LOW-VOLUME · SEX-BALANCED
inclisiran Side Effects
inclisiran (also sold as Leqvio) is a LOW-VOLUME FAERS extract #363 of 524 by FAERS report count. Still opens on SEX-BALANCED: 57% of sex-coded reports are female (3,298 F / 2,479 M).
Data updated 2026-05-15
- 6,989
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
inclisiran reporting skew - 57% of sex-coded reports are female (3,298 F / 2,479 M). Volume band LOW-VOLUME #363 of 524 by FAERS report count; caseload WATCHLIST.
Thinner FAERS extract for inclisiran (Leqvio) (6,989 reports #363 of 524 by FAERS report count). 57% of sex-coded reports are female (3,298 F / 2,479 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2018–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ARTHRALGIA leads 740 of 6,989 reports
Who reports · age peak 65-74 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 65-74 (1,305 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 190 reports (2.7% - MARKED). Reactions below co-occur in those rows only.
| 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
Hospitalization is lighter here (651). Reactions in that subset:
| 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 |
| GAIT DISTURBANCE | 20 |
| MUSCLE SPASMS | 20 |
| VERTIGO | 20 |
How to read inclisiran FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 6,989 voluntary reports linked to inclisiran (Leqvio), 2018-2025. Death is listed on 190 (2.7%). Hospitalization appears on 651 (9.3%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with inclisiran
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.
ABS(total_reports) peer at 7,061 FAERS cases (Δ 72 heavier vs inclisiran); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 7,063 FAERS cases (Δ 74 heavier vs inclisiran); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 6,862 FAERS cases (Δ 127 lighter vs inclisiran); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 6,848 FAERS cases (Δ 141 lighter vs inclisiran); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 59.4 pp vs inclisiran's DEATH-MARKED): CASELOAD · HOSP-MID.
inclisiran stamps WATCHLIST · SEX-BALANCED; class peers and methodology beat restating the same FAERS caveats on every effects URL.