Ceftaroline Fosamil side effects: what 808 FDA adverse event reports show

Ceftaroline Fosamil · 21 reaction terms · 348 drug–reaction co-reports · data 2026-09-14

Drug class

Cephalosporin antibacterial

FDA label, Indications wording

Who reports

808 reports · 81% serious · 151 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1. INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin .

FDA label, Indications and Usage

What it is

11. DESCRIPTION Ceftaroline fosamil for injection is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β- lactams).

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 17 strongest signals

Labeled adverse reaction 4Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 8

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. 4 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
Agranulocytosis (severe loss of white cells)	39	54.9 40.4–74.5ROR 57.6 · χ² 2,006 / p <1e-300	53.4 EB05 40.8 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 39.1 · ♀ 18% (drug 42%) · 100% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	25	43.1 29.3–63.4ROR 44.4 · χ² 985 / p 1e-216	41.8 EB05 29.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.7 · ♀ 71% (drug 42%) · 100% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	31	31.5 22.3–44.5ROR 32.7 · χ² 886 / p 6e-195	30.9 EB05 22.8 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.4 · ♀ 82% (drug 42%) · 100% clinician	no trial data cached
Eosinophilia	19	28.2 18.1–44.1ROR 28.9 · χ² 472 / p 5e-105	27.5 EB05 18.6 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.0	no trial data cached
Bacteraemia	8	17.6 8.9–35.2ROR 17.8 · χ² 110 / p 6e-26	15.6 EB05 6.9 · IC025 +1.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 12.7	no trial data cached
Staphylococcal infection	22	17.3 11.4–26.1ROR 17.7 · χ² 321 / p 4e-72	16.9 EB05 11.5 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 13.6	no trial data cached
Transaminases increased	14	16.4 9.7–27.5ROR 16.6 · χ² 187 / p 7e-43	15.5 EB05 9.1 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Cytomegalovirus infection	10	15.6 8.4–28.9ROR 15.8 · χ² 123 / p 9e-29	14.0 EB05 7.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Inappropriate antidiuretic hormone secretion	6	15.3 6.9–34.0ROR 15.4 · χ² 67 / p 2e-16	11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	13	15.1 8.8–26.0ROR 15.4 · χ² 158 / p 2e-36	14.0 EB05 7.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	74	14.2 11.4–17.6ROR 15.5 · χ² 899 / p 9e-198	14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.6 · 91% clinician	no trial data cached
Hepatic cytolysis	6	12.7 5.7–28.3ROR 12.8 · χ² 54 / p 1e-13	9.1 EB05 3.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Leukopenia (low white blood cells)	23	12.0 8.0–17.9ROR 12.3 · χ² 221 / p 3e-50	11.2 EB05 7.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5 · 100% clinician	no trial data cached
Rash maculo-papular	10	11.7 6.3–21.7ROR 11.9 · χ² 88 / p 4e-21	9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Hepatotoxicity (liver damage)	10	11.7 6.3–21.7ROR 11.8 · χ² 88 / p 4e-21	9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Tubulointerstitial nephritis	8	11.1 5.6–22.1ROR 11.2 · χ² 64 / p 7e-16	8.5 EB05 4.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Product storage error	17	5.1 3.2–8.2ROR 5.2 · χ² 52 / p 3e-13	4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	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
Neutropenia (low neutrophils (infection-fighting cells))	74	14.2 11.4–17.6ROR 15.5 · χ² 899 / p 9e-198	14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.6 · 91% clinician	no trial data cached
Agranulocytosis (severe loss of white cells)	39	54.9 40.4–74.5ROR 57.6 · χ² 2,006 / p <1e-300	53.4 EB05 40.8 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 39.1 · ♀ 18% (drug 42%) · 100% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	31	31.5 22.3–44.5ROR 32.7 · χ² 886 / p 6e-195	30.9 EB05 22.8 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.4 · ♀ 82% (drug 42%) · 100% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	25	43.1 29.3–63.4ROR 44.4 · χ² 985 / p 1e-216	41.8 EB05 29.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.7 · ♀ 71% (drug 42%) · 100% clinician	no trial data cached
Leukopenia (low white blood cells)	23	12.0 8.0–17.9ROR 12.3 · χ² 221 / p 3e-50	11.2 EB05 7.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5 · 100% clinician	no trial data cached
Staphylococcal infection	22	17.3 11.4–26.1ROR 17.7 · χ² 321 / p 4e-72	16.9 EB05 11.5 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 13.6	no trial data cached
Eosinophilia	19	28.2 18.1–44.1ROR 28.9 · χ² 472 / p 5e-105	27.5 EB05 18.6 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.0	no trial data cached
Product storage error	17	5.1 3.2–8.2ROR 5.2 · χ² 52 / p 3e-13	4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Transaminases increased	14	16.4 9.7–27.5ROR 16.6 · χ² 187 / p 7e-43	15.5 EB05 9.1 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	13	15.1 8.8–26.0ROR 15.4 · χ² 158 / p 2e-36	14.0 EB05 7.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Hepatotoxicity (liver damage)	10	11.7 6.3–21.7ROR 11.8 · χ² 88 / p 4e-21	9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Rash maculo-papular	10	11.7 6.3–21.7ROR 11.9 · χ² 88 / p 4e-21	9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Cytomegalovirus infection	10	15.6 8.4–28.9ROR 15.8 · χ² 123 / p 9e-29	14.0 EB05 7.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Tubulointerstitial nephritis	8	11.1 5.6–22.1ROR 11.2 · χ² 64 / p 7e-16	8.5 EB05 4.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Bacteraemia	8	17.6 8.9–35.2ROR 17.8 · χ² 110 / p 6e-26	15.6 EB05 6.9 · IC025 +1.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 12.7	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.

Toxic epidermal necrolysis — n=25, PRR 43.1

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 Ceftaroline Fosamil?

In FDA FAERS, the most frequently co-reported reaction terms for Ceftaroline Fosamil are neutropenia, agranulocytosis, drug reaction with eosinophilia and systemic symptoms, toxic epidermal necrolysis, leukopenia, staphylococcal infection. 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 Ceftaroline Fosamil have an FDA boxed warning?

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

Do FAERS signals prove that Ceftaroline Fosamil 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 3cee3c08-ed60-06c5-ac49-103b7ad2ef5f, effective 20260529; matched on openfda.generic_name.exact:"CEFTAROLINE FOSAMIL")
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, 21 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.