Uses

What is isotretinoin used for?

Isotretinoin is used to treat a certain type of severe acne vulgaris (nodular acne) that has not responded to other treatments.

Isotretinoin may also be used for other conditions as determined by your healthcare provider.

How does isotretinoin work (mechanism of action)?

Isotretinoin decreases excess oil and changes how your skin cells grow and shed so they do not clog pores or form acne. It also helps decrease redness and swelling that happens with acne.

How is  isotretinoin supplied (dosage forms)?

Isotetinoin is available as Absorica, Absorica LD, Accutane, Amnesteem, Claravis, Myorisan, Zenatane and generic isotretinoin in the following dosage forms that are taken by mouth.

  • 10mg, 20mg, 25mg, 30mg, 35mg, 40mg oral capsules
  • 8mg, 16mg, 20mg, 24mg, 28mg, 32mg micronized oral capsules

How should I store isotretinoin?

Isotretinoin should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of isotretinoin?

The most common side effects of isotretinoin are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Dry nose and nose bleeds
  • Dry, chapped, or peeling lips
  • Dry eyes
  • Dry skin

There may be other side effects of isotretinoin that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of isotretinoin?

While less common, the most serious side effects of isotretinoin are described below, along with what to do if they happen.

Bone Growth Changes. In people who are still growing, such as adolescents, isotretinoin may cause some bones to stop growing earlier than normal.

Hearing Changes. Isotretinoin can cause hearing loss and ringing in the ears (tinnitus). Call your healthcare provider right away if you experience any hearing changes.

High Triglycerides. Isotretinoin may increase the levels of a certain blood fat (lipid), called triglycerides. If you take isotretinoin, your healthcare provider will monitor your triglyceride levels.

Increased Pressure Around the Brain. Isotretinoin can increase the pressure around the brain, a serious condition called pseudotumor cerebri. Stop taking isotretinoin and call your healthcare provider right away if you experience any of the following symptoms.

  • Dizziness
  • Nausea and vomiting
  • Severe headache
  • Vision changes

Inflammation of the Pancreas (Pancreatitis). Isotretinoin may cause inflammation of the pancreas, which is called pancreatitis. Stop taking isotretinoin and call your healthcare provider right away if you have symptoms of pancreatitis including vomiting or severe pain in the upper part of your belly that travels to your back.

Inflammatory Bowel Disease (IBD). Isotretinoin can cause a condition called inflammatory bowel disease (IBD). Call your healthcare provider right away if you experience any of the following symptoms of IBD.

  • Bloody diarrhea
  • Severe diarrhea
  • Severe stomach pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking isotretinoin. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Mental Health Changes. Isotretinoin can cause changes in mental health, including depression, mood changes, irritability, psychosis, and violence. Stop taking isotretinoin and call your healthcare provider right away if you notice any of these changes in your mental health.

Sensitivity to Sunlight. Your skin may be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds, while you are taking certain drugs, including isotretinoin. This is called photosensitivity. Use sunscreen and wear a hat and clothes that cover your skin if you need to be in the sunlight. Exposing your skin to this kind of light, even for a short time, can cause your skin to be severely sunburned, blistered, or swollen. Tell your healthcare provider right away if any of these happen.

Severe Allergic Reactions. Isotretinoin can cause allergic reactions, which can be serious. Stop using isotretinoin and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Severe Skin Reactions. Isotretinoin can cause severe skin reactions called Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) that can lead to death if not treated. If you develop a rash, stop isotretinoin and immediately call your healthcare provider. Get emergency help right away if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes

Suicidal Thoughts and Actions. Isotretinoin may cause suicidal thoughts or actions in a small number of people. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Vision Changes. Isotretinoin can cause changes to the eyes, including scarring of the front layer of the eye (cornea). This can cause the eye to look white or cloudy and can make it more difficult to see. Isotretinoin can also make it more difficult to see at night. Call your healthcare provider right away if you experience any vision changes.

Weak Bones. Isotretinoin may reduce bone density, causing the bones to become weaker (osteopenia). Isotretinoin may also cause a more serious condition called osteoporosis, which can cause bones to break (fracture) more easily. If you take isotretinoin, your healthcare provider may monitor your bone density.

Muscle Problems. Isotretinoin can rarely cause muscle to break down (rhabdomyolysis), which can be serious and rarely lead to kidney damage and death. This is more likely to happen after strenuous activity. Stop taking isotretinoin and get help right away if you have any of the following symptoms of rhabdomyolysis.

  • Unexplained muscle pain, weakness, or tenderness
  • Low energy levels or feeling easily tired, especially with activity
  • Dark colored urine
  • Fever
  • Muscle cramps
  • Stomach pain
  • Nausea or vomiting

Increased Blood Sugar. Isotretinoin may increase your blood sugar levels. Talk to your healthcare provider about how to maintain healthy blood sugar levels.

Warnings & Precautions

Who should not use isotretinoin?

Allergies to Ingredients. People who are allergic to any of the following should not use isotretinoin.

  • Absorica
  • Absorica LD
  • Accutane
  • Amnesteem
  • Claravis
  • Isotretinoin
  • Myorisan
  • Vitamin A
  • Zenatane

Pregnancy. Do not take isotretinoin if you are pregnant. If you become pregnant, stop taking isotretinoin and contact your healthcare provider right away. See the Pregnancy section below for more details.

What should I know about isotretinoin before using it?

Do not take isotretinoin unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share isotretinoin with other people, even if they have the same condition as you. It may harm them.

Keep isotretinoin out of the reach of children.

Isotretinoin can make it more difficult to see at night. Do not drive at night until you know how isotretinoin affects you.

Isotretinoin may make it harder to use contact lenses.

You should not donate blood while taking isotretinoin or for one month after stopping isotretinoin.

Isotretinoin can increase the risk of scarring after some procedures that are used to smooth the skin, such as waxing, dermabrasion, and laser resurfacing. Avoid these procedures while taking isotretinoin.

Isotretinoin can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.

Isotretinoin can cause serious harm to an unborn baby. To reduce the risk of this happening, isotretinoin is only available through a restricted program called iPLEDGE. As part of this program, people who can become pregnant must have two negative pregnancy tests before starting isotretinoin. In order to continue taking isotretinoin, people who can become pregnant must commit to using two forms of birth control and also take a pregnancy test each month.

What should I tell my healthcare provider before using isotretinoin?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if isotretinoin is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. Isotretinoin may cause death or serious harm to an unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. A negative pregnancy test is necessary before starting isotretinoin. Pregnancy tests must be repeated monthly during treatment and 1 month after stopping isotretinoin. If you can become pregnant, use effective birth control for at least 1 month before starting isotretinoin, while you are taking isotretinoin, and for 1 month after your last dose. Talk to your healthcare provider about your birth control options.

There is a Pregnancy Exposure Registry that monitors the health of you and your unborn baby if you are exposed to isotretinoin during pregnancy or within 1 month after stopping isotretinoin.  Talk to your healthcare provider right away if you think you or your partner may have been exposed to isotretinoin during pregnancy. If you become pregnant during treatment with isotretinoin, you or your healthcare provider should report your pregnancy to the FDA via the MedWatch telephone number 800-FDA-1088 and also to the iPLEDGE pregnancy registry at 866-495-0654 or www.ipledgeprogram.com.

Breastfeeding. Do not take isotretinoin while you are breastfeeding. It is not known if isotretinoin passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Interactions

Does isotretinoin interact with foods or drinks?

There are no known interactions between isotretinoin and foods or drinks. Isotretinoin should always be taken with a full glass of liquid. Certain isotretinoin products should be taken with food. Ask your healthcare provider or pharmacist if you are unsure if you should take your isotretinoin with or without food.

It is unknown if drinking alcohol will affect isotretinoin.

Does isotretinoin interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using isotretinoin.

  • A corticosteroid, which is a medicine for certain inflammatory conditions
  • A tetracycline antibiotic, such as doxycycline, minocycline, seracycline, or tetracycline
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Vitamin A
  • St. John’s wort (Hypericum perforatum), an herbal supplement
  • A progestin only birth control pill, also called the minipill
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Overdose/Missed Dose

What should I do if I accidentally use too much isotretinoin?

If you or someone else has used too much isotretinoin, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of isotretinoin?

Skip the missed dose and take your next dose at the normal time. Do not take double or extra doses.

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