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Claravis

(KLAR-a-vis)

For the treatment of a severe, nodular, hard-to-treat acne

Disclaimer

The content on this page is not medical advice and should be used for informational purposes only. Always consult your health care provider or pharmacist to determine what medication and dosage are right for you.

Last updatedFebruary 23, 2023

Claravis

Claravis is an oral retinoid reserved for treating severe, nodular, hard-to-treat acne.

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Generic name

Isotretinoin
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Rx or OTC

Available by prescription only

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Black box warning

Claravis should not be taken by females who are or may become pregnant. There is an extremely high risk that severe birth defects, some life-threatening, will result if pregnancy occurs while taking Claravis, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected.

Claravis is available only through a restricted program called the iPLEDGE program. Prescribers, patients, pharmacies, and distributors must enroll in the program.

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When & How

  • Take 2 times a day, preferably with fatty foods, like milk, eggs, or cheese.
  • Swallow capsule whole—do not break—with a full glass of water.
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Do’s

  • Female users must confirm they are not pregnant before starting Claravis.
  • You must enroll in the iPLEDGE program.
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Don’ts

  • Do not take on an empty stomach.
  • Don’t take two doses at the same time; if you miss a dose, skip it.
  • Never take if pregnant or plan on becoming pregnant.
  • Do not take other medicines or herbal products without discussing with your healthcare provider.
  • Avoid driving at night. Your night vision might be affected while taking Claravis.
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Discuss with your doctor

  • If you are pregnant or plan on becoming pregnant. Two negative pregnancy tests are required before starting.
  • If you are experiencing suicidal thoughts or had an attempted suicide.
  • If you are depressed or had depression in the past.
  • If you have an eating disorder like anorexia.
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What is Claravis?

Claravis is an oral retinoid that is taken to treat severe, nodular, and hard-to-treat acne that has not been helped by other treatments.

It works by shrinking the oil glands in the skin. It is taken for 4 to 6 months.

It has a very high risk of birth defects. Females need to confirm they are not pregnant or trying to become pregnant before and while taking it.

Claravis is a prescription-only medication restricted to patients who enroll in the iPledge program agree to be monitored for compliance with the guidelines.

Claravis dosages
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Capsules

  • 10 mg
  • 20 mg
  • 40 mg

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Side effects

Disclaimer

Medications may affect individuals differently. Usage of any medication may include side effects and other interactions. Here is a list of known common side effects and interactions. This list is not exhaustive -- there may be other side effects or interactions for this medication that are not listed here. In some cases, the likelihood of side effects or interactions may increase depending on dosage. It’s important to keep in mind that in extreme cases, other serious side effects, even death, may occur. Always consult your health care provider or pharmacist to determine what medication and dosage is right for you.

Common side effects

  • Inflammation of the lips
  • Dry mouth
  • Dry eyes
  • Dry nose
  • Nosebleeds
  • Itchy, dry skin
  • Bone or joint pain
  • Conjunctivitis
  • Decreased bone mineral density
  • Back pain in pediatric patients

Full list of side effects

  • Inflammation of the lips
  • Dry mouth
  • Dry eyes
  • Dry nose
  • Nosebleeds
  • Itchy, dry skin
  • Bone or joint pain
  • Conjunctivitis
  • Decreased bone mineral density
  • Back pain in pediatric patients
  • Skin infections
  • Decreased night vision
  • Ringing in the ears
  • Thinning of hair
  • Bone or joint pain
  • Broken bone
  • Lethargy
  • Headache
  • Fatigue
  • Anorexia
  • Nausea
  • Thirst
  • Generalized muscle aches
  • Pancreatitis
  • Severe stomach, chest or bowel pain
  • New or worsening heartburn
  • Diarrhea
  • Rectal bleeding
  • Dark urine
  • Yellowing of eyes or skin
  • Corneal opacities
  • Anemia
  • Premature closure of the growth bone plate

Long-term complications

  • Lipid abnormalities
  • Hepatitis
  • Mental illness like depression, psychosis (seeing or hearing things that are not real) and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive or violent behaviors
  • Hearing impairment or tinnitus

Safety notes

  • Claravis can cause serious birth defects, including abnormalities of the eyes, face, ears and skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Two forms of contraception are recommended to prevent pregnancy.
  • Miscarriage and premature births may occur if pregnancy was not prevented.
  • You need to wait at least one month after stopping Claravis to try to get pregnant.
  • Waxing and skin dermabrasion should be avoided because of a risk of scarring.
  • Skin is more sensitive to UV light from the sun. Avoid being in the sun for a long period of time and always apply sunscreen before going outdoors.
  • If you wear contact lenses, you may not be able to tolerate them because of dry eyes.
  • Do not donate blood while taking Claravis and for 1 month after stopping because the blood might be given to a pregnant woman, putting her fetus at risk of exposure.
  • Claravis increases your risk of liver disease and high cholesterol levels. Screening tests are necessary before treatment and monthly testing is necessary while taking Claravis.
  • Claravis may cause serious mental health problems like depression, psychosis (seeing or hearing things that are not real) and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive or violent behaviors.
  • Serious allergic reaction

What else you should know

  • Acne may get worse when you first start taking it. This will only last a short while.
  • Refills are not allowed. A new prescription is required each time you need to refill your medication.
  • Both your physician and the pharmacy must also be active in the FDA’s iPledge Program.

Claravis interactions

Disclaimer

Medications may affect individuals differently. Usage of any medication may include side effects and other interactions. Here is a list of known common side effects and interactions. This list is not exhaustive -- there may be other side effects or interactions for this medication that are not listed here. In some cases, the likelihood of side effects or interactions may increase depending on dosage. It’s important to keep in mind that in extreme cases, other serious side effects, even death, may occur. Always consult your health care provider or pharmacist to determine what medication and dosage is right for you.

Tell your doctor if you are taking any of these medications or supplements

  • Doxycycline
  • Tetracycline
  • Minocycline
  • Vitamin A
  • Calcium
  • Dilantin
  • Steroids
  • St. John’s wort
  • Dilantin (phenytoin)
  • The minipill (progesterone-only) birth control is not an adequate form of contraception while taking Claravis.

Tell your doctor if you have any of these pre-existing conditions

  • Pregnant or plan on becoming pregnant
  • Breastfeeding
  • Depression
  • Suicidal ideation, attempted suicide
  • Aggressive behavior
  • Anorexia or eating too little

Claravis pricing

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