Palopegteriparatide side effects: what 368 FDA adverse event reports show

Palopegteriparatide · Yorvipath · 11 reaction terms · 205 drug–reaction co-reports · data 2026-09-14

Drug class

Parathyroid hormone analog (pth(1-34))

FDA label, Indications wording

Brand names

Yorvipath

openFDA label

Who reports

368 reports · 35% serious · 6 with death outcome · 94% female

openFDA FAERS counts, all years, deduplication not applied

Used for

YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. ( 1 ) Limitations of Use : Not studied for acute post-surgical hypoparathyroidism.

FDA label, Indications and Usage

What it is

YORVIPATH (palopegteriparatide injection) is a parathyroid hormone analog (PTH(1-34)). Palopegteriparatide is a prodrug of teriparatide (PTH(1-34)) consisting of PTH(1-34) transiently conjugated to an inert carrier via a proprietary TransCon Linker.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 9 strongest signals

Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 2

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hypocalcaemia (low calcium)	69	209.0 168.9–258.7ROR 257.0 · χ² 14,039 / p <1e-300	197.0 EB05 161.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 201.7	no trial data cached
Hypercalcaemia	42	194.7 146.4–258.9ROR 219.6 · χ² 7,878 / p <1e-300	178.4 EB05 137.5 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 204.7	no trial data cached
Blood calcium decreased	18	91.0 58.0–142.9ROR 95.7 · χ² 1,513 / p <1e-300	83.1 EB05 55.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 62.7	no trial data cached
Brain fog	9	35.2 18.4–67.1ROR 36.0 · χ² 266 / p 5e-60	32.9 EB05 18.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.9	no trial data cached
Injection site reaction	29	24.1 17.0–34.2ROR 26.1 · χ² 621 / p 3e-137	23.7 EB05 17.3 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.5	no trial data cached
Product availability issue	7	17.8 8.5–37.1ROR 18.1 · χ² 95 / p 1e-22	15.2 EB05 6.2 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.7	no trial data cached
Wrong technique in device usage process	13	16.2 9.5–27.6ROR 16.8 · χ² 171 / p 2e-39	15.2 EB05 8.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Injection site urticaria	5	11.7 4.9–28.1ROR 11.9 · χ² 39 / p 2e-10	7.6 EB05 3.0 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Device use error	6	10.0 4.5–22.2ROR 10.2 · χ² 40 / p 1e-10	6.8 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Hypocalcaemia (low calcium)	69	209.0 168.9–258.7ROR 257.0 · χ² 14,039 / p <1e-300	197.0 EB05 161.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 201.7	no trial data cached
Hypercalcaemia	42	194.7 146.4–258.9ROR 219.6 · χ² 7,878 / p <1e-300	178.4 EB05 137.5 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 204.7	no trial data cached
Injection site reaction	29	24.1 17.0–34.2ROR 26.1 · χ² 621 / p 3e-137	23.7 EB05 17.3 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.5	no trial data cached
Blood calcium decreased	18	91.0 58.0–142.9ROR 95.7 · χ² 1,513 / p <1e-300	83.1 EB05 55.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 62.7	no trial data cached
Wrong technique in device usage process	13	16.2 9.5–27.6ROR 16.8 · χ² 171 / p 2e-39	15.2 EB05 8.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Brain fog	9	35.2 18.4–67.1ROR 36.0 · χ² 266 / p 5e-60	32.9 EB05 18.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 24.9	no trial data cached
Product availability issue	7	17.8 8.5–37.1ROR 18.1 · χ² 95 / p 1e-22	15.2 EB05 6.2 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.7	no trial data cached
Device use error	6	10.0 4.5–22.2ROR 10.2 · χ² 40 / p 1e-10	6.8 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Injection site urticaria	5	11.7 4.9–28.1ROR 11.9 · χ² 39 / p 2e-10	7.6 EB05 3.0 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Needle issue	4	8.0 3.0–21.1ROR 8.0 · χ² 18 / p 1e-5	4.8 EB05 2.0 · IC025 +0.4	Not in label — unassessed	serious n=1	no trial data cached
Incorrect dose administered by device	3	6.7 2.2–20.8ROR 6.8 · χ² 9 / p 0.001	3.8 EB05 1.5 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Hypocalcaemia — n=69, PRR 209.0

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 Palopegteriparatide?

In FDA FAERS, the most frequently co-reported reaction terms for Palopegteriparatide are hypocalcaemia, hypercalcaemia, injection site reaction, blood calcium decreased, brain fog, injection site urticaria. 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 Palopegteriparatide have an FDA boxed warning?

No. The FDA label retrieved for Palopegteriparatide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Palopegteriparatide 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 a1fa23fd-c434-443e-9a17-5750578c8602, effective 20260812; matched on openfda.generic_name.exact:"PALOPEGTERIPARATIDE")
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, field patient.drug.openfda.generic_name.exact, 11 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.