Juxtapid Side Effects

Generic name: lomitapide

Note: This document contains side effect information about lomitapide. Some of the dosage forms listed on this page may not apply to the brand name Juxtapid.

Some side effects of Juxtapid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lomitapide: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking lomitapide (the active ingredient contained in Juxtapid) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using lomitapide and call your doctor at once if you have signs of a liver problem, such as:

• nausea, upper stomach pain, loss of appetite;

• dark urine, clay-colored stools; or

• itching, or jaundice (yellowing of the skin or eyes).

Common side effects may include:

• vomiting, gas, indigestion, stomach pain;

• diarrhea, constipation;

• chest pain; or

• weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to lomitapide: oral capsule

Cardiovascular

Very common (10% or more): Chest pain (24%), angina pectoris (10%), palpitations (10%)

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%)

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%

Immunologic

Very common (10% or more): Influenza (21%)

Metabolic

Very common (10% or more): Weight loss (24%)

Nervous system

Very common (10% or more): Fatigue (17%), fever (10%), headache (10%), dizziness (10%)

Respiratory

Very common (10% or more): Nasopharyngitis (17%), pharyngolaryngeal pain (14%), nasal congestion (10%)

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