Qfitlia Side Effects
Generic name: fitusiran
Note: This document provides detailed information about Qfitlia Side Effects associated with fitusiran. Some dosage forms listed on this page may not apply specifically to the brand name Qfitlia.
Applies to fitusiran: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
Using this medicine can increase your risk of blood clots especially if you have certain medical conditions or you also use other medicines to help treat blood clots.
Fitusiran can increase your risk of gallbladder disease.
Call your doctor right away if you have unexplained stomach pain, nausea, vomiting, or heartburn.
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Seek medical help right away if you show signs of a blood clot such as sudden numbness or weakness (especially on one side of the body), severe headache, confusion, vision changes, slurred speech, chest pain, shortness of breath, fast heart rate, dizziness, coughing up blood, or pain, swelling, or warmth in arms or legs.
Call your doctor at once if you have:
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liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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gallbladder problems--stomach pain after eating, nausea, vomiting, heartburn, bloating, and severe upper stomach pain that may spread to your back.
Common side effects may include:
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bacterial or viral infections; or
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cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For healthcare professionals
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
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References
1. (2025) "Product Information. Qfitlia (fitusiran)." Genzyme Corporation
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Further information
Qfitlia 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.