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bempedoic acid

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Brand names: Nexletol

ACL Inhibitor Rx

Nexlizet is a combination medicine that helps lower cholesterol. It is used with diet and exercise.

Drug Pricing (NADAC)

Brand Price

$13.05/unit

Generic Available

No

ESPERION THERAPS INC

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Nexlizet is used to lower LDL-C (bad cholesterol) in adults.

Common side effects

Upper respiratory tract infection, Muscle spasms, High uric acid levels in the blood

Key warnings

This medicine can raise uric acid levels in your blood, which may cause gout.

How It Works

Nexlizet contains two medicines that lower cholesterol in different ways. Bempedoic acid blocks an enzyme that your body uses to make cholesterol. Ezetimibe stops your body from absorbing cholesterol from food.

How to Take It

Take one Nexlizet tablet each day. You can take it with or without food. Swallow the tablet whole with a glass of water. If you take a bile acid sequestrant medicine, take Nexlizet at least 2 hours before or 4 hours after it.

Pregnancy & Breastfeeding

This medicine may harm your unborn baby. You should stop taking Nexlizet if you become pregnant, unless your doctor decides that the benefits of taking Nexlizet outweigh the risks to the fetus. Talk to your doctor if you are pregnant or plan to become pregnant.

Missed Dose

If you miss a dose, take it as soon as you remember. Do not take two doses at the same time to make up for the missed dose.

Storage

Store Nexlizet at room temperature, between 68°F to 77°F, in the original package, away from heat and humidity. Do not throw away the desiccant.

Side Effects (from patient reports)

Based on 1,474 FDA adverse event reports.

Muscle pain
335
Joint pain
214
Muscle cramps
153
Pain in arm or leg
135
Feeling sick to your stomach
130
Feeling lightheaded
116
Tiredness
111
Head pain
105
Loose stools
97
Increased level of a muscle enzyme in the blood
78

FDA Adverse Event Report Analysis

Detailed analysis of 2,157 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2018–2025.

Total Reports

2,157

Death-Related Reports

16

Hospitalization Reports

188

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 1,103 (63%)
Male 645 (37%)

Age Distribution

0–17 28
18–44 42
45–64 359
65–74 435
75+ 310

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 MYALGIA 335
2 ARTHRALGIA 214
3 MUSCLE SPASMS 153
4 PAIN IN EXTREMITY 135
5 NAUSEA 130
6 DIZZINESS 116
7 FATIGUE 111
8 HEADACHE 105
9 DIARRHOEA 97
10 BLOOD CREATINE PHOSPHOKINASE INCREASED 78
11 BACK PAIN 69
12 MUSCULAR WEAKNESS 66
13 GOUT 65
14 PAIN 65
15 DYSPNOEA 64

Reactions in Death Reports

DEATH 13
OFF LABEL USE 2
PAIN IN EXTREMITY 2
ASTHENIA 1
BRONCHIAL CARCINOMA 1
CARDIAC FAILURE 1
CARDIOVASCULAR DISORDER 1
CEREBRAL HAEMORRHAGE 1
CONSTIPATION 1
CYTOPENIA 1

Reactions in Hospitalization Reports

MYALGIA 36
BLOOD PRESSURE INCREASED 25
DIARRHOEA 21
NAUSEA 18
PALPITATIONS 18
MUSCULAR WEAKNESS 17
ASTHENIA 16
DEPRESSION 16
BLOOD CREATINE PHOSPHOKINASE INCREASED 15
RHABDOMYOLYSIS 15

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

This medicine can raise uric acid levels in your blood, which may cause gout. Tell your doctor if you have symptoms of high uric acid. Nexlizet can also increase your risk of tendon rupture. Stop taking Nexlizet and contact your doctor right away if you have tendon pain, swelling, or inflammation.

Known Drug Interactions

moderate simvastatin

Clinically Important Drug Interactions with NEXLIZET Simvastatin Clinical Impact: Concomitant use of NEXLIZET with simvastatin causes an increase in simvastatin concentration and may increase the risk of simvastatin-related myopathy [see Clinical Pharmacology (12.3) ] . Intervention: Avoid concomitant use of NEXLIZET with simvastatin greater than 20 mg. Simvastatin: Avoid concomitant use of NEXLIZET with simvastatin greater than 20 mg.

Mechanism: This medication increases the amount of simvastatin in your blood. Higher levels of simvastatin can increase your risk of muscle pain or damage.

What to do: Avoid taking more than 20 mg of simvastatin while using this medication. Your doctor may need to lower your simvastatin dose.

moderate pravastatin

Pravastatin Clinical Impact: Concomitant use of NEXLIZET with pravastatin causes an increase in pravastatin concentration and may increase the risk of pravastatin-related myopathy [see Clinical Pharmacology (12.3) ] . Intervention: Avoid concomitant use of NEXLIZET with pravastatin greater than 40 mg. ( 7 ) Pravastatin: Avoid concomitant use of NEXLIZET with pravastatin greater than 40 mg.

Mechanism: This drug causes pravastatin levels to rise in your body. This increase can make you more likely to experience muscle-related side effects.

What to do: Do not take more than 40 mg of pravastatin daily while on this medication. Your healthcare provider should review your statin dose.

moderate fenofibrate

Fibrates Clinical Impact: Both fenofibrate and ezetimibe (a component of NEXLIZET) may increase cholesterol excretion into the bile, leading to cholelithiasis. Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended [see Adverse Reactions (6.1) ] . Intervention: If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered.

Mechanism: Both of these medicines can increase the amount of cholesterol that moves into the bile, which may cause gallstones to form.

What to do: If you have symptoms of gallstones, your doctor should check your gallbladder and may switch your medicine.

7 DRUG INTERACTIONS No specific pharmacokinetic drug interaction studies with NEXLIZET have been conducted. Table 4 lists drug interactions with NEXLIZET that have been identified in studies with bempedoic acid or ezetimibe. Clinically Important Drug Interactions with NEXLIZET Simvastatin Clinical Impact: Concomitant use of NEXLIZET with simvastatin causes an increase in simvastatin concentration and may increase the risk of simvastatin-related myopathy [see Clinical Pharmacology (12.3) ] .

Mechanism: This combination can cause simvastatin levels to build up in your body, which increases the risk of muscle damage.

What to do: Your doctor may need to adjust your dose or monitor you closely for muscle pain.

Table 4 lists drug interactions with NEXLIZET that have been identified in studies with bempedoic acid or ezetimibe. Cyclosporine Clinical Impact: Concomitant use of NEXLIZET and cyclosporine increases ezetimibe and cyclosporine concentrations. The degree of increase in ezetimibe exposure may be greater in patients with severe renal insufficiency [see Clinical Pharmacology (12.3) ] .

Mechanism: Taking these medications together can cause the levels of both drugs to increase in your bloodstream.

What to do: Your doctor should monitor your health closely, especially if you have kidney problems, as the drug levels could rise even higher.

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Common Questions

What should I do if I experience muscle pain while taking Nexlizet?
Contact your doctor. Muscle pain can be a side effect of Nexlizet.
Can I take Nexlizet with other cholesterol-lowering medications?
Yes, Nexlizet can be taken with other cholesterol-lowering medications, but talk to your doctor about potential interactions.
How often should I have my cholesterol levels checked while taking Nexlizet?
Your doctor will check your cholesterol levels 8 to 12 weeks after starting Nexlizet.
Can I drink alcohol while taking Nexlizet?
Talk to your doctor about alcohol consumption while taking Nexlizet.
What if I have kidney problems?
Tell your doctor if you have kidney problems, as this medicine can affect your kidneys.
Can Nexlizet cause liver problems?
Nexlizet can cause elevated liver enzymes. Your doctor may monitor your liver function.
Is it safe to take Nexlizet if I have diabetes?
Yes, you can take Nexlizet if you have diabetes, but monitor your blood sugar levels.
How long does it take for Nexlizet to start working?
Nexlizet starts working soon after you begin taking it, but it may take several weeks to see the full effect.
Can I stop taking Nexlizet if my cholesterol levels improve?
Do not stop taking Nexlizet without talking to your doctor first.
What should I do if I have an allergic reaction to Nexlizet?
Stop taking Nexlizet and seek immediate medical attention if you have signs of an allergic reaction.
What are the common side effects of bempedoic acid?
The most commonly reported side effects of bempedoic acid include Upper respiratory tract infection, Muscle spasms, High uric acid levels in the blood, Back pain, Stomach pain or discomfort. Based on 1,474 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does bempedoic acid interact with other medications?
Yes, bempedoic acid has 7 known drug interactions. Notable interactions include simvastatin, pravastatin, fenofibrate. Always inform your doctor about all medications you are taking.
What drug class is bempedoic acid?
bempedoic acid belongs to the ACL Inhibitor drug class. It requires a prescription (Rx). Nexlizet is used to lower LDL-C (bad cholesterol) in adults.
Is bempedoic acid safe during pregnancy?
This medicine may harm your unborn baby. You should stop taking Nexlizet if you become pregnant, unless your doctor decides that the benefits of taking Nexlizet outweigh the risks to the fetus. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for bempedoic acid

The FDA label for bempedoic acid (sold under brand names such as Nexletol) classifies it as a prescription-only medication in the ACL Inhibitor class. Nexlizet is used to lower LDL-C (bad cholesterol) in adults. Official labeling lists 14 commonly reported side effects, including Upper respiratory tract infection, Muscle spasms, High uric acid levels in the blood.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,474 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: January 15, 2026

All federal data sources used on this page