Ceftriaxone Sodium side effects: what 38,124 FDA adverse event reports show
Drug class
Cephalosporin antibacterial
Brand names
Ceftriaxone And Dextrose
Who reports
38,124 reports · 94% serious · 6,744 with death outcome · 47% female
Used for
Ceftriaxone for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible bacteria. Ceftriaxone for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatme.
What it is
Ceftriaxone for Injection and Dextrose Injection is a sterile, nonpyrogenic, single-dose, packaged combination of Ceftriaxone Sodium and Dextrose Injection (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,219 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 |
|---|---|---|---|---|---|---|
| Pseudocholelithiasis | 103 | 13,949.6 5,137.9–37,873.3ROR 13,987.3 · calibrated p 4e-23 ✓ | 476.0 EB05 403.7 · IC025 +6.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=89 · 100% clinician | not reported in cached trials |
| Appendicolith | 307 | 2,445.8 1,881.1–3,179.9ROR 2,465.6 · calibrated p 1e-21 ✓ | 432.3 EB05 393.2 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=307 · ♀ 6% (drug 47%) · 96% clinician | not reported in cached trials |
| Antacid therapy | 91 | 1,760.6 1,152.8–2,688.9ROR 1,764.8 · calibrated p 7e-19 ✓ | 381.6 EB05 320.2 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=91 · ♀ 20% (drug 47%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 128 | 1,238.2 904.7–1,694.8ROR 1,242.4 · calibrated p 1e-17 ✓ | 357.3 EB05 308.3 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious n=128 · ♀ 0% (drug 47%) · 98% clinician | not reported in cached trials |
| Analgesic therapy | 148 | 517.3 413.0–647.8ROR 519.3 · calibrated p 8e-14 ✓ | 256.3 EB05 223.5 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=148 · ♀ 12% (drug 47%) · 97% clinician | not reported in cached trials |
| Drug therapy | 147 | 471.2 377.8–587.6ROR 473.0 · calibrated p 2e-13 ✓ | 244.5 EB05 213.1 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=147 · ♀ 12% (drug 47%) · 97% clinician | not reported in cached trials |
| Factor v inhibition | 67 | 285.8 212.6–384.2ROR 286.3 · calibrated p 4e-11 ✓ | 178.0 EB05 145.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=65 · 100% clinician | not reported in cached trials |
| Malignant melanoma stage 0 | 61 | 280.0 205.6–381.4ROR 280.5 · calibrated p 5e-11 ✓ | 174.9 EB05 141.1 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Anticoagulant therapy | 89 | 260.6 202.4–335.5ROR 261.2 · calibrated p 7e-11 ✓ | 169.9 EB05 142.3 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=89 · ♀ 20% (drug 47%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 64 | 223.7 167.2–299.2ROR 224.1 · calibrated p 3e-10 ✓ | 151.5 EB05 122.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Penile abscess | 25 | 188.1 119.4–296.4ROR 188.2 · calibrated p 4e-9 ✓ | 126.6 EB05 90.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 47%) | not reported in cached trials |
| Jarisch-herxheimer reaction | 168 | 169.5 142.6–201.5ROR 170.2 · calibrated p 2e-9 ✓ | 127.5 EB05 112.1 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=162 · 97% clinician | not reported in cached trials |
| Postrenal failure | 95 | 150.0 119.6–188.3ROR 150.4 · calibrated p 7e-9 ✓ | 115.0 EB05 96.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 24% (drug 47%) · 100% clinician | not reported in cached trials |
| Acquired factor v deficiency | 22 | 135.4 84.9–216.1ROR 135.5 · calibrated p 5e-8 ✓ | 99.4 EB05 69.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
| Bacteroides infection | 47 | 121.8 88.8–167.1ROR 122.0 · calibrated p 5e-8 ✓ | 95.9 EB05 75.0 · IC025 +5.1 3/3 methods agree | Likely indication confounding term in indications | serious n=47 · ♀ 0% (drug 47%) · 94% clinician | not reported in cached trials |
| Clostridium test positive | 273 | 78.7 69.3–89.3ROR 79.2 · calibrated p 7e-7 ✓ | 68.5 EB05 61.9 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=273 · 96% clinician | not reported in cached trials |
| Pulmonary function test abnormal | 180 | 71.6 61.3–83.6ROR 71.9 · calibrated p 1e-6 ✓ | 63.0 EB05 55.6 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=180 · ♀ 100% (drug 47%) | not reported in cached trials |
| Renal papillary necrosis | 24 | 68.1 44.5–104.1ROR 68.1 · calibrated p 5e-6 ✓ | 57.9 EB05 41.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Disseminated strongyloidiasis | 23 | 65.6 42.5–101.1ROR 65.6 · calibrated p 6e-6 ✓ | 56.0 EB05 39.3 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Hyperphosphataemia | 191 | 54.4 46.9–63.1ROR 54.7 · calibrated p 8e-6 ✓ | 49.3 EB05 43.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=191 · ♀ 15% (drug 47%) · 96% clinician | not reported in cached trials |
| Microsporidia infection | 32 | 54.3 37.8–78.1ROR 54.4 · calibrated p 1e-5 ✓ | 48.2 EB05 35.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 47%) · 100% consumer | not reported in cached trials |
| Pleocytosis | 50 | 51.9 38.8–69.3ROR 52.0 · calibrated p 2e-5 ✓ | 46.7 EB05 36.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 69% (drug 47%) · 91% clinician | not reported in cached trials |
| Vitamin k deficiency | 34 | 51.3 36.1–72.9ROR 51.4 · calibrated p 2e-5 ✓ | 45.8 EB05 34.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Trichosporon infection | 32 | 48.3 33.6–69.3ROR 48.3 · calibrated p 3e-5 ✓ | 43.4 EB05 32.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Blood phosphorus increased | 220 | 48.3 42.1–55.4ROR 48.5 · calibrated p 2e-5 ✓ | 44.2 EB05 39.5 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=220 · ♀ 10% (drug 47%) · 95% clinician | not reported in cached trials |
| Pneumococcal infection | 46 | 46.8 34.6–63.2ROR 46.8 · calibrated p 3e-5 ✓ | 42.4 EB05 33.1 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 · ♀ 100% (drug 47%) | not reported in cached trials |
| Disseminated aspergillosis | 35 | 44.3 31.4–62.5ROR 44.3 · calibrated p 5e-5 ✓ | 40.2 EB05 30.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 0% (drug 47%) · 91% clinician | not reported in cached trials |
| Vancomycin infusion reaction | 27 | 44.1 29.8–65.2ROR 44.1 · calibrated p 6e-5 ✓ | 39.8 EB05 28.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Chest x-ray abnormal | 219 | 41.8 36.4–47.9ROR 42.0 · calibrated p 4e-5 ✓ | 38.7 EB05 34.6 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=219 · ♀ 100% (drug 47%) | not reported in cached trials |
| Disseminated mucormycosis | 27 | 41.1 27.8–60.8ROR 41.1 · calibrated p 8e-5 ✓ | 37.3 EB05 26.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Calculus ureteric | 50 | 40.1 30.1–53.5ROR 40.2 · calibrated p 7e-5 ✓ | 36.9 EB05 29.1 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=50 · ♀ 20% (drug 47%) · 100% clinician | not reported in cached trials |
| Intensive care unit acquired weakness | 25 | 38.5 25.6–57.7ROR 38.5 · calibrated p 1e-4 ✓ | 35.1 EB05 25.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 58 | 37.1 28.4–48.4ROR 37.2 · calibrated p 1e-4 ✓ | 34.4 EB05 27.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Generalised bullous fixed drug eruption | 23 | 36.9 24.2–56.2ROR 36.9 · calibrated p 2e-4 ✓ | 33.7 EB05 23.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Choreoathetosis | 43 | 36.7 27.0–50.0ROR 36.8 · calibrated p 1e-4 ✓ | 34.0 EB05 26.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=42 · 100% clinician | not reported in cached trials |
| Ear pruritus | 203 | 34.0 29.5–39.2ROR 34.2 · calibrated p 1e-4 ✓ | 32.0 EB05 28.5 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=203 · ♀ 100% (drug 47%) | not reported in cached trials |
| Corynebacterium infection | 31 | 33.9 23.6–48.8ROR 34.0 · calibrated p 2e-4 ✓ | 31.4 EB05 23.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Kounis syndrome | 130 | 33.5 28.1–40.0ROR 33.6 · calibrated p 2e-4 ✓ | 31.5 EB05 27.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=130 · ♀ 26% (drug 47%) · 100% clinician | not reported in cached trials |
| Blood gases abnormal | 29 | 31.5 21.7–45.8ROR 31.5 · calibrated p 3e-4 ✓ | 29.3 EB05 21.4 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=29 · ♀ 100% (drug 47%) | not reported in cached trials |
| Breath sounds abnormal | 262 | 30.8 27.2–34.9ROR 31.0 · calibrated p 2e-4 ✓ | 29.1 EB05 26.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=262 · ♀ 82% (drug 47%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ceftriaxone as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT03959527 — Zoliflodacin in Uncomplicated Gonorrhoea (N=1011, PHASE3; 8 AE terms posted; arms: Zoliflodacin; Ceftriaxone and Azithromycin Combination)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 3,897 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.754 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 95% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 3,549 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.663 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 · 94% clinician | not reported in cached trials |
| Pyrexia (fever) | 2,054 | 3.3 3.1–3.4ROR 3.4 · calibrated p 0.508 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 1,824 | 6.7 6.4–7.0ROR 6.9 · calibrated p 0.101 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 95% clinician | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,591 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.689 | 1.5 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.3 | not reported in cached trials |
| Condition aggravated | 1,585 | 2.9 2.8–3.0ROR 3.0 · calibrated p 0.633 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 95% clinician | not reported in cached trials |
| Pneumonia (lung infection) | 1,330 | 2.3 2.2–2.4ROR 2.3 · calibrated p 0.896 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 1.4 | not reported in cached trials |
| Vomiting | 1,263 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.641 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Nausea | 1,253 | 0.9 0.8–0.9ROR 0.9 · calibrated p 0.224 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT03959527: 12/308 (3.9%) on Ceftriaxone |
| Drug interaction | 1,154 | 4.0 3.8–4.3ROR 4.1 · calibrated p 0.357 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 93% clinician | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,136 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.288 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT03959527: 22/308 (7.1%) on Ceftriaxone |
| Sepsis (blood infection) | 1,091 | 5.4 5.1–5.7ROR 5.6 · calibrated p 0.183 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 93% clinician | not reported in cached trials |
| Rash | 1,083 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.566 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 · 90% clinician | not reported in cached trials |
| Drug reaction with eosinophilia and systemic symptoms | 1,080 | 24.2 22.8–25.7ROR 24.9 · calibrated p 7e-4 ✓ | 23.2 EB05 22.1 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.1 · 98% clinician | not reported in cached trials |
| Hypotension (low blood pressure) | 999 | 2.8 2.6–2.9ROR 2.8 · calibrated p 0.695 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 92% clinician | not reported in cached trials |
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.
- Appendicolith — n=307, PRR 2,445.8
- Factor v inhibition — n=67, PRR 285.8
- Malignant melanoma stage 0 — n=61, PRR 280.0
- Congenital hiatus hernia — n=64, PRR 223.7
- Penile abscess — n=25, PRR 188.1
- Jarisch-herxheimer reaction — n=168, PRR 169.5
- Postrenal failure — n=95, PRR 150.0
- Acquired factor v deficiency — n=22, PRR 135.4
- Renal papillary necrosis — n=24, PRR 68.1
- Hyperphosphataemia — n=191, PRR 54.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
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 Ceftriaxone?
In FDA FAERS, the most frequently co-reported reaction terms for Ceftriaxone are pyrexia, acute kidney injury, dyspnoea, pneumonia, vomiting, nausea. 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 Ceftriaxone have an FDA boxed warning?
No. The FDA label retrieved for Ceftriaxone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ceftriaxone 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 67153914-16bc-490d-82d7-638061618467, effective 20220113; matched on
openfda.generic_name.exact:"CEFTRIAXONE") - 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, 1,259 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 - ClinicalTrials.gov API v2 (query
CEFTRIAXONE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.