What the label lists and what reports show
Lomitapide side effects
Lomitapide's FDA label: “Most common adverse reactions in adult patients (incidence ≥10%) are diarrhea, nausea, dyspepsia, vomiting, and abdominal pain (6.1).” FAERS holds 3,759 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (1,069 reports).
- No generic listed
- Boxed warning
Check it at the source: the lomitapide FDA label on DailyMed (effective March 30, 2026, Chiesi USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of JUXTAPID?JUXTAPID can cause serious side effects, including: See " What is the most important information I should know about JUXTAPID? " problems absorbing certain nutrients. JUXTAPID may decrease your ability to absorb fat-soluble nutrients such as Vitamin E and fatty acids. You should take supplements each day that contain fat-soluble vitamins. People with bowel or pancreas problems may have an increased chance of not being able to absorb these nutrients. See " How should I take JUXTAPID? " gastrointestinal symptoms. Diarrhea, nausea, vomiting, and stomach pain or discomfort are very common when taking JUXTAPID. Strictly following a low-fat diet may help lower the chance of having these symptoms. […]
Source: FDA drug label, Chiesi USA, Inc., effective March 30, 2026 (SPL set 61a0be9d-ee58-43e0-b5cb-141011835081), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in adult patients (incidence ≥10%) are diarrhea, nausea, dyspepsia, vomiting, and abdominal pain (6.1).
Table 8: Adverse Reactions Reported in ≥10% of Patients in the Adult Clinical Trial
| ADVERSE REACTION | N (%) |
|---|---|
| Diarrhea | 23 (79) |
| Nausea | 19 (65) |
| Dyspepsia | 11 (38) |
| Abdominal pain | 10 (34) |
| Vomiting | 10 (34) |
| Chest pain | 7 (24) |
| Decreased weight | 7 (24) |
| Abdominal discomfort | 6 (21) |
| Abdominal distension | 6 (21) |
| Constipation | 6 (21) |
| Flatulence | 6 (21) |
| Influenza | 6 (21) |
| Fatigue | 5 (17) |
| Increased ALT | 5 (17) |
| Nasopharyngitis | 5 (17) |
| Back pain | 4 (14) |
| Gastroenteritis | 4 (14) |
| Pharyngolaryngeal pain | 4 (14) |
| Angina pectoris | 3 (10) |
| Defecation urgency | 3 (10) |
| Dizziness | 3 (10) |
| Fever | 3 (10) |
| Gastroesophageal reflux disease | 3 (10) |
| Headache | 3 (10) |
| Nasal congestion | 3 (10) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions have been observed and are discussed in detail in other sections of the label: Risk of hepatotoxicity [see Warnings and Precautions (5.1) ] Reduced absorption of fat-soluble vitamins, and serum fatty acids [see Warnings and Precautions (5.4) ] Gastrointestinal adverse reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions in adult patients (incidence ≥10%) are diarrhea, nausea, dyspepsia, vomiting, and abdominal pain (6.1). Most common adverse reactions in pediatric patients aged 5 to 17 years old (incidence ≥15%) are abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, and vomiting ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults with HoFH One single-arm, open-label, 78-week trial has been conducted in 29 adult patients with HoFH, 23 of whom completed at least one year of treatment. …
Source: FDA drug label, 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?
3,759 reports list lomitapide among the medicines taken, 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. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lomitapide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions