Calaspargase Pegol side effects: what 745 FDA adverse event reports show

Calaspargase Pegol · Asparlas · 19 reaction terms · 644 drug–reaction co-reports · data 2026-09-14

Drug class

Asparagine-specific Enzyme

FDA label (Established Pharmacologic Class)

Brand names

Asparlas

openFDA label

Who reports

745 reports · 91% serious · 54 with death outcome · 46% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblasti.

FDA label, Indications and Usage

What it is

Calaspargase pegol-mknl contains an asparagine specific enzyme derived from Escherichia coli , as a conjugate of L-asparaginase (L-asparagine amidohydrolase) and monomethoxypolyethylene glycol (mPEG) with a succinimidyl carbonate (SC) 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 19 strongest signals

Labeled adverse reaction 5Labeled (related wording) 3Reporting / coding artifact 2Not in label — unassessed 9

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.
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. 0 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
Anaphylactic reaction (severe allergic reaction)	98	50.3 41.8–60.5ROR 57.8 · χ² 4,690 / p <1e-300	49.8 EB05 42.0 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.0 · 100% clinician	no trial data cached
Pancreatitis (pancreas inflammation)	71	37.8 30.3–47.2ROR 41.7 · χ² 2,511 / p <1e-300	37.4 EB05 30.7 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.5 · 100% clinician	no trial data cached
Hypersensitivity (allergic reaction)	204	31.0 27.6–34.9ROR 42.3 · χ² 5,941 / p <1e-300	30.9 EB05 27.5 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.0 · 100% clinician	no trial data cached
Infusion related reaction (reaction during infusion)	67	28.6 22.7–35.9ROR 31.3 · χ² 1,759 / p <1e-300	28.3 EB05 23.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 18.3 · 100% clinician	no trial data cached
Electrolyte imbalance	11	26.9 15.0–48.4ROR 27.3 · χ² 249 / p 2e-56	25.7 EB05 15.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.6	no trial data cached
Polyneuropathy	11	26.0 14.5–46.8ROR 26.4 · χ² 240 / p 2e-54	24.9 EB05 14.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.6	no trial data cached
Coagulopathy	15	25.4 15.4–42.0ROR 25.9 · χ² 328 / p 1e-73	24.7 EB05 15.8 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.7	no trial data cached
Eyelid ptosis	9	24.9 13.0–47.7ROR 25.2 · χ² 183 / p 4e-42	23.5 EB05 12.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Febrile neutropenia	52	22.1 17.0–28.7ROR 23.7 · χ² 1,030 / p 3e-226	21.9 EB05 17.4 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4 · 98% clinician	no trial data cached
Hepatotoxicity (liver damage)	17	21.6 13.5–34.6ROR 22.1 · χ² 314 / p 2e-70	21.1 EB05 13.8 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.9	no trial data cached
Pancreatitis acute	15	18.9 11.5–31.3ROR 19.3 · χ² 237 / p 8e-54	18.3 EB05 11.4 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0	no trial data cached
Circulatory collapse	11	18.1 10.1–32.6ROR 18.4 · χ² 161 / p 3e-37	17.0 EB05 9.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Hyperbilirubinaemia	6	16.4 7.4–36.4ROR 16.5 · χ² 72 / p 1e-17	12.9 EB05 4.8 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Hyperglycaemia (high blood sugar)	21	16.3 10.7–24.8ROR 16.7 · χ² 286 / p 1e-64	15.8 EB05 10.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Clostridium difficile infection	11	14.3 7.9–25.7ROR 14.5 · χ² 123 / p 7e-29	12.7 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Drug level decreased	5	13.8 5.7–33.0ROR 13.9 · χ² 47 / p 3e-12	9.4 EB05 3.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.3	no trial data cached
Acute hepatic failure	6	12.4 5.6–27.6ROR 12.5 · χ² 52 / p 3e-13	8.8 EB05 3.6 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.8	no trial data cached
Drug level increased	7	11.9 5.7–24.9ROR 12.0 · χ² 59 / p 6e-15	8.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 8.3	no trial data cached
Neurotoxicity	7	11.3 5.4–23.7ROR 11.4 · χ² 56 / p 3e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	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
Hypersensitivity (allergic reaction)	204	31.0 27.6–34.9ROR 42.3 · χ² 5,941 / p <1e-300	30.9 EB05 27.5 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.0 · 100% clinician	no trial data cached
Anaphylactic reaction (severe allergic reaction)	98	50.3 41.8–60.5ROR 57.8 · χ² 4,690 / p <1e-300	49.8 EB05 42.0 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.0 · 100% clinician	no trial data cached
Pancreatitis (pancreas inflammation)	71	37.8 30.3–47.2ROR 41.7 · χ² 2,511 / p <1e-300	37.4 EB05 30.7 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.5 · 100% clinician	no trial data cached
Infusion related reaction (reaction during infusion)	67	28.6 22.7–35.9ROR 31.3 · χ² 1,759 / p <1e-300	28.3 EB05 23.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 18.3 · 100% clinician	no trial data cached
Febrile neutropenia	52	22.1 17.0–28.7ROR 23.7 · χ² 1,030 / p 3e-226	21.9 EB05 17.4 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4 · 98% clinician	no trial data cached
Hyperglycaemia (high blood sugar)	21	16.3 10.7–24.8ROR 16.7 · χ² 286 / p 1e-64	15.8 EB05 10.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Hepatotoxicity (liver damage)	17	21.6 13.5–34.6ROR 22.1 · χ² 314 / p 2e-70	21.1 EB05 13.8 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.9	no trial data cached
Pancreatitis acute	15	18.9 11.5–31.3ROR 19.3 · χ² 237 / p 8e-54	18.3 EB05 11.4 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0	no trial data cached
Coagulopathy	15	25.4 15.4–42.0ROR 25.9 · χ² 328 / p 1e-73	24.7 EB05 15.8 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.7	no trial data cached
Clostridium difficile infection	11	14.3 7.9–25.7ROR 14.5 · χ² 123 / p 7e-29	12.7 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Circulatory collapse	11	18.1 10.1–32.6ROR 18.4 · χ² 161 / p 3e-37	17.0 EB05 9.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Polyneuropathy	11	26.0 14.5–46.8ROR 26.4 · χ² 240 / p 2e-54	24.9 EB05 14.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.6	no trial data cached
Electrolyte imbalance	11	26.9 15.0–48.4ROR 27.3 · χ² 249 / p 2e-56	25.7 EB05 15.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.6	no trial data cached
Eyelid ptosis	9	24.9 13.0–47.7ROR 25.2 · χ² 183 / p 4e-42	23.5 EB05 12.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Neurotoxicity	7	11.3 5.4–23.7ROR 11.4 · χ² 56 / p 3e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	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.

Infusion related reaction — n=67, PRR 28.6
Hyperglycaemia — n=21, PRR 16.3

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 Calaspargase Pegol?

In FDA FAERS, the most frequently co-reported reaction terms for Calaspargase Pegol are hypersensitivity, anaphylactic reaction, pancreatitis, infusion related reaction, febrile neutropenia, hyperglycaemia. 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 Calaspargase Pegol have an FDA boxed warning?

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

Do FAERS signals prove that Calaspargase Pegol 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 6585bd0d-bd78-4341-9e87-0f7664821f05, effective 20241008; matched on openfda.generic_name.exact:"CALASPARGASE PEGOL")
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, 19 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.