Drug · FAERS side-effect profile with label screen
Cefdinir side effects: what 7,626 FDA adverse event reports show
Drug class
Cephalosporin Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
7,626 reports · 63% serious · 579 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
FDA label, Indications and Usage
What it is
DESCRIPTION Cefdinir for oral suspension, USP contains the active ingredient cefdinir USP, an extended-spectrum, semisynthetic cephalosporin, 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 4Labeled (related wording) 8Likely indication confounding 8Reporting / coding artifact 1Not in label — unassessed 19
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. 638 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 148 | 22.3 19.0–26.1ROR 22.7 · χ² 2,962 / p <1e-300 | 22.0 EB05 19.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 | no trial data cached |
| Chronic kidney disease | 485 | 17.5 16.1–19.1ROR 18.6 · χ² 7,507 / p <1e-300 | 17.4 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Ear infection | 123 | 12.8 10.7–15.3ROR 13.0 · χ² 1,321 / p 2e-289 | 12.7 EB05 10.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.5 | no trial data cached |
| Economic problem | 70 | 12.5 9.9–15.8ROR 12.6 · χ² 729 / p 8e-161 | 12.3 EB05 10.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.2 · 77% consumer | no trial data cached |
| Sinusitis | 361 | 9.7 8.8–10.7ROR 10.1 · χ² 2,807 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.5 | no trial data cached |
| Renal injury | 103 | 9.5 7.8–11.5ROR 9.6 · χ² 769 / p 1e-169 | 9.2 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Infusion site pain | 43 | 9.3 6.9–12.5ROR 9.3 · χ² 309 / p 2e-69 | 8.8 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=25 | no trial data cached |
| Pharyngitis streptococcal | 35 | 8.9 6.4–12.4ROR 8.9 · χ² 237 / p 7e-54 | 8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Faeces discoloured | 70 | 8.9 7.0–11.2ROR 9.0 · χ² 482 / p 4e-107 | 8.6 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Seasonal allergy | 45 | 8.8 6.6–11.8ROR 8.8 · χ² 302 / p 6e-68 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=31 · 77% consumer | no trial data cached |
| Tubulointerstitial nephritis | 59 | 8.7 6.7–11.2ROR 8.7 · χ² 393 / p 1e-87 | 8.3 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Renal tubular necrosis | 29 | 8.1 5.6–11.7ROR 8.2 · χ² 174 / p 6e-40 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Anhedonia | 77 | 8.0 6.4–10.0ROR 8.1 · χ² 465 / p 2e-103 | 7.7 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 90% consumer | no trial data cached |
| Clostridium difficile colitis | 30 | 7.8 5.4–11.1ROR 7.8 · χ² 170 / p 3e-39 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Renal failure (kidney failure) | 362 | 7.5 6.7–8.2ROR 7.8 · χ² 2,025 / p <1e-300 | 7.4 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Clostridium difficile infection | 57 | 7.2 5.6–9.4ROR 7.3 · χ² 300 / p 1e-67 | 6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 121 | 7.2 6.1–8.6ROR 7.3 · χ² 642 / p 5e-142 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | no trial data cached |
| Respiratory tract infection | 67 | 7.1 5.6–9.0ROR 7.2 · χ² 345 / p 2e-77 | 6.8 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Gastroenteritis viral | 43 | 6.5 4.9–8.8ROR 6.6 · χ² 196 / p 8e-45 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Nephropathy | 22 | 6.5 4.3–9.8ROR 6.5 · χ² 96 / p 6e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 326 | 5.9 5.3–6.6ROR 6.1 · χ² 1,327 / p 8e-291 | 5.8 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Dermatitis contact | 24 | 5.8 3.9–8.7ROR 5.8 · χ² 91 / p 8e-22 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=21 · 71% consumer | no trial data cached |
| Ear pain | 40 | 5.7 4.2–7.7ROR 5.7 · χ² 149 / p 2e-34 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Eye infection | 23 | 5.6 3.8–8.5ROR 5.7 · χ² 83 / p 4e-20 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=11 · ♀ 85% (drug 63%) | no trial data cached |
| Osteopenia | 31 | 5.6 3.9–8.0ROR 5.6 · χ² 112 / p 2e-26 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Bronchitis | 151 | 5.6 4.8–6.5ROR 5.7 · χ² 565 / p 3e-125 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.4 | no trial data cached |
| Sinus disorder | 39 | 5.4 4.0–7.4ROR 5.4 · χ² 136 / p 1e-31 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.8 · ♀ 87% (drug 63%) | no trial data cached |
| Atelectasis | 19 | 5.4 3.4–8.5ROR 5.4 · χ² 64 / p 8e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Cystitis | 61 | 5.3 4.1–6.7ROR 5.3 · χ² 206 / p 6e-47 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Decreased activity | 20 | 5.1 3.3–8.0ROR 5.1 · χ² 63 / p 1e-15 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Erythema multiforme | 17 | 5.0 3.1–8.1ROR 5.0 · χ² 51 / p 5e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Respiratory tract congestion | 29 | 5.0 3.5–7.2ROR 5.0 · χ² 89 / p 2e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Impaired gastric emptying | 23 | 5.0 3.3–7.5ROR 5.0 · χ² 69 / p 5e-17 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 91% (drug 63%) | no trial data cached |
| Urinary tract infection (bladder infection) | 304 | 4.9 4.4–5.5ROR 5.1 · χ² 952 / p 3e-209 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 39 | 4.8 3.5–6.6ROR 4.8 · χ² 114 / p 6e-27 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Pharyngitis | 21 | 4.6 3.0–7.1ROR 4.6 · χ² 56 / p 3e-14 | 4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.2 | no trial data cached |
| Kidney infection | 32 | 4.5 3.2–6.3ROR 4.5 · χ² 83 / p 4e-20 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 84% (drug 63%) | no trial data cached |
| Hospice care | 16 | 4.5 2.7–7.3ROR 4.5 · χ² 40 / p 2e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Insurance issue | 24 | 4.4 3.0–6.6ROR 4.5 · χ² 61 / p 3e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 75% consumer | no trial data cached |
| Productive cough (cough with phlegm) | 76 | 4.4 3.5–5.5ROR 4.5 · χ² 198 / p 3e-45 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.3 | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 530 | 2.3 2.1–2.5ROR 2.4 · χ² 385 / p 5e-86 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Chronic kidney disease | 485 | 17.5 16.1–19.1ROR 18.6 · χ² 7,507 / p <1e-300 | 17.4 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Pneumonia (lung infection) | 482 | 4.1 3.8–4.5ROR 4.3 · χ² 1,144 / p 4e-251 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.8 | no trial data cached |
| Fatigue (tiredness) | 462 | 1.6 1.5–1.8ROR 1.7 · χ² 118 / p 1e-27 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Nausea | 400 | 1.4 1.3–1.5ROR 1.4 · χ² 46 / p 6e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Pain | 374 | 1.7 1.5–1.8ROR 1.7 · χ² 103 / p 2e-24 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Renal failure (kidney failure) | 362 | 7.5 6.7–8.2ROR 7.8 · χ² 2,025 / p <1e-300 | 7.4 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Sinusitis | 361 | 9.7 8.8–10.7ROR 10.1 · χ² 2,807 / p <1e-300 | 9.6 EB05 8.8 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.5 | no trial data cached |
| Headache | 332 | 1.5 1.3–1.6ROR 1.5 · χ² 49 / p 1e-12 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 327 | 1.6 1.4–1.8ROR 1.6 · χ² 73 / p 7e-18 | 1.6 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 326 | 5.9 5.3–6.6ROR 6.1 · χ² 1,327 / p 8e-291 | 5.8 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Urinary tract infection (bladder infection) | 304 | 4.9 4.4–5.5ROR 5.1 · χ² 952 / p 3e-209 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Death | 290 | 0.9 0.8–1.0ROR 0.9 · χ² 2 / p 0.094 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
| Pyrexia (fever) | 287 | 2.3 2.0–2.6ROR 2.3 · χ² 208 / p 2e-47 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Rash | 283 | 1.8 1.6–2.0ROR 1.8 · χ² 101 / p 5e-24 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 | 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.
- End stage renal disease — n=148, PRR 22.3
- Chronic kidney disease — n=485, PRR 17.5
- Renal injury — n=103, PRR 9.5
- Faeces discoloured — n=70, PRR 8.9
- Seasonal allergy — n=45, PRR 8.8
- Tubulointerstitial nephritis — n=59, PRR 8.7
- Renal tubular necrosis — n=29, PRR 8.1
- Anhedonia — n=77, PRR 8.0
- Gastroenteritis viral — n=43, PRR 6.5
- Dermatitis contact — n=24, PRR 5.8
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 Cefdinir?
In FDA FAERS, the most frequently co-reported reaction terms for Cefdinir are diarrhoea, chronic kidney disease, pneumonia, fatigue, nausea, pain. 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 Cefdinir have an FDA boxed warning?
No. The FDA label retrieved for Cefdinir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Cefdinir 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 06fbdb63-d32f-4212-9962-f1de15597dda, effective 20240214; matched on
openfda.generic_name.exact:"CEFDINIR") - 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, 678 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.