Cefepime side effects: what 14,252 FDA adverse event reports show

Cefepime · 1,087 reaction terms · 51,370 drug–reaction co-reports · data 2026-09-14

Drug class

Cephalosporin antibacterial

FDA label, Indications wording

Who reports

14,252 reports · 94% serious · 3,078 with death outcome · 44% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia ( 1.1 ); empiric therapy for febrile neutropenic patients ( 1.2 ); unc.

FDA label, Indications and Usage

What it is

Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration.

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 40 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 4Lab value / disease marker 4Not in label — unassessed 30

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 1,047 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
Burkholderia test positive	15	201.5 117.5–345.7ROR 201.7 · χ² 2,455 / p <1e-300	144.8 EB05 93.2 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=15	not reported in cached trials
Aeromonas infection	13	117.9 67.0–207.4ROR 118.0 · χ² 1,287 / p 3e-282	94.4 EB05 58.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Hepatosplenic candidiasis	10	106.7 56.1–202.7ROR 106.8 · χ² 879 / p 2e-193	84.0 EB05 48.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Cutaneous mucormycosis	12	106.2 59.1–190.7ROR 106.3 · χ² 1,069 / p 1e-234	85.9 EB05 52.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Antibiotic level above therapeutic	25	98.0 65.4–146.9ROR 98.2 · χ² 2,159 / p <1e-300	86.0 EB05 61.3 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=25 · 92% clinician	not reported in cached trials
Trichosporon infection	24	94.9 62.8–143.3ROR 95.0 · χ² 2,005 / p <1e-300	83.4 EB05 59.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=24 · 100% clinician	not reported in cached trials
Phrenic nerve paralysis	10	71.1 37.7–134.2ROR 71.2 · χ² 594 / p 2e-131	60.4 EB05 35.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Uraemic encephalopathy	14	69.8 40.8–119.3ROR 69.9 · χ² 841 / p 3e-185	61.3 EB05 38.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Septic embolus	36	66.4 47.5–92.7ROR 66.5 · χ² 2,154 / p <1e-300	61.5 EB05 46.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=36	not reported in cached trials
Cns ventriculitis	13	60.8 34.9–106.0ROR 60.9 · χ² 678 / p 9e-150	54.1 EB05 33.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Disseminated mucormycosis	15	59.1 35.3–99.1ROR 59.2 · χ² 769 / p 2e-169	53.2 EB05 34.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Nail bed inflammation	12	57.7 32.4–102.6ROR 57.7 · χ² 589 / p 2e-130	51.2 EB05 31.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Cerebral aspergillosis	22	54.7 35.7–83.6ROR 54.7 · χ² 1,066 / p 5e-234	50.5 EB05 35.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=22 · 90% clinician	not reported in cached trials
Nephritis allergic	14	54.3 31.9–92.6ROR 54.4 · χ² 656 / p 6e-145	49.1 EB05 31.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Fungaemia	55	53.6 41.0–70.1ROR 53.8 · χ² 2,687 / p <1e-300	50.9 EB05 40.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=55 · 96% clinician	not reported in cached trials
Eye infection fungal	13	52.2 30.1–90.8ROR 52.3 · χ² 582 / p 6e-129	47.2 EB05 29.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Enterococcal bacteraemia	35	50.4 36.0–70.6ROR 50.6 · χ² 1,591 / p <1e-300	47.6 EB05 35.8 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=35 · 94% clinician	not reported in cached trials
Vancomycin infusion reaction	12	50.2 28.2–89.2ROR 50.2 · χ² 512 / p 9e-114	45.3 EB05 27.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Pneumonia necrotising	20	47.3 30.3–73.8ROR 47.3 · χ² 833 / p 2e-183	44.0 EB05 30.1 · IC025 +3.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20 · ♀ 75% (drug 44%)	not reported in cached trials
Ureaplasma infection	11	41.1 22.6–74.9ROR 41.2 · χ² 381 / p 4e-85	37.6 EB05 22.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Stenotrophomonas infection	36	40.6 29.2–56.5ROR 40.7 · χ² 1,315 / p 3e-288	38.8 EB05 29.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=36 · 100% clinician	not reported in cached trials
Corynebacterium infection	14	39.7 23.3–67.4ROR 39.7 · χ² 477 / p 5e-106	36.9 EB05 23.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Cytomegalovirus enterocolitis	20	39.6 25.4–61.8ROR 39.7 · χ² 696 / p 1e-153	37.4 EB05 25.5 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20 · 100% clinician	not reported in cached trials
Methaemoglobinaemia	60	39.4 30.5–50.9ROR 39.5 · χ² 2,148 / p <1e-300	37.9 EB05 30.5 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=59 · ♀ 15% (drug 44%) · 100% clinician	not reported in cached trials
Crystalluria	14	38.6 22.7–65.6ROR 38.7 · χ² 464 / p 4e-103	36.0 EB05 22.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Dysbiosis	19	35.7 22.7–56.3ROR 35.8 · χ² 592 / p 4e-131	33.8 EB05 22.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Fusarium infection	16	35.2 21.5–57.8ROR 35.3 · χ² 487 / p 4e-108	33.2 EB05 21.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Disseminated cryptococcosis	17	34.8 21.5–56.3ROR 34.8 · χ² 512 / p 1e-113	32.9 EB05 21.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Blastomycosis	11	34.5 19.0–62.8ROR 34.6 · χ² 318 / p 2e-71	32.0 EB05 19.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Mucormycosis	58	33.9 26.1–43.9ROR 34.0 · χ² 1,777 / p <1e-300	32.8 EB05 26.3 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=58 · 91% clinician	not reported in cached trials
Urinary tract infection pseudomonal	13	33.1 19.1–57.3ROR 33.1 · χ² 365 / p 1e-81	31.0 EB05 19.3 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=13	not reported in cached trials
Sputum culture positive	18	32.8 20.6–52.3ROR 32.8 · χ² 512 / p 1e-113	31.2 EB05 20.8 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious n=17	not reported in cached trials
Enterococcus test positive	14	32.2 19.0–54.7ROR 32.3 · χ² 385 / p 6e-86	30.4 EB05 19.2 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious n=14	not reported in cached trials
Neutropenic colitis	44	32.1 23.8–43.3ROR 32.2 · χ² 1,267 / p 9e-278	31.0 EB05 24.1 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=44 · 95% clinician	not reported in cached trials
Pulmonary mucormycosis	11	32.0 17.6–58.2ROR 32.1 · χ² 294 / p 3e-66	29.9 EB05 17.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Bacillus infection	13	31.2 18.0–54.1ROR 31.3 · χ² 343 / p 6e-77	29.4 EB05 18.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Mediastinitis	12	31.0 17.5–54.9ROR 31.0 · χ² 312 / p 4e-70	29.1 EB05 17.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Glomerulosclerosis	13	30.9 17.8–53.5ROR 30.9 · χ² 339 / p 5e-76	29.1 EB05 18.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Encephalopathy	503	30.8 28.3–33.6ROR 31.9 · χ² 14,204 / p <1e-300	30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.4 · 95% clinician	NCT05887908: 1/306 (0.3%) on Cefepime (serious AE)
Engraftment syndrome	12	30.7 17.3–54.3ROR 30.7 · χ² 309 / p 2e-69	28.8 EB05 17.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Cefepime as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).

NCT03840148 — Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections (N=661, PHASE3; 30 AE terms posted; arms: Cefepime/VNRX-5133 (Taniborbactam); Meropenem)
NCT05887908 — Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects (N=614, PHASE3; 26 AE terms posted; arms: Cefepime/Nacubactam; Aztreonam/Nacubactam; Imipenem/Cilastatin)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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 ineffective (drug did not work)	1,465	1.6 1.6–1.7ROR 1.7 · χ² 387 / p 2e-86	1.6 EB05 1.6 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.8 · 94% clinician	not reported in cached trials
Acute kidney injury (sudden kidney damage)	1,164	11.3 10.7–12.0ROR 12.2 · χ² 10,941 / p <1e-300	11.2 EB05 10.7 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.9 · 95% clinician	NCT05887908: 1/152 (0.7%) on Cefepime (serious AE)
Off label use (used outside approved label)	1,120	1.9 1.8–2.0ROR 2.0 · χ² 497 / p 3e-110	1.9 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	serious PRR 1.8 · 93% clinician	not reported in cached trials
Pyrexia (fever)	896	3.8 3.6–4.1ROR 4.0 · χ² 1,885 / p <1e-300	3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.9	NCT03840148: 5/440 (1.1%) on Cefepime
Febrile neutropenia	689	15.5 14.4–16.6ROR 16.2 · χ² 9,235 / p <1e-300	15.3 EB05 14.4 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 9.4 · 93% clinician	not reported in cached trials
Pneumonia (lung infection)	673	3.1 2.8–3.3ROR 3.2 · χ² 949 / p 1e-208	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 2.0	not reported in cached trials
Sepsis (blood infection)	558	7.4 6.8–8.0ROR 7.6 · χ² 3,077 / p <1e-300	7.3 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	not reported in cached trials
Hypotension (low blood pressure)	557	4.1 3.8–4.4ROR 4.2 · χ² 1,312 / p 2e-287	4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 2.9 · 91% clinician	not reported in cached trials
Encephalopathy	503	30.8 28.3–33.6ROR 31.9 · χ² 14,204 / p <1e-300	30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.4 · 95% clinician	NCT05887908: 1/306 (0.3%) on Cefepime (serious AE)
Thrombocytopenia (low platelets)	485	6.4 5.9–7.0ROR 6.6 · χ² 2,217 / p <1e-300	6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0 · 94% clinician	not reported in cached trials
Neutropenia (low neutrophils (infection-fighting cells))	483	5.3 4.8–5.7ROR 5.4 · χ² 1,667 / p <1e-300	5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.3 · 93% clinician	not reported in cached trials
Septic shock	464	16.0 14.6–17.5ROR 16.5 · χ² 6,433 / p <1e-300	15.8 EB05 14.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · 94% clinician	not reported in cached trials
Respiratory failure	445	9.0 8.2–9.9ROR 9.3 · χ² 3,157 / p <1e-300	8.9 EB05 8.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.5 · 93% clinician	not reported in cached trials
Condition aggravated	440	2.1 2.0–2.4ROR 2.2 · χ² 272 / p 3e-61	2.1 EB05 2.0 · IC025 +0.9	Reporting / coding artifact	serious PRR 2.0 · 94% clinician	not reported in cached trials
Diarrhoea (diarrhea)	429	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.355	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.0	NCT03840148: 18/440 (4.1%) on Cefepime

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.

Trichosporon infection — n=24, PRR 94.9
Septic embolus — n=36, PRR 66.4
Cerebral aspergillosis — n=22, PRR 54.7
Fungaemia — n=55, PRR 53.6
Stenotrophomonas infection — n=36, PRR 40.6
Methaemoglobinaemia — n=60, PRR 39.4
Mucormycosis — n=58, PRR 33.9

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 Cefepime?

In FDA FAERS, the most frequently co-reported reaction terms for Cefepime are acute kidney injury, pyrexia, febrile neutropenia, pneumonia, sepsis, hypotension. 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 Cefepime have an FDA boxed warning?

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

Do FAERS signals prove that Cefepime 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 be5f8ca6-7232-423a-a2d5-cccb7abe7921, effective 20260625; matched on openfda.generic_name.exact:"CEFEPIME")
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, 1,087 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
ClinicalTrials.gov API v2 (query CEFEPIME, results-bearing studies sorted by enrollment)

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.