Drug · FAERS side-effect profile with label screen
Cefixime side effects: what 2,959 FDA adverse event reports show
Drug class
Cephalosporin antibacterial drug
FDA label, Indications wording
Who reports
2,959 reports · 85% serious · 197 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exac.
FDA label, Indications and Usage
What it is
Cefixime is a semisynthetic, cephalosporin antibacterial for oral 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 6Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 27
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. 140 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 54 | 32.2 24.7–42.0ROR 32.8 · χ² 1,597 / p <1e-300 | 31.8 EB05 25.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Clostridium difficile colitis | 34 | 22.8 16.3–31.8ROR 23.0 · χ² 684 / p 6e-151 | 22.4 EB05 16.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 · 97% clinician | no trial data cached |
| Tooth abscess | 31 | 21.6 15.2–30.6ROR 21.8 · χ² 586 / p 1e-129 | 21.2 EB05 15.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 · ♀ 100% (drug 63%) | no trial data cached |
| Pulmonary congestion | 39 | 20.9 15.3–28.6ROR 21.2 · χ² 719 / p 1e-158 | 20.7 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 41 | 19.3 14.2–26.2ROR 19.6 · χ² 692 / p 8e-153 | 19.1 EB05 14.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.0 · 100% clinician | no trial data cached |
| Secretion discharge | 33 | 19.0 13.5–26.6ROR 19.2 · χ² 543 / p 2e-120 | 18.7 EB05 13.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 | no trial data cached |
| Pulmonary mass | 34 | 16.2 11.6–22.7ROR 16.4 · χ² 470 / p 2e-104 | 16.0 EB05 11.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Oral candidiasis (oral thrush) | 29 | 15.8 11.0–22.7ROR 16.0 · χ² 387 / p 2e-86 | 15.5 EB05 11.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · 93% clinician | no trial data cached |
| Vaginal discharge | 21 | 14.8 9.7–22.7ROR 14.9 · χ² 257 / p 4e-58 | 14.3 EB05 9.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=21 · 90% clinician | no trial data cached |
| Ankylosing spondylitis | 27 | 14.7 10.1–21.4ROR 14.8 · χ² 331 / p 3e-74 | 14.3 EB05 10.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 92% (drug 63%) | no trial data cached |
| Clostridium difficile infection | 37 | 12.1 8.8–16.7ROR 12.3 · χ² 366 / p 7e-82 | 11.7 EB05 8.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 · 95% clinician | no trial data cached |
| Paraesthesia oral | 23 | 11.4 7.6–17.1ROR 11.4 · χ² 207 / p 4e-47 | 10.5 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 33 | 10.5 7.5–14.8ROR 10.6 · χ² 274 / p 7e-62 | 9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 100% clinician | no trial data cached |
| Skin lesion | 39 | 10.2 7.4–13.9ROR 10.3 · χ² 313 / p 2e-70 | 9.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 91% (drug 63%) | no trial data cached |
| Tubulointerstitial nephritis | 24 | 9.1 6.1–13.5ROR 9.2 · χ² 165 / p 5e-38 | 8.2 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 100% clinician | no trial data cached |
| Impaired gastric emptying | 16 | 8.9 5.5–14.5ROR 8.9 · χ² 104 / p 9e-25 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Febrile neutropenia | 81 | 8.7 7.0–10.8ROR 8.9 · χ² 543 / p 2e-120 | 8.4 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 98% clinician | no trial data cached |
| Erythema multiforme | 11 | 8.4 4.6–15.1ROR 8.4 · χ² 64 / p 6e-16 | 6.7 EB05 3.8 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Anhedonia | 31 | 8.3 5.8–11.8ROR 8.4 · χ² 192 / p 6e-44 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 32% (drug 63%) | no trial data cached |
| Joint dislocation | 12 | 8.1 4.6–14.2ROR 8.1 · χ² 67 / p 1e-16 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Rash maculo-papular | 25 | 8.0 5.4–11.8ROR 8.1 · χ² 146 / p 6e-34 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 96% clinician | no trial data cached |
| Frequent bowel movements | 30 | 7.9 5.5–11.3ROR 8.0 · χ² 174 / p 5e-40 | 7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 28 | 7.8 5.4–11.2ROR 7.8 · χ² 158 / p 1e-36 | 7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 93% clinician | no trial data cached |
| Psoriatic arthropathy | 44 | 7.8 5.8–10.4ROR 7.9 · χ² 252 / p 4e-57 | 7.3 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Colitis | 40 | 7.5 5.5–10.2ROR 7.6 · χ² 220 / p 4e-50 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 90% clinician | no trial data cached |
| Tendonitis | 16 | 7.3 4.5–11.9ROR 7.3 · χ² 81 / p 1e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Movement disorder | 32 | 7.0 5.0–9.9ROR 7.1 · χ² 160 / p 7e-37 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 18 | 6.9 4.4–10.9ROR 6.9 · χ² 85 / p 1e-20 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Economic problem | 15 | 6.9 4.2–11.4ROR 6.9 · χ² 70 / p 3e-17 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 16 | 6.5 4.0–10.6ROR 6.5 · χ² 69 / p 5e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Eosinophilia | 16 | 6.5 4.0–10.6ROR 6.5 · χ² 69 / p 5e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Paralysis | 13 | 6.4 3.7–11.0ROR 6.4 · χ² 54 / p 1e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Septic shock | 39 | 6.4 4.7–8.7ROR 6.5 · χ² 172 / p 1e-39 | 6.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 23% (drug 63%) · 95% clinician | no trial data cached |
| Panic attack | 31 | 6.0 4.2–8.6ROR 6.1 · χ² 125 / p 3e-29 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Bacteraemia | 10 | 6.0 3.2–11.2ROR 6.0 · χ² 37 / p 6e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.1 | no trial data cached |
| Hepatocellular injury | 12 | 6.0 3.4–10.5ROR 6.0 · χ² 45 / p 1e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Procedural pain | 23 | 5.9 3.9–8.9ROR 5.9 · χ² 89 / p 2e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 95% (drug 63%) · 91% clinician | no trial data cached |
| Face oedema | 14 | 5.9 3.5–9.9ROR 5.9 · χ² 52 / p 3e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Cystitis | 26 | 5.8 3.9–8.5ROR 5.8 · χ² 98 / p 2e-23 | 5.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 87% (drug 63%) | no trial data cached |
| Pharyngitis | 10 | 5.7 3.1–10.6ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.0 | 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 |
|---|---|---|---|---|---|---|
| Covid-19 | 89 | 3.6 2.9–4.4ROR 3.6 · χ² 163 / p 1e-37 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Erythema (skin redness) | 82 | 2.8 2.3–3.5ROR 2.9 · χ² 96 / p 5e-23 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 91% clinician | no trial data cached |
| Febrile neutropenia | 81 | 8.7 7.0–10.8ROR 8.9 · χ² 543 / p 2e-120 | 8.4 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 98% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 70 | 3.7 2.9–4.6ROR 3.7 · χ² 134 / p 3e-31 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 93% clinician | no trial data cached |
| Treatment failure | 61 | 5.3 4.1–6.8ROR 5.4 · χ² 207 / p 3e-47 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 | no trial data cached |
| Inappropriate schedule of product administration | 58 | 2.3 1.8–3.0ROR 2.4 · χ² 43 / p 3e-11 | 2.3 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Macular degeneration | 54 | 32.2 24.7–42.0ROR 32.8 · χ² 1,597 / p <1e-300 | 31.8 EB05 25.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Psoriatic arthropathy | 44 | 7.8 5.8–10.4ROR 7.9 · χ² 252 / p 4e-57 | 7.3 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Intentional product use issue | 42 | 3.4 2.5–4.6ROR 3.4 · χ² 68 / p 7e-17 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 41 | 19.3 14.2–26.2ROR 19.6 · χ² 692 / p 8e-153 | 19.1 EB05 14.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.0 · 100% clinician | no trial data cached |
| Colitis | 40 | 7.5 5.5–10.2ROR 7.6 · χ² 220 / p 4e-50 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 90% clinician | no trial data cached |
| Haematochezia (blood in stool) | 39 | 5.0 3.7–6.9ROR 5.1 · χ² 122 / p 1e-28 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Septic shock | 39 | 6.4 4.7–8.7ROR 6.5 · χ² 172 / p 1e-39 | 6.0 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 23% (drug 63%) · 95% clinician | no trial data cached |
| Skin lesion | 39 | 10.2 7.4–13.9ROR 10.3 · χ² 313 / p 2e-70 | 9.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 91% (drug 63%) | no trial data cached |
| Pulmonary congestion | 39 | 20.9 15.3–28.6ROR 21.2 · χ² 719 / p 1e-158 | 20.7 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | 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.
- Macular degeneration — n=54, PRR 32.2
- Tooth abscess — n=31, PRR 21.6
- Pulmonary congestion — n=39, PRR 20.9
- Secretion discharge — n=33, PRR 19.0
- Pulmonary mass — n=34, PRR 16.2
- Oral candidiasis — n=29, PRR 15.8
- Vaginal discharge — n=21, PRR 14.8
- Ankylosing spondylitis — n=27, PRR 14.7
- Paraesthesia oral — n=23, PRR 11.4
- Skin lesion — n=39, PRR 10.2
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 Cefixime?
In FDA FAERS, the most frequently co-reported reaction terms for Cefixime are covid-19, erythema, febrile neutropenia, neutropenia, macular degeneration, psoriatic arthropathy. 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 Cefixime have an FDA boxed warning?
No. The FDA label retrieved for Cefixime has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefixime 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 9cdb156f-7a99-413e-b49a-ffafaf9e93fe, effective 20260325; matched on
openfda.generic_name.exact:"CEFIXIME") - 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, 180 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.