Does GIVOSIRAN Cause Unevaluable event? 38 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 38 reports of Unevaluable event have been filed in association with GIVOSIRAN (GIVLAARI). This represents 3.1% of all adverse event reports for GIVOSIRAN.
38
Reports of Unevaluable event with GIVOSIRAN
3.1%
of all GIVOSIRAN reports
0
Deaths
18
Hospitalizations
How Dangerous Is Unevaluable event From GIVOSIRAN?
Of the 38 reports, 18 (47.4%) required hospitalization, and 1 (2.6%) were considered life-threatening.
Is Unevaluable event Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for GIVOSIRAN. However, 38 reports have been filed with the FAERS database.
What Other Side Effects Does GIVOSIRAN Cause?
Porphyria acute (381)
Hospitalisation (141)
Nausea (91)
Product dose omission issue (85)
Fatigue (84)
Therapy interrupted (83)
Pain (74)
Intentional dose omission (63)
Abdominal pain (62)
Vomiting (58)