Fitusiran Side Effects
Applies to fitusiran: subcutaneous solution.
General adverse events
The most common adverse reactions in patients treated with the antithrombin-based dose regimen were viral infection, nasopharyngitis, and bacterial infection.
Refer to the manufacturer product information for detailed descriptions of adverse reactions and/or for definitions of included terms.[Ref]
Cardiovascular
- Common (1% to 10%): Serious thrombotic events
- Frequency not reported: Cerebral venous sinus thrombosis, post-operative deep vein thrombosis
Dermatologic
- Frequency not reported: Pruritus
Gastrointestinal
- Common (1% to 10%): Acute or recurrent gallbladder disease, including cholelithiasis and cholecystitis
- Frequency not reported: Dyspepsia, abdominal pain
Hematologic
- Common (1% to 10%): Prothrombin fragment 1.2 increased
Hepatic
- Common (1% to 10%): Hepatic/liver injury, including increased ALT/AST
Immunologic
- Common (1% to 10%): Antidrug antibodies
Local
- Common (1% to 10%): Injection site reaction
Adverse effects at the injection site included bruising, erythema, pain, hematoma, atrophy, hemorrhage, discomfort, swelling, discoloration, pruritus, induration, nodule, mass, vesicles, deformation, rash, and joint pain.
Musculoskeletal
- Common (1% to 10%): Arthralgia
Nervous system
- Common (1% to 10%): Headache
- Frequency not reported: Cerebral infarction
Other
- Very common (10% or more): Viral infection (29%), bacterial infection (11%)
Respiratory
- Very common (10% or more): Nasopharyngitis (26%)
- Common (1% to 10%): Cough
References
1. (2025) "Product Information. Qfitlia (fitusiran)." Genzyme Corporation
More about fitusiran
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- Drug class: miscellaneous coagulation modifiers
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Further information
Fitusiran side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.