The below information on Accutane has been taken from official FDA sources, but we cannot guarantee it's accuracy. Please use this site for educational purposes only. This site does not replace a proper discussion with your doctor.
|This drug was approved by the FDA in one form or another on:|
|This drug is made in one form or another by the following companies:|
F. Hoffmann–La Roche, Ltd.
|This drug is available in the following forms:|
|View the actual FDA approved label for this drug at the following links:|
Isotretinoin is used to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Isotretinoin is only for patients who understand and agree to carry out all the instructions in the iPLEDGE program, because isotretinoin can cause serious side effects.
Side Effects of Accutane
Birth defects (deformed babies), loss of baby before birth (miscarriage), death of baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take isotretinoin. Female patients must not get pregnant:
- For 1 month before starting isotretinoin,
- While taking isotretinoin
- For 1 month after stopping isotretinoin
If you get pregnant while taking isotretinoin, stop taking it right away and call your doctor.
- Serious mental health problems: Isotretinoin may cause:
- Psychosis (seeing or hearing things that are not real)
- Suicidal thoughts or actions
- Aggressive and violent behavior
- Start to feel sad or have crying spells
- Lose interest in activities you once enjoyed
- Sleep too much or have trouble sleeping
- Become more irritable, angry or aggressive than usual
- Have a change in your appetite or body weight
- Have trouble concentrating
- Withdraw from your family or friends
- Feel like you have no energy
- Have feelings of worthlessness or wrong guilt
- Start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
- Start acting on dangerous impulses
- Start seeing or hearing things that are not real
- Serious brain problems: Isotretinoin may increase the pressure in your brain, possibly leading to permanent loss of eyesight, or in rare cases, death. Stop taking isotretinoin and call your doctor right away if you get any signs of increased brain pressure such as bad headaches, blurred vision, dizziness, nausea or vomiting, seizures (convulsions) or stroke.
- Stomach area (abdomen) problems: Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). Stop taking isotretinoin and call your doctor if you get severe stomach, chest or bowel pain, trouble swallowing or painful swallowing, new or worsening heartburn, diarrhea, rectal bleeding, yellowing of your skin or eyes, or dark urine.
- Bone and muscle problems: Tell your doctor if you plan any vigorous physical activity during treatment with isotretinoin. Tell your doctor if you get muscle weakness, back pain, joint pain, or a broken bone.
- Hearing problems: Stop taking isotretinoin and call your doctor if your hearing gets worse or if you have ringing in the ears.
- Vision problems: Isotretinoin may affect your ability to see in the dark. Stop taking isotretinoin and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking isotretinoin and after treatment.
- Lipid (fats and cholesterol in blood) problems: Isotretinoin can raise the level of fats and cholesterol in your blood.
- Allergic reactions: Stop taking isotretinoin and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking isotretinoin and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
- Blood sugar problems: Tell your doctor if you are very thirsty or urinate a lot.
- Decreased red and white blood cells: Call your doctor if you have trouble breathing, faint, or feel weak.
The common, less serious side effects of isotretinoin are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.
Who Should Not Take Accutane
Isotretinoin should NOT be used by pregnant women.
Do not take isotretinoin if you are:
- Pregnant, plan to become pregnant, or become pregnant during isotretinoin treatment
- Allergic to anything in it. Isotretinoin contains parabens, which are used as preservatives in the gelatin capsule.
Interactions with Accutane
Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Isotretinoin and other medicines may affect each other sometimes causing serious side effects. Especially tell your healthcare professional if you take:
- Progestin-only containing birth control pills (“minipills”)
- Vitamin A supplements
- Tetracycline medicines
- Dilantin (phenytoin)
- Corticosteroid medicines
- St. John’s Wort
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