GIVOSIRAN for Porphyria: Side Effects & Safety Data
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There are 148 adverse event reports in the FDA FAERS database where GIVOSIRAN was used for Porphyria.
Most Reported Side Effects for GIVOSIRAN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Porphyria acute | 381 | 31.1% | 2 | 245 |
| Hospitalisation | 141 | 11.5% | 0 | 141 |
| Nausea | 91 | 7.4% | 0 | 38 |
| Product dose omission issue | 85 | 6.9% | 2 | 60 |
| Fatigue | 84 | 6.9% | 0 | 29 |
| Therapy interrupted | 83 | 6.8% | 0 | 65 |
| Pain | 74 | 6.1% | 1 | 48 |
| Intentional dose omission | 63 | 5.2% | 0 | 48 |
| Abdominal pain | 62 | 5.1% | 0 | 35 |
| Vomiting | 58 | 4.7% | 0 | 37 |
| Malaise | 56 | 4.6% | 0 | 32 |
| Seizure | 48 | 3.9% | 0 | 15 |
| Ill-defined disorder | 40 | 3.3% | 0 | 17 |
| Weight decreased | 40 | 3.3% | 0 | 26 |
| Blood homocysteine increased | 39 | 3.2% | 0 | 10 |