Recorlev

Pronunciation: re-kor-lev
Generic name: levoketoconazole
Dosage form: oral tablets (150 mg)
Drug class: Adrenal corticosteroid inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 9, 2025.

What is Recorlev?

Recorlev is used to treat high cortisol (endogenous hypercortisolemia) levels in adults with Cushing’s syndrome (CS) who cannot have surgery or who have had surgery that did not cure their Cushing's syndrome. It is an oral tablet that is taken 2 times a day.

Recorlev is a prescription medicine but is not available through every pharmacy. PANTHERx Rare Pharmacy is the only pharmacy that carries it, and they will deliver it right to you. Your support team will make sure you receive your treatment.

Recorlev works by blocking three key enzymes that make cortisol and testosterone in the body: CYP11B1, which produces cortisol; CYP11A1, which starts converting cholesterol to hormones; and CYP17A1, which helps make both cortisol and testosterone. This blocking action reduces cortisol production and helps return cortisol levels to normal. Recorlev belongs to the drug class called cortisol synthesis inhibitors.

Recorlev (levoketoconazole) gained FDA approval on December 30, 2021. There is no generic. It is not approved for the treatment of fungal infections.

Side effects

The most common side effects of Recorlev are:

• nausea/vomiting
• hypokalemia (low potassium)
• hemorrhage (easy bleeding)/contusion (easy bruising)
• high blood pressure
• headache
• liver injury
• abnormal uterine bleeding
• erythema (redness of the skin)
• fatigue
• abdominal pain/dyspepsia (upset stomach)
• arthritis
• upper respiratory infection
• myalgia (muscle pain)
• abnormal heart rhythm
• back pain
• sleep disturbances
• peripheral edema (fluid retention).

Recorlev may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

Serious side effects and warnings

Recorlev carries a Boxed Warning for liver damage and QT prolongation.

Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take Recorlev. Some people who are treated with ketoconazole, a medicine like the active ingredient in Recorlev, had serious liver problems that required a liver transplant or led to death. Call your healthcare provider right away if you have any of the following signs or symptoms:

• pain on the upper right side of your stomach area (abdomen) associated with nausea
• unusual fatigue
• yellowing of your skin or the whites of your eyes (jaundice)
• unusual bruising or bleeding.

Recorlev should not be used if you have any of the following conditions:

• cirrhosis
• active or poorly controlled liver disease
• frequent stones in your gallbladder (cholelithiasis)
• history of liver problems due to use of a drug.

Your healthcare provider will do liver tests before and during treatment with Recorlev.

Heart rhythm problems (QT prolongation). Recorlev can cause a heart problem called QT interval prolongation, or QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Call your healthcare provider right away if you feel severe lightheadedness or if you faint during treatment with Recorlev.

• Low blood electrolyte levels of potassium and magnesium can increase your chances of QT prolongation during treatment with Recorlev.
• Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and do blood tests to check your blood electrolyte levels before and during treatment with Recorlev.
• Recorlev should not be taken with certain other medicines that cause QT prolongation. Talk to your healthcare provider about the medicines you are taking before you start taking Recorlev.

Recorlev can cause other serious side effects, including:

• Low cortisol levels (adrenal insufficiency). Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones, such as cortisol. Recorlev may cause adrenal function insufficiency by excessively lowering the production of cortisol. Call your healthcare provider right away if you have one or more of the following symptoms, as these may be symptoms of reduced adrenal function:
  • nausea or vomiting
  • dizziness
  • unusual fatigue
  • low blood pressure (hypotension)
  • unexplained stomach pain (abdomen)
  • abnormal electrolyte levels
  • loss of appetite
  • low blood sugar (hypoglycemia)
  • body aches.

Your healthcare provider will collect blood or urine samples to measure your cortisol.

• Hypersensitivity reactions. Serious allergic reactions can happen in people who take Recorlev. Call your healthcare provider right away, or visit an emergency center, if you get a rash, itching, hives, fever, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
• Risks related to decreased testosterone. Recorlev may lower testosterone levels in males and females. Call your healthcare provider if you have any of these symptoms:
  • Males: breast enlargement (gynecomastia) and erectile dysfunction (impotence)
  • Females: low desire for sex (decreased libido) and mood changes.

These are not all the possible side effects of Recorlev. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

Related/similar drugs

Before taking

Do not take Recorlev if you:

• have or have had liver problems
• take certain other medicines that cause QT prolongation
• have a history of certain heart problems which may include one of the following conditions: torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome
• are allergic to levoketoconazole, ketoconazole, or any of the ingredients in Recorlev
• take certain medicines that may affect how your liver works (for example, CYP3A4 inhibitors). If you are not sure if you should take these medicines, please ask your healthcare provider.

Before taking Recorlev, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had liver problems
• have any heart problems, including a condition called long QT syndrome
• have a history of low blood levels of potassium or magnesium
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Your healthcare provider will obtain baseline liver and electrocardiogram tests and correct low potassium levels (hypokalemia) or low magnesium levels ( hypomagnesemia) before starting Recorlev.

Pregnancy

Recorlev may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Recorlev or think you might be pregnant.

Breastfeeding

Recorlev can pass into your breast milk. You and your healthcare provider should decide if you should take Recorlev or breastfeed. You should not breastfeed during treatment with Recorlev and for 1 day after the final dose.

How should I take Recorlev?

Take Recorlev exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Recorlev to take and when to take it.

• Recorlev is taken by mouth 2 times a day.
• Take with or without food.

Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with Recorlev if needed.

Dosing information

Dose of Recorlev for Cushing's syndrome in Adults

• Initial: 150 mg orally twice daily.
• Titration: Titrate dosage by 150 mg daily, no more frequently than every 2-3 weeks.
• Maximum Dosage: 600 mg twice daily (total 1200 mg/day).

See the Recorlev Full Prescribing Information for additional recommendations on titration, monitoring, and dosage modifications for hepatotoxicity, QT prolongation, and hypocortisolism.

What happens if I miss a dose?

If you miss a dose of Recorlev, take the next dose at your regular scheduled time.

What happens if I take too much?

If you take too much Recorlev, call your healthcare provider or go to the nearest hospital emergency room right away

What should I avoid while taking Recorlev?

Avoid drinking alcohol to excess while taking Recorlev because it may increase your chances of having serious side effects.

What other drugs will affect Recorlev?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Recorlev and other medicines may affect each other causing side effects. Recorlev may affect the way other medicines work, and other medicines may affect how Recorlev works.

Storage

Store Recorlev at room temperature between 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

Ingredients

What are the ingredients in Recorlev?

Active ingredient: levoketoconazole.

Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, modified corn starch, and silicified microcrystalline cellulose.

Available as 150 mg tablets.

Company

Recorlev is distributed by Xeris Pharmaceuticals, Inc., Chicago, IL 60607.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer