Drug · FAERS side-effect profile with label screen

Cefiderocol Tosylate side effects: what 303 FDA adverse event reports show

Cefiderocol Sulfate Tosylate · 7 reaction terms · 83 drug–reaction co-reports · data 2026-09-14

Drug class

Cephalosporin antibacterial

FDA label, Indications wording of the closest related product

Label matched

Cefiderocol Sulfate Tosylate (Fetroja)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

303 reports · 90% serious · 145 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

FETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Complicated Urinary Tract Infections (cUTI), including Pyelonephri.

FDA label, Indications and Usage

What it is

FETROJA is a cephalosporin antibacterial drug product consisting of cefiderocol sulfate tosylate for intravenous infusion. Cefiderocol functions as a siderophore [see Microbiology (12.4) ] .

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 6 strongest signals

Labeled adverse reaction 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.
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. 1 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
Drug resistance	31	83.6 59.9–116.8ROR 93.0 · χ² 2,449 / p <1e-300	79.6 EB05 58.7 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 52.3 · 97% clinician	no trial data cached
Hepatic cytolysis	13	73.7 43.3–125.5ROR 77.0 · χ² 860 / p 2e-189	66.7 EB05 41.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 47.0	no trial data cached
Cholestasis (bile flow blockage)	10	36.3 19.7–66.7ROR 37.5 · χ² 309 / p 2e-69	34.1 EB05 19.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.4	no trial data cached
Multiple organ dysfunction syndrome	14	34.7 20.8–57.9ROR 36.4 · χ² 426 / p 6e-95	33.3 EB05 21.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Drug effect less than expected	6	29.5 13.3–65.1ROR 30.0 · χ² 138 / p 4e-32	26.4 EB05 11.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Incorrect product administration duration	6	20.5 9.3–45.2ROR 20.9 · χ² 93 / p 3e-22	17.4 EB05 6.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious n=5	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
Drug resistance	31	83.6 59.9–116.8ROR 93.0 · χ² 2,449 / p <1e-300	79.6 EB05 58.7 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 52.3 · 97% clinician	no trial data cached
Multiple organ dysfunction syndrome	14	34.7 20.8–57.9ROR 36.4 · χ² 426 / p 6e-95	33.3 EB05 21.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 22.2	no trial data cached
Hepatic cytolysis	13	73.7 43.3–125.5ROR 77.0 · χ² 860 / p 2e-189	66.7 EB05 41.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 47.0	no trial data cached
Cholestasis (bile flow blockage)	10	36.3 19.7–66.7ROR 37.5 · χ² 309 / p 2e-69	34.1 EB05 19.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.4	no trial data cached
Incorrect product administration duration	6	20.5 9.3–45.2ROR 20.9 · χ² 93 / p 3e-22	17.4 EB05 6.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Drug effect less than expected	6	29.5 13.3–65.1ROR 30.0 · χ² 138 / p 4e-32	26.4 EB05 11.7 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious n=5	no trial data cached
Status epilepticus	3	18.3 6.0–56.6ROR 18.5 · χ² 33 / p 4e-9	10.1 EB05 2.5 · IC025 +0.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.7	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 Cefiderocol Tosylate?

In FDA FAERS, the most frequently co-reported reaction terms for Cefiderocol Tosylate are multiple organ dysfunction syndrome, hepatic cytolysis, cholestasis, status epilepticus. 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 Cefiderocol Tosylate have an FDA boxed warning?

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

Do FAERS signals prove that Cefiderocol Tosylate 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 75c0c785-38e0-4049-a6fb-b77581f5b35c, effective 20260224; matched on openfda.generic_name.exact:"CEFIDEROCOL SULFATE TOSYLATE")
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, 7 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.