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Recorlev is used to treat Cushing’s disease, a disorder where you have too much cortisol (a stress hormone) in your body. Common side effects include nausea, vomiting, headache, upset stomach, and joint or muscle pain. Serious side effects are less likely but may include liver damage, heart rhythm changes, reduced adrenal function, and low testosterone levels. Contact your health care provider right away if you have breathing problems, weakness, or unusual tiredness or feel like your heart is beating fast or skipping beats.

Uses

What is Recorlev used for?

Recorlev (levoketoconazole) is commonly used to treat Cushing’s disease. 

Recorlev may also be used for other conditions as determined by your health care provider.

How does Recorlev work (mechanism of action)?

Cortisol is a stress hormone that affects various body functions, including inflammation, blood pressure, and blood sugar management. People with Cushing’s disease have an increased level of cortisol in their blood (hypercortisolemia). Recorlev reduces the amount of cortisol your body makes. 

How is Recorlev supplied (dosage forms)?

Brands and other names

  • Recorlev

Dosage forms and strengths

  • 150 mg oral tablets

How should I store Recorlev?

Recorlev should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Recorlev?

The most common side effects of Recorlev are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea, vomiting, upset stomach, or indigestion
  • Low potassium levels
  • Bleeding or bruising, including vaginal bleeding
  • High blood pressure
  • Headache
  • Liver damage (see below)
  • Skin redness
  • Tiredness
  • Joint, muscle, or back pain
  • Infection in the nose or throat
  • Heart rhythm changes (see below)
  • Trouble sleeping
  • Fluid retention in arms or legs

There may be other side effects of Recorlev that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Recorlev?

While less common, the most serious side effects of Recorlev are described below, along with what to do if they happen.

Severe Allergic Reactions. Recorlev may cause allergic reactions, which can be serious. Stop taking Recorlev and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Recorlev. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish (also called jaundice)

Heart Rhythm Changes. Recorlev may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Reduced Adrenal Function. Recorlev can cause an excessive decrease in the amount of cortisol your adrenal glands produce (adrenal insufficiency). Sometimes the reduction in adrenal function can be life-threatening. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.

  • Nausea and vomiting
  • Weakness, tiredness, or lack of energy
  • Stomach pain
  • Feel achy
  • Loss of appetite
  • Low blood pressure
  • Low blood sugar

Low Testosterone Levels. Recorlev can lower the level of testosterone (male sex hormone) in your blood. This can affect all people who take it. Tell your health care provider if you have any of the following symptoms of low testosterone levels.

  • Sexual dysfunction and decreased libido
  • Enlarged breasts (in males)
  • Lower sperm count (in males)
  • Mood changes (in females)

Warnings & Precautions

Who should not use Recorlev?

Allergies to Ingredients. People who are allergic to any of the following should not take Recorlev.

  • Ketoconazole
  • Levoketoconazole
  • Recorlev
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Recorlev.

Liver or Gallbladder Problems. Recorlev should not be taken if your liver is not working as well as it should be or you had liver problems with other medicines before. You should also not take Recorlev if you have trouble with frequent gallstones. If there is a concern about the health of your liver or gallbladder, your health care provider may do tests to see if they are working well enough to take this medicine.

Drug Interactions. Recorlev should not be taken while you are using certain other medicines. Before taking Recorlev, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Heart Rhythm or Rate Problems. Recorlev should not be taken if you have certain heart rhythm or heart rate problems, including family history of certain conditions. If there is a concern about your heart condition, your health care provider may do tests to see if Recorlev is safe for you to take.

What should I know about Recorlev before using it?

Do not take Recorlev unless it has been prescribed to you by a health care provider. Take it as prescribed.

Follow any dosing instructions from your health care provider closely. They will tell you exactly how many Recorlev tablets to take. 

Do not share Recorlev with other people, even if they have the same condition as you. It may harm them.

Keep Recorlev out of the reach of children.

While you are taking Recorlev, your health care provider may do blood tests or heart monitoring to make sure that Recorlev is both safe and effective for you. Keep all appointments you make with your health care provider.

Recorlev may make it hard for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Recorlev?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Recorlev is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Heart failure
  • Electrolyte imbalance, including low potassium or magnesium levels

Pregnancy. Recorlev may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. If you get pregnant or think you are pregnant while taking Recorlev, tell your health care provider right away.

Breastfeeding. Recorlev passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Recorlev.

How can I get more information about Recorlev?

For more information about Recorlev, you can visit the drugmaker’s website at www.recorlev.com or call them at 877-937-4737.

Interactions

Does Recorlev interact with foods or drinks?

There are no known interactions between Recorlev and foods or drinks.

Drinking alcohol while taking Recorlev may cause unpleasant side effects, including flushing, rash, swelling, nausea, and headache. Both Recorlev and alcohol can increase your risk of liver damage. It is best to limit the amount of alcohol you drink.

Does Recorlev interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Recorlev.

  • Medicines that can cause QT prolongation (a potentially dangerous heart rhythm problem), such as clarithromycin, pimozide, or quinidine
  • A medicine to reduce stomach acid, such as an antacid, an H2 blocker (such as cimetidine, famotidine, or nizatidine), a proton pump inhibitor (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole), or sucralfate (Carafate)
  • A medicine for HIV, AIDS, or hepatitis C
  • Any medicine for seizures, such as carbamazepine or phenytoin
  • Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection
  • Rifampin (Rifadin) or isoniazid, which are medicines commonly used to treat an infection called tuberculosis
  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • A statin, such as atorvastatin (Lipitor and others), lovastatin (Altoprev), or simvastatin (Zocor), which is a medicine to lower cholesterol
  • Metformin (Fortamet, Glumetza), which is a medicine used to lower blood sugar levels in people with type 2 diabetes
  • Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure
  • A benzodiazepine, such as midazolam or triazolam, which is a medicine used for anxiety, muscle spasms, or seizures
  • Felodipine, nicardipine, or nisoldipine, which are medicines used for high blood pressure and other conditions
  • Lurasidone (Latuda), which is a medicine for certain mental health conditions
  • An opioid, such as methadone, which is a medicine used for certain types of pain
  • Vardenafil (Levitra, Staxyn), which is a medicine used for erectile dysfunction 
  • Tacrolimus (Astagraf XL, Envarsus XR, Prograf), which is a medicine used to prevent organ rejection after a transplant
  • Disopyramide, dofetilide, or dronedarone (Multaq), which are medicines used to control your heart rate or rhythm (antiarrhythmic)
  • Ranolazine, which is a medicine used to treat chest pain

Many other medicines may alter the blood levels of Recorlev, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Recorlev. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Recorlev?

If you or someone else has used too much Recorlev, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Recorlev?

If you miss a dose, take the next dose at the regularly scheduled time. Do not take double or extra doses. 

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