Etelcalcetide side effects: what 2,871 FDA adverse event reports show

Etelcalcetide · Parsabiv · 43 reaction terms · 1,411 drug–reaction co-reports · data 2026-09-14

Drug class

Calcium-sensing receptor agonist

FDA label, Indications wording

Brand names

Parsabiv

openFDA label

Who reports

2,871 reports · 49% serious · 333 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

FDA label, Indications and Usage

What it is

PARSABIV (etelcalcetide) is a synthetic peptide calcium-sensing receptor agonist. Etelcalcetide is a white to off-white powder with a molecular formula of C 38 H 73 N 21 O 10 S 2 ∙xHCl (4 ≤ x ≤ 5) and a molecular weight of 1047.5 g/mol (monoisotopic; free base). It is soluble in water.

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 28 strongest signals

Labeled adverse reaction 2Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 6Outcome field, not a reaction 1Not in label — unassessed 13

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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 15 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
Blood calcium decreased	124	81.2 68.3–96.5ROR 84.8 · χ² 9,634 / p <1e-300	79.3 EB05 68.3 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 33.5 · 98% clinician	no trial data cached
Hypocalcaemia (low calcium)	149	58.1 49.7–68.0ROR 61.2 · χ² 8,246 / p <1e-300	57.2 EB05 49.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 39.9 · 98% clinician	no trial data cached
Underdose	247	24.8 22.0–27.9ROR 27.0 · χ² 5,611 / p <1e-300	24.6 EB05 22.2 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 23.0 · 98% clinician	no trial data cached
Circumstance or information capable of leading to medication error	82	17.9 14.5–22.2ROR 18.4 · χ² 1,290 / p 1e-282	17.8 EB05 14.8 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Myocardial ischaemia	27	17.2 11.8–25.1ROR 17.4 · χ² 396 / p 2e-88	16.9 EB05 12.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.4 · 100% clinician	no trial data cached
Hypercalcaemia	27	16.0 11.0–23.3ROR 16.2 · χ² 365 / p 1e-81	15.7 EB05 11.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.0 · 100% clinician	no trial data cached
Sudden death	20	13.7 8.8–21.2ROR 13.8 · χ² 222 / p 1e-50	13.0 EB05 8.4 · IC025 +2.6 3/3 methods agree	Outcome field, not a reaction	serious PRR 16.2 · 100% clinician	no trial data cached
Product storage error	149	12.6 10.8–14.7ROR 13.2 · χ² 1,583 / p <1e-300	12.5 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Cerebral infarction	41	12.3 9.0–16.6ROR 12.4 · χ² 413 / p 5e-92	11.9 EB05 9.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.5 · 100% clinician	no trial data cached
Therapy non-responder	61	10.0 7.8–12.8ROR 10.2 · χ² 486 / p 5e-108	9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 100% clinician	no trial data cached
Carpal tunnel syndrome	14	7.3 4.3–12.3ROR 7.3 · χ² 70 / p 3e-17	6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Dialysis	14	7.2 4.3–12.1ROR 7.2 · χ² 69 / p 6e-17	6.0 EB05 3.7 · IC025 +1.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 8.3	no trial data cached
Muscle twitching	22	7.0 4.6–10.6ROR 7.0 · χ² 106 / p 3e-25	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · 100% clinician	no trial data cached
Cardiac failure (heart failure)	66	6.0 4.7–7.6ROR 6.1 · χ² 271 / p 3e-61	5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1 · 98% clinician	no trial data cached
Pneumonia aspiration	17	5.0 3.1–8.0ROR 5.0 · χ² 50 / p 7e-13	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial data cached
Device related infection	10	4.7 2.5–8.8ROR 4.7 · χ² 26 / p 2e-7	4.0 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 5.7	no trial data cached
Treatment noncompliance	34	4.6 3.3–6.4ROR 4.6 · χ² 92 / p 5e-22	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 100% clinician	no trial data cached
Arrhythmia	27	4.1 2.8–6.0ROR 4.2 · χ² 61 / p 2e-15	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.1 · 93% clinician	no trial data cached
Acute myocardial infarction	16	3.9 2.4–6.4ROR 4.0 · χ² 32 / p 6e-9	3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Gastrointestinal disorder	46	3.8 2.9–5.1ROR 3.8 · χ² 93 / p 3e-22	3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.8 · 96% clinician	no trial data cached
Angina pectoris	15	3.8 2.3–6.3ROR 3.8 · χ² 28 / p 5e-8	3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Skin ulcer	13	3.7 2.1–6.3ROR 3.7 · χ² 23 / p 9e-7	3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.3	no trial data cached
Cerebral haemorrhage	18	3.7 2.3–5.8ROR 3.7 · χ² 33 / p 6e-9	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Electrocardiogram qt prolonged	17	3.5 2.1–5.5ROR 3.5 · χ² 27 / p 9e-8	3.2 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1	no trial data cached
Cardiovascular disorder	12	3.4 1.9–6.0ROR 3.4 · χ² 18 / p 1e-5	3.1 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 4.0	no trial data cached
Drug effect incomplete	15	3.0 1.8–4.9ROR 3.0 · χ² 18 / p 1e-5	2.8 EB05 1.8 · IC025 +0.6	Reporting / coding artifact	serious PRR 4.6	no trial data cached
Gastrointestinal haemorrhage	33	2.9 2.0–4.0ROR 2.9 · χ² 38 / p 3e-10	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.4 · 100% clinician	no trial data cached
Femur fracture	12	2.8 1.6–5.0ROR 2.8 · χ² 12 / p 2e-4	2.6 EB05 1.6 · IC025 +0.4	Not in label — unassessed	serious PRR 3.4	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
Underdose	247	24.8 22.0–27.9ROR 27.0 · χ² 5,611 / p <1e-300	24.6 EB05 22.2 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 23.0 · 98% clinician	no trial data cached
Product storage error	149	12.6 10.8–14.7ROR 13.2 · χ² 1,583 / p <1e-300	12.5 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Hypocalcaemia (low calcium)	149	58.1 49.7–68.0ROR 61.2 · χ² 8,246 / p <1e-300	57.2 EB05 49.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 39.9 · 98% clinician	no trial data cached
Blood calcium decreased	124	81.2 68.3–96.5ROR 84.8 · χ² 9,634 / p <1e-300	79.3 EB05 68.3 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 33.5 · 98% clinician	no trial data cached
Circumstance or information capable of leading to medication error	82	17.9 14.5–22.2ROR 18.4 · χ² 1,290 / p 1e-282	17.8 EB05 14.8 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Cardiac failure (heart failure)	66	6.0 4.7–7.6ROR 6.1 · χ² 271 / p 3e-61	5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1 · 98% clinician	no trial data cached
Therapy non-responder	61	10.0 7.8–12.8ROR 10.2 · χ² 486 / p 5e-108	9.7 EB05 7.7 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 100% clinician	no trial data cached
Gastrointestinal disorder	46	3.8 2.9–5.1ROR 3.8 · χ² 93 / p 3e-22	3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.8 · 96% clinician	no trial data cached
Cerebral infarction	41	12.3 9.0–16.6ROR 12.4 · χ² 413 / p 5e-92	11.9 EB05 9.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.5 · 100% clinician	no trial data cached
Treatment noncompliance	34	4.6 3.3–6.4ROR 4.6 · χ² 92 / p 5e-22	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 100% clinician	no trial data cached
Gastrointestinal haemorrhage	33	2.9 2.0–4.0ROR 2.9 · χ² 38 / p 3e-10	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.4 · 100% clinician	no trial data cached
Arrhythmia	27	4.1 2.8–6.0ROR 4.2 · χ² 61 / p 2e-15	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.1 · 93% clinician	no trial data cached
Hypercalcaemia	27	16.0 11.0–23.3ROR 16.2 · χ² 365 / p 1e-81	15.7 EB05 11.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.0 · 100% clinician	no trial data cached
Myocardial ischaemia	27	17.2 11.8–25.1ROR 17.4 · χ² 396 / p 2e-88	16.9 EB05 12.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 20.4 · 100% clinician	no trial data cached
Muscle twitching	22	7.0 4.6–10.6ROR 7.0 · χ² 106 / p 3e-25	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · 100% clinician	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=149, PRR 58.1
Myocardial ischaemia — n=27, PRR 17.2
Hypercalcaemia — n=27, PRR 16.0
Cerebral infarction — n=41, PRR 12.3
Muscle twitching — n=22, PRR 7.0

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 Etelcalcetide?

In FDA FAERS, the most frequently co-reported reaction terms for Etelcalcetide are hypocalcaemia, blood calcium decreased, circumstance or information capable of leading to medication error, cardiac failure, gastrointestinal disorder, cerebral infarction. 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 Etelcalcetide have an FDA boxed warning?

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

Do FAERS signals prove that Etelcalcetide 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 cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c, effective 20260308; matched on openfda.generic_name.exact:"ETELCALCETIDE")
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, 43 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.