inclisiran
Brand names: Leqvio
Leqvio is a medicine that helps lower bad cholesterol (LDL-C) in adults. It is used along with diet and exercise.
What it does
Leqvio is used to lower LDL-C (bad cholesterol) in adults who have high cholesterol.
Common side effects
Injection site reaction (pain, redness, or rash), Joint pain, Bronchitis
Key warnings
You should not take Leqvio if you have had a serious allergic reaction to inclisiran or any of its ingredients.
How It Works
Leqvio contains inclisiran, which is a small interfering RNA (siRNA). It targets a substance in the liver called PCSK9. By targeting PCSK9, Leqvio helps your body remove more LDL-C from your blood.
How to Take It
Leqvio is given as a shot under the skin (subcutaneous injection) by a healthcare provider. You will get a 284 mg shot to start. Then, you will get another shot after 3 months. After that, you will get a shot every 6 months.
Pregnancy & Breastfeeding
Stop taking Leqvio when you know you are pregnant. Lowering cholesterol may not be helpful during pregnancy and Leqvio could potentially harm the baby.
Missed Dose
If you miss a planned dose by less than 3 months, get the shot as soon as possible and continue with your original schedule. If you miss a planned dose by more than 3 months, restart the dosing schedule with a shot now, another in 3 months, and then every 6 months.
Storage
Store Leqvio at room temperature, between 68°F and 77°F.
Side Effects (from patient reports)
Based on 4,456 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 6,989 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2018–2025.
Total Reports
6,989
Death-Related Reports
190
Hospitalization Reports
651
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ARTHRALGIA | 740 |
| 2 | MYALGIA | 584 |
| 3 | INJECTION SITE PAIN | 509 |
| 4 | LOW DENSITY LIPOPROTEIN INCREASED | 447 |
| 5 | PAIN IN EXTREMITY | 442 |
| 6 | PAIN | 370 |
| 7 | FATIGUE | 363 |
| 8 | DRUG INEFFECTIVE | 356 |
| 9 | DIARRHOEA | 326 |
| 10 | DYSPNOEA | 319 |
| 11 | HEADACHE | 259 |
| 12 | RASH | 241 |
| 13 | MUSCLE SPASMS | 221 |
| 14 | PRODUCT STORAGE ERROR | 210 |
| 15 | DIZZINESS | 202 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take Leqvio if you have had a serious allergic reaction to inclisiran or any of its ingredients. Serious allergic reactions can include swelling of the face, lips, tongue, or throat (angioedema).
Common Questions
How quickly will Leqvio lower my cholesterol?
Can I inject Leqvio myself?
Where on my body will the injection be given?
What should the medicine look like?
What if I see particles in the medicine?
Will I need to continue my diet and exercise plan while taking Leqvio?
How often will I need to get Leqvio injections?
What if I have a skin condition at the injection site?
Can I take Leqvio if I am breastfeeding?
Will my doctor check my cholesterol levels while I'm on this medication?
What are the common side effects of inclisiran?
What drug class is inclisiran?
Is inclisiran safe during pregnancy?
Related Medications in PCSK9 siRNA
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What the FDA Data Shows for inclisiran
The FDA label for inclisiran (sold under brand names such as Leqvio) classifies it as a prescription-only medication in the PCSK9 siRNA class. Leqvio is used to lower LDL-C (bad cholesterol) in adults who have high cholesterol. Official labeling lists 3 commonly reported side effects, including Injection site reaction (pain, redness, or rash), Joint pain, Bronchitis.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,456 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: July 31, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages