Leqvio adverse effects
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Leqvio (Inclisiran) Adverse Effects: Safety Profile and Common Reactions
Overview of Leqvio (Inclisiran) Safety in Clinical Trials
Leqvio (inclisiran) is a small interfering RNA (siRNA) therapy used to lower LDL cholesterol in adults with atherosclerotic cardiovascular disease or familial hypercholesterolemia who need further LDL-C reduction despite maximally tolerated statin therapy. Across several large clinical trials, the overall safety and tolerability of inclisiran were found to be similar to placebo, with most adverse effects being mild or moderate in severity Larkin2022Frampton2023Larkin2022.
Most Common Adverse Effects of Leqvio
The most frequently reported side effects of Leqvio are:
- Injection site reactions (such as redness, pain, or swelling)
- Joint stiffness
- Urinary tract infections
- Diarrhea
- Bronchitis
- Pain in extremities
- Difficulty breathing
These reactions were generally mild to moderate and transient, with injection site reactions being more common in the inclisiran group compared to placebo Larkin2022Frampton2023Larkin2022.
Real-World Experience and Discontinuation Due to Adverse Events
In real-world clinical practice, adverse drug events leading to discontinuation of inclisiran were rare. In one academic medical center, only 2 out of 26 patients (7.7%) stopped the medication due to side effects—one experienced flu-like symptoms, and another had both skin and cardiovascular effects . This suggests that while adverse effects can occur, they are infrequent and usually not severe enough to require stopping the medication.
Serious Adverse Events and Long-Term Safety
No significant increase in serious adverse events was observed in clinical trials when comparing inclisiran to placebo. However, ongoing studies are still evaluating the long-term effects of inclisiran on cardiovascular morbidity and mortality, as current evidence is not yet sufficient to confirm a reduction in these outcomes Larkin2022Frampton2023Larkin2022+1 MORE.
Conclusion
Leqvio (inclisiran) is generally well tolerated, with a safety profile similar to placebo in clinical trials. The most common adverse effects are mild injection site reactions and occasional flu-like or gastrointestinal symptoms. Serious adverse events are rare, and discontinuation due to side effects is uncommon. Ongoing research will provide more information on its long-term safety and impact on cardiovascular outcomes.
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