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Recorlev Side Effects

Generic name: levoketoconazole

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Note: This document provides detailed information about Recorlev Side Effects associated with levoketoconazole. Some dosage forms listed on this page may not apply specifically to the brand name Recorlev.

Applies to levoketoconazole: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Hepatotoxicity. Cases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with the use of oral ketoconazole.

Some patients had no obvious risk factors for liver disease.

Serious hepatotoxicity has been reported in patients receiving levoketoconazole.Levoketoconazole is contraindicated in patients with cirrhosis, acute liver disease or poorly controlled chronic liver disease, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease.Evaluate liver enzymes prior to and during treatment.

Interrupt levoketoconazole treatment immediately if signs of hepatotoxicity occur.QT Prolongation. Levoketoconazole is associated with dose-related QT interval prolongation.

QT interval prolongation may lead to life-threatening ventricular dysrhythmias such as torsades de pointes.Coadministration of levoketoconazole with other drugs that prolong the QT interval associated with ventricular arrhythmias, including torsades de pointes, and use in patients with a prolonged QTcF interval of greater than 470 msec at baseline, history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history) are contraindicated.Perform an ECG and correct hypokalemia and hypomagnesemia prior to and during treatment.

Temporarily discontinue levoketoconazole if QTcF interval exceeds 500 msec.

Precautions

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

You should not use this medicine together with alfentanil (Alfenta®), avanafil (Stendra®), bosutinib (Bosulif®), buspirone (Buspar®), cisapride (Prepulsid®), clarithromycin (Biaxin®), cobimetinib (Cotellic™), conivaptan (Vaprisol®), crizotinib (Xalkori®), dabigatran (Pradaxa®), darifenacin (Enablex®), darunavir (Prezista®), digoxin (Lanoxin®), disopyramide (Norpace®), dofetilide (Tikosyn®), dronedarone (Multaq®), ebastine (Ebast®), eliglustat (Cerdelga®), everolimus (Afinitor®), fexofenadine (Allegra®), ibrutinib (Imburvica™), ivabradine (Corlanor®), lomitapide (Juxtapid®), lovastatin (Mevacor®), lurasidone (Latuda®), methadone (Methadose®), midazolam (Versed®), midostaurin (Rydapt®), naloxegol (Alfenta®), nicardipine (Cardene®), nisoldipine (Alfenta®), pimozide (Alfenta®), quinidine (Alfenta®), ranolazine (Movantik®), saquinavir (Invirase®), simvastatin (Zocor®), sirolimus (Rapamune®), tacrolimus (Astagraf XL®), tipranavir (Aptivus®), triazolam (Halcion®), or vardenafil (Levitra®).

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

This medicine may cause heart rhythm problems (eg, QT prolongation). Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.

Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problems (eg, low cortisol levels).

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, or unusual tiredness or weakness.

This medicine may decrease testosterone levels in men and women. Check with your doctor right away if you have decreased interest in sexual intercourse, inability to have or keep an erection, loss in sexual ability, desire, drive, or performance, mood changes swelling of the breasts or breast soreness.

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Recorlev

Along with its needed effects, levoketoconazole (the active ingredient contained in Recorlev) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levoketoconazole:

More common side effects

  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chills
  • cough
  • coughing up blood
  • darkening of the skin
  • decreased interest in sexual intercourse
  • decreased urine
  • diarrhea
  • difficulty in swallowing
  • dizziness
  • dry mouth
  • ear congestion
  • fainting
  • fever
  • headache
  • inability to have or keep an erection
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • loss in sexual ability, desire, drive, or performance
  • loss of appetite
  • loss of voice
  • mental depression
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • paralysis
  • prolonged bleeding from cuts
  • pounding in the ears
  • rapid weight gain
  • red or black, tarry stools
  • red or dark brown urine
  • seizures
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • trouble breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss

Less common side effects

  • swelling of the breasts or breast soreness in both females and males

Incidence not known

  • bulging soft spot on head of an infant
  • change in ability to see colors, especially blue or yellow
  • chest tightness
  • dark urine
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • stomach pain, severe
  • trouble sleeping
  • unusual bleeding or bruising
  • yellow eyes or skin

Other side effects of Recorlev

Some side effects of levoketoconazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • acid or sour stomach
  • back pain
  • belching
  • difficulty in moving
  • heartburn
  • indigestion
  • loss or thinning of the hair
  • muscle aches or stiffness
  • pain, swelling, or redness in the joints
  • stomach discomfort or upset

Incidence not known

  • increased sensitivity of the skin to sunlight
  • redness or other discoloration of the skin
  • severe sunburn

For healthcare professionals

Applies to levoketoconazole: oral tablet.

General adverse events

The most significant adverse reactions were hepatotoxicity, QT prolongation, and hypocortisolism.[Ref]

Hepatic

Percentage of patients with elevations in AST or ALT:

AST or ALT greater than the upper limit of normal (ULN): 45%

AST or ALT greater than 3 times ULN (3 x ULN): 11%

AST or ALT greater than 5 x ULN: 5%

AST or ALT greater than 10 x ULN: 3%[Ref]

Ketoconazole:

Level 2

Up to 27% of the patients had at least 1 liver-related adverse reaction.

Cardiovascular

Level 2

In general, 2.4% of the patients experienced QTcF greater than 500 msec, while 14.7% of patients experienced change-from-baseline QTcF greater than 60 msec.[Ref]

Endocrine

Ketoconazole:

Dermatologic

Ketoconazole:

Other

Nervous system

Ketoconazole:

Gastrointestinal

Metabolic

Musculoskeletal

Genitourinary

Ketoconazole:

Level 2

Azoospermia was reported with dosages higher than 200 or 400 mg daily.[Ref]

Psychiatric

Respiratory

Hypersensitivity

Ketoconazole:

Hematologic

Ketoconazole:

See also:

References

1. (2022) "Product Information. Recorlev (levoketoconazole)." Xeris Pharmaceuticals Inc

Further information

Recorlev side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.