FDA Adverse Events Reports (FAERS) Summary for NEXLETOL

These tables and charts are based on 871 total reports for NEXLETOL (BEMPEDOIC ACID) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 799 pharmaceutical company-submitted and non-U.S. FAERS reports and 72 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 72 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	74
2	MUSCLE PAIN	69
3	PAIN IN EXTREMITY	60
4	MUSCLE SPASMS	52
5	BACK PAIN	48
6	NAUSEA	44
7	FATIGUE	39
8	DRUG INEFFECTIVE	38
9	HEADACHE	37
10	DIZZINESS	35
11	OFF LABEL USE	34
12	DIARRHEA	32
13	PAIN	31
14	GOUT	30
15	RASH	28
16	BLOOD URIC ACID INCREASED	26
17	TENDON RUPTURE	24
18	ABDOMINAL DISCOMFORT	23
19	PRODUCT DOSE OMISSION ISSUE	23
20	ITCHING	23
21	GAIT DISTURBANCE	19
22	ELEVATED LIVER ENZYMES	18
23	ABDOMINAL PAIN UPPER	17
24	SHORTNESS OF BREATH	17
25	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	17
26	FEELING ABNORMAL	16
27	BLOOD CHOLESTEROL INCREASED	15
28	LOWER LIMBS SWELLING	15
29	LACK OF STRENGTH AND ENERGY (ASTHENIA)	14
30	MALAISE	14
31	NECK PAIN	14
32	COUGH	13
33	INSOMNIA	13
34	LOW DENSITY LIPOPROTEIN INCREASED	13
35	TENDON DISORDER	13
36	VOMITING	13
37	ARTHRITIS	12
38	BLOOD CREATINE PHOSPHOKINASE INCREASED	12
39	FALL	12
40	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	12
41	RUNNY NOSE	12
42	BLOOD CREATININE INCREASED	11
43	BLOOD TRIGLYCERIDES INCREASED	11
44	GASTROINTESTINAL DISORDER	11
45	WEIGHT DECREASED	11
46	ABDOMINAL PAIN	10
47	BLOOD PRESSURE INCREASED	10
48	MUSCULAR WEAKNESS	10
49	PINS AND NEEDLES	10
50	TENDON PAIN	10
51	PRODUCT USE ISSUE	9
52	DRUG EFFECT INCREASED	9
53	ADVERSE DRUG REACTION	8
54	ANEMIA	8
55	BLOOD UREA INCREASED	8
56	BRONCHITIS	8
57	CHEST PAIN	8
58	DEATH	8
59	FLATULENCE	8
60	LOW BLOOD PRESSURE	8
61	INFLUENZA LIKE ILLNESS	8
62	INJECTION SITE PAIN	8
63	COMMON COLD	8
64	THROAT PAIN	8
65	HIVES	8
66	ANXIETY	7
67	BLOOD GLUCOSE INCREASED	7
68	CHEST DISCOMFORT	7
69	CONSTIPATION	7
70	DRUG DOSE OMISSION BY DEVICE	7
71	EYE PAIN	7
72	ILLNESS	7
73	INFECTION	7
74	NEUROPATHY PERIPHERAL	7
75	SWELLING OF LIMBS	7
76	PAIN IN JAW	7
77	FEVER	7
78	ROTATOR CUFF SYNDROME	7
79	VISION BLURRED	7
80	ALT LIVER ENZYME INCREASED	6
81	ASPARTATE AMINOTRANSFERASE INCREASED	6
82	ATRIAL FIBRILLATION	6
83	BURNING SENSATION	6
84	CONDITION AGGRAVATED	6
85	BRUISE	6
86	COVID-19	6
87	DEVICE DIFFICULT TO USE	6
88	SKIN REDNESS	6
89	DIFFICULTY WALKING	6
90	HIGH BLOOD PRESSURE	6
91	HYPERURICAEMIA	6
92	NUMBNESS	6
93	JOINT SWELLING	6
94	MIGRAINE	6
95	PRODUCT PHYSICAL ISSUE	6
96	PRODUCT USE IN UNAPPROVED INDICATION	6
97	SINUSITIS	6
98	THERAPY CESSATION	6
99	HAIR LOSS	5
100	BLOOD PRESSURE DECREASED	5

Latest Known Outcomes for Reactions Reported for NEXLETOL

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	527
2	Patient recovered	212
3	Patient has not recovered/symtoms have not resolved	176
4	Patient is recovering/symptoms resolving	79
5	Patient died	7

Search all MedWatch and FAERS by keyword:

NEXLETOL Total Reports

Male	Female	Unknown	Total
231	483		871

Top Countries Reporting

	Country	Number of Reports
1	United States	862
2	Japan	6
3	Ireland	1

Outcomes for Reports

Serious: 187
Not Serious: 684
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

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 April 28, 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.