Cefepime Hydrochloride side effects: what 16,017 FDA adverse event reports show

Cefepime Hydrochloride · 1,097 reaction terms · 58,039 drug–reaction co-reports · data 2026-09-14

Drug class

Cephalosporin antibacterial

FDA label, Indications wording

Who reports

16,017 reports · 94% serious · 3,529 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

Likely indication confounding 5Lab value / disease marker 3Not in label — unassessed 32

What the badges mean

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. 1,057 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
Meningitis candida	11	253.6 132.9–483.9ROR 253.7 · χ² 2,107 / p <1e-300	155.5 EB05 92.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Burkholderia test positive	18	221.3 134.3–364.8ROR 221.5 · χ² 3,184 / p <1e-300	157.7 EB05 105.6 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=18	not reported in cached trials
Corynebacterium bacteraemia	11	200.0 106.0–377.4ROR 200.1 · χ² 1,717 / p <1e-300	133.7 EB05 79.7 · IC025 +3.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	not reported in cached trials
Aeromonas infection	13	104.9 59.6–184.6ROR 105.0 · χ² 1,143 / p 8e-251	85.3 EB05 53.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Hepatosplenic candidiasis	10	94.9 50.0–180.4ROR 95.0 · χ² 780 / p 5e-172	76.1 EB05 44.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Antibiotic level above therapeutic	27	94.7 64.1–140.0ROR 94.9 · χ² 2,246 / p <1e-300	83.3 EB05 60.1 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=27 · 93% clinician	not reported in cached trials
Cutaneous mucormycosis	12	94.5 52.6–169.7ROR 94.5 · χ² 949 / p 1e-208	77.6 EB05 47.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=12	not reported in cached trials
Trichosporon infection	25	88.2 58.8–132.2ROR 88.3 · χ² 1,936 / p <1e-300	77.9 EB05 55.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=25 · 100% clinician	not reported in cached trials
Uraemic encephalopathy	16	71.5 43.2–118.2ROR 71.5 · χ² 988 / p 4e-217	62.9 EB05 41.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Phrenic nerve paralysis	11	70.0 38.1–128.3ROR 70.0 · χ² 645 / p 1e-142	59.9 EB05 35.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Nail bed inflammation	15	64.8 38.6–108.8ROR 64.8 · χ² 837 / p 2e-184	57.4 EB05 37.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Geotrichum infection	10	64.5 34.2–121.8ROR 64.6 · χ² 537 / p 5e-119	55.4 EB05 32.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Cns ventriculitis	15	62.9 37.5–105.5ROR 62.9 · χ² 813 / p 4e-179	56.0 EB05 36.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Engraft failure	13	62.4 35.8–108.8ROR 62.4 · χ² 692 / p 1e-152	55.0 EB05 34.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Septic embolus	37	60.8 43.7–84.5ROR 60.9 · χ² 2,021 / p <1e-300	56.5 EB05 42.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=37	not reported in cached trials
Disseminated mucormycosis	15	52.6 31.4–88.2ROR 52.7 · χ² 681 / p 2e-150	47.7 EB05 30.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Fungaemia	59	51.3 39.6–66.5ROR 51.5 · χ² 2,750 / p <1e-300	48.6 EB05 39.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=59 · 97% clinician	not reported in cached trials
Enterococcal bacteraemia	39	50.2 36.5–69.1ROR 50.3 · χ² 1,763 / p <1e-300	47.3 EB05 36.1 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=39 · 92% clinician	not reported in cached trials
Cerebral aspergillosis	22	48.6 31.8–74.4ROR 48.7 · χ² 944 / p 2e-207	45.2 EB05 31.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=22 · 90% clinician	not reported in cached trials
Vancomycin infusion reaction	13	48.5 27.9–84.4ROR 48.5 · χ² 538 / p 3e-119	44.0 EB05 27.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Nephritis allergic	14	48.3 28.3–82.4ROR 48.4 · χ² 581 / p 1e-128	44.0 EB05 27.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Eye infection fungal	13	46.5 26.7–80.8ROR 46.5 · χ² 515 / p 2e-114	42.3 EB05 26.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Stenotrophomonas infection	42	42.4 31.2–57.6ROR 42.5 · χ² 1,602 / p <1e-300	40.4 EB05 31.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=42 · 100% clinician	not reported in cached trials
Pneumonia necrotising	20	42.0 26.9–65.6ROR 42.1 · χ² 737 / p 1e-162	39.4 EB05 26.9 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20	not reported in cached trials
Corynebacterium infection	15	37.9 22.7–63.3ROR 37.9 · χ² 488 / p 2e-108	35.3 EB05 22.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Cytomegalovirus enterocolitis	21	37.1 24.0–57.2ROR 37.1 · χ² 682 / p 1e-150	35.0 EB05 24.2 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=21 · 100% clinician	not reported in cached trials
Engraftment syndrome	16	36.6 22.3–60.2ROR 36.7 · χ² 505 / p 4e-112	34.3 EB05 22.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Ureaplasma infection	11	36.6 20.1–66.6ROR 36.6 · χ² 337 / p 2e-75	33.7 EB05 20.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Blastomycosis	13	36.5 21.0–63.3ROR 36.5 · χ² 402 / p 8e-90	33.9 EB05 21.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Differentiation syndrome	19	35.7 22.6–56.3ROR 35.7 · χ² 590 / p 1e-130	33.7 EB05 22.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Cytokine storm	18	35.5 22.2–56.7ROR 35.6 · χ² 555 / p 6e-123	33.5 EB05 22.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Methaemoglobinaemia	60	35.0 27.1–45.3ROR 35.2 · χ² 1,898 / p <1e-300	33.8 EB05 27.2 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=59 · ♀ 15% (drug 44%) · 100% clinician	not reported in cached trials
Crystalluria	14	34.4 20.2–58.4ROR 34.4 · χ² 410 / p 2e-91	32.2 EB05 20.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Glomerulosclerosis	16	34.0 20.7–55.8ROR 34.0 · χ² 467 / p 6e-104	32.0 EB05 20.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Dysbiosis	20	33.5 21.5–52.2ROR 33.5 · χ² 583 / p 4e-129	31.8 EB05 21.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	not reported in cached trials
Neutropenic colitis	50	32.5 24.6–43.1ROR 32.6 · χ² 1,461 / p <1e-300	31.4 EB05 24.8 · IC025 +4.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=50 · 96% clinician	not reported in cached trials
Nasal mucosal disorder	14	32.1 18.9–54.5ROR 32.1 · χ² 382 / p 3e-85	30.2 EB05 19.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Fusarium infection	16	31.3 19.1–51.5ROR 31.4 · χ² 430 / p 9e-96	29.7 EB05 19.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=16	not reported in cached trials
Disseminated cryptococcosis	17	31.0 19.1–50.1ROR 31.0 · χ² 452 / p 1e-100	29.4 EB05 19.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Enterococcus test positive	15	30.8 18.5–51.4ROR 30.8 · χ² 394 / p 7e-88	29.1 EB05 18.7 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious n=15	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 (0 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)	1,563	1.6 1.5–1.6ROR 1.6 · χ² 329 / p 7e-74	1.6 EB05 1.5 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.6 · 94% clinician	not reported in cached trials
Acute kidney injury (sudden kidney damage)	1,268	11.0 10.4–11.6ROR 11.8 · χ² 11,483 / p <1e-300	10.9 EB05 10.4 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.6 · 96% clinician	NCT05887908: 1/152 (0.7%) on Cefepime (serious AE)
Off label use (used outside approved label)	1,204	1.8 1.7–1.9ROR 1.9 · χ² 460 / p 2e-102	1.8 EB05 1.7 · IC025 +0.8	Reporting / coding artifact	serious PRR 1.7 · 93% clinician	not reported in cached trials
Pyrexia (fever)	1,086	4.1 3.9–4.4ROR 4.3 · χ² 2,594 / p <1e-300	4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.1	NCT03840148: 5/440 (1.1%) on Cefepime
Febrile neutropenia	877	17.6 16.5–18.7ROR 18.5 · χ² 13,538 / p <1e-300	17.3 EB05 16.4 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 10.6 · 93% clinician	not reported in cached trials
Pneumonia (lung infection)	807	3.3 3.1–3.5ROR 3.4 · χ² 1,289 / p 1e-282	3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree	Likely indication confounding term in indications	serious PRR 2.1	not reported in cached trials
Sepsis (blood infection)	614	7.2 6.7–7.8ROR 7.5 · χ² 3,294 / p <1e-300	7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	not reported in cached trials
Hypotension (low blood pressure)	593	3.9 3.6–4.2ROR 4.0 · χ² 1,276 / p 1e-279	3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree	Likely indication confounding term in indications	serious PRR 2.7 · 91% clinician	not reported in cached trials
Encephalopathy	560	30.6 28.2–33.2ROR 31.7 · χ² 15,660 / p <1e-300	29.9 EB05 27.9 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.2 · 95% clinician	NCT05887908: 1/306 (0.3%) on Cefepime (serious AE)
Neutropenia (low neutrophils (infection-fighting cells))	555	5.4 5.0–5.8ROR 5.5 · χ² 1,980 / p <1e-300	5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.4 · 94% clinician	not reported in cached trials
Thrombocytopenia (low platelets)	549	6.5 6.0–7.0ROR 6.7 · χ² 2,536 / p <1e-300	6.4 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0 · 94% clinician	not reported in cached trials
Septic shock	507	15.5 14.2–16.9ROR 16.0 · χ² 6,810 / p <1e-300	15.3 EB05 14.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 94% clinician	not reported in cached trials
Diarrhoea (diarrhea)	496	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.424	1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.1	NCT03840148: 18/440 (4.1%) on Cefepime
Respiratory failure	467	8.4 7.7–9.2ROR 8.6 · χ² 3,039 / p <1e-300	8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · 93% clinician	not reported in cached trials
Condition aggravated	466	2.0 1.8–2.2ROR 2.1 · χ² 243 / p 5e-55	2.0 EB05 1.9 · IC025 +0.9	Reporting / coding artifact	serious PRR 1.9 · 94% clinician	not reported in cached trials

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=25, PRR 88.2
Septic embolus — n=37, PRR 60.8
Fungaemia — n=59, PRR 51.3
Cerebral aspergillosis — n=22, PRR 48.6
Stenotrophomonas infection — n=42, PRR 42.4
Methaemoglobinaemia — n=60, PRR 35.0
Dysbiosis — n=20, PRR 33.5

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, 1,097 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.