Lomitapide Side Effects
Medically reviewed by Drugs.com. Last updated on Jan 26, 2025.
Applies to lomitapide: oral capsule.
Important warnings
This medicine can cause some serious health issues
Oral route (capsule)
Lomitapide mesylate can cause elevations in transaminases.
Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended.
During treatment, adjust the dose of lomitapide mesylate if the ALT or AST is 3 times the ULN or greater.
Discontinue lomitapide mesylate for clinically significant liver toxicity.
Lomitapide mesylate increases hepatic fat (hepatic steatosis) with or without concomitant increases in transaminases.
Hepatic steatosis associated with lomitapide mesylate may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
Because of the risk of hepatotoxicity, lomitapide mesylate is available only through a restricted program called the Juxtapid® REMS Program.
Prescribe lomitapide mesylate only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
The safety and effectiveness of lomitapide mesylate have not been established in patients with hypercholesterolemia who do not have HoFH.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your bad cholesterol levels and to decide if you should continue to take it. Blood 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 and for at least 2 weeks after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
You must have a negative pregnancy test before you will be allowed to take this medicine. If you miss a period while you are using this medicine, tell your doctor right away.
Do not use this medicine if you also use any of the following: aprepitant (Emend®), boceprevir (Victrelis®), conivaptan (Vaprisol®), crizotinib (Xalkori®), diltiazem (Cardizem®), imatinib (Gleevec®), mibefradil (Posicor®), nefazodone (Serzone®), telaprevir (Incivek®), verapamil (Calan®), medicine to treat infections (such as ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicine to treat HIV/AIDS (such as amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir/ritonavir, Crixivan®, Kaletra®, Norvir®, Reyataz®). Using these medicines together can cause serious side effects.
Call your doctor right away if you have severe diarrhea, decrease in how much or how often you urinate, lightheadedness, or tiredness after using this medicine.
Using this medicine together with lovastatin or simvastatin may increase risk of a serious muscle problem called myopathy. Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever.
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 (including fatty liver). Do not use other medicines to lower cholesterol that can increase liver fat. Ask your doctor about these medicines.
Do not change your dose or Stop taking lomitapide without first talking with your doctor.
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 lomitapide
Along with its needed effects, lomitapide 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 lomitapide:
More common side effects
- arm, back, or jaw pain
- chest pain or discomfort
- chest tightness or heaviness
- dark urine
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- light-colored stools
- loss of appetite
- nausea and vomiting
- sweating
- trouble breathing
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
Other side effects of lomitapide
Some side effects of lomitapide 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
- chills
- constipation
- cough
- decreased weight
- diarrhea
- dizziness
- excess air or gas in the stomach or intestines
- frequent urge to defecate
- full or bloated feeling
- general feeling of discomfort or illness
- headache
- heartburn
- indigestion
- joint pain
- muscle aches and pains
- passing gas
- pressure in the stomach
- shivering
- sore throat
- stomach discomfort, upset, or pain
- straining while passing stool
- stuffy or runny nose
- sweating
- swelling of the abdominal or stomach area
- trouble sleeping
- weakness
Incidence not known
- hair loss or thinning of the hair
For healthcare professionals
Applies to lomitapide: oral capsule.
Cardiovascular adverse events
- Very common (10% or more): Chest pain (24%), angina pectoris (10%), palpitations (10%)[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (79%), nausea (65%), dyspepsia (38%), vomiting (34%), abdominal pain (34%), abdominal discomfort (21%), abdominal distention (21%), constipation (21%), flatulence (21%), gastroesophageal reflux disease (10%), defecation urgency ((10%), rectal tenesmus (10%), gastroenteritis (14%)[Ref]
Hepatic
- Very common (10% or more): Increased ALT (17%), at least one elevation in ALT and/or AST greater than or equal to 3 times ULN (29%), hepatic steatosis: of 23 patients in a study for 78 weeks, 18 (78%) exhibited an increase in hepatic fat greater than 5% and 3 (13%) exhibited an increase greater than 20%[Ref]
Immunologic
- Very common (10% or more): Influenza (21%)[Ref]
Metabolic
- Very common (10% or more): Weight loss (24%)[Ref]
Nervous system
- Very common (10% or more): Fatigue (17%), fever (10%), headache (10%), dizziness (10%)[Ref]
Respiratory
- Very common (10% or more): Nasopharyngitis (17%), pharyngolaryngeal pain (14%), nasal congestion (10%)[Ref]
Dermatologic
- Common (1% to 10%): Ecchymosis, papule, rash erythematous, xanthoma[Ref]
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References
1. (2013) "Product Information. Juxtapid (lomitapide)." Aegerion Pharmaceuticals Inc
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
Frequently asked questions
- Is Juxtapid FDA-approved as a high cholesterol treatment?
- What is the mechanism of action for Juxtapid (lomitapide)?
More about lomitapide
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: miscellaneous antihyperlipidemic agents
- Breastfeeding
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Further information
Lomitapide 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.