Olezarsen side effects: what 602 FDA adverse event reports show
Drug class
Apolipoprotein c-iii (apoc-iii)-directed antisense oligonucleotide (aso)
Label matched
Olezarsen Sodium (Tryngolza)
Who reports
602 reports · 26% serious · 3 with death outcome · 100% female
Used for
TRYNGOLZA ® is indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL).
What it is
Olezarsen is an ASO directed inhibitor of apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three GalNAc residues to enable delivery of the ASO to hepatocytes. TRYNGOLZA contains olezarsen sodium as the active ingredient.
Boxed warning
None in the current label
Causality screen of the 15 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 3 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood triglycerides increased | 63 | 110.6 87.4–140.0ROR 121.9 · χ² 6,716 / p <1e-300 | 106.7 EB05 86.4 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 159.0 · 71% consumer | no trial data cached |
| Injection site discolouration | 16 | 40.1 24.7–65.1ROR 41.0 · χ² 571 / p 2e-126 | 38.4 EB05 25.0 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Pancreatitis acute | 26 | 36.2 24.8–52.8ROR 37.6 · χ² 855 / p 4e-188 | 35.3 EB05 25.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 87.6 | no trial data cached |
| Injection site rash | 20 | 20.5 13.3–31.5ROR 21.0 · χ² 351 / p 1e-78 | 20.0 EB05 13.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | 90% consumer | no trial data cached |
| Injection site urticaria | 13 | 16.6 9.7–28.5ROR 16.9 · χ² 176 / p 2e-40 | 15.7 EB05 9.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Glycosylated haemoglobin increased | 13 | 16.0 9.3–27.4ROR 16.3 · χ² 168 / p 8e-39 | 15.0 EB05 8.5 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
| Injection site irritation | 6 | 14.7 6.6–32.6ROR 14.8 · χ² 64 / p 8e-16 | 11.1 EB05 4.3 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Pancreatitis (pancreas inflammation) | 25 | 14.7 10.0–21.5ROR 15.2 · χ² 305 / p 1e-68 | 14.2 EB05 9.8 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 35.9 | no trial data cached |
| Injection site erythema (redness where injected) | 51 | 12.8 9.8–16.7ROR 13.8 · χ² 547 / p 3e-121 | 12.6 EB05 9.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.6 · 98% consumer | no trial data cached |
| Injection site pruritus | 22 | 10.3 6.8–15.5ROR 10.6 · χ² 175 / p 3e-40 | 9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 · 86% consumer | no trial data cached |
| Injection site swelling | 24 | 9.8 6.6–14.6ROR 10.2 · χ² 182 / p 8e-42 | 9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Injection site bruising | 21 | 8.3 5.4–12.6ROR 8.5 · χ² 127 / p 8e-30 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 100% consumer | no trial data cached |
| Injection site pain (pain where injected) | 59 | 6.0 4.7–7.7ROR 6.5 · χ² 246 / p 9e-56 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 95% consumer | no trial data cached |
| Injection site mass | 5 | 4.2 1.8–10.1ROR 4.2 · χ² 9 / p 0.001 | 3.2 EB05 1.6 · IC025 +0.1 | Labeled (related wording) related wording | serious PRR 11.2 | no trial data cached |
| Injection site haemorrhage | 8 | 3.1 1.6–6.2ROR 3.2 · χ² 10 / p 1e-3 | 2.8 EB05 1.5 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood triglycerides increased | 63 | 110.6 87.4–140.0ROR 121.9 · χ² 6,716 / p <1e-300 | 106.7 EB05 86.4 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 159.0 · 71% consumer | no trial data cached |
| Injection site pain (pain where injected) | 59 | 6.0 4.7–7.7ROR 6.5 · χ² 246 / p 9e-56 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 95% consumer | no trial data cached |
| Injection site erythema (redness where injected) | 51 | 12.8 9.8–16.7ROR 13.8 · χ² 547 / p 3e-121 | 12.6 EB05 9.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.6 · 98% consumer | no trial data cached |
| Pancreatitis acute | 26 | 36.2 24.8–52.8ROR 37.6 · χ² 855 / p 4e-188 | 35.3 EB05 25.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 87.6 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 25 | 14.7 10.0–21.5ROR 15.2 · χ² 305 / p 1e-68 | 14.2 EB05 9.8 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 35.9 | no trial data cached |
| Injection site swelling | 24 | 9.8 6.6–14.6ROR 10.2 · χ² 182 / p 8e-42 | 9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | no trial data cached |
| Injection site pruritus | 22 | 10.3 6.8–15.5ROR 10.6 · χ² 175 / p 3e-40 | 9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 · 86% consumer | no trial data cached |
| Injection site bruising | 21 | 8.3 5.4–12.6ROR 8.5 · χ² 127 / p 8e-30 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 100% consumer | no trial data cached |
| Injection site rash | 20 | 20.5 13.3–31.5ROR 21.0 · χ² 351 / p 1e-78 | 20.0 EB05 13.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | 90% consumer | no trial data cached |
| Injection site discolouration | 16 | 40.1 24.7–65.1ROR 41.0 · χ² 571 / p 2e-126 | 38.4 EB05 25.0 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Glycosylated haemoglobin increased | 13 | 16.0 9.3–27.4ROR 16.3 · χ² 168 / p 8e-39 | 15.0 EB05 8.5 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
| Injection site urticaria | 13 | 16.6 9.7–28.5ROR 16.9 · χ² 176 / p 2e-40 | 15.7 EB05 9.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Injection site haemorrhage | 8 | 3.1 1.6–6.2ROR 3.2 · χ² 10 / p 1e-3 | 2.8 EB05 1.5 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Injection site irritation | 6 | 14.7 6.6–32.6ROR 14.8 · χ² 64 / p 8e-16 | 11.1 EB05 4.3 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Injection site mass | 5 | 4.2 1.8–10.1ROR 4.2 · χ² 9 / p 0.001 | 3.2 EB05 1.6 · IC025 +0.1 | Labeled (related wording) related wording | serious PRR 11.2 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Olezarsen?
In FDA FAERS, the most frequently co-reported reaction terms for Olezarsen are blood triglycerides increased, injection site pain, injection site erythema, pancreatitis acute, pancreatitis, injection site swelling. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Olezarsen have an FDA boxed warning?
No. The FDA label retrieved for Olezarsen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Olezarsen causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0f51aa8e-8475-8cf9-e063-6394a90a6848, effective 20260703; matched on
openfda.generic_name.exact:"OLEZARSEN SODIUM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 18 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.