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 drugs Absorica, Amnesteem, Claravis, Myorisan, and Zenatane.
Boxed warning: Risk of harm during pregnancy
Isotretinoin oral capsule has a boxed warning for the risk of harm during pregnancy. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
For details, see the “Warnings for isotretinoin” section below.
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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:
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:
* 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:
* 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 “Warnings for isotretinoin” section below.
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Side 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 to 17 years old.
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 oral capsule. 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:
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 females compare with those seen in males?
Most side effects of isotretinoin oral capsule were similar in males* and females*. But in studies, back pain occurred more frequently in female children compared with male children.
Isotretinoin oral capsule also has a boxed warning for the risk of life threatening birth defects in an unborn fetus during pregnancy†. A boxed warning is the most serious warning from the FDA.
Because of this risk, females who can become pregnant are required to use two forms of birth control for 1 month before, during, and 1 month after isotretinoin treatment. They must also take a pregnancy test before treatment, each month during treatment, and 1 month after stopping isotretinoin.
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.
† 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 “Warnings for isotretinoin” section below.
Can I have cosmetic procedures done while taking isotretinoin?
No. Isotretinoin oral capsule can increase your risk of scarring. So it’s best to avoid having cosmetic procedures done while taking isotretinoin and for at least 6 months after stopping the medication. Examples of cosmetic procedures include waxing, dermabrasion, or laser procedures.
If you are taking isotretinoin and have concerns about cosmetic procedures, talk with your doctor.
Side effects of isotretinoin in detail
Below you’ll find details on some of the side effects of isotretinoin oral capsule.
Serious skin reactions
In rare cases, isotretinoin oral capsule may cause serious skin reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN). But it’s important to note that skin reactions weren’t seen during studies of isotretinoin. There have been reports of this side effect in people using isotretinoin, but it’s unclear how often this has happened or whether isotretinoin was the cause.
SJS is a serious condition that causes your skin to loosen and detach. TEN causes severe skin peeling and blistering. Other symptoms of these severe skin reactions may include:
- fever
- sore throat
- muscle aches
- runny nose
- rash that starts on the face or chest and then spreads to the mucous membranes
- skin peeling with or without blistering
- large, raw areas of skin
These skin reactions can be severe and lead to hospitalization, disability, or even death.
Ways to manage
These skin reactions are considered medical emergencies that require treatment right away. If you develop a rash or any of the symptoms above, call 911 or your local emergency number right away. You will likely receive treatment and your doctor will have you stop taking isotretinoin.
Sensitivity to sunlight
In studies, sensitivity to sunlight was common in people taking isotretinoin oral capsule. This side effect may be serious. This side effect can increase your risk of sunburns and skin reactions.
Ways to manage
Limit your exposure to sunlight and ultraviolet (UV) rays while taking isotretinoin oral capsule. If you are going to be outside, be sure to use and reapply sunscreen and cover exposed skin by wearing hats, sunglasses, and long sleeves.
If you experience symptoms of sensitivity to sunlight or experience more frequent sunburns or skin reactions, tell your doctor. They’ll likely recommend avoiding prolonged periods outside. If you develop symptoms of sun sensitivity, they may suggest over-the-counter pain medication or topical steroid creams to decrease inflammation.
Vision problems
In studies, vision problems were rare in people taking isotretinoin oral capsule. This side effect may be serious. Vision problems may include vision loss, blurry vision, cataracts, trouble seeing at night, and sensitivity to light.
Isotretinoin can also cause dry eyes, making it difficult to wear contact lenses. In most cases, these side effects will go away once you stop taking isotretinoin. But in some cases, they can be permanent.
Ways to manage
If you experience any vision changes while taking isotretinoin oral capsule, stop taking the drug and contact your doctor. Avoid driving at night until you know how this medication affects your vision.
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 or trouble breathing, 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 oral capsule, 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 during pregnancy
Isotretinoin has a boxed warning for the risk of harm during pregnancy. A boxed warning is the most serious warning from the Food and Drug Administration (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:
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 may suggest birth control options to use during treatment with isotretinoin.
Risk of harm during pregnancy
Isotretinoin oral capsule can cause serious harm to your unborn baby if you’re pregnant. These include problems with fetal development (commonly known as birth defects), miscarriage, death of the baby, and premature birth.
Due to these risks, people who are pregnant or who plan to become pregnant should not take isotretinoin oral capsule. And people should not get pregnant 1 month before, during, or 1 month after isotretinoin treatment.
To minimize these risks, isotretinoin is only available through the iPledge REMS Program. This program ensures everyone who takes isotretinoin is aware of the risk of serious harm during pregnancy. The program has strict requirements, such as two negative urine or blood pregnancy tests before starting isotretinoin.
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 oral capsule is not known to interact with alcohol.
But your doctor may still recommend that you limit alcohol while taking isotretinoin oral capsule. Both isotretinoin and alcohol can increase your cholesterol and cause liver problems. Combining the two can greatly increase your risk of these problems.
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with isotretinoin oral capsule.
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:
- How do the side effects of isotretinoin compare to the side effects of other drugs used for my condition?
- Am I at higher risk of side effects given my medical history?
- Is my risk of vision problems 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.
