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
- Myalgia
Myalgia
335 reports
- Arthralgia
Arthralgia
214 reports
- Muscle Spasms
Muscle Spasms
153 reports
- Pain In Extremity
Pain In Extremity
135 reports
- Nausea 130
Nausea
130 reports
- Dizziness 116
Dizziness
116 reports
- Fatigue 111
Fatigue
111 reports
- Headache 105
Headache
105 reports
- Diarrhoea 97
Diarrhoea
97 reports
- Blood Creatine Phosphokinase Increased 78
Blood Creatine Phosphokinase Increased
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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of bempedoic acid?
Does bempedoic acid interact with other medications?
What drug class is bempedoic acid?
Related Medications in ACL Inhibitor
Other drugs grouped near bempedoic acid - same-class peers and common alternatives.
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atorvastatin
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bempedoic acid/ezetimibe
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cholestyramine
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colestipol
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for bempedoic acid: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,157.
- baloxavir marboxil Δ 7 reports · Endonuclease Inhibitor (Antiviral) 2,164reports
- imiquimod Δ 22 reports · Immune Response Modifier (Topical) 2,179reports
- mefenamic acid Δ 53 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 2,104reports
- alfuzosin Δ 65 reports · Alpha-1 Blocker (BPH) 2,222reports
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 0.74%.
- benzoyl peroxide Δ 0.03 pts · 6,624 reports · Antimicrobial (Topical) 0.77%death share
- dexmethylphenidate Δ 0.14 pts · 4,083 reports · CNS Stimulant 0.88%death share
- tirzepatide Δ 0.20 pts · 120,921 reports · Dual GIP/GLP-1 Receptor Agonist 0.54%death share
- minoxidil Δ 0.27 pts · 43,650 reports · Vasodilator 1.01%death share
Medication Guides
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 15, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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