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bempedoic acid Side Effects

Also known as: Nexletol

Analysis of 2,157 adverse event reports submitted to the FDA from 2018 to 2025.

Total Reports

2,157

Death-Related

16

0.7% of reports

Hospitalizations

188

8.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

MYALGIA
335
ARTHRALGIA
214
MUSCLE SPASMS
153
PAIN IN EXTREMITY
135
NAUSEA
130
DIZZINESS
116
FATIGUE
111
HEADACHE
105
DIARRHOEA
97
BLOOD CREATINE PHOSPHOKINASE INCREASED
78
BACK PAIN
69
MUSCULAR WEAKNESS
66
GOUT
65
PAIN
65
DYSPNOEA
64
MALAISE
64
RASH
64
ABDOMINAL PAIN UPPER
58
ABDOMINAL DISCOMFORT
53
DRUG INEFFECTIVE
52

Who Reports Side Effects

Gender Distribution

Female 1,103 (63%)
Male 645 (37%)

Age Distribution

0-17 28 (2%)
18-44 42 (4%)
45-64 359 (31%)
65-74 435 (37%)
75+ 310 (26%)

Reporting Trend by Year

18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 16 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 13
OFF LABEL USE 2
PAIN IN EXTREMITY 2
ASTHENIA 1
BRONCHIAL CARCINOMA 1
CARDIAC FAILURE 1
CARDIOVASCULAR DISORDER 1
CEREBRAL HAEMORRHAGE 1
CONSTIPATION 1
CYTOPENIA 1
DEHYDRATION 1
DIARRHOEA 1
DISEASE PROGRESSION 1
DISTURBANCE IN ATTENTION 1
DRUG INTERACTION 1
FALL 1
FATIGUE 1
GENERAL PHYSICAL HEALTH DETERIORATION 1
HEAD INJURY 1
HODGKIN^S DISEASE 1

Reactions in Hospitalization Reports

Top reactions in 188 reports where hospitalization was an outcome.

Reaction Reports
MYALGIA 36
BLOOD PRESSURE INCREASED 25
DIARRHOEA 21
NAUSEA 18
PALPITATIONS 18
MUSCULAR WEAKNESS 17
ASTHENIA 16
DEPRESSION 16
BLOOD CREATINE PHOSPHOKINASE INCREASED 15
RHABDOMYOLYSIS 15
ASPARTATE AMINOTRANSFERASE INCREASED 13
DIZZINESS 13
PAIN IN EXTREMITY 13
ARTHRALGIA 12
GAMMA-GLUTAMYLTRANSFERASE INCREASED 12
MYOGLOBIN BLOOD INCREASED 12
QUADRIPARESIS 12
HEADACHE 11
ACUTE KIDNEY INJURY 10
DYSPNOEA 9

Nearby — Related Medications

Compare bempedoic acid vs alirocumab →

What the FAERS Data Reveals About bempedoic acid Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,157 voluntary reports linked to bempedoic acid and its brand equivalents (Nexletol), spanning 2018 through 2025. Of those, 16 (0.7%) listed death as an outcome and 188 (8.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 63% were female and 37% male; age distribution skews toward 65-74, with 435 reports in that bracket. The single most reported reaction is myalgia with 335 submissions, followed by arthralgia and muscle spasms.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.