Drug · FAERS side-effect profile with label screen
Cefadroxil side effects: what 1,980 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,980 reports · 80% serious · 127 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Cefadroxil Capsules USP are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli , P. mirabilis , and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci.
FDA label, Indications and Usage
What it is
DESCRIPTION Cefadroxil monohydrate is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable.
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 4Labeled (related wording) 7Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 24
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. 99 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 |
|---|---|---|---|---|---|---|
| Respiratory tract infection | 191 | 78.5 68.5–89.8ROR 86.7 · χ² 14,441 / p <1e-300 | 77.3 EB05 68.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 68.6 · ♀ 100% (drug 66%) · 91% clinician | no trial data cached |
| Oedema | 207 | 40.6 35.7–46.3ROR 45.3 · χ² 7,955 / p <1e-300 | 40.4 EB05 35.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.6 · ♀ 98% (drug 66%) | no trial data cached |
| Wheezing | 188 | 33.8 29.5–38.7ROR 37.2 · χ² 5,941 / p <1e-300 | 33.5 EB05 29.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · ♀ 100% (drug 66%) | no trial data cached |
| End stage renal disease | 45 | 25.9 19.4–34.6ROR 26.5 · χ² 1,052 / p 4e-231 | 25.6 EB05 19.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · ♀ 45% (drug 66%) | no trial data cached |
| Scratch | 25 | 25.6 17.4–37.9ROR 25.9 · χ² 566 / p 2e-125 | 25.1 EB05 17.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 96% (drug 66%) | no trial data cached |
| Asthma | 251 | 23.8 21.2–26.7ROR 27.1 · χ² 5,468 / p <1e-300 | 23.7 EB05 21.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 · ♀ 93% (drug 66%) | no trial data cached |
| Dizziness postural | 21 | 23.2 15.2–35.5ROR 23.4 · χ² 424 / p 2e-94 | 22.7 EB05 15.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 95% (drug 66%) | no trial data cached |
| Clostridium difficile colitis | 20 | 20.0 12.9–30.9ROR 20.2 · χ² 341 / p 2e-76 | 19.5 EB05 13.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.6 · 95% clinician | no trial data cached |
| Secretion discharge | 22 | 18.9 12.5–28.6ROR 19.1 · χ² 355 / p 2e-79 | 18.5 EB05 12.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 · ♀ 100% (drug 66%) | no trial data cached |
| Chronic kidney disease | 129 | 17.9 15.1–21.1ROR 19.0 · χ² 2,039 / p <1e-300 | 17.8 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Drug hypersensitivity | 277 | 15.1 13.6–16.9ROR 17.4 · χ² 3,669 / p <1e-300 | 15.1 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.3 · ♀ 96% (drug 66%) | no trial data cached |
| Economic problem | 20 | 13.8 8.9–21.3ROR 13.9 · χ² 224 / p 6e-51 | 13.1 EB05 8.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · ♀ 45% (drug 66%) | no trial data cached |
| Chest pain | 235 | 13.4 11.9–15.1ROR 15.1 · χ² 2,711 / p <1e-300 | 13.4 EB05 12.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 97% (drug 66%) | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 30 | 12.4 8.7–17.8ROR 12.6 · χ² 304 / p 2e-68 | 12.0 EB05 8.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 · 100% clinician | no trial data cached |
| Skin infection | 13 | 12.3 7.2–21.2ROR 12.4 · χ² 124 / p 3e-29 | 10.9 EB05 6.1 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.3 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 17 | 11.9 7.4–19.2ROR 12.0 · χ² 160 / p 6e-37 | 10.9 EB05 6.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Blood pressure systolic increased | 21 | 11.4 7.4–17.4ROR 11.5 · χ² 188 / p 4e-43 | 10.5 EB05 6.8 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 · ♀ 90% (drug 66%) · 90% clinician | no trial data cached |
| Cellulitis (skin infection) | 54 | 11.3 8.7–14.8ROR 11.6 · χ² 500 / p 5e-111 | 11.0 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 88% (drug 66%) | no trial data cached |
| Localised infection | 25 | 11.0 7.4–16.2ROR 11.1 · χ² 216 / p 3e-49 | 10.2 EB05 7.0 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.0 | no trial data cached |
| Wound infection | 11 | 10.7 5.9–19.3ROR 10.8 · χ² 87 / p 4e-21 | 8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Bladder disorder | 10 | 10.7 5.7–19.8ROR 10.7 · χ² 78 / p 5e-19 | 8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Nocturia (night-time urination) | 11 | 9.6 5.3–17.4ROR 9.7 · χ² 77 / p 1e-18 | 7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Anhedonia | 24 | 9.6 6.5–14.3ROR 9.7 · χ² 177 / p 1e-40 | 8.7 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Cough | 241 | 9.1 8.1–10.3ROR 10.3 · χ² 1,758 / p <1e-300 | 9.0 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 97% (drug 66%) | no trial data cached |
| Pneumonia (lung infection) | 278 | 9.1 8.2–10.2ROR 10.4 · χ² 2,030 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · ♀ 91% (drug 66%) | no trial data cached |
| Tubulointerstitial nephritis | 16 | 9.1 5.6–14.8ROR 9.1 · χ² 107 / p 3e-25 | 7.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Osteoarthritis | 34 | 8.5 6.1–11.8ROR 8.6 · χ² 217 / p 2e-49 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Skin cancer | 16 | 7.9 4.8–12.8ROR 7.9 · χ² 89 / p 2e-21 | 6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Haematoma | 19 | 7.7 4.9–12.1ROR 7.8 · χ² 105 / p 6e-25 | 6.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Hepatotoxicity (liver damage) | 16 | 7.6 4.7–12.5ROR 7.7 · χ² 86 / p 9e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | no trial data cached |
| Hypomagnesaemia | 10 | 7.6 4.1–14.2ROR 7.7 · χ² 51 / p 4e-13 | 6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 109 | 7.6 6.3–9.1ROR 8.0 · χ² 621 / p 3e-137 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Renal failure (kidney failure) | 88 | 7.0 5.7–8.6ROR 7.2 · χ² 447 / p 2e-99 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Osteopenia | 10 | 6.9 3.7–12.9ROR 7.0 · χ² 45 / p 9e-12 | 5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Basal cell carcinoma | 10 | 6.8 3.7–12.6ROR 6.8 · χ² 44 / p 2e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Rash maculo-papular | 13 | 6.2 3.6–10.7ROR 6.3 · χ² 52 / p 3e-13 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Pain | 355 | 6.1 5.6–6.7ROR 7.2 · χ² 1,558 / p <1e-300 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 92% (drug 66%) | no trial data cached |
| Staphylococcal infection | 19 | 6.1 3.9–9.5ROR 6.1 · χ² 76 / p 2e-18 | 5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.8 | no trial data cached |
| Vomiting | 265 | 6.0 5.4–6.7ROR 6.8 · χ² 1,121 / p 5e-246 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · ♀ 95% (drug 66%) | no trial data cached |
| Rhinorrhoea (runny nose) | 36 | 5.9 4.3–8.2ROR 6.0 · χ² 143 / p 4e-33 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 91% (drug 66%) | 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 |
|---|---|---|---|---|---|---|
| Pain | 355 | 6.1 5.6–6.7ROR 7.2 · χ² 1,558 / p <1e-300 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 92% (drug 66%) | no trial data cached |
| Pneumonia (lung infection) | 278 | 9.1 8.2–10.2ROR 10.4 · χ² 2,030 / p <1e-300 | 9.0 EB05 8.2 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · ♀ 91% (drug 66%) | no trial data cached |
| Drug hypersensitivity | 277 | 15.1 13.6–16.9ROR 17.4 · χ² 3,669 / p <1e-300 | 15.1 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.3 · ♀ 96% (drug 66%) | no trial data cached |
| Vomiting | 265 | 6.0 5.4–6.7ROR 6.8 · χ² 1,121 / p 5e-246 | 5.9 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · ♀ 95% (drug 66%) | no trial data cached |
| Asthma | 251 | 23.8 21.2–26.7ROR 27.1 · χ² 5,468 / p <1e-300 | 23.7 EB05 21.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 · ♀ 93% (drug 66%) | no trial data cached |
| Cough | 241 | 9.1 8.1–10.3ROR 10.3 · χ² 1,758 / p <1e-300 | 9.0 EB05 8.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 97% (drug 66%) | no trial data cached |
| Malaise (feeling unwell) | 237 | 5.7 5.1–6.4ROR 6.4 · χ² 936 / p 8e-206 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 97% (drug 66%) | no trial data cached |
| Chest pain | 235 | 13.4 11.9–15.1ROR 15.1 · χ² 2,711 / p <1e-300 | 13.4 EB05 12.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 97% (drug 66%) | no trial data cached |
| Oedema | 207 | 40.6 35.7–46.3ROR 45.3 · χ² 7,955 / p <1e-300 | 40.4 EB05 35.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.6 · ♀ 98% (drug 66%) | no trial data cached |
| Respiratory tract infection | 191 | 78.5 68.5–89.8ROR 86.7 · χ² 14,441 / p <1e-300 | 77.3 EB05 68.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 68.6 · ♀ 100% (drug 66%) · 91% clinician | no trial data cached |
| Wheezing | 188 | 33.8 29.5–38.7ROR 37.2 · χ² 5,941 / p <1e-300 | 33.5 EB05 29.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · ♀ 100% (drug 66%) | no trial data cached |
| Chronic kidney disease | 129 | 17.9 15.1–21.1ROR 19.0 · χ² 2,039 / p <1e-300 | 17.8 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 109 | 7.6 6.3–9.1ROR 8.0 · χ² 621 / p 3e-137 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Renal failure (kidney failure) | 88 | 7.0 5.7–8.6ROR 7.2 · χ² 447 / p 2e-99 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Cellulitis (skin infection) | 54 | 11.3 8.7–14.8ROR 11.6 · χ² 500 / p 5e-111 | 11.0 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 88% (drug 66%) | 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.
- Respiratory tract infection — n=191, PRR 78.5
- Wheezing — n=188, PRR 33.8
- End stage renal disease — n=45, PRR 25.9
- Scratch — n=25, PRR 25.6
- Asthma — n=251, PRR 23.8
- Dizziness postural — n=21, PRR 23.2
- Secretion discharge — n=22, PRR 18.9
- Chronic kidney disease — n=129, PRR 17.9
- Chest pain — n=235, PRR 13.4
- Cellulitis — n=54, PRR 11.3
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 Cefadroxil?
In FDA FAERS, the most frequently co-reported reaction terms for Cefadroxil are pain, pneumonia, drug hypersensitivity, vomiting, asthma, cough. 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 Cefadroxil have an FDA boxed warning?
No. The FDA label retrieved for Cefadroxil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefadroxil 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 1c50c0db-ca03-6217-e063-6294a90a89fa, effective 20251225; matched on
openfda.generic_name.exact:"CEFADROXIL") - 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, 139 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.