Cefpodoxime Proxetil side effects: what 976 FDA adverse event reports show
Drug class
Not stated in label
Who reports
976 reports · 83% serious · 107 with death outcome · 57% female
Used for
Cefpodoxime proxetil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Recommended dosages, durations of therapy, and applicable patient populations vary among these infections. Please see DOSAGE AND ADMINISTRATION for specific recommendations.
What it is
DESCRIPTION Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class.
Boxed warning
None in the current label
Causality screen of the 15 strongest signals
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.
- 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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Clostridium difficile colitis | 13 | 26.3 15.3–45.2ROR 26.7 · χ² 292 / p 1e-65 | 25.4 EB05 15.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.1 | no trial data cached |
| Erythema multiforme | 7 | 16.1 7.7–33.8ROR 16.3 · χ² 85 / p 2e-20 | 13.4 EB05 5.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 16 | 15.4 9.5–25.1ROR 15.7 · χ² 202 / p 4e-46 | 14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Toxic skin eruption | 7 | 14.9 7.1–31.2ROR 15.0 · χ² 77 / p 7e-19 | 12.0 EB05 5.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Eosinophilia | 12 | 14.8 8.4–25.9ROR 14.9 · χ² 141 / p 1e-32 | 13.5 EB05 7.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 10 | 14.3 7.7–26.4ROR 14.4 · χ² 110 / p 4e-26 | 12.5 EB05 6.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| No therapeutic response | 8 | 13.9 7.0–27.7ROR 14.0 · χ² 83 / p 4e-20 | 11.4 EB05 5.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 13.4 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 10 | 11.6 6.3–21.5ROR 11.7 · χ² 87 / p 6e-21 | 9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Platelet count increased | 7 | 11.5 5.5–24.1ROR 11.6 · χ² 57 / p 2e-14 | 8.5 EB05 3.8 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Pancreatitis acute | 11 | 10.6 5.9–19.1ROR 10.7 · χ² 86 / p 8e-21 | 8.7 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Hepatocellular injury | 6 | 9.1 4.1–20.1ROR 9.1 · χ² 35 / p 1e-9 | 6.1 EB05 2.9 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Face oedema | 7 | 8.9 4.2–18.6ROR 8.9 · χ² 41 / p 6e-11 | 6.3 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 15 | 7.3 4.4–12.1ROR 7.4 · χ² 76 / p 2e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Plasma cell myeloma | 8 | 4.4 2.2–8.8ROR 4.4 · χ² 18 / p 1e-5 | 3.6 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Drug exposure during pregnancy | 6 | 3.7 1.7–8.3ROR 3.8 · χ² 9 / p 0.001 | 3.1 EB05 1.6 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Stevens-johnson syndrome (severe blistering skin reaction) | 16 | 15.4 9.5–25.1ROR 15.7 · χ² 202 / p 4e-46 | 14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 15 | 7.3 4.4–12.1ROR 7.4 · χ² 76 / p 2e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Clostridium difficile colitis | 13 | 26.3 15.3–45.2ROR 26.7 · χ² 292 / p 1e-65 | 25.4 EB05 15.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.1 | no trial data cached |
| Eosinophilia | 12 | 14.8 8.4–25.9ROR 14.9 · χ² 141 / p 1e-32 | 13.5 EB05 7.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 | no trial data cached |
| Pancreatitis acute | 11 | 10.6 5.9–19.1ROR 10.7 · χ² 86 / p 8e-21 | 8.7 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 10 | 11.6 6.3–21.5ROR 11.7 · χ² 87 / p 6e-21 | 9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 10 | 14.3 7.7–26.4ROR 14.4 · χ² 110 / p 4e-26 | 12.5 EB05 6.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Plasma cell myeloma | 8 | 4.4 2.2–8.8ROR 4.4 · χ² 18 / p 1e-5 | 3.6 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| No therapeutic response | 8 | 13.9 7.0–27.7ROR 14.0 · χ² 83 / p 4e-20 | 11.4 EB05 5.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 13.4 | no trial data cached |
| Face oedema | 7 | 8.9 4.2–18.6ROR 8.9 · χ² 41 / p 6e-11 | 6.3 EB05 3.1 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Platelet count increased | 7 | 11.5 5.5–24.1ROR 11.6 · χ² 57 / p 2e-14 | 8.5 EB05 3.8 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Toxic skin eruption | 7 | 14.9 7.1–31.2ROR 15.0 · χ² 77 / p 7e-19 | 12.0 EB05 5.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Erythema multiforme | 7 | 16.1 7.7–33.8ROR 16.3 · χ² 85 / p 2e-20 | 13.4 EB05 5.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Drug exposure during pregnancy | 6 | 3.7 1.7–8.3ROR 3.8 · χ² 9 / p 0.001 | 3.1 EB05 1.6 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Hepatocellular injury | 6 | 9.1 4.1–20.1ROR 9.1 · χ² 35 / p 1e-9 | 6.1 EB05 2.9 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | 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 Cefpodoxime Proxetil?
In FDA FAERS, the most frequently co-reported reaction terms for Cefpodoxime Proxetil are stevens-johnson syndrome, angioedema, clostridium difficile colitis, eosinophilia, pancreatitis acute, agranulocytosis. 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 Cefpodoxime Proxetil have an FDA boxed warning?
No. The FDA label retrieved for Cefpodoxime Proxetil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefpodoxime Proxetil 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 4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9, effective 20240103; matched on
openfda.generic_name.exact:"CEFPODOXIME PROXETIL") - 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, 20 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.