inclisiran Side Effects
Also known as: Leqvio
Analysis of 6,989 adverse event reports submitted to the FDA from 2018 to 2025.
Total Reports
6,989
Death-Related
190
2.7% of reports
Hospitalizations
651
9.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 190 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 114 |
| MYOCARDIAL INFARCTION | 15 |
| DYSPNOEA | 11 |
| ACUTE MYOCARDIAL INFARCTION | 7 |
| SEPSIS | 6 |
| CARDIAC ARREST | 5 |
| PNEUMONIA | 5 |
| ASTHENIA | 4 |
| CEREBROVASCULAR ACCIDENT | 4 |
| FATIGUE | 4 |
| MALAISE | 4 |
| BLOOD LOSS ANAEMIA | 3 |
| CARDIAC FAILURE | 3 |
| CARDIAC FAILURE CONGESTIVE | 3 |
| CEREBRAL HAEMORRHAGE | 3 |
| GASTRIC DISORDER | 3 |
| GASTRITIS EROSIVE | 3 |
| HYPERVOLAEMIA | 3 |
| HYPOGLYCAEMIA | 3 |
| LOW DENSITY LIPOPROTEIN INCREASED | 3 |
Reactions in Hospitalization Reports
Top reactions in 651 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 56 |
| CHEST PAIN | 41 |
| PAIN IN EXTREMITY | 39 |
| PNEUMONIA | 34 |
| FATIGUE | 33 |
| DIARRHOEA | 32 |
| DIZZINESS | 32 |
| PAIN | 28 |
| CEREBROVASCULAR ACCIDENT | 27 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 27 |
| ARTHRALGIA | 24 |
| HEADACHE | 24 |
| MYOCARDIAL INFARCTION | 23 |
| NAUSEA | 23 |
| INJECTION SITE PAIN | 21 |
| MYALGIA | 21 |
| DRUG INEFFECTIVE | 20 |
| GAIT DISTURBANCE | 20 |
| MUSCLE SPASMS | 20 |
| VERTIGO | 20 |
Nearby — Related Medications
What the FAERS Data Reveals About inclisiran Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,989 voluntary reports linked to inclisiran and its brand equivalents (Leqvio), spanning 2018 through 2025. Of those, 190 (2.7%) listed death as an outcome and 651 (9.3%) 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, 57% were female and 43% male; age distribution skews toward 65-74, with 1,305 reports in that bracket. The single most reported reaction is arthralgia with 740 submissions, followed by myalgia and injection site pain.
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.
Read our methodology — how this data is sourced, computed, and verified.