Prescription medicine
Lomitapide Brand names: Juxtapid
Lomitapide (Juxtapid) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the lomitapide FDA label on DailyMed (effective March 30, 2026, Chiesi USA, Inc.); the NDA 203858 record on Drugs@FDA; every lomitapide label on DailyMed.
Highlights of the record
FDA label of March 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF HEPATOTOXICITY.
JUXTAPID can cause elevations in transaminases. In the adult clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase. In the pediatric clinical trial (5 to 17 years of age), 6 (14%) of the 43 patients experienced elevations in ALT and/or AST ≥ 3 times ULN. No concomitant clinically meaningful elevations in total bilirubin or alkaline phosphatase were observed [see Warnings and Precautions (5.1) ]. JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat in adult patients was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy (MRS). The median absolute increase in hepatic fat in pediatric patients aged 5 to 17 years was 4% after 24 weeks and 104 weeks of treatment, from 3% at baseline, measured by nuclear magnetic resonance (NMR). Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageJUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH).
Forms and strengths
- 2 mg
- 5 mg
- 10 mg
- 20 mg
- 30 mg
Capsule.
On the market
- Earliest approval on file
- December 21, 2012 Juxtapid, Chiesi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 29, 2041 Juxtapid capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,759 through July 30, 2026
What is lomitapide used for?
From the label: indications and usageJUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH). JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and exercise and other low-density lipoprotein cholesterol (LDL-C) therapies, to reduce LDL-C in adult and pediatric patients aged 2 years and older with HoFH. ( 1 ).
Conditions named in the indications of lomitapide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Microsomal Triglyceride Transfer Protein Inhibitor.
Source: FDA drug label (Juxtapid), Chiesi USA, Inc., effective March 30, 2026 (SPL set 61a0be9d-ee58-43e0-b5cb-141011835081), via openFDA; the full label on DailyMed
What does the patient leaflet for lomitapide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about JUXTAPID?JUXTAPID is available only through certified pharmacies that are enrolled in the JUXTAPID REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed JUXTAPID. There is a registry that collects information about the effects of taking JUXTAPID over time. Ask your healthcare provider for more information about this registry or visit www.JUXTAPID.com or call 1-877-902-4099. JUXTAPID may cause serious side effects including: Liver problems. JUXTAPID can cause liver problems such as increased liver enzymes or increased fat in the liver. Your healthcare provider should do blood tests to check your liver before you start JUXTAPID, if your dose is increased, and while you take JUXTAPID. If your tests show some liver problems, your healthcare provider may adjust your dose of JUXTAPID or stop it altogether. Tell your healthcare provider if you have had liver problems, including liver problems while taking other medicines. JUXTAPID may cause nausea, vomiting, and stomach pain, especially if you do not eat a low-fat diet. These side effects can also be symptoms of liver problems. Tell your healthcare provider right away if you have any of these symptoms of liver problems while taking JUXTAPID: Nausea, vomiting, or stomach pain that gets worse, does not go away, or changes fever flu-like symptoms yellowing of your eyes or skin you are more tired than usual Drinking alcohol may increase your chance of having liver problems or make your liver problems worse. You should not have more than 1 alcoholic drink each day while taking JUXTAPID. Harm to your unborn baby. JUXTAPID may cause harm to your unborn baby. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take JUXTAPID. […]
From the patient leaflet: How should I store JUXTAPID?Store JUXTAPID at room temperature, between 68°F and 77°F (20°C and 25°C). Keep JUXTAPID in a tightly closed container. Keep JUXTAPID capsules dry. Safely throw away medicine that is out of date or no longer needed. Keep JUXTAPID and all medicines out of the reach of children.
Source: FDA drug label (Juxtapid), Chiesi USA, Inc., effective March 30, 2026 (SPL set 61a0be9d-ee58-43e0-b5cb-141011835081), via openFDA; the full label on DailyMed
Is there a generic for lomitapide (Juxtapid)?
No generic lomitapide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Juxtapid capsules, the last expiring on July 29, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lomitapide label say about other medicines?
The lomitapide label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name lomitapide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Exercise caution when using JUXTAPID with other medications known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen. |
| Amiodarone | warnings and precautions | Exercise caution when using JUXTAPID with other medications known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen. |
| Clarithromycin | warnings and precautions | … several possible causes, including a drug-drug interaction between JUXTAPID and the strong CYP3A4 inhibitor clarithromycin [see Drug Interactions (7.1) ]. |
| Isotretinoin | warnings and precautions | Exercise caution when using JUXTAPID with other medications known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen. |
| Lovastatin | drug interactions | Simvastatin and lovastatin exposure increase with JUXTAPID. |
| Methotrexate | warnings and precautions | Exercise caution when using JUXTAPID with other medications known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen. |
| Simvastatin | drug interactions | Simvastatin and lovastatin exposure increase with JUXTAPID. |
| Tamoxifen | warnings and precautions | Exercise caution when using JUXTAPID with other medications known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen. |
| Warfarin | drug interactions | Lomitapide increases plasma concentrations of warfarin. |
Other labels that name lomitapide
Source: FDA drug label (Juxtapid), Chiesi USA, Inc., effective March 30, 2026 (SPL set 61a0be9d-ee58-43e0-b5cb-141011835081), via openFDA; the full label on DailyMed
What do FAERS reports show for lomitapide?
The FDA Adverse Event Reporting System holds 3,759 reports that list lomitapide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 386 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lomitapide?
15 other medicines are given the same way (oral) and in the same FDA class as lomitapide or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Fenofibrate | High cholesterol | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Lovastatin | High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Gemfibrozil | High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe | High cholesterol | 23 labelers | $0.0667 per tablet 10 mg tablet | No current entry |
| Cholestyramine | High cholesterol | 15 labelers | $0.834 per packet Cholestyramine packet | No current entry |
| Colesevelam | High cholesterol | 15 labelers | $0.262 per tablet 625 mg tablet | No current entry |
Every medicine labeled for the same conditions as lomitapide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lomitapide
- 15 medicines for the same use
- Lomitapide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other