Short answer: In the Leqvio label's three placebo-controlled trials in 1,833 adults, the side effects reported more often than on placebo were injection site reactions (8% vs 2%), joint pain (5% vs 4%) and bronchitis (4% vs 3%). In children with HeFH, headache was 13% vs 6%. There is no boxed warning; the one warning is serious allergic reactions, including anaphylaxis and angioedema.
What Leqvio is approved for: Leqvio is a small interfering RNA (siRNA) aimed at PCSK9, approved alongside diet and exercise to lower LDL cholesterol in adults with high cholesterol (hypercholesterolemia), in adults and children 12 and older with heterozygous familial hypercholesterolemia (HeFH), and in children 12 and older with homozygous familial hypercholesterolemia (HoFH) (section 1).
Source
LEQVIO (inclisiran) injection, for subcutaneous use, prescribing information and Instructions for Use. Novartis. DailyMed, version published August 21, 2026. DailyMed setid 6fc0afca-4513-4c35-b594-6544aee29a44
No. The current Leqvio label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Leqvio.
| Adverse Reactions | Placebo (N = 1,822) % | LEQVIO (N = 1,833) % |
|---|---|---|
| Injection site reaction | 2 | 8 |
| Arthralgia | 4 | 5 |
| Bronchitis | 3 | 4 |
1,833 adults on Leqvio, 1,682 of them treated for 18 months (median 77 weeks). Injection site reaction includes injection site pain, redness and rash.
Side effects led to stopping treatment in 2.5% on Leqvio vs 1.9% on placebo. The most common reason on Leqvio was injection site reactions (0.2% vs 0%).
In 141 children aged 12 and older with HeFH, side effects were in line with adults except headache: 13% on Leqvio vs 6% on placebo in the first year. In 13 children with HoFH, the safety profile was in line with adults.
Antibodies to inclisiran were found in 5% of adults during 18 months of treatment (2% before treatment). The label found no clinically significant effect, though long-term effects are unknown.
Reported after approval: anaphylaxis, angioedema (swelling under the skin), rash, itching and hives.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Allergic reactions. Allergic reactions, including anaphylaxis and angioedema, have been reported. The label says patients are told the signs and to seek medical attention promptly.
Pregnancy. Based on how it works, Leqvio may harm an unborn baby. The label says to stop Leqvio when pregnancy is recognized, or to weigh the person's ongoing treatment needs. A pregnancy safety study is in place.
Who should not use it. People who have had a serious allergic reaction to inclisiran or any ingredient in Leqvio. Such reactions have included anaphylaxis and angioedema.
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.