Important note: If you are a woman taking ACCUTANE, please read about Pregnancy Prevention.

Do not use ACCUTANE if you are pregnant.

• • ACCUTANE can cause birth defects (deformed babies).
  • ACCUTANE can cause miscarriage, premature birth, or death of the baby.

Do not get pregnant while taking ACCUTANE and for one month after treatment (ACCUTANE can cause serious birth defects).

• • Start to use two methods of effective birth control together for at least one month before, during, and for one month after ACCUTANE therapy, don’t have sex during this time.
  • Have two negative pregnancy tests performed in a licensed laboratory.
    
    • • The first pregnancy test should be done once you and your doctor have decided to use ACCUTANE.
      • The second pregnancy test should be done within 11 days before starting ACCUTANE.
  • Wait until the second or third day of your next normal period before starting ACCUTANE.
  • Have a pregnancy test performed in an approved laboratory every month you take ACCUTANE and one month after treatment stops.
  • If your period is abnormal in length or intensity, contact your doctor.
  • If you become pregnant, stop taking ACCUTANE and contact your doctor immediately.

Do not breastfeed while taking ACCUTANE and for one month after treatment.

• • ACCUTANE may pass through your milk and harm the baby.

If you become depressed or have any serious mental problems tell your doctor immediately — it may be necessary to stop ACCUTANE treatment.

• • Signs of mental health problems include:
    
    • • Changes in your mood such as becoming depressed, feeling sad, or having crying spells.
      • Losing interest in your usual activities that you once enjoyed.
      • Changes in your normal sleep patterns.
      • Becoming more irritable or aggressive than usual (for example, temper outbursts, thoughts of violence).
      • Losing your appetite or a change in your body weight.
      • Becoming unusually tired.
      • Feeling like you have no energy.
      • Having trouble concentrating.
      • Having feelings of worthlessness or guilt.
      • Withdrawing from family and friends.
      • Having thoughts about hurting yourself or taking your own life (suicidal thoughts).
      • Acting on dangerous impulses.
      • Seeing or hearing things that are not real.

Stop using ACCUTANE and call your doctor immediately if you develop a serious skin reaction.

• • Symptoms of a skin reaction include blisters, peeling skin, severe red/purple rash, multiple lesions and sores, particularly in your mouth, nose, eyes and genitals, as well as facial and tongue swelling.
  • Some patients taking ACCUTANE have had serious skin reactions, such as erythema multiforme, Stevens-Johnson Syndrome and toxic epidermal necrolysis which can result in hospitalization, disability and/or death.

Do not take tetracyclines with ACCUTANE.

• • For some antibiotics, you may have to stop taking ACCUTANE until the antibiotic treatment is finished.
  • Use of tetracyclines with ACCUTANE together can increase the chances of getting increased pressure in the brain.
  • Certain antibiotics interfere with the effectiveness of birth control pills.

Do not take vitamin A supplements.

• • Vitamin A in high doses has many of the same side effects as ACCUTANE — taking both together may increase your chance of getting side effects.

Do not take ACCUTANE if you have liver or kidney disease or if you have high blood fat (lipid) levels.

• • Tell your doctor if you have any of these health problems.

Do not take ACCUTANE if you are sensitive to any of its ingredients, including retinoids, or hydrogenated soybean oil, parabens, partially hydrogenated soybean oil, soybean oil, or any other non-medicinal ingredients

• • If you have an allergic reaction while taking ACCUTANE, stop taking ACCUTANE and contact your doctor immediately.
  • See full list of non-medicinal ingredients.

Do not give blood while taking ACCUTANE and for one month after treatment.

• • If someone who is pregnant gets your donated blood, her baby may be exposed to ACCUTANE and may be born with birth defects.

Do not take low-dose contraceptives, antibiotics, corticosteroids, phenytoin, and natural health products such as herbs (i.e., St. John’s Wort) while taking ACCUTANE unless you talk to your doctor.

• • These medications may interact with ACCUTANE or ACCUTANE may interfere with the actions of these medications.

Do not use abrasive cleansers or exfoliative anti-acne agents on your skin while taking ACCUTANE.

• • Some skin products, like exfoliants may be irritating to your skin while you are taking ACCUTANE.

Do not have cosmetic procedures to smooth your skin such as waxing, dermabrasion, or laser procedures while taking ACCUTANE and for at least 6 months after you stop.

• • ACCUTANE can increase your chance of scarring or inflammation of the skin from these procedures.
  • Check with your doctor for advice about when you can have cosmetic procedures.

Avoid the use of artificial ultraviolet lights (such as the ones used in tanning machines) and protect yourself from excessive sunlight.

• • ACCUTANE may make your skin more sensitive to ultraviolet light.
  • When necessary, use sunscreen with a high protection factor of at least SPF 30.

Do not share ACCUTANE with anyone.

• • ACCUTANE is a prescription product that can cause serious side effects – a doctor must prescribe it.

Avoid drinking alcohol while on ACCUTANE.

• • You are at a greater risk of liver damage with the combination of ACCUTANE and alcohol.

See your doctor regularly.

• • ACCUTANE may affect blood fat, cholesterol, or sugar levels so it’s important to see your doctor regularly.

Tell all healthcare practitioners, such as your family doctor, dentist or cosmetic surgeon that you are taking ACCUTANE.

• • ACCUTANE can interfere with other prescriptions and treatments.

Questions or concerns about taking ACCUTANE?
Talk to your doctor or call 1-888-XEDITON (933-4866).