Drug · FAERS side-effect profile with label screen
Cefotaxime side effects: what 4,277 FDA adverse event reports show
Drug class
Not stated in label
Who reports
4,277 reports · 98% serious · 847 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Treatment Cefotaxime for Injection, USP is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) Lower respiratory tract infections, including pn.
FDA label, Indications and Usage
What it is
DESCRIPTION Sterile cefotaxime sodium is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester).
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 9Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 23
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.
- 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. 165 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug reaction with eosinophilia and systemic symptoms | 240 | 46.5 41.1–52.6ROR 49.2 · χ² 10,546 / p <1e-300 | 45.9 EB05 41.2 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.0 · 98% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 129 | 42.3 35.7–50.2ROR 43.6 · χ² 5,119 / p <1e-300 | 41.7 EB05 36.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.6 · 96% clinician | no trial data cached |
| Hepatocellular injury | 113 | 39.3 32.7–47.1ROR 40.3 · χ² 4,145 / p <1e-300 | 38.7 EB05 33.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · 97% clinician | no trial data cached |
| Clostridium difficile colitis | 65 | 30.2 23.7–38.5ROR 30.6 · χ² 1,795 / p <1e-300 | 29.8 EB05 24.2 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.0 · 100% clinician | no trial data cached |
| Eosinophilia | 95 | 26.8 22.0–32.7ROR 27.4 · χ² 2,323 / p <1e-300 | 26.5 EB05 22.3 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 · 91% clinician | no trial data cached |
| Rash maculo-papular | 116 | 25.8 21.5–30.9ROR 26.5 · χ² 2,729 / p <1e-300 | 25.6 EB05 21.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 97% clinician | no trial data cached |
| Hepatic cytolysis | 51 | 20.5 15.6–27.0ROR 20.8 · χ² 925 / p 2e-203 | 20.3 EB05 16.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 100% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 73 | 19.4 15.5–24.4ROR 19.8 · χ² 1,254 / p 5e-275 | 19.3 EB05 15.8 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · 99% clinician | no trial data cached |
| Toxic skin eruption | 35 | 17.0 12.2–23.7ROR 17.2 · χ² 511 / p 2e-113 | 16.8 EB05 12.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 97% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 60 | 15.4 12.0–19.9ROR 15.7 · χ² 795 / p 4e-175 | 15.3 EB05 12.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 100% clinician | no trial data cached |
| Hyperbilirubinaemia | 32 | 15.3 10.8–21.6ROR 15.4 · χ² 412 / p 9e-92 | 15.0 EB05 10.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 100% clinician | no trial data cached |
| Hypotonia | 30 | 14.7 10.3–21.0ROR 14.8 · χ² 369 / p 2e-82 | 14.3 EB05 10.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Disseminated intravascular coagulation | 42 | 14.6 10.8–19.8ROR 14.8 · χ² 518 / p 5e-115 | 14.4 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 78 | 13.7 11.0–17.1ROR 14.0 · χ² 907 / p 1e-199 | 13.6 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 97% clinician | no trial data cached |
| Septic shock | 105 | 11.9 9.9–14.4ROR 12.2 · χ² 1,041 / p 1e-228 | 11.8 EB05 10.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.0 · 99% clinician | no trial data cached |
| Brain oedema | 30 | 11.7 8.2–16.7ROR 11.7 · χ² 282 / p 2e-63 | 11.1 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 96% clinician | no trial data cached |
| Thrombotic microangiopathy | 23 | 11.7 7.8–17.5ROR 11.7 · χ² 213 / p 1e-48 | 10.9 EB05 7.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 17% (drug 45%) · 100% clinician | no trial data cached |
| Drug resistance | 55 | 10.5 8.1–13.7ROR 10.6 · χ² 464 / p 4e-103 | 10.2 EB05 8.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 98% clinician | no trial data cached |
| Encephalopathy | 52 | 10.4 8.0–13.7ROR 10.5 · χ² 433 / p 1e-96 | 10.1 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 98% clinician | no trial data cached |
| Status epilepticus | 24 | 10.4 7.0–15.5ROR 10.5 · χ² 195 / p 2e-44 | 9.6 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 95% clinician | no trial data cached |
| Premature baby | 64 | 10.4 8.2–13.3ROR 10.6 · χ² 535 / p 1e-118 | 10.1 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 76% (drug 45%) · 94% clinician | no trial data cached |
| Transaminases increased | 43 | 9.5 7.1–12.8ROR 9.6 · χ² 319 / p 2e-71 | 9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 90% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 43 | 9.5 7.0–12.8ROR 9.6 · χ² 317 / p 3e-71 | 9.0 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 98% clinician | no trial data cached |
| Leukocytosis | 33 | 9.0 6.4–12.6ROR 9.0 · χ² 225 / p 3e-51 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 90% clinician | no trial data cached |
| Coagulopathy | 28 | 8.3 5.7–12.0ROR 8.3 · χ² 172 / p 2e-39 | 7.5 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 100% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 16 | 8.3 5.1–13.5ROR 8.3 · χ² 95 / p 1e-22 | 7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Electrolyte imbalance | 19 | 8.1 5.2–12.7ROR 8.1 · χ² 111 / p 3e-26 | 7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Generalised tonic-clonic seizure | 27 | 8.1 5.6–11.8ROR 8.1 · χ² 161 / p 4e-37 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 · ♀ 77% (drug 45%) · 100% clinician | no trial data cached |
| Acute respiratory distress syndrome | 29 | 8.0 5.6–11.6ROR 8.1 · χ² 172 / p 1e-39 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 100% clinician | no trial data cached |
| Candida infection (yeast infection) | 27 | 7.9 5.5–11.6ROR 8.0 · χ² 157 / p 3e-36 | 7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 96% clinician | no trial data cached |
| Respiratory distress | 44 | 7.8 5.8–10.5ROR 7.9 · χ² 255 / p 1e-57 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 95% clinician | no trial data cached |
| Erythema multiforme | 14 | 7.4 4.4–12.4ROR 7.4 · χ² 71 / p 2e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Tachypnoea | 20 | 7.2 4.7–11.2ROR 7.3 · χ² 101 / p 4e-24 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Pancytopenia (all blood cells low) | 77 | 6.8 5.4–8.5ROR 6.9 · χ² 374 / p 1e-83 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 97% clinician | no trial data cached |
| Generalised oedema | 17 | 6.8 4.2–10.9ROR 6.8 · χ² 78 / p 5e-19 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Gamma-glutamyltransferase increased | 30 | 6.6 4.6–9.5ROR 6.7 · χ² 138 / p 4e-32 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · 93% clinician | no trial data cached |
| Lymphopenia | 19 | 6.6 4.2–10.4ROR 6.7 · χ² 85 / p 1e-20 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Thrombocytopenia (low platelets) | 150 | 6.6 5.6–7.7ROR 6.8 · χ² 710 / p 8e-157 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 97% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 48 | 6.5 4.9–8.7ROR 6.6 · χ² 220 / p 4e-50 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.9 · 98% clinician | no trial data cached |
| Face oedema | 22 | 6.4 4.2–9.7ROR 6.4 · χ² 94 / p 1e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 100% clinician | 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 |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 280 | 4.0 3.5–4.4ROR 4.2 · χ² 628 / p 6e-139 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 92% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 240 | 46.5 41.1–52.6ROR 49.2 · χ² 10,546 / p <1e-300 | 45.9 EB05 41.2 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.0 · 98% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 195 | 6.3 5.5–7.2ROR 6.5 · χ² 866 / p 1e-190 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · 98% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 150 | 6.6 5.6–7.7ROR 6.8 · χ² 710 / p 8e-157 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 97% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 149 | 5.4 4.6–6.3ROR 5.6 · χ² 532 / p 5e-118 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 129 | 5.7 4.8–6.7ROR 5.8 · χ² 494 / p 1e-109 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.3 · 97% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 129 | 42.3 35.7–50.2ROR 43.6 · χ² 5,119 / p <1e-300 | 41.7 EB05 36.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.6 · 96% clinician | no trial data cached |
| Anaemia (low red blood cells) | 120 | 3.1 2.6–3.7ROR 3.1 · χ² 168 / p 9e-39 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · 96% clinician | no trial data cached |
| Rash maculo-papular | 116 | 25.8 21.5–30.9ROR 26.5 · χ² 2,729 / p <1e-300 | 25.6 EB05 21.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 97% clinician | no trial data cached |
| Hepatocellular injury | 113 | 39.3 32.7–47.1ROR 40.3 · χ² 4,145 / p <1e-300 | 38.7 EB05 33.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · 97% clinician | no trial data cached |
| Drug interaction | 105 | 3.2 2.7–3.9ROR 3.3 · χ² 162 / p 2e-37 | 3.2 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 95% clinician | no trial data cached |
| Septic shock | 105 | 11.9 9.9–14.4ROR 12.2 · χ² 1,041 / p 1e-228 | 11.8 EB05 10.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.0 · 99% clinician | no trial data cached |
| Eosinophilia | 95 | 26.8 22.0–32.7ROR 27.4 · χ² 2,323 / p <1e-300 | 26.5 EB05 22.3 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 · 91% clinician | no trial data cached |
| Renal failure (kidney failure) | 91 | 3.3 2.7–4.1ROR 3.4 · χ² 147 / p 3e-34 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 · 91% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 78 | 13.7 11.0–17.1ROR 14.0 · χ² 907 / p 1e-199 | 13.6 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 97% clinician | 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.
- Hepatocellular injury — n=113, PRR 39.3
- Rash maculo-papular — n=116, PRR 25.8
- Hepatic cytolysis — n=51, PRR 20.5
- Toxic skin eruption — n=35, PRR 17.0
- Hyperbilirubinaemia — n=32, PRR 15.3
- Hypotonia — n=30, PRR 14.7
- Disseminated intravascular coagulation — n=42, PRR 14.6
- Multiple organ dysfunction syndrome — n=78, PRR 13.7
- Brain oedema — n=30, PRR 11.7
- Thrombotic microangiopathy — n=23, PRR 11.7
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 Cefotaxime?
In FDA FAERS, the most frequently co-reported reaction terms for Cefotaxime are pyrexia, drug reaction with eosinophilia and systemic symptoms, acute kidney injury, thrombocytopenia, neutropenia, sepsis. 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 Cefotaxime have an FDA boxed warning?
No. The FDA label retrieved for Cefotaxime has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefotaxime 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 ed23b6bc-32c7-4c50-a53d-313ae78e5623, effective 20240411; matched on
openfda.generic_name.exact:"CEFOTAXIME") - 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, fieldpatient.drug.openfda.generic_name.exact, 205 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.