This article describes possible side effects of isotretinoin oral capsule. You can explore this overview article to learn more about isotretinoin, including the drug’s uses, side effects, ways to save on cost, and more.
Isotretinoin oral capsule is a generic version of the brand-name drug Accutane. But Accutane is no longer available.
Boxed warning: Risk of harm to unborn fetus during pregnancy
Isotretinoin has a boxed warning for the risk of harm to an unborn fetus during pregnancy. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
For details, see the “Pregnancy and isotretinoin” section below.
More common side effects of isotretinoin
Isotretinoin oral capsule may cause mild or serious side effects. Below are some of the more common side effects of this medication.
Commonly reported side effects of isotretinoin oral capsule include:
- dry skin
- chapped lips
- dry eyes
- dry nose, which may cause nosebleeds
- back pain
Mild side effects of isotretinoin
Isotretinoin may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.
Mild side effects of isotretinoin oral capsule that occurred in studies include:
- dry skin
- chapped lips
- dry eyes
- dry nose, which may cause nosebleeds
- back pain
- fatigue (low energy)
- weight loss
- dizziness
- drowsiness
- headache
- trouble sleeping
- lethargy
- nervousness
- light sensitivity
- weakness
- numbness and tingling of the skin
- mild allergic reaction*
* To learn more about this side effect, see the “Side effects of isotretinoin in detail” section below.
Isotretinoin oral capsule may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.
Serious side effects of isotretinoin
Isotretinoin may cause certain serious side effects. If you have any serious side effects from isotretinoin oral capsule, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.
After the FDA approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with isotretinoin.
Serious side effects of isotretinoin oral capsule that occurred in studies include:
- mental health problems, such as depression, psychosis, and suicidal thoughts*
- brain problems*, which can lead to permanent vision loss, seizures, or stroke
- severe skin rashes
- organ damage, including damage to the liver and pancreas
- bone or muscle problems
- hearing problems, including hearing loss
- vision problems*
- increased fat and cholesterol levels in your blood
- blood clots in your legs or lungs
- stroke
- gastrointestinal problems, including damage to the esophagus and intestines
- increased blood sugar levels, which can cause new or worsened diabetes
- decreased red and white blood cell counts
- risk of harm during pregnancy†
- severe allergic reaction*
* To learn more about this side effect, see the “Side effects of isotretinoin in detail” section below.
† Isotretinoin oral capsule has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Isotretinoin and pregnancy” section below.
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Get free cardSide effects of isotretinoin in children
For children, doctors prescribe isotretinoin oral capsule to treat severe nodular acne. The drug is used for this purpose in children ages 12 years and older.
In studies, the following side effects were more common in children than in adults:
- back pain
- joint pain
- muscle aches
If you’d like to know more about side effects in children taking isotretinoin oral capsule, talk with your doctor or pharmacist.
Common questions about side effects of isotretinoin
Here are answers to some common questions about side effects of isotretinoin. If you have other questions, talk with your doctor or pharmacist.
Does isotretinoin cause long-term side effects?
Yes, in some cases isotretinoin oral capsule may cause long-term side effects. These can last for a while after you’ve stopped taking the drug.
Examples of long-term side effects reported with isotretinoin oral capsule include:
- vision problems, such as vision loss or trouble seeing in the dark
- hearing loss
- organ damage, including the pancreas, liver, or intestines
Talk with your doctor to learn more about these side effects and how to manage them. Ask your doctor for more information about how long these side effects of isotretinoin may last.
How do side effects of isotretinoin in males compare with those seen in females?
For the most part, the side effects of isotretinoin oral capsule were similar in males* and females*. However, in studies, back pain occurred more frequently in female children compared to male children†.
Isotretinoin also has a boxed warning for the risk of harm to an unborn fetus during pregnancy‡. A boxed warning is the most serious warning from the FDA. Isotretinoin oral capsule can increase the risk of life threatening birth defects in an unborn baby.
Because of this risk, people who can get pregnant need to use two forms of birth control for one month before, during, and after isotretinoin treatment. They also need to take monthly pregnancy tests.
If you have more questions about this, talk with your doctor.
* Sex and gender exist on spectrums. In this article, we use the terms “male” and “female” to refer to a person’s sex assigned at birth.
† To learn more about this side effect, see the “Side effects of isotretinoin in children” section above.
‡ To learn more about this side effect, see the “Isotretinoin and pregnancy” section below.
Do I need to stay out of the sun if I am taking isotretinoin?
Yes, you may be more likely to develop a sunburn or have a skin reaction if you’re exposed to sunlight or ultraviolet light (like those used in tanning beds) when taking isotretinoin. To protect yourself you should limit your time in the sun, wear protective clothing, and use sunscreen.
Talk with your doctor if you have questions about sun exposure while taking isotretinoin.
Side effects of isotretinoin in detail
Below you’ll find details on some of the side effects of isotretinoin oral capsule.
Mental health problems
In studies, serious mental health conditions such as depression, psychosis, and suicidal thoughts occurred in people taking isotretinoin oral capsule. With depression, you may experience constant feelings of sadness or anger that interfere with your daily activities. With psychosis, your thoughts, feelings, and senses feel real to you, but don’t line up with reality.
Symptoms of depression may include:
- feeling hopeless, sad, or “empty”
- crying a lot
- feeling annoyed or angry
- losing interest in activities you once enjoyed
- having difficulty sleeping or sleeping too much
- experiencing changes in weight or appetite
- having suicidal thoughts or behavior
Symptoms of psychosis may include:
- hallucinations
- disorganized speech or behavior
- decreased motivation
- not showing as much emotion
- personality changes
- anxiety and depression
- suicidal thoughts or behavior
Ways to manage
If you develop any symptoms of depression, psychosis, or have suicidal thoughts, tell your doctor right away. They may recommend that you stop taking isotretinoin and seek treatment from a medical professional.
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 Text Line 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.
Vision problems
In studies, vision problems occurred in people taking isotretinoin oral capsule. This side effect may be serious.
With vision problems, you may experience vision loss, blurry vision, cataracts, pink eye, and sensitivity to light. Isotretinoin oral capsule can also make it difficult to see at night. This issue typically goes away after you stop taking isotretinoin, but in some cases, it can be permanent.
Ways to manage
If you experience any changes to your vision, tell your doctor right away. They may recommend that you stop taking isotretinoin. Do not drive at night until you know how isotretinoin affects your vision.
Serious brain problems
In studies, serious brain problems occurred in people taking isotretinoin oral capsule.
Isotretinoin oral capsule can increase the pressure in your brain. This increased pressure can cause symptoms such as:
In severe cases, this can lead to death.
Ways to manage
If you experience any of the signs above, contact your doctor right away. They may recommend that you stop taking isotretinoin. If your symptoms feel life threatening or if you think you’re having a medical emergency, call 911 or your local emergency number right away.
Allergic reaction
For some people, isotretinoin oral capsule can cause an allergic reaction.
Symptoms can be mild or serious, and they may include:
- itchiness
- skin rash
- swelling under the skin, usually affecting eyelids, lips, hands, or feet
- swelling of the mouth, tongue, or throat, which can make it hard to breathe
- flushing (temporary warmth, redness, or deepening of skin color)
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling, trouble breathing, severe rash, or severe skin reactions, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to isotretinoin, your doctor may recommend taking a different medication instead.
Warnings for isotretinoin
Below are some factors you may want to discuss with your doctor before taking isotretinoin oral capsule.
Boxed warning: Risk of harm to unborn fetus during pregnancy
Isotretinoin has a boxed warning for the risk of harm to an unborn fetus during pregnancy. A boxed warning is the most serious warning from the FDA.
For details, see the “isotretinoin and pregnancy” section below.
Other warnings
It may not be safe for you to take isotretinoin oral capsule if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether isotretinoin oral capsule is a safe treatment option for you.
Before taking isotretinoin oral capsule, tell your doctor about your health and medications you take. Things to consider include:
- mental health conditions
- asthma
- liver disease
- diabetes
- heart disease
- osteoporosis
- anorexia nervosa
- past allergic reaction to isotretinoin
Isotretinoin and pregnancy
Isotretinoin oral capsule 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 require you to use two forms of birth control during your treatment with isotretinoin.
Boxed warning: Risk of harm to unborn fetus during pregnancy
Isotretinoin oral capsule has a boxed warning for the risk of harm to an unborn fetus during pregnancy. A boxed warning is the most serious warning from the FDA.
Isotretinoin can cause serious birth defects in an unborn fetus. Due to this risk, isotretinoin is only prescribed through the iPLEDGE Program. This is a program that ensures everyone who takes isotretinoin is aware of the risk of serious harm during pregnancy.
People who can get pregnant are required to use two forms of birth control during treatment with isotretinoin oral capsule. People who can get pregnant are also required to use two forms of birth control one month before and one month after isotretinoin treatment. Doctors will also require monthly pregnancy tests.
If you have more questions about this risk, talk with your doctor.
Isotretinoin and breastfeeding
Isotretinoin oral capsule 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 may recommend other ways to feed your child during treatment with isotretinoin.
Isotretinoin and alcohol
Isotretinoin oral capsule is not known to interact with alcohol.
But drinking alcohol while taking isotretinoin is generally not recommended. Isotretinoin and alcohol can both increase the risk of liver problems. So mixing the two can greatly increase the chance of liver damage.
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with isotretinoin.
What to ask your doctor
This article describes common and serious side effects of isotretinoin oral capsule. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.
Here’s a list of some possible questions you may want to ask your doctor:
- Am I at higher risk of side effects from isotretinoin when I first start treatment?
- Are there other drugs used for my condition that don’t have as many risks?
- Is the risk of mental health conditions higher if I take a higher dosage?
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.