Accutane (ack·yoo·tane) is US Food and Drug Association (FDA)-approved to treat severe acne with painful nodules and cysts.
Doctors sometimes prescribe Accutane as an off-label treatment for moderate acne, rosacea (a chronic inflammatory skin condition), pyoderma (a bacterial infection of the skin), and certain skin cancers. While the drug may be used therapeutically to treat these conditions, it is not yet FDA-approved for those particular uses.
It’s essential to note that the brand name drug Accutane is no longer available. It is, however, available under the drug’s generic name — isotretinoin. Throughout this article, we’ll continue to use the brand name Accutane, with which most people are familiar.
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You should not take Accutane if you're pregnant or planning a pregnancy.
Taking this medication while pregnant dramatically increases the risks of premature birth, miscarriage, congenital abnormalities, and infant mortality.¹
Everyone taking Accutane must register with the iPLEDGE program, an online Accutane risk management program created by the US FDA.²
The objective of the risk management and evaluation program is that no patient:
Starts isotretinoin therapy while pregnant
Becomes pregnant while undergoing isotretinoin therapy
If you are able to become pregnant and plan to start Accutane therapy, you must first consent and agree to using two forms of birth control. For example, condoms or cervical caps alongside hormonal contraceptives.
Before using Accutane, you must take a pregnancy test at your doctor’s office. Once you receive your negative test result, your doctor will file your registration within the iPLEDGE portal.
You'll need to take a second pregnancy test (at an approved lab) before receiving your Accutane prescription. In addition, you’ll need subsequent pregnancy tests before each refill and for 30 days after stopping the medication.
While these are strict measures, they help reduce the incidence of severe pregnancy complications. Following the iPLEDGE terms and your doctor's instructions will help you avoid adverse outcomes from using Accutane.
Do not breastfeed while taking Accutane or for one month after stopping. Consult your doctor for guidance on fertility and reproductive health while using Accutane.
Accutane, or isotretinoin, belongs to a group of drugs called retinoids. It’s a synthetic form of vitamin A.
Accutane is a treatment for severe acne that doesn't respond to conventional therapies, including antibiotics.³
In particular, Accutane treats severe nodular acne, a skin condition characterized by redness, inflammation, nodules (swollen bumps), cysts, and scarring. It is the only drug therapy that targets all the factors that contribute to acne.
Accutane reduces sebum production, helps prevent clogged pores, lowers the presence of P. acnes bacteria on the skin's surface and within the pores, and helps relieve inflammation.¹
The drug can, in some instances, offer a permanent cure for acne.
Accutane is an oral medication available in capsule form that’s usually taken once or twice a day, typically for four to five months.¹
Dosage and treatment duration vary from person to person, so follow your doctor's instructions carefully. It's also essential to follow all directions on the medication label.
When taking Accutane, ensure you:
Take it with food
Swallow the capsule whole with a glass of water or other liquid
Do not chew, break, suck, or crush the capsule
If you adhere to the prescribed course of Accutane, you will likely be clear of acne at the end of your treatment. However, it can take many weeks to begin seeing results, so be patient.
Accutane may make your acne worse at first. Still, keep taking Accutane as directed. Most people see improvements as they continue the course of their treatment.
Accutane is associated with a range of side effects. Some of the more common side effects include:
Taking Accutane while pregnant increases the risk of miscarriage, stillbirth, and severe congenital disorders. Routine pregnancy tests and adequate birth control methods are essential in reducing the risk of pregnancy complications related to Accutane use.
You may experience dryness of your eyes, skin, mouth, or nose (leading to nosebleeds). Some people also experience vaginal dryness while taking Accutane.
Your skin may become more sensitive to sunlight. Always remember to apply sunscreen before going outside to prevent sunburn.
It’s normal for acne to flare up in the first month or two of treatment with Accutane.
Other common and usually temporary side effects may include:
Muscle or joint pain
Reduced night vision
Fluctuations in certain blood test levels, such as a decrease in white blood cells or increased cholesterol¹
Accutane is associated with a number of serious side effects, including:
Inhibited bone growth, particularly in teens
Hearing changes and tinnitus (ringing in the ears)
There may be a connection between isotretinoin therapy and inflammatory bowel disease (IBD), but more research is needed to understand the relationships (if any exist) between the two. Some researchers suggest further examining a link between acne and IBD rather than the use of isotretinoin as a risk factor for developing IBD.⁴
Inform your doctor of any changes or side effects you experience while taking this medication.
Taking Accutane long-term may affect the functioning of your liver, stomach, and brain. There is a risk of increased brain pressure, which can affect your eyesight.⁵
Long-term use of Accutane can boost cholesterol levels, but the elevation is usually temporary and not cause for concern. In most cases, cholesterol levels return to normal after treatment ends.⁶
If you miss a dose of Accutane, take it as soon as you remember. However, if you're late by several hours, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose of Accutane to make up for a missed one.
Very few cases of Accutane overdose have been reported.
Overdose or toxicity symptoms may include vomiting, stomach pain, flushing, lightheadedness, loss of coordination, and severely chapped lips.
Female patients who have overdosed on Accutane should take all possible measures to prevent pregnancy within the month following the overdose. Because high levels of isotretinoin can remain in the semen, men who overdose on Accutane should use a condom or avoid sexual activity for one month.
All patients who overdose on Accutane should refrain from giving blood for at least 30 days.⁷
If you have taken more than your prescribed dosage of Accutane or someone has accidentally ingested the medication, call 911.
Before you take Accutane, discuss any concerns you may have with your doctor.
In particular, you may wish to discuss the following:
Could a pre-existing condition worsen and require different management while taking Accutane? For example, can you expect more discomfort if you have dry eyes due to Sjögren's syndrome? If so, what is the treatment approach?
If you have diabetes, you may need to check your blood sugar levels more frequently while taking Accutane. How will this differ from the way you presently manage your diabetes?
Will any medications, nutritional supplements, or multivitamins you take interfere with Accutane or pose a risk of an adverse interaction?
It may be unsuitable to engage in vigorous exercise while taking Accutane. A small number of cases have been reported in which individuals taking Accutane have developed musculoskeletal complaints.⁸
Will you be able to train or engage in intense activities, or is it best to wait until your course of Accutane ends?
Which methods of birth control are appropriate for use alongside Accutane? Will taking Accutane affect your plans to become pregnant in the future? When and how will you take your required monthly pregnancy test during your treatment?
Will you be able to wear contacts while taking Accutane? If so, how will you combat dryness?
There are no withdrawal symptoms from stopping Accutane. However, stopping the medication before completing the entire course may cause acne to return. Speak with your doctor if you have concerns about continuing Accutane therapy.
Typically, your doctor will monitor side effects and ask you to check in once monthly.
Your doctor may advise against taking Accutane if you have:
Plans to become pregnant or reason to believe you may be pregnant
Plans to breastfeed, as there is a lack of data on using Accutane while breastfeeding, and you should not breastfeed while taking Accutane or for one month after stopping the drug⁹
An allergic reaction to any of the ingredients in the medication
A diagnosed mental health condition or a history of psychiatric illness
Inflammatory bowel disease, including Crohn's disease or ulcerative colitis
High cholesterol or triglyceride levels
Too much vitamin A in your body
Not tried other acne treatments first
Alcohol should be avoided while taking Accutane, as both affect liver function and health.⁷
Interactions between Accutane and certain drugs may affect how the medication works and make it more likely for side effects to occur.
Some medications known to interfere with Accutane include (but may not be limited to):
Tetracyclines, such as doxycycline, minocycline, lymecycline, and oxytetracycline
Vitamin A-based drugs, like acitretin, bexarotene, and vitamin A supplements
Glucocorticoids and anti-seizure medications that can cause bone loss
If you plan to take any new medications, vitamins, or herbal supplements, let your doctor know. Typically, supplements are not tested for interactions with medications.
Avoid Accutane if you have a known hypersensitivity to its ingredients or vitamin A.⁷
Call 911 or go to the nearest hospital if you experience any of the following symptoms of an allergic reaction:
Tightness in the chest
Swelling of the mouth, lips, tongue, or airways
1982: FDA approves Hoffmann-La Roche’s Accutane (isotretinoin) for the treatment of severe acne
1989: FDA decides the Accutane iPLEDGE program must be implemented
2000: FDA and Hoffmann-La Roche create a requirement for a monthly pregnancy test for Accutane refills
2001: A Medication Guide on Accutane's side effects is created for distribution by pharmacists to patients
2009: Hoffmann-La Roche discontinues the use of Accutane while generic versions of the drug continue
2021: FDA creates two reproductive categories (male and female) for iPLEDGE
2021: Journey Medical Corporation in-licenses and launches Accutane for severe acne¹⁰
The following tips can help you take Accutane safely while ensuring optimal effectiveness:
Follow the prescribed dosage and course
Carry lip balm to prevent and treat dry lips
Use sun protection
Do not use tanning beds
Carry lubricating eye drops
Avoid waxing and other types of hair removal to prevent scarring
Use effective birth control during Accutane treatment and for one month after finishing treatment
Take monthly pregnancy tests
Report uncomfortable or unexpected side effects to your doctor
Make sure to keep all follow-up appointments with your doctor or dermatologist
Do not donate blood for at least one month after completing Accutane treatment
Do not have unprotected sex for at least one month after completing Accutane treatment
It’s best to avoid direct sun or tanning beds, drinking alcohol, using supplemental vitamin A, using other acne medications, and procedures that aggravate the skin (such as laser hair removal). Ask your doctor for a complete list of medications and substances to avoid while taking Accutane.
Taking Accutane may be helpful for individuals with severe acne that is unresponsive to other treatments. Ask your doctor to help you weigh the risks and possible benefits of Accutane.
Accutane has several ways of clearing acne, including shrinking oil glands, slowing sebum production, and inhibiting keratinization (skin cells producing a large amount of the substance keratin).
Isotretinoin use and the risk of inflammatory bowel disease: A population-based cohort study (2013)
Isotretinoin: The truth about side effects | American Academy of Dermatology Association
A common drug with a dangerous side effect: Acute rhabdomyolysis caused by the synergistic effect of isotretinoin and exercise in an adolescent (2020)
Fortress biotech’s partner company, journey medical corporation, in-licenses and launches accutane® for the treatment of severe recalcitrant nodular acne | GlobeNewsWire
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Here at HealthMatch, we’ve done our best to ensure that the information provided in this article is helpful, up to date, and, most importantly, accurate.
However, we can’t replace the one-to-one advice of a qualified medical practitioner or outline all of the possible risks associated with this particular drug and your circumstances.
It is therefore important for you to note that the information contained in this article does not constitute professional medical or healthcare advice, diagnosis or recommendation of treatment and is not intended to, nor should be used to, replace professional medical advice. This article may not always be up to date and is not exhaustive of all of the risks and considerations relevant to this particular drug. In no circumstances should this article be relied upon without independent consideration and confirmation by a qualified medical practitioner.
Your doctor will be able to explain all possible uses, dosages, precautions, interactions with other drugs, and other potential adverse effects, and you should always talk to them about any kind of medication you are taking, thinking about taking or wanting to stop taking.
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