Isotretinoin, Zenatane, Accutane, Amnesteem, Myorisan, Claravis

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Amber Watson, PharmD
Updated on August 30, 2023

Isotretinoin (eye soe TRET i noyn) is a generic medication prescribed for a type of severe acne called nodular acne. Isotretinoin belongs to a group of drugs called retinoids.

Boxed warning: Risk of harm during pregnancy

Isotretinoin oral capsule has a boxed warning about the risk of harm during pregnancy. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for isotretinoin” section.

Side effects of isotretinoin

Isotretinoin may cause mild or serious side effects. More common mild side effects of isotretinoin and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about isotretinoin’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for isotretinoin listed in the “Resources” section.

Mild side effects

More common mild side effects reported with some forms of isotretinoin are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about isotretinoin’s side effects, refer to the prescribing information for isotretinoin listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Isotretinoin oral capsule’s mild side effects include:

• dry skin
• chapped lips
• dry eyes
• dry nose, which may cause nosebleeds
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for isotretinoin” section.

Serious side effects

Serious side effects of isotretinoin are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about isotretinoin’s side effects, refer to the prescribing information for isotretinoin listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, isotretinoin’s serious side effects may include:

• mental health conditions, such as depression or suicidal thoughts
• brain problems, which may lead to vision loss, seizures, or stroke
• severe skin reactions
• damage to your liver, pancreas, or digestive tract
• muscle or bone problems
• hearing problems
• vision problems, such as trouble seeing in the dark
• increased lipids (fats such as cholesterol) in your blood
• increased blood sugar levels, which may lead to new or worsened diabetes
• decreased red and white blood cell levels
• boxed warning: risk of harm during pregnancy*
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for isotretinoin” section.

Suicide prevention

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

• Call the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Textline at 741741.
• Not in the United States? Find a helpline in your country with Befrienders Worldwide.
• Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you are not in the same household, stay on the phone with them until help arrives.

Common questions about isotretinoin

Below you’ll find answers to a few commonly asked questions about isotretinoin.

What brand names are available for isotretinoin?

Isotretinoin is a generic drug. The original brand-name version of isotretinoin was Accutane. But this brand is no longer available.

A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less compared to brand-name drugs.

Other medications that contain isotretinoin include:

• Absorica
• Amnesteem
• Claravis
• Myorisan
• Zenatane

If you have questions about brand or generic versions of isotretinoin, talk with your doctor or pharmacist.

Is isotretinoin available as a topical cream?

No. Isotretinoin only comes as an oral capsule. It belongs to a group of drugs called retinoids.

Tretinoin (Retin-A) is a retinoid drug that comes as a cream. It’s prescribed to treat acne vulgaris. Your doctor will likely have you try tretinoin or other acne medications before considering isotretinoin for your acne. But oral isotretinoin is generally more effective for treating severe nodular acne than topical retinoids, including tretinoin. (Isotretinoin oral capsule is used to treat severe nodular acne in people whose symptoms haven’t resolved with previous treatments.)

Talk with your doctor to determine if one of these drugs may be an option for treating your acne.

How does isotretinoin work? And how long does it take to start working?

It isn’t fully understood how isotretinoin works. The drug is thought to work by reducing how much sebum your body makes. Sebum is a sticky, waxy mixture of oil and other natural substances that your body makes to protect and moisturize your skin. But too much sebum can clog your pores and lead to acne.

Isotretinoin usually starts working within a few weeks. But it may take a full course of treatment, usually 15–20 weeks, to see the full benefit of the medication. Within this time frame, symptoms of nodular acne usually disappear for many people.

Some people may continue to see clearer skin after completing the full course of isotretinoin treatment. But some people may need a second course of isotretinoin treatment, starting at least 8 weeks after the end of the first course.  

If you’d like to know more about how isotretinoin works, talk with your doctor or pharmacist.

Uses of isotretinoin

The Food and Drug Administration (FDA) approves prescription drugs such as isotretinoin for certain conditions. Approved uses for isotretinoin are described below.

Use for acne

Doctors may prescribe isotretinoin for treating severe nodular acne in people whose acne hasn’t responded to other treatments, including oral antibiotics. It’s used for this purpose in adults and children ages 12 years and older. Isotretinoin is usually prescribed as a short-term treatment.

With severe nodular acne, a person has many nodules (pimples or bumps) on their skin that are inflamed (red, discolored, or swollen). These nodules are at least 5 millimeters (mm) in diameter and may bleed, drain pus, or be painful.

Interactions and warnings for isotretinoin

Below you’ll find information about isotretinoin’s possible interactions and warnings.

Interactions of isotretinoin

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take isotretinoin, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for isotretinoin” section below.

Warnings for isotretinoin

Some people should not take isotretinoin, and others should take it cautiously.

Boxed warning: Risk of use during pregnancy

Isotretinoin has a boxed warning about the risk of harm during pregnancy. For more information about this risk, see the “Pregnancy or breastfeeding and isotretinoin” section below.

Other warnings

Isotretinoin could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether isotretinoin is a safe option for you.

Ask your doctor about specific warnings for isotretinoin, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Isotretinoin can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to isotretinoin or any of its ingredients, your doctor will likely not prescribe isotretinoin. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to isotretinoin, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of isotretinoin

Do not take more isotretinoin than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much isotretinoin, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and isotretinoin

Information about isotretinoin and pregnancy and breastfeeding is described below.

Isotretinoin and pregnancy

Isotretinoin should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor will prescribe birth control options to use during treatment with isotretinoin.

Boxed warning: Risk of harm during pregnancy

Isotretinoin has a boxed warning about the risk of harm during pregnancy. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

Isotretinoin capsules should not be taken during pregnancy. Taking isotretinoin while pregnant, even briefly, is known to cause severe congenital anomalies (commonly called birth defects) in a developing fetus. The drug also increases the risk of premature birth and pregnancy loss.

Because of these risks, isotretinoin oral capsules must be prescribed and dispensed only by healthcare professionals and pharmacies who are part of a special program called iPledge.

To be eligible to get a prescription for isotretinoin, you must also enroll in iPledge and meet all the program requirements. These requirements may include taking a pregnancy test before starting isotretinoin and at regular intervals during treatment to confirm you’re not pregnant. Also, if you’re sexually active and able to become pregnant, you must use two forms of birth control for:

• at least 1 month before starting isotretinoin
• during treatment, and
• for 1 month after their your dose

If you become pregnant while taking isotretinoin, contact your doctor right away. They’ll have you stop taking the drug and discuss your options with you. To learn more, talk with your doctor or pharmacist.

Isotretinoin and breastfeeding

Isotretinoin should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor will recommend other ways to feed your child during treatment with isotretinoin.

What to ask your doctor

Let your doctor know if you have questions about isotretinoin or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• How effective is isotretinoin for acne compared to topical acne treatments, such as creams or ointments?
• Are there any skin care products you recommend using (or avoiding) during isotretinoin treatment for acne?
• How long after stopping isotretinoin is it safe to try to get pregnant?
• How does the iPledge program work, and what requirements apply to me?

Resources

• Eichenfield DZ, et al. (2021). Management of acne vulgaris: A review. https://jamanetwork.com/journals/jama/article-abstract/2786495
• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Isotretinoin- isotretinoin capsule, liquid filled. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/c369e1c3-90c5-4768-9741-56c62253a2c4/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.