Prescription medication · ACL Inhibitor
bempedoic acid
Also sold as Nexletol.
Data updated 2026-05-15
- 2,157
- FDA reportsRarely reported
- 7
- InteractionsFew interactions
- $13.05
- Brand price (NADAC)
What the data shows
bempedoic acid (Nexletol) is a prescription ACL Inhibitor, among the least-reported drugs the FDA tracks (2,157 FDA reports), with 7 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
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
Information not available.
Common side effects
Upper respiratory tract infection, Muscle spasms, High uric acid levels in the blood
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 2,157 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for bempedoic acid, by number of reports
- Muscle pain
Muscle pain
335 reports
- Joint pain
Joint pain
214 reports
- Muscle cramps
Muscle cramps
153 reports
- Pain in arm or leg
Pain in arm or leg
135 reports
- Feeling sick to your stomach 130
Feeling sick to your stomach
130 reports
- Feeling lightheaded 116
Feeling lightheaded
116 reports
- Tiredness 111
Tiredness
111 reports
- Head pain 105
Head pain
105 reports
- Loose stools 97
Loose stools
97 reports
- Increased level of a muscle enzyme in the blood 78
Increased level of a muscle enzyme in the blood
78 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for bempedoic acid each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where bempedoic acid sits
bempedoic acid has more FDA adverse-event reports than 13% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is bempedoic acid; the line is the median (50th percentile).
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
Reports Mentioning Death
16
0.7% of reports — not proof of cause
Hospitalization Reports
188
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
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
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
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.
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.
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What are the common side effects of bempedoic acid?
Does bempedoic acid interact with other medications?
What drug class is bempedoic acid?
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Medication Guides
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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. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. 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 2,157 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
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages