OpenClaim

Inclisiran Side Effects

The most commonly reported side effects of inclisiran include arthralgia, myalgia, and injection site pain, based on 6,994 FDA adverse event reports from 2020 to 2025. 5.1% of reports found the drug to be ineffective.

Inclisiran side effects

Percentages show how often each reaction appears relative to total reports for inclisiran.

1
Arthralgia10.6%740
2
Myalgia8.4%585
3
Injection Site Pain7.3%509
4
Low Density Lipoprotein Increased6.4%447
5
Pain In Extremity6.3%442
6
Pain5.3%370
7
Fatigue5.2%363
8
Drug Ineffective5.1%356
9
Diarrhoea4.7%328
10
Dyspnoea4.6%319
11
Headache3.7%259
12
Rash3.4%241
13
Muscle Spasms3.2%221
14
Product Storage Error3.0%210
15
Dizziness2.9%202

These are voluntary reports and do not establish that inclisiran caused these reactions.

Report severity

39.4%Serious2,758 reports
9.3%Hospitalizations651 reports
2.7%Fatal190 reports

Seriousness is determined by the reporter, not by OpenClaim.

Inclisiran drug interactions

Other drugs that appear in adverse event reports alongside inclisiran. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ezetimibe4.6%321
2
Rosuvastatin3.6%251
3
Atorvastatin-calcium2.1%147
4
Evolocumab1.4%97
5
Simvastatin0.7%52
6
Pravastatin-sodium0.5%38
7
Aspirin0.5%35
8
Pantoprazole-sodium0.5%33
9
Rivaroxaban0.4%25
10
Alirocumab0.3%24
11
Bempedoic0.3%24
12
Gemfibrozil0.3%20
13
Bisoprolol-fumarate0.3%19
14
Ibuprofen0.2%17
15
Valsartan0.2%16

Taken alongside

1
Aspirin5.4%376
2
Ezetimibe3.9%273
3
Rosuvastatin2.3%162
4
Amlodipine2.1%148
5
Atorvastatin-calcium2.0%138
6
Metoprolol1.8%126
7
Bisoprolol-fumarate1.6%115
8
Levothyroxine-sodium1.6%115
9
Ergocalciferol1.6%113
10
Omeprazole1.3%90
11
Losartan-potassium1.2%86
12
Pantoprazole-sodium1.2%86
13
Metformin1.2%82
14
Gemfibrozil1.1%75
15
Acetaminophen1.0%67

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports inclisiran side effects

47.2% of inclisiran adverse event reports involve female patients and 35.5% involve male patients. The largest age group is elderly at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.2%
Male35.5%
Unknown17.3%

Age group

< 20.1%
2–11<0.1%
12–170.0%
18–6433.2%
65+66.6%

What is inclisiran used for

Conditions and purposes for which patients were taking inclisiran when the adverse event was reported.

ArteriosclerosisAbdominal DiscomfortAbdominal PainAcute Coronary SyndromeAcute Myocardial InfarctionAdjuvant TherapyAngina PectorisAngiogramAortic ArteriosclerosisArteriosclerosisArteriosclerosis Coronary ArteryArthralgiaAtrioventricular Septal DefectBack PainBlood Calcium Increased

Showing 15 of 123 indications

Inclisiran brand names and reporting trend

Inclisiran is sold under the brand name Leqvio.

Brand names

Leqvio792

Quarterly reports (20202025)

2020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking inclisiran with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.