Important safety information and consumer warnings you should know about isotretinoin.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Read this Medication Guide every time you get a prescription or a refill for Isotretinoin (ACK-u-tane). There may be new information. This information does not take the place of talking with your prescriber (doctor or other health care provider).
What is the most important information I should know about Isotretinoin?
Isotretinoin is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. However, Isotretinoin can cause serious side effects. Before starting Isotretinoin, discuss with your prescriber how bad your acne is, the possible benefits of Isotretinoin, and its possible side effects, to decide if Isotretinoin is right for you. Your prescriber will ask you to read and sign a form or forms indicating you understand some of the serious risks of Isotretinoin.
Possible serious side effects of taking Isotretinoin include birth defects and mental disorders.
- Birth defects. Isotretinoin can cause birth defects (deformed babies) if taken by a pregnant woman. It can also cause miscarriage (losing the baby before birth), premature (early) birth, or death of the baby. Do not take Isotretinoin if you are pregnant or plan to become pregnant while you are taking Isotretinoin. Do not get pregnant for 1 month after you stop taking Isotretinoin. Also, if you get pregnant while taking Isotretinoin, stop taking it right away and call your prescriber.
All females should read the section in this Medication Guide "What are the important warnings for females taking Isotretinoin?"
- Mental problems and suicide. Some patients, while taking Isotretinoin or soon after stopping Isotretinoin, have become depressed or developed other serious mental problems. Symptoms of these problems include sad, “anxious” or empty mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking Isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on Isotretinoin becoming aggressive or violent. No one knows if Isotretinoin caused these behaviors or if they would have happened even if the person did not take Isotretinoin.
All patients should read the section in this Medication Guide "What are the signs of mental problems?"
For other possible serious side effects of Isotretinoin, see "What are the possible side effects of Isotretinoin?" in this Medication Guide.
What are the important warnings for females taking Isotretinoin?
You must not become pregnant while taking Isotretinoin, or for 1 month after you stop taking Isotretinoin. Isotretinoin can cause severe birth defects in babies of women who take it while they are pregnant, even if they take Isotretinoin for only a short time. There is an extremely high risk that your baby will be deformed or will die if you are pregnant while taking Isotretinoin. Taking Isotretinoin also increases the chance of miscarriage and premature births.
Female patients will not get their first prescription for Isotretinoin unless there is proof they have had 2 negative pregnancy tests. The first test must be done when your prescriber decides to prescribe Isotretinoin. The second pregnancy test must be done during the first 5 days of the menstrual period right before starting Isotretinoin therapy, or as instructed by your prescriber. Each month of treatment, you must have a negative result from a urine or serum pregnancy test. Female patients cannot get another prescription for Isotretinoin unless there is proof that they have had a negative pregnancy test.
A yellow self-adhesive Isotretinoin Qualification Sticker on your prescription indicates to the pharmacist that you are qualified by your prescriber to get Isotretinoin.
While you are taking Isotretinoin, you must use effective birth control. You must use 2 separate effective forms of birth control at the same time for at least 1 month before starting Isotretinoin, while you take it, and for 1 month after you stop taking it. You can either discuss effective birth control methods with your prescriber or go for a free visit to discuss birth control with another physician or family planning expert. Your prescriber can arrange this free visit, which will be paid for by the manufacturer.
You must use 2 separate forms of effective birth control because any method, including birth control pills and sterilization, can fail. There are only 2 reasons you would not need to use 2 separate methods of effective birth control:
- You have had your womb removed by surgery (a hysterectomy).
- You are absolutely certain you will not have genital-to-genital sexual contact with a male before, during, and for 1 month after Isotretinoin treatment.
If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your period, stop using Isotretinoin and call your prescriber right away.
All patients should read the rest of this Medication Guide
What are the signs of mental problems?
Tell your prescriber if, to the best of your knowledge, you or someone in your family has ever had any mental illness, including depression, suicidal behavior, or psychosis. Psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there. Also, tell your prescriber if you take medicines for any of these problems.
Stop using Isotretinoin and tell your provider right away if you:
- 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 (for example, temper outbursts, thoughts of violence)
- Have a change in your appetite or body weight
- Have trouble concentrating
- Withdraw from your friends or family
- Feel like you have no energy
- Have feelings of worthlessness or inappropriate guilt
- Start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
What is Isotretinoin?
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. In severe nodular acne, many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars. However, because Isotretinoin can have serious side effects, you should talk with your prescriber about all of the possible treatments for your acne, and whether Isotretinoin’s possible benefits outweigh its possible risks.
Who should not take Isotretinoin?
- Do not take Isotretinoin if you are pregnant, plan to become pregnant, or become pregnant during Isotretinoin treatment. Isotretinoin causes severe birth defects. All females should read the section “What are the important warnings for females taking Isotretinoin?” for more information and warnings about Isotretinoin and pregnancy.
- Do not take Isotretinoin unless you completely understand its possible risks and are willing to follow all of the instructions in this Medication Guide.
Tell your prescriber if you or someone in your family has had any kind of mental problems, asthma, liver disease, diabetes, heart disease, osteoporosis (bone loss), weak bones, anorexia nervosa (an eating disorder where people eat too little), or any other important health problems. Tell your prescriber about any food or drug allergies you have had in the past. These problems do not necessarily mean you cannot take Isotretinoin, but your prescriber needs this information to discuss if Isotretinoin is right for you.
How should I take Isotretinoin?
- You will get no more than a 30-day supply of Isotretinoin at a time, to be sure you check in with your prescriber each month to discuss side effects.
- Your prescription should have a special yellow self-adhesive sticker attached to it. The sticker is YELLOW. If your prescription does not have this yellow self-adhesive sticker, call your prescriber. The pharmacy should not fill your prescription unless it has the yellow self- adhesive sticker.
- The amount of Isotretinoin you take has been specially chosen for you and may change during treatment.
- You will take Isotretinoin 2 times a day with a meal, unless your prescriber tells you otherwise. Swallow your Isotretinoin capsules with a full glass of liquid. This will help prevent the medicine inside the capsule from irritating the lining of your esophagus (connection between mouth and stomach). For the same reason, do not chew or suck on the capsule.
- If you miss a dose, just skip that dose. Do not take 2 doses the next time.
- You should return to your prescriber as directed to make sure you don’t have signs of serious side effects. Because some of Isotretinoin’s serious side effects show up in blood tests, some of these visits may involve blood tests (monthly visits for female patients should always include a urine or serum pregnancy test).
What should I avoid while taking Isotretinoin?
- Do not get pregnant while taking Isotretinoin. See “What is the most important information I should know about Isotretinoin?” and “What are the important warnings for females taking Isotretinoin?”
- Do not breastfeed while taking Isotretinoin and for 1 month after stopping Isotretinoin. We do not know if Isotretinoin can pass through your milk and harm the baby.
- Do not give blood while you take Isotretinoin and for 1 month after stopping Isotretinoin. If someone who is pregnant gets your donated blood, her baby may be exposed to Isotretinoin and may be born with birth defects.
- Do not take vitamin A supplements. Vitamin A in high doses has many of the same side effects as Isotretinoin. Taking both together may increase your chance of getting side effects.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Isotretinoin and for at least 6 months after you stop. Isotretinoin can increase your chance of scarring from these procedures. Check with your prescriber for advice about when you can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Isotretinoin may make your skin more sensitive to light.
- Do not use birth control pills that do not contain estrogen (“mini pills”). They may not work while you take Isotretinoin. Ask your prescriber or pharmacist if you are not sure what type you are using.
- Talk with your doctor if you plan to take other drugs or herbal products. This is especially important for patients using birth control pills and other hormonal types of birth control because the birth control may not work as effectively if you are taking certain drugs or herbal products. You should not take the herbal supplement St. John’s Wort because this herbal supplement may make birth control pills not work as effectively.
- Talk with your doctor if you are currently taking an oral or injected corticosteroid or anticonvulsant (seizure) medicine prior to using Isotretinoin. These drugs may weaken your bones.
- Do not share Isotretinoin with other people. It can cause birth defects and other serious health problems.
- Do not take Isotretinoin with antibiotics unless you talk to your prescriber. For some antibiotics, you may have to stop taking Isotretinoin until the antibiotic treatment is finished. Use of both drugs together can increase the chances of getting increased pressure in the brain.
What are the possible side effects of Isotretinoin?
Isotretinoin has possible serious side effects
- Isotretinoin can cause birth defects, premature births, and death in babies whose mothers took Isotretinoin while they were pregnant. See “What is the most important information I should know about Isotretinoin?” and “What are the important warnings for females taking Isotretinoin?”
- Serious mental health problems. See “What is the most important information I should know about Isotretinoin?”
- Serious brain problems. Isotretinoin can increase the pressure in your brain. This can lead to permanent loss of sight, or in rare cases, death. Stop taking Isotretinoin and call your prescriber right away if you get any of these signs of increased brain pressure: bad headache, blurred vision, dizziness, nausea, or vomiting. Also, some patients taking Isotretinoin have had seizures (convulsions) or stroke.
- Abdomen (stomach area) 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). If your organs are damaged, they may not get better even after you stop taking Isotretinoin. Stop taking Isotretinoin and call your prescriber 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. Isotretinoin may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you plan vigorous physical activity during treatment with Isotretinoin. Tell your prescriber if you develop pain, particularly back pain or joint pain. There are reports that some patients have had stunted growth after taking Isotretinoin for acne as directed. There are also some reports of broken bones or reduced healing of broken bones after taking Isotretinoin for acne as directed. No one knows if taking Isotretinoin for acne will affect your bones. If you have a broken bone, tell your provider that you are taking Isotretinoin. Muscle weakness with or without pain can be a sign of serious muscle damage. If this happens, stop taking Isotretinoin and call your prescriber right away.
- Hearing problems. Some people taking Isotretinoin have developed hearing problems. It is possible that hearing loss can be permanent. Stop using Isotretinoin and call your prescriber if your hearing gets worse or if you have ringing in your ears.
- Vision problems. While taking Isotretinoin you may develop a sudden inability to see in the dark, so driving at night can be dangerous. This condition usually clears up after you stop taking Isotretinoin, but it may be permanent. Other serious eye effects can occur. Stop taking Isotretinoin and call your prescriber right away if you have any problems with your vision or dryness of the eyes that is painful or constant.
- Lipid (fats and cholesterol in blood) problems. Many people taking Isotretinoin develop high levels of cholesterol and other fats in their blood. This can be a serious problem. Return to your prescriber for blood tests to check your lipids and to get any needed treatment. These problems generally go away when Isotretinoin treatment is finished.
- Allergic reactions. In some people, Isotretinoin can cause serious 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 prescriber if you develop a fever, rash, or red patches or bruises on your legs.
- Signs of other possibly serious problems. Isotretinoin may cause other problems. Tell your prescriber if you have trouble breathing (shortness of breath), are fainting, are very thirsty or urinate a lot, feel weak, have leg swelling, convulsions, slurred speech, problems moving, or any other serious or unusual problems. Frequent urination and thirst can be signs of blood sugar problems.
Serious permanent problems do not happen often. However, because the symptoms listed above may be signs of serious problems, if you get these symptoms, stop taking Isotretinoin and call your prescriber. If not treated, they could lead to serious health problems. Even if these problems are treated, they may not clear up after you stop taking Isotretinoin.
Isotretinoin has less serious possible side effects
The common less serious side effects of Isotretinoin are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. People who wear contact lenses may have trouble wearing them while taking Isotretinoin and after therapy. Sometimes, people’s acne may get worse for a while. They should continue taking Isotretinoin unless told to stop by their prescriber.
These are not all of Isotretinoin’s possible side effects. Your prescriber or pharmacist can give you more detailed information that is written for healthcare professionals.
This Medication Guide is a summary of some important information about Isotretinoin. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns or questions about Isotretinoin, ask your prescriber. Do not use Isotretinoin for a condition for which it was not prescribed.
Active Ingredient: Isotretinoin. Inactive Ingredients:
- butylated hydroxyanisole
- edetate disodium
- hydrogenated soybean oil flakes
- hydrogenated vegetable oil
- soybean oil
Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems:
- 10 mg — iron oxide (red) and titanium dioxide
- 20 mg — FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide
- 40 mg — FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide