Claravis (Isotretinoin) – Oral

Warning:

Claravis (isotretinoin) carries a warning against its use to treat people who are pregnant or may become pregnant unless other forms of treatment have been tried first and have failed. Claravis can cause harm to the fetus if used during pregnancy.

What Is Claravis?

Claravis (isotretinoin) is a powerful oral medication used to treat severe inflammatory acne that is not resolved by other treatments. It is available in a gelatin capsule form. 

Claravis treats acne by preventing oil production in glands underneath the skin. When the skin cannot produce excessive amounts of oil, the skin's pores are unlikely to clog and create pimples. 

This medication carries a warning against its use in people who are pregnant or can become pregnant unless other forms of treatment have been tried first and have failed. When used during pregnancy, Claravis can cause birth defects.

Drug Facts

Generic Name: Isotretinoin

Brand Name(s): Claravis, Absorica, Amnesteem, Myorisan, Zenatane

Administration Route: Oral

Drug Availability: Prescription

Therapeutic Classification: Retinoid

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Isotretinoin

Dosage Form(s): Capsule

What Is Claravis Used For?

The Food and Drug Administration (FDA) approved Claravis to treat severe forms of acne in individuals 12 years of age and older. This type of acne, known as inflammatory acne, is typically deep and painful. Often, it is resistant to treatment by most topical and oral medications.

Your healthcare provider might prescribe Claravis for you if you have not had any success with other therapies.

How to Take Claravis

Follow your healthcare provider’s instructions when taking this medication. The amount that you take each day is based on body weight. Claravis is usually prescribed for use twice per day. Your healthcare provider may change your dose if necessary.

When taking Claravis, swallow the gelatin capsule whole with a full glass of water or other liquid.

Sun sensitivity is very common while taking this medication. It is important to wear sunscreen daily, especially on the face and lips, regardless of the time of year.

Storage

Store this medication at controlled room temperature (68 degrees to 77 degrees Fahrenheit). It must be protected from light and kept out of the reach of children and pets.

Off-Label Uses

Healthcare providers may prescribe Claravis for off-label uses, meaning for conditions not specifically indicated by the FDA.

Off-label uses for Claravis include:

How Long Does Claravis Take to Work?

A single course of therapy for Claravis is around 15–20 weeks. For most people, their disease will clear up in one course.

What Are the Side Effects of Claravis?

Claravis is a very powerful drug that has the potential for serious side effects that may be dose-related.

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

There are common side effects that may go away after continuous use of this medication. Although they aren’t alarming, it is important to contact your doctor if the side effects are persistent or concerning. Common side effects include:

  • Dry mouth, eyes, skin, and lips 
  • Nose irritation 
  • Poor night vision 
  • Discomfort with contact lenses

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Stop taking this medication and contact your healthcare provider immediately if you develop these rare side effects: 

  • Weakness on one side of the body
  • Trouble speaking or thinking 
  • Vision impairment
  • Hearing impairment
  • Depression
  • Psychosis
  • Suicidal thoughts, rarely
  • Acute pancreatitis (inflammation of the pancreas)
  • Increase in triglycerides
  • Infection 
  • Liver problems: Characterized by dark urine, fatigue, lack of appetite, nausea 
  • Inflammatory bowel disease and abdominal pain
  • Abnormal heartbeat 
  • Stevens-Johnson Syndrome (rare disorder of the skin and mucous membranes)

If you begin to have thoughts of hurting yourself, seek immediate medical help. Help is always available, and if you have any trouble finding help, you can contact the National Suicide Prevention Lifeline at 800-273-8255.

Long-Term Side Effects

Long-term use of Claravis has not been studied and is not recommended. Your healthcare provider will monitor you carefully while taking this medication. You will not typically take this medication longer than the approved and recommended timeframe.

Report Side Effects

Claravis may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much of Claravis Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For acne:
      • Adults and children 12 years of age and older—Dose is based on body weight and must be determined by your doctor.
        • Absorica® and Accutane®: The dose is usually 0.5 to 1 milligram (mg) per kilogram (kg) of body weight per day, taken as 2 divided doses for 15 to 20 weeks. Your doctor may adjust your dose as needed.
        • Absorica LD™: The dose is usually 0.4 to 0.8 milligram (mg) per kilogram (kg) of body weight per day, taken as 2 divided doses for 15 to 20 weeks. Your doctor may adjust your dose as needed.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Modifications

In certain cases, your healthcare provider may adjust your dosage of Claravis or decide not to prescribe Claravis to you.

Children 

Use of Claravis is only indicated in children 12 years of age and older. The medication has not been studied in individuals younger than 12. 

Pregnancy 

Pregnant individuals cannot take this medication under any circumstances. It can cause extreme harm to the fetus, increasing the risk of abnormalities and premature birth. If you become pregnant while taking Claravis, you must stop taking it immediately. 

Breastfeeding

It is currently unknown if this drug can be found in breast milk. However, with the potential for serious adverse reactions in nursing infants, it may be under the recommendation of the healthcare provider to discontinue nursing or discontinue the medication. 

Older Adults (Aged 65 and Older)

It is currently unknown if adults aged 65 and older will have a different response to Claravis compared to younger adults. Use of the medication will be under the decision of the prescribing healthcare practitioner.

Missed Dose

If you miss a dose, skip the missed dose and continue with your normal timing of taking the medication. Do not take two doses at the same time or extra doses.

Overdose: What Happens If I Take Too Much Claravis?

Overdose symptoms can include: 

  • Headache
  • Dizziness
  • Vomiting
  • Stomach pain

An overdose is more likely to occur if Claravis is taken with vitamin A, supplements that have vitamin A, or if taken more often than prescribed by your healthcare provider.

What Happens If I Overdose on Claravis?

If you think you or someone else may have overdosed on Claravis, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses, has a seizure, has trouble breathing, or can’t wake up after taking too much Claravis, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Isotretinoin causes birth defects in humans if taken during pregnancy. If you suspect that you may have become pregnant, check with your doctor right away.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant 1 month before beginning treatment, while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap.

Isotretinoin must not be taken by women of reproductive age who may become pregnant unless 2 effective forms of birth control have been used for at least 1 month before the start of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure that you have discussed this information with your doctor.

If you are a woman who is able to have children, you must have 2 pregnancy tests before beginning treatment with isotretinoin to make sure you are not pregnant. The second pregnancy test must be taken at least 19 days after the first test and during the first 5 days of the menstrual period immediately before beginning treatment. In addition, you must have a pregnancy test each month while you are using this medicine and 1 month after treatment is completed.

Do not take vitamin A or any vitamin supplement containing vitamin A while using this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

During the first 3 weeks you are taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within 1 to 2 months after starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop using isotretinoin and may take up to 6 months. Your doctor can help you choose the right skin products to reduce skin dryness and irritation.

You or your child should not donate blood to a blood bank while using isotretinoin or for 30 days after you stop using it. This is to prevent a pregnant patient from receiving blood that contains the medicine.

In some patients, isotretinoin may cause a decrease in night vision. This problem may occur suddenly. If it does occur, do not drive or do anything else that could be dangerous until you know how this medicine affects you. Also, check with your doctor.

Isotretinoin may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them during the time you are using isotretinoin and for up to 2 weeks after stopping it. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.

Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to sunlight, wind, or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks of treatment. However, you or your child should not stop using this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.

To help isotretinoin to work properly, use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

Isotretinoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

This medicine may increase pressure in your head, which may lead to vision loss or serious brain problems. Check with your doctor right away if you have a bad headache, blurred vision, dizziness, nausea, vomiting, or seizures.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may also heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.

It is very important that you or your child not use wax epilation to remove hair while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from wax epilation.

It is very important that you or your child not have any cosmetic procedures to smooth your skin (eg, dermabrasion, laser) while you are using isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.

This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Isotretinoin may cause some people to have hearing problems within a few weeks after they start using it. Check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you or your child have abdominal or stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, redness, soreness, or itching skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine contains FD&C Yellow No.5 (tartrazine) which may cause an allergic reaction, including asthma, in some people. This reaction is more often seen in people who also have an allergy to aspirin.

This medicine lowers the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, and prescription or nonprescription (over-the-counter [OTC]) medicines. Some medicines or nutritional supplements (eg, St. John's wort) may cause your birth control pills to not work as well.

What Are Reasons I Shouldn’t Take Claravis?

There are some cases in which Claravis may not be the right medication for you.

Pregnancy 

Claravis can cause major harm to a developing fetus.

Anyone taking Claravis must be registered in the iPLEDGE™ risk management program as the medication is toxic to a potential fetus. In addition, the program requires you to be on two forms of contraception. Both contraceptive forms must be used simultaneously, beginning one month before treatment, during treatment, and one month after stopping therapy.

If you are of childbearing potential, your healthcare provider will not begin this medication without two negative pregnancy tests at least 19 days apart. Testing should continue monthly during therapy. Upon finishing your treatment, you should have a pregnancy test soon after your last dose and one month after your last dose to ensure that you are not pregnant.

Hypersensitivity 

Any signs of an allergic reaction (e.g., hives, itching, swelling) may mean that your body is not tolerating the ingredients used to make this medication. It is important to let your healthcare provider know so that they can recommend an alternative acne treatment.

What Other Medications Interact With Claravis?

Claravis can interact with the following substances:

  • Vitamin A: If vitamin A is taken with Claravis there can be excessive amounts of it in the body, increasing the risk of unwanted side effects. It is important to avoid vitamin A while taking this medication. 
  • Tetracyclines: Use with Claravis is not recommended. It has the potential to cause swelling of the brain that can have serious and permanent consequences (pseudotumor cerebri
  • Saint-John’s-wort: Use of Claravis and Saint-John’s-wort together have been associated with depression.
  • Corticosteroids: When taken with Claravis, these medications may weaken your bones.
  • Progestin-only birth control pills: Claravis may make these less effective. 
  • Dilantin (phenytoin): Taking Dilantin with Claravis can weaken your bones.

What Medications Are Similar?

There are numerous medications that your healthcare provider may recommend to try before starting you on Claravis.

Common medications used similarly for persistent acne may include: 

  • Retinoids: Retinoids (such as adapalene) are topical medications that work differently than Claravis. Their action against acne is to promote the breakdown of the top layers of the skin to allow for cell growth in its deeper layers. 
  • Antibiotics: Topical or oral antibiotics can help to clear the acne-causing bacteria within the pores of the skin. Common antibiotics include tetracyclines, such as Cleocin (clindamycin), Vibramycin (doxycycline), and others; and macrolides, including Zithromax (azithromycin) and Ery-Tab (erythromycin), among others.
  • Benzoyl peroxide: Like antibiotics, benzoyl peroxide works by ridding the skin of acne-causing bacteria. It is available as a prescription or found over the counter. 
  • Hormonal treatments: Hormonal imbalances can cause the skin to produce excess amounts of oil, causing persistent acne. Birth control pills can help to treat acne by keeping one’s hormones under control. Some examples of birth control pills used for acne include Beyaz (ethinyl estradiol/drospirenone/levomefolate), Ortho Tri-Cyclen (ethinyl estradiol/norgestimate), and Yaz (ethinyl estradiol/drospirenone).

The above is a list of drugs also prescribed for acne. It is not a list of drugs recommended to take with Clavaris. You should not take these drugs together. Ask your pharmacist or a healthcare practitioner if you have questions.

Frequently Asked Questions

  • What is iPLEDGE?

    iPLEDGE is a program designed to protect patients and eliminate the risks of using Claravis during pregnancy. 

    This program requires that:

    • Only prescribing healthcare practitioners registered in this program can prescribe Claravis.
    • Only registered pharmacies can dispense Claravis.
    • People taking Claravis register for and meet the requirements of the program.
    • All people of childbearing potential use two forms of effective birth control at least one month before starting therapy and throughout its course.
  • Will I ever have to use Claravis again after finishing my course?

    This varies from person to person. You may need to take another course of this medication after time off of using Claravis for at least eight weeks.

  • How can I protect my skin while taking Claravis?

    Protecting your skin from the sun by wearing protective clothing and sunscreen and avoiding tanning are recommended. For any specific questions or concerns regarding skin maintenance, contact your dermatologist.

How Can I Stay Healthy While Taking Claravis?

As with any medication, it is important to make appropriate lifestyle changes to achieve maximum benefits. To stay healthy, here are some recommendations: 

  • Take the medication exactly as directed.
  • Use two forms of contraception and get regular pregnancy tests.
  • Maintain a regular exercise regimen.
  • Avoid vitamins and supplements with vitamin A.
  • Communicate your symptoms or concerns with trusted healthcare providers.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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