Bempedoic Acid side effects: what 2,565 FDA adverse event reports show
Drug class
Adenosine Triphosphate-Citrate Lyase Inhibitor
Brand names
Nexletol
Who reports
2,565 reports · 56% serious · 22 with death outcome · 61% female
Used for
NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
What it is
NEXLETOL tablets, for oral use, contain bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor.
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 24 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Gout | 81 | 37.0 29.9–45.9ROR 38.2 · χ² 2,793 / p <1e-300 | 36.6 EB05 30.4 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.0 | no trial data cached |
| Tendon rupture (torn tendon) | 35 | 23.2 16.7–32.2ROR 23.5 · χ² 719 / p 1e-158 | 22.9 EB05 17.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 · ♀ 41% (drug 61%) | no trial data cached |
| Blood creatine phosphokinase increased | 82 | 23.0 18.6–28.4ROR 23.7 · χ² 1,699 / p <1e-300 | 22.8 EB05 19.0 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 20.0 · ♀ 16% (drug 61%) · 90% clinician | no trial data cached |
| Myalgia (muscle pain) | 400 | 19.3 17.6–21.1ROR 22.7 · χ² 6,955 / p <1e-300 | 19.2 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Glomerular filtration rate decreased | 22 | 14.9 9.8–22.6ROR 15.0 · χ² 271 / p 4e-61 | 14.3 EB05 9.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 · 91% clinician | no trial data cached |
| Musculoskeletal discomfort | 22 | 10.5 6.9–15.9ROR 10.5 · χ² 179 / p 4e-41 | 9.5 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 | no trial data cached |
| Blood triglycerides increased | 22 | 10.2 6.7–15.4ROR 10.2 · χ² 172 / p 1e-39 | 9.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 91% clinician | no trial data cached |
| Drug effect less than expected | 17 | 9.9 6.1–15.9ROR 9.9 · χ² 127 / p 1e-29 | 8.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Renal pain | 10 | 7.7 4.2–14.4ROR 7.8 · χ² 52 / p 3e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Muscle spasms | 169 | 7.5 6.5–8.7ROR 8.0 · χ² 958 / p 1e-210 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | no trial data cached |
| Micturition urgency | 10 | 7.2 3.9–13.4ROR 7.2 · χ² 47 / p 3e-12 | 5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Restless legs syndrome | 14 | 6.3 3.7–10.6ROR 6.3 · χ² 57 / p 2e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Angina pectoris | 21 | 6.0 3.9–9.1ROR 6.0 · χ² 82 / p 8e-20 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Paralysis | 10 | 5.7 3.1–10.6ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Chromaturia | 15 | 5.4 3.3–9.0ROR 5.5 · χ² 50 / p 8e-13 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Muscular weakness | 72 | 5.2 4.1–6.5ROR 5.3 · χ² 240 / p 2e-54 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Drug intolerance | 60 | 5.1 4.0–6.5ROR 5.2 · χ² 194 / p 2e-44 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 90% clinician | no trial data cached |
| Arthralgia (joint pain) | 245 | 4.8 4.3–5.4ROR 5.2 · χ² 756 / p 9e-167 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Hepatotoxicity (liver damage) | 13 | 4.8 2.8–8.3ROR 4.8 · χ² 35 / p 1e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Gamma-glutamyltransferase increased | 13 | 4.8 2.8–8.2ROR 4.8 · χ² 35 / p 1e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 24 | 4.7 3.2–7.0ROR 4.8 · χ² 67 / p 2e-16 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Pain in extremity | 159 | 4.4 3.8–5.1ROR 4.6 · χ² 421 / p 8e-94 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Blood cholesterol increased | 25 | 4.4 3.0–6.5ROR 4.4 · χ² 62 / p 2e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.4 | no trial data cached |
| Diverticulitis | 14 | 4.1 2.5–7.0ROR 4.2 · χ² 30 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Arrhythmia | 24 | 4.1 2.8–6.1ROR 4.2 · χ² 54 / p 1e-13 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 10% (drug 61%) | no trial data cached |
| Nightmare | 11 | 2.6 1.4–4.7ROR 2.6 · χ² 9 / p 0.001 | 2.4 EB05 1.5 · IC025 +0.3 | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Therapeutic response unexpected | 13 | 2.4 1.4–4.1ROR 2.4 · χ² 9 / p 0.001 | 2.2 EB05 1.4 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 26 | 2.3 1.6–3.4ROR 2.3 · χ² 18 / p 9e-6 | 2.3 EB05 1.6 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.5 · ♀ 33% (drug 61%) · 96% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Myalgia (muscle pain) | 400 | 19.3 17.6–21.1ROR 22.7 · χ² 6,955 / p <1e-300 | 19.2 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Arthralgia (joint pain) | 245 | 4.8 4.3–5.4ROR 5.2 · χ² 756 / p 9e-167 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Muscle spasms | 169 | 7.5 6.5–8.7ROR 8.0 · χ² 958 / p 1e-210 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | no trial data cached |
| Pain in extremity | 159 | 4.4 3.8–5.1ROR 4.6 · χ² 421 / p 8e-94 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Blood creatine phosphokinase increased | 82 | 23.0 18.6–28.4ROR 23.7 · χ² 1,699 / p <1e-300 | 22.8 EB05 19.0 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 20.0 · ♀ 16% (drug 61%) · 90% clinician | no trial data cached |
| Gout | 81 | 37.0 29.9–45.9ROR 38.2 · χ² 2,793 / p <1e-300 | 36.6 EB05 30.4 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.0 | no trial data cached |
| Muscular weakness | 72 | 5.2 4.1–6.5ROR 5.3 · χ² 240 / p 2e-54 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Drug intolerance | 60 | 5.1 4.0–6.5ROR 5.2 · χ² 194 / p 2e-44 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 90% clinician | no trial data cached |
| Tendon rupture (torn tendon) | 35 | 23.2 16.7–32.2ROR 23.5 · χ² 719 / p 1e-158 | 22.9 EB05 17.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 · ♀ 41% (drug 61%) | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 26 | 2.3 1.6–3.4ROR 2.3 · χ² 18 / p 9e-6 | 2.3 EB05 1.6 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.5 · ♀ 33% (drug 61%) · 96% clinician | no trial data cached |
| Blood cholesterol increased | 25 | 4.4 3.0–6.5ROR 4.4 · χ² 62 / p 2e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.4 | no trial data cached |
| Arrhythmia | 24 | 4.1 2.8–6.1ROR 4.2 · χ² 54 / p 1e-13 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 10% (drug 61%) | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 24 | 4.7 3.2–7.0ROR 4.8 · χ² 67 / p 2e-16 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Blood triglycerides increased | 22 | 10.2 6.7–15.4ROR 10.2 · χ² 172 / p 1e-39 | 9.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 91% clinician | no trial data cached |
| Musculoskeletal discomfort | 22 | 10.5 6.9–15.9ROR 10.5 · χ² 179 / p 4e-41 | 9.5 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Myalgia — n=400, PRR 19.3
- Musculoskeletal discomfort — n=22, PRR 10.5
- Angina pectoris — n=21, PRR 6.0
- Muscular weakness — n=72, PRR 5.2
- Rhabdomyolysis — n=24, PRR 4.7
- Arrhythmia — n=24, PRR 4.1
- Suicidal ideation — n=26, PRR 2.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Bempedoic Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Bempedoic Acid are myalgia, arthralgia, muscle spasms, pain in extremity, blood creatine phosphokinase increased, gout. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Bempedoic Acid have an FDA boxed warning?
No. The FDA label retrieved for Bempedoic Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bempedoic Acid causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 88d06d89-a3da-40b4-b273-8f4f7d56c4c9, effective 20260625; matched on
openfda.generic_name.exact:"BEMPEDOIC ACID") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 52 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.