Ceftriaxone side effects: what 32,617 FDA adverse event reports show

Ceftriaxone · Ceftriaxone And Dextrose · 1,232 reaction terms · 114,944 drug–reaction co-reports · data 2026-09-14

Drug class

Cephalosporin antibacterial

FDA label, Indications wording

Brand names

Ceftriaxone And Dextrose

openFDA label

Who reports

32,617 reports · 94% serious · 5,590 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

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

Likely indication confounding 6Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 26

What the badges mean

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. 1,192 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pseudocholelithiasis	78	1,703.5 1,112.4–2,608.7ROR 1,707.6 · χ² 35,510 / p <1e-300	415.2 EB05 343.4 · IC025 +6.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=64 · 100% clinician	not reported in cached trials
Appendicolith	179	578.4 472.5–708.1ROR 581.6 · χ² 53,628 / p <1e-300	293.3 EB05 259.0 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=179 · ♀ 0% (drug 47%) · 96% clinician	not reported in cached trials
Sleep disorder therapy	68	371.3 275.3–500.7ROR 372.1 · χ² 15,598 / p <1e-300	220.0 EB05 179.5 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious n=68 · ♀ 0% (drug 47%) · 96% clinician	not reported in cached trials
Factor v inhibition	61	290.5 214.6–393.3ROR 291.0 · χ² 11,867 / p <1e-300	187.8 EB05 151.5 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=59 · 100% clinician	not reported in cached trials
Antacid therapy	37	285.8 193.9–421.3ROR 286.1 · χ² 7,040 / p <1e-300	179.1 EB05 135.7 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=37 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Penile abscess	24	208.2 131.3–330.2ROR 208.4 · χ² 3,570 / p <1e-300	139.7 EB05 98.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 0% (drug 47%)	not reported in cached trials
Analgesic therapy	72	197.4 151.6–257.1ROR 197.8 · χ² 10,577 / p <1e-300	145.0 EB05 119.0 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious n=72 · ♀ 0% (drug 47%) · 96% clinician	not reported in cached trials
Postrenal failure	104	197.2 158.3–245.7ROR 197.8 · χ² 15,333 / p <1e-300	146.6 EB05 124.4 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=104 · ♀ 22% (drug 47%) · 100% clinician	not reported in cached trials
Drug therapy	69	176.9 135.5–231.0ROR 177.3 · χ² 9,298 / p <1e-300	133.5 EB05 109.1 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	serious n=69 · ♀ 0% (drug 47%) · 96% clinician	not reported in cached trials
Jarisch-herxheimer reaction	140	156.9 130.5–188.8ROR 157.6 · χ² 17,260 / p <1e-300	123.9 EB05 107.6 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=134 · 97% clinician	not reported in cached trials
Acquired factor v deficiency	20	140.7 86.7–228.5ROR 140.8 · χ² 2,157 / p <1e-300	104.1 EB05 71.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	not reported in cached trials
Anticoagulant therapy	38	102.0 72.4–143.6ROR 102.1 · χ² 3,186 / p <1e-300	84.4 EB05 64.2 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious n=38 · ♀ 0% (drug 47%) · 95% clinician	not reported in cached trials
Malignant melanoma stage 0	24	98.1 63.8–150.7ROR 98.1 · χ² 1,913 / p <1e-300	79.8 EB05 56.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Congenital hiatus hernia	27	89.1 59.5–133.2ROR 89.1 · χ² 1,985 / p <1e-300	74.3 EB05 53.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=27 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Bacteroides infection	28	77.8 52.5–115.1ROR 77.8 · χ² 1,822 / p <1e-300	66.4 EB05 48.2 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious n=28 · ♀ 0% (drug 47%)	not reported in cached trials
Renal papillary necrosis	22	72.2 46.5–112.2ROR 72.2 · χ² 1,323 / p 5e-290	61.6 EB05 42.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=22	not reported in cached trials
Portal fibrosis	21	70.7 45.1–111.0ROR 70.8 · χ² 1,237 / p 3e-271	60.4 EB05 41.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=21	not reported in cached trials
Clostridium test positive	210	68.5 59.4–78.9ROR 68.9 · χ² 12,537 / p <1e-300	61.5 EB05 54.9 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	serious n=210 · 96% clinician	not reported in cached trials
Disseminated strongyloidiasis	20	65.6 41.4–104.0ROR 65.7 · χ² 1,096 / p 2e-240	56.5 EB05 38.6 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20 · 100% clinician	not reported in cached trials
Pleocytosis	49	59.3 44.3–79.5ROR 59.4 · χ² 2,517 / p <1e-300	53.3 EB05 41.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 68% (drug 47%) · 91% clinician	not reported in cached trials
Trichosporon infection	32	56.5 39.3–81.0ROR 56.5 · χ² 1,550 / p <1e-300	50.5 EB05 37.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Vitamin k deficiency	31	54.2 37.6–78.3ROR 54.3 · χ² 1,443 / p <1e-300	48.6 EB05 35.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Disseminated aspergillosis	34	50.2 35.4–71.2ROR 50.2 · χ² 1,474 / p <1e-300	45.5 EB05 34.0 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 47%) · 91% clinician	not reported in cached trials
Morganella infection	21	49.4 31.7–77.1ROR 49.5 · χ² 880 / p 1e-193	44.2 EB05 30.5 · IC025 +3.8 3/3 methods agree	Likely indication confounding term in indications	serious n=21 · 100% clinician	not reported in cached trials
Pneumococcal infection	40	47.0 34.1–64.8ROR 47.1 · χ² 1,634 / p <1e-300	43.0 EB05 32.9 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=40 · ♀ 75% (drug 47%)	not reported in cached trials
Disseminated mucormycosis	26	46.1 31.0–68.7ROR 46.2 · χ² 1,028 / p 7e-226	41.8 EB05 30.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=26 · 100% clinician	not reported in cached trials
Calculus ureteric	49	45.9 34.4–61.3ROR 46.0 · χ² 1,965 / p <1e-300	42.2 EB05 33.2 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=49 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Vancomycin infusion reaction	23	43.4 28.4–66.1ROR 43.4 · χ² 851 / p 2e-187	39.4 EB05 27.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	not reported in cached trials
Intensive care unit acquired weakness	24	43.1 28.5–65.1ROR 43.1 · χ² 884 / p 1e-194	39.2 EB05 27.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	not reported in cached trials
Generalised bullous fixed drug eruption	21	39.1 25.2–60.8ROR 39.1 · χ² 699 / p 2e-154	35.8 EB05 24.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=21 · 100% clinician	not reported in cached trials
Corynebacterium infection	30	38.3 26.5–55.4ROR 38.3 · χ² 993 / p 3e-218	35.4 EB05 26.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=30 · ♀ 0% (drug 47%) · 100% clinician	not reported in cached trials
Bronchopleural fistula	21	37.7 24.3–58.5ROR 37.7 · χ² 673 / p 9e-149	34.6 EB05 23.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=21 · 100% clinician	not reported in cached trials
Blood gases abnormal	27	34.1 23.2–50.3ROR 34.2 · χ² 793 / p 1e-174	31.8 EB05 22.9 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=27 · ♀ 100% (drug 47%)	not reported in cached trials
Propofol infusion syndrome	34	32.5 23.0–45.8ROR 32.5 · χ² 957 / p 2e-210	30.5 EB05 22.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 72% (drug 47%) · 100% clinician	not reported in cached trials
Blood phosphorus increased	130	32.2 27.0–38.3ROR 32.3 · χ² 3,706 / p <1e-300	30.5 EB05 26.4 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=130 · ♀ 0% (drug 47%) · 93% clinician	not reported in cached trials
Hyperphosphataemia	101	32.1 26.3–39.2ROR 32.2 · χ² 2,870 / p <1e-300	30.5 EB05 25.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=101 · ♀ 12% (drug 47%) · 95% clinician	not reported in cached trials
Infective aneurysm	23	31.7 20.9–48.2ROR 31.8 · χ² 623 / p 8e-138	29.6 EB05 20.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=23 · 100% clinician	not reported in cached trials
Hyperferritinaemia	19	30.9 19.5–48.9ROR 30.9 · χ² 495 / p 5e-110	28.7 EB05 19.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Choreoathetosis	30	29.4 20.4–42.3ROR 29.4 · χ² 759 / p 3e-167	27.7 EB05 20.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=29 · 100% clinician	not reported in cached trials
Kounis syndrome	98	29.1 23.8–35.6ROR 29.2 · χ² 2,516 / p <1e-300	27.7 EB05 23.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=98 · ♀ 26% (drug 47%) · 100% clinician	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)	3,548	2.6 2.6–2.7ROR 2.8 · χ² 3,737 / p <1e-300	2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.6 · 95% clinician	not reported in cached trials
Drug ineffective (drug did not work)	3,206	1.6 1.5–1.6ROR 1.6 · χ² 699 / p 3e-154	1.6 EB05 1.5 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.7 · 94% clinician	not reported in cached trials
Pyrexia (fever)	1,736	3.2 3.1–3.4ROR 3.4 · χ² 2,709 / p <1e-300	3.2 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)	1,618	6.9 6.6–7.2ROR 7.2 · χ² 8,116 / p <1e-300	6.8 EB05 6.5 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.1 · 95% clinician	not reported in cached trials
Condition aggravated	1,363	2.9 2.8–3.1ROR 3.0 · χ² 1,724 / p <1e-300	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
Dyspnoea (shortness of breath)	1,123	1.3 1.2–1.4ROR 1.3 · χ² 69 / p 5e-17	1.3 EB05 1.2 · IC025 +0.3	Not in label — unassessed	serious PRR 1.1	not reported in cached trials
Pneumonia (lung infection)	1,081	2.2 2.0–2.3ROR 2.2 · χ² 675 / p 4e-149	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 1.4	not reported in cached trials
Drug interaction	1,049	4.3 4.0–4.5ROR 4.4 · χ² 2,628 / p <1e-300	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9 · 93% clinician	not reported in cached trials
Vomiting	1,019	1.4 1.3–1.5ROR 1.4 · χ² 117 / p 1e-27	1.4 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.2	not reported in cached trials
Nausea	972	0.8 0.7–0.8ROR 0.8 · χ² 55 / p 6e-14	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.9	NCT03959527: 12/308 (3.9%) on Ceftriaxone
Drug reaction with eosinophilia and systemic symptoms	916	23.9 22.4–25.5ROR 24.5 · χ² 19,347 / p <1e-300	23.0 EB05 21.8 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.0 · 99% clinician	not reported in cached trials
Diarrhoea (diarrhea)	906	0.9 0.8–1.0ROR 0.9 · χ² 9 / p 0.001	0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.0	NCT03959527: 22/308 (7.1%) on Ceftriaxone
Hypotension (low blood pressure)	882	2.8 2.7–3.0ROR 2.9 · χ² 1,054 / p 1e-231	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.0 · 93% clinician	not reported in cached trials
Rash	861	1.3 1.2–1.4ROR 1.3 · χ² 52 / p 2e-13	1.3 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 1.6 · 91% clinician	not reported in cached trials
Sepsis (blood infection)	861	5.0 4.7–5.3ROR 5.1 · χ² 2,737 / p <1e-300	4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.0 · 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=179, PRR 578.4
Factor v inhibition — n=61, PRR 290.5
Penile abscess — n=24, PRR 208.2
Postrenal failure — n=104, PRR 197.2
Jarisch-herxheimer reaction — n=140, PRR 156.9
Acquired factor v deficiency — n=20, PRR 140.7
Malignant melanoma stage 0 — n=24, PRR 98.1
Congenital hiatus hernia — n=27, PRR 89.1
Renal papillary necrosis — n=22, PRR 72.2
Portal fibrosis — n=21, PRR 70.7

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, field patient.drug.openfda.generic_name.exact, 1,232 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 2026-10-08. 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.