FDA Adverse Events Reports (FAERS) Summary for NEXLETOL

These tables and charts are based on 903 total reports for NEXLETOL (BEMPEDOIC ACID) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 830 pharmaceutical company-submitted and non-U.S. FAERS reports and 73 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 73 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch NEXLETOL summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with NEXLETOL (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	JOINT PAIN	76
2	MUSCLE PAIN	70
3	PAIN IN EXTREMITY	61
4	MUSCLE SPASMS	54
5	BACK PAIN	48
6	NAUSEA	45
7	FATIGUE	41
8	HEADACHE	39
9	DRUG INEFFECTIVE	38
10	DIZZINESS	37
11	OFF LABEL USE	35
12	DIARRHEA	34
13	PAIN	32
14	GOUT	30
15	RASH	28
16	BLOOD URIC ACID INCREASED	26
17	TENDON RUPTURE	24
18	ABDOMINAL DISCOMFORT	23
19	ITCHING	23
20	PRODUCT DOSE OMISSION ISSUE	22
21	GAIT DISTURBANCE	20
22	ELEVATED LIVER ENZYMES	19
23	ABDOMINAL PAIN UPPER	18
24	SHORTNESS OF BREATH	18
25	MALAISE	17
26	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	17
27	FEELING ABNORMAL	16
28	LACK OF STRENGTH AND ENERGY (ASTHENIA)	15
29	BLOOD CHOLESTEROL INCREASED	15
30	NECK PAIN	15
31	LOWER LIMBS SWELLING	15
32	COUGH	14
33	INSOMNIA	14
34	VOMITING	14
35	FALL	13
36	LOW DENSITY LIPOPROTEIN INCREASED	13
37	TENDON DISORDER	13
38	WEIGHT DECREASED	13
39	ARTHRITIS	12
40	BLOOD CREATINE PHOSPHOKINASE INCREASED	12
41	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	12
42	MUSCULAR WEAKNESS	12
43	RUNNY NOSE	12
44	BLOOD CREATININE INCREASED	11
45	BLOOD TRIGLYCERIDES INCREASED	11
46	GASTROINTESTINAL DISORDER	11
47	ABDOMINAL PAIN	10
48	BLOOD PRESSURE INCREASED	10
49	INJECTION SITE PAIN	10
50	PINS AND NEEDLES	10
51	PRODUCT USE ISSUE	10
52	TENDON PAIN	10
53	ADVERSE DRUG REACTION	9
54	COMMON COLD	9
55	THROAT PAIN	9
56	DRUG EFFECT INCREASED	9
57	ANEMIA	8
58	BLOOD GLUCOSE INCREASED	8
59	BLOOD UREA INCREASED	8
60	BRONCHITIS	8
61	CHEST PAIN	8
62	CONDITION AGGRAVATED	8
63	DEATH	8
64	DRUG DOSE OMISSION BY DEVICE	8
65	FLATULENCE	8
66	LOW BLOOD PRESSURE	8
67	INFLUENZA LIKE ILLNESS	8
68	NEUROPATHY PERIPHERAL	8
69	PRODUCT USE IN UNAPPROVED INDICATION	8
70	HIVES	8
71	ANXIETY	7
72	BURNING SENSATION	7
73	CHEST DISCOMFORT	7
74	CONSTIPATION	7
75	DEVICE DIFFICULT TO USE	7
76	EYE PAIN	7
77	DIFFICULTY WALKING	7
78	ILLNESS	7
79	SWELLING OF LIMBS	7
80	PAIN IN JAW	7
81	FEVER	7
82	ROTATOR CUFF SYNDROME	7
83	SINUSITIS	7
84	THERAPY CESSATION	7
85	VISION BLURRED	7
86	ACUTE KIDNEY INJURY	6
87	ALT LIVER ENZYME INCREASED	6
88	ASPARTATE AMINOTRANSFERASE INCREASED	6
89	ATRIAL FIBRILLATION	6
90	BRUISE	6
91	COVID-19	6
92	DRUG INTOLERANCE	6
93	SKIN REDNESS	6
94	HIGH BLOOD PRESSURE	6
95	HYPERURICAEMIA	6
96	NUMBNESS	6
97	INFECTION	6
98	JOINT SWELLING	6
99	MIGRAINE	6
100	PALPITATIONS	6

Latest Known Outcomes for Reactions Reported for NEXLETOL

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	554
2	Patient recovered	224
3	Patient has not recovered/symtoms have not resolved	179
4	Patient is recovering/symptoms resolving	82
5	Patient died	7

NEXLETOL Total Reports

Male	Female	Unknown	Total
242	503		903

Top Countries Reporting

	Country	Number of Reports
1	United States	885
2	Japan	14
3	Ireland	1

Outcomes for Reports

Serious: 206
Not Serious: 697
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Blood cholesterol increased
Product used for unknown indication
Drug intolerance
Blood cholesterol abnormal
Arteriosclerosis

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 2020-02-21

NEXLETOL (BEMPEDOIC ACID) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with NEXLETOL? Rate NEXLETOL at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for NEXLETOL reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "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."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.