What the label lists and what reports show
Givosiran side effects
Givosiran's FDA label: “The most common adverse reactions (≥20% of patients) included nausea and injection site reactions.” FAERS holds 1,462 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is porphyria acute (469 reports).
- No generic listed
Check it at the source: the givosiran FDA label on DailyMed (effective September 10, 2025, Alnylam Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20% of patients) included nausea and injection site reactions.
Table 1: Adverse Reactions that Occurred at Least 5% More Frequently in Patients Treated with GIVLAARI Compared to Patients Treated with Placebo
| Adverse Reaction | GIVLAARI N=48 N (%) | Placebo N=46 N (%) |
|---|---|---|
| Nausea | 13 (27) | 5 (11) |
| Injection site reactions | 12 (25) | 0 |
| Rash Grouped term includes pruritus, eczema, erythema, rash, rash pruritic, urticaria | 8 (17) | 2 (4) |
| Serum creatinine increase Grouped term includes blood creatinine increased, glomerular… | 7 (15) | 2 (4) |
| Transaminase elevations | 6 (13) | 1 (2) |
| Fatigue | 5 (10) | 2 (4) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Anaphylactic Reaction [see Warnings and Precautions (5.1) ] Transaminase Elevations [see Warnings and Precautions (5.2) ] Serum Creatinine Increase [see Warnings and Precautions (5.3) ] Injection Site Reactions [see Warnings and Precautions (5.4) ] Blood Homocysteine Increased [see Warnings and Precautions (5.5) ] Pancreatitis [see Warnings and Precautions (5.6) ] The most common adverse reactions (≥20% of patients) included nausea and injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the pivotal placebo-controlled, double-blind study (ENVISION), 48 patients received 2.5 mg/kg GIVLAARI and 46 patients received placebo, administered once monthly via subcutaneous injection for up to 6 months. Patients received GIVLAARI for a median of 5.5 months (range 2.7-6.4 months). Of these, 47 patients received ≥5 months of treatment. …
Source: FDA drug label, Alnylam Pharmaceuticals, Inc., effective September 10, 2025 (SPL set 167e663c-11e1-497b-a3fc-951d65d58eaa), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,462 reports list givosiran among the medicines taken, each a report of something that happened, not proof the medicine caused it; 47 are coded as a death and 713 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Givosiran: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions