Pharmacologic class (EPC) · 3 drug pages

Adenosine Triphosphate-Citrate lyase inhibitor: adverse event reports filed with FDA

2,558 reports list a drug in this class as a suspect or interacting product, 2019–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,558
reports across the class: 0% of all reports; 470
reports, 12 months to June 2026: 530 in the 12 months before; 45.5%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Adenosine Triphosphate-Citrate lyase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 2,558 adverse event reports received by FDA, 0% of the database, from June 2019 to June 2026.

470 reports arrived in the 12 months to June 2026, down 11% from 530 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 45.5% of the class's reports are marked serious, 0.5% record death among the outcomes and 6.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are myalgia (16.8%), arthralgia (10.8%) and pain in extremity (7.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Bempedoic acid	generic	1,363	275	71.2%	Myalgia
NexletolBempedoic acid	brand	689	128	18.3%	Myalgia
NexlizetBempedoic acid and ezetimibe	brand	506	67	13.4%	Myalgia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Myalgiamuscle pain16.8%429
Arthralgiajoint pain10.8%277
Pain in extremitypain in an arm or leg7.1%182
Muscle spasmsmuscle cramps6.6%169
Dizzinesslight-headedness or unsteadiness4.9%125
Nauseafeeling sick4.8%122
Fatiguetiredness4.7%119
Headachehead pain4.5%114
Diarrhoealoose or frequent stools3.9%100
Goutgout3.7%94
Back painback pain3.5%89
Abdominal pain upperupper stomach pain3%76
Painpain, site not specified2.9%74
Blood creatine phosphokinase increased2.7%69
Muscular weaknessmuscle weakness2.5%64
Rashskin rash2.5%64
Dyspnoeashortness of breath2.3%60
Blood uric acid increasedraised uric acid2.2%56
Drug ineffectivethe medicine did not work as expected2.1%54
Malaisegeneral feeling of being unwell2.1%54
Abdominal discomfortstomach discomfort1.9%49
Tendon rupturea torn tendon1.9%48
Astheniaweakness or lack of energy1.8%45
Off label useused for a purpose or in a way not on the label1.8%45
Pruritusitching1.7%44

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.5%12

Life-threatening1.3%32

Hospitalisation (initial or prolonged)6.9%177

Disability4.2%108

Congenital anomaly0%0

Other serious39.6%1,014

Not serious54.5%1,394

Patient age

Under 20%0

2 to 110.1%2

12 to 170%0

18 to 442.1%54

45 to 6415.3%392

65 to 7417.7%454

75 and over12.5%320

Age not given52.2%1,336

Who reported

Physician44.4%1,136

Pharmacist10.1%259

Other health professional14%357

Lawyer0%0

Consumer or non-health professional31.4%802

Not given0.2%4

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Adenosine Triphosphate-Citrate lyase inhibitor reports

Which drugs are in the Adenosine Triphosphate-Citrate lyase inhibitor class on this site?

Bempedoic acid, Nexletol and Nexlizet. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,558 reports through June 2026, 470 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

myalgia (16.8%), arthralgia (10.8%), pain in extremity (7.1%), muscle spasms (6.6%) and dizziness (4.9%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.