallow the capsule whole with a full glass (8 ounces) of water or other liquid. Do not crush, break, chew, or suck it.
• Absorica® capsules should not be substituted with other forms of isotretinoin (including Absorica LD®, Accutane®). Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how isotretinoin works. Tell your doctor if you are using any of the following:
  • Phenytoin, St John's wort
  • Birth control pills
  • Steroid medicine
  • Tetracycline antibiotics (including doxycycline, minocycline, tetracycline)
  • Vitamin A supplements

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy because it can cause serious birth defects. All patients who can become pregnant must follow the requirements of the iPLEDGE™ program. You must use 2 forms of birth control for 1 month before you start taking isotretinoin, for the entire time you are being treated, and for 1 month after your last dose. You will need to have a pregnancy test every month during your treatment and 1 month after treatment ends. Tell your doctor right away if you miss a period or become pregnant.
• Do not breastfeed during treatment with this medicine and for 8 days after your last dose.
• Tell your doctor if you have liver disease, heart disease, asthma, bowel or digestion problems, diabetes, high cholesterol, obesity, a history of depression, lipid disorder, anorexia, or bone problems (including osteoporosis). Tell your doctor if you drink alcohol regularly. Tell your doctor if you had an allergic reaction to FD&C Yellow No. 5 (tartrazine) or aspirin.
• This medicine may cause the following problems:
  • Depression, changes in mood or behavior
  • Benign intracranial hypertension (increased pressure in the brain)
  • Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Pancreatitis (swelling of the pancreas)
  • Liver problems
  • Inflammatory bowel disease
• This medicine may cause bone or muscle problems, including fractures. You may get hurt more easily or heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.
• This medicine may cause hearing or vision problems, including decreased night vision. Do not drive at night until you know how this medicine affects you.
• Do not donate blood during treatment with this medicine or for 1 month after your last dose.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Do not use wax to remove hair or have any cosmetic procedures to smooth your skin (including dermabrasion, laser) while you are using this medicine and for 6 months after your last dose. Isotretinoin can increase your risk of scarring from these procedures.
• Your acne may get worse for a short time before it starts to improve.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Depression, unusual moods or behaviors, thought of hurting yourself or others
• Fever, chills, cough, sore throat, body aches
• Hearing loss, ringing in your ears
• Seizures
• Severe diarrhea, stomach pain, or bleeding from your rectum
• Sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness
• Sudden or severe headache, dizziness, faintness, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness, bloody urine
• Vision changes, trouble seeing at night

If you notice these less serious side effects, talk with your doctor:

• Dry skin, eyes, lips, mouth, or nose
• Heartburn (new or worsening), painful or trouble with swallowing
• Increase in thirst, change in how much or how often you urinate
• Muscle, back, or joint pain (more likely in children)
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088