What the label lists and what reports show
Eplontersen side effects
Eplontersen's FDA label: “Most common adverse reactions (that occurred in at least 9% of patients treated with WAINUA) were vitamin A decreased and vomiting.” FAERS holds 168 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 fatigue (13 reports).
- No generic listed
Check it at the source: the eplontersen FDA label on DailyMed (effective April 15, 2026, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (that occurred in at least 9% of patients treated with WAINUA) were vitamin A decreased and vomiting.
Table 1: Adverse Reactions Reported in at least 5% of Patients Treated with WAINUA (Study 1)
| Adverse Reaction | WAINUA N=144 % |
|---|---|
| Vitamin A decreased Vitamin A decreased includes vitamin A deficiency and vitamin A… | 15 |
| Vomiting | 9 |
| Proteinuria | 8 |
| Injection site reactions Injection site reactions includes erythema, pain, and pruritus. | 7 |
| Blurred vision | 6 |
| Cataract | 6 |
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: • Reduced Serum Vitamin A Levels and Recommended Supplementation [see Warnings and Precautions (5.1) ]. Most common adverse reactions (that occurred in at least 9% of patients treated with WAINUA) were vitamin A decreased and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of WAINUA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Study 1 [see Clinical Studies (14) ], a total of 144 patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) were randomized to WAINUA and received at least one dose of WAINUA. Of these, 141 patients received at least 6 months of treatment and 107 patients received at least 12 months of treatment. The mean duration of treatment was 15 months (range: 1.9 to 19.4 months). The median patient age at baseline was 52 years and 69% of the patients were male. …
Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective April 15, 2026 (SPL set d7dcb847-71dd-4fff-82d0-d43a465fc096), via openFDA; the full label on DailyMed
What do FAERS reports show?
168 reports list eplontersen among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 21 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 21 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.
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?
- Eplontersen: 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