Drug · FAERS side-effect profile with label screen
Inclisiran side effects: what 7,972 FDA adverse event reports show
Drug class
Small interfering rna (sirna) directed
FDA label, Indications wording
Brand names
Leqvio
openFDA label
Who reports
7,972 reports · 42% serious · 226 with death outcome · 57% female
openFDA FAERS counts, all years, deduplication not applied
Used for
LEQVIO ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH). pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
FDA label, Indications and Usage
What it is
LEQVIO contains inclisiran sodium, a small interfering RNA (siRNA) directed to proprotein convertase subtilisin kexin type 9 (PCSK9) mRNA. Inclisiran contains a covalently linked ligand containing three N-acetylgalactosamine (GalNAc) residues to facilitate delivery to hepatocytes.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 2Likely indication confounding 7Reporting / coding artifact 1Lab value / disease marker 11Not in label — unassessed 19
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 815 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Apolipoprotein b decreased | 10 | 8,647.8 2,380.4–31,417.0ROR 8,658.7 · χ² 18,006 / p <1e-300 | 413.2 EB05 239.9 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Spleen ischaemia | 11 | 3,567.2 1,435.2–8,866.3ROR 3,572.2 · χ² 15,045 / p <1e-300 | 414.9 EB05 247.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Apolipoprotein b increased | 10 | 1,081.0 517.1–2,259.8ROR 1,082.3 · χ² 6,873 / p <1e-300 | 310.3 EB05 180.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Leriche syndrome | 16 | 560.9 326.9–962.5ROR 562.1 · χ² 6,900 / p <1e-300 | 297.4 EB05 194.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Ischaemic nephropathy | 12 | 479.0 258.8–886.3ROR 479.7 · χ² 4,436 / p <1e-300 | 246.2 EB05 150.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Lipoprotein (a) increased | 33 | 329.3 229.4–472.7ROR 330.6 · χ² 9,295 / p <1e-300 | 250.0 EB05 186.3 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious n=28 · ♀ 29% (drug 57%) | no trial data cached |
| Peripheral artery bypass | 10 | 214.4 112.5–408.5ROR 214.7 · χ² 1,770 / p <1e-300 | 144.3 EB05 83.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Low density lipoprotein decreased | 97 | 193.1 157.3–237.1ROR 195.5 · χ² 17,078 / p <1e-300 | 173.7 EB05 146.6 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications | serious n=38 | no trial data cached |
| Low density lipoprotein increased | 503 | 184.0 168.5–200.8ROR 196.3 · χ² 85,325 / p <1e-300 | 170.7 EB05 158.6 · IC025 +7.1 3/3 methods agree | Likely indication confounding term in indications | serious n=149 | no trial data cached |
| Dehiscence | 11 | 162.1 88.2–298.0ROR 162.4 · χ² 1,510 / p <1e-300 | 121.1 EB05 72.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Low density lipoprotein abnormal | 33 | 149.2 105.1–211.7ROR 149.8 · χ² 4,453 / p <1e-300 | 130.6 EB05 97.3 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | no trial data cached |
| High density lipoprotein abnormal | 11 | 129.1 70.5–236.5ROR 129.3 · χ² 1,213 / p 5e-266 | 101.8 EB05 60.7 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=7 | no trial data cached |
| Ulnar nerve injury | 11 | 126.8 69.3–232.2ROR 127.0 · χ² 1,192 / p 2e-261 | 100.4 EB05 59.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Blood cholesterol decreased | 81 | 119.6 95.8–149.3ROR 120.8 · χ² 8,994 / p <1e-300 | 111.4 EB05 92.5 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=43 · 91% consumer | no trial data cached |
| Creatine kinase increased | 16 | 101.0 61.3–166.3ROR 101.2 · χ² 1,430 / p <1e-300 | 87.4 EB05 57.0 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Morphoea | 16 | 91.4 55.6–150.5ROR 91.6 · χ² 1,296 / p 3e-284 | 80.2 EB05 52.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| High density lipoprotein increased | 33 | 91.1 64.4–128.8ROR 91.5 · χ² 2,754 / p <1e-300 | 83.9 EB05 62.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=22 | no trial data cached |
| Vascular stent stenosis | 13 | 84.7 48.8–147.2ROR 84.9 · χ² 962 / p 1e-211 | 73.6 EB05 45.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Muscle discomfort | 14 | 48.6 28.6–82.4ROR 48.6 · χ² 594 / p 1e-131 | 45.0 EB05 28.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Waist circumference increased | 16 | 40.9 25.0–67.0ROR 41.0 · χ² 574 / p 3e-127 | 38.6 EB05 25.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| High density lipoprotein decreased | 50 | 40.0 30.2–52.8ROR 40.2 · χ² 1,833 / p <1e-300 | 38.8 EB05 30.6 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=39 | no trial data cached |
| Blood triglycerides abnormal | 11 | 33.4 18.4–60.5ROR 33.4 · χ² 310 / p 1e-69 | 31.3 EB05 18.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=5 | no trial data cached |
| Induration | 19 | 28.3 18.0–44.5ROR 28.4 · χ² 469 / p 3e-104 | 27.3 EB05 18.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Blood triglycerides increased | 183 | 27.4 23.7–31.7ROR 28.0 · χ² 4,588 / p <1e-300 | 27.1 EB05 23.9 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 38.6 | no trial data cached |
| Lipids increased | 19 | 25.1 16.0–39.5ROR 25.2 · χ² 413 / p 4e-92 | 24.4 EB05 16.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Peripheral arterial occlusive disease | 37 | 23.9 17.3–33.0ROR 24.0 · χ² 783 / p 2e-172 | 23.5 EB05 17.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | no trial data cached |
| Blood cholesterol abnormal | 39 | 22.4 16.3–30.6ROR 22.5 · χ² 769 / p 2e-169 | 22.0 EB05 16.8 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=18 · 85% consumer | no trial data cached |
| Blood creatine phosphokinase mb increased | 10 | 20.4 10.9–38.0ROR 20.4 · χ² 164 / p 7e-38 | 19.0 EB05 10.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Discharge | 10 | 19.4 10.4–36.1ROR 19.4 · χ² 155 / p 6e-36 | 18.0 EB05 9.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Product temperature excursion issue | 33 | 18.4 13.1–25.9ROR 18.5 · χ² 522 / p 7e-116 | 18.1 EB05 13.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Blood uric acid increased | 38 | 17.4 12.7–24.0ROR 17.5 · χ² 569 / p 6e-126 | 17.1 EB05 13.0 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=37 · ♀ 23% (drug 57%) | no trial data cached |
| Injection site rash | 187 | 16.3 14.1–18.8ROR 16.7 · χ² 2,658 / p <1e-300 | 16.2 EB05 14.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=48 · ♀ 83% (drug 57%) | no trial data cached |
| Coronary artery stenosis | 28 | 14.7 10.1–21.3ROR 14.7 · χ² 341 / p 2e-76 | 14.2 EB05 10.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Blood cholesterol increased | 226 | 12.8 11.3–14.6ROR 13.1 · χ² 2,440 / p <1e-300 | 12.7 EB05 11.4 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.2 · 74% consumer | no trial data cached |
| Hepatic fibrosis | 15 | 11.6 7.0–19.2ROR 11.6 · χ² 134 / p 3e-31 | 10.2 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Injection site hypersensitivity | 13 | 11.2 6.5–19.2ROR 11.2 · χ² 110 / p 5e-26 | 9.5 EB05 5.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Spinal stenosis | 17 | 11.0 6.8–17.7ROR 11.0 · χ² 144 / p 2e-33 | 9.8 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Protein total increased | 11 | 10.9 6.1–19.8ROR 11.0 · χ² 89 / p 2e-21 | 9.0 EB05 4.9 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Arteriosclerosis | 38 | 10.6 7.7–14.6ROR 10.7 · χ² 321 / p 4e-72 | 10.1 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Myalgia (muscle pain) | 661 | 10.3 9.5–11.0ROR 11.1 · χ² 5,541 / p <1e-300 | 10.2 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Arthralgia (joint pain) | 846 | 5.4 5.0–5.7ROR 5.9 · χ² 3,066 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 71% consumer | no trial data cached |
| Myalgia (muscle pain) | 661 | 10.3 9.5–11.0ROR 11.1 · χ² 5,541 / p <1e-300 | 10.2 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Injection site pain (pain where injected) | 568 | 4.9 4.6–5.3ROR 5.2 · χ² 1,798 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 · 79% consumer | no trial data cached |
| Low density lipoprotein increased | 503 | 184.0 168.5–200.8ROR 196.3 · χ² 85,325 / p <1e-300 | 170.7 EB05 158.6 · IC025 +7.1 3/3 methods agree | Likely indication confounding term in indications | serious n=149 | no trial data cached |
| Pain in extremity | 485 | 4.3 4.0–4.7ROR 4.5 · χ² 1,253 / p 9e-275 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 77% consumer | no trial data cached |
| Fatigue (tiredness) | 410 | 1.4 1.3–1.5ROR 1.4 · χ² 46 / p 7e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 · 74% consumer | no trial data cached |
| Pain | 410 | 1.8 1.6–1.9ROR 1.8 · χ² 136 / p 1e-31 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Drug ineffective (drug did not work) | 409 | 0.8 0.7–0.9ROR 0.8 · χ² 18 / p 1e-5 | 0.8 EB05 0.8 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Diarrhoea (diarrhea) | 360 | 1.5 1.3–1.6ROR 1.5 · χ² 56 / p 4e-14 | 1.5 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 360 | 1.7 1.5–1.9ROR 1.7 · χ² 100 / p 9e-24 | 1.7 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Headache | 301 | 1.3 1.1–1.4ROR 1.3 · χ² 17 / p 2e-5 | 1.3 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Rash | 275 | 1.7 1.5–1.9ROR 1.7 · χ² 74 / p 3e-18 | 1.7 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Muscle spasms | 254 | 3.6 3.2–4.1ROR 3.7 · χ² 488 / p 2e-108 | 3.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 70% consumer | no trial data cached |
| Cough | 234 | 2.2 1.9–2.5ROR 2.2 · χ² 154 / p 1e-35 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.9 · 77% consumer | no trial data cached |
| Blood cholesterol increased | 226 | 12.8 11.3–14.6ROR 13.1 · χ² 2,440 / p <1e-300 | 12.7 EB05 11.4 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.2 · 74% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Peripheral arterial occlusive disease — n=37, PRR 23.9
- Coronary artery stenosis — n=28, PRR 14.7
- Arteriosclerosis — n=38, PRR 10.6
- Myalgia — n=661, PRR 10.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Inclisiran?
In FDA FAERS, the most frequently co-reported reaction terms for Inclisiran are arthralgia, myalgia, injection site pain, low density lipoprotein increased, pain in extremity, fatigue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Inclisiran have an FDA boxed warning?
No. The FDA label retrieved for Inclisiran has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Inclisiran causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 6fc0afca-4513-4c35-b594-6544aee29a44, effective 20260819; matched on
openfda.generic_name.exact:"INCLISIRAN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 855 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.