Evigrade

Ceftriaxone

AEMPS

Third-generation cephalosporins

ATC code: J01DD04

Brand names: Ceftriaxona Normon, Rocephin, Ceftriaxona Kabi

Updated · Methodology

Indications

A

Community-acquired pneumonia

First line

Moderate-to-severe community-acquired pneumonia. /ATS 2019 and Spanish SEPAR 2024 position ceftriaxone 1–2 g once daily as the empiric backbone in hospitalized patients combined with a macrolide (azithromycin 500 mg or clarithromycin) or a respiratory fluoroquinolone (levofloxacin). Treatment duration 5–7 days with typical response. ICU patients receive 2 g/day.

ICD-10: J18.9 · ICD-11: CA40.Z

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Common cold

Not recommended

Ceftriaxone is used in outpatient settings for upper respiratory infections and mild COVID-19 as a fallback. 2024 AWaRe places ceftriaxone in the Watch category, recommending limited inpatient use. NG191 2020 and 2019 do not include ceftriaxone in outpatient URI standards. Intramuscular pediatric use without bacterial confirmation drives irrational use and resistance.

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Parenteral third-generation cephalosporin. Inhibits bacterial cell wall synthesis via penicillin-binding protein (PBP) binding. Spectrum includes Gram-negative (E. coli, K. pneumoniae, P. mirabilis, H. influenzae, M. catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis) and some Gram-positive (S. pneumoniae, S. pyogenes). Not active against Pseudomonas aeruginosa, MRSA, Enterococcus, or most anaerobes. Half-life 6–9 hours – among the longest in the class, allowing once-daily dosing.

Safety

Contraindications

  • Cephalosporin hypersensitivity
  • Anaphylaxis to penicillins (cross-allergy 1–10%)
  • Neonatal hyperbilirubinemia – kernicterus risk
  • Calcium-containing solutions in neonates

Serious adverse effects

  • Anaphylaxis
  • C. difficile colitis
  • Pseudocholelithiasis (ceftriaxone-calcium sludge in gallbladder, in 20–40% on prolonged therapy, asymptomatic)
  • Hemolytic anemia (rare)
  • Severe neutropenia and agranulocytosis (very rare)

Common adverse effects

  • IM injection-site pain (without lidocaine)
  • Diarrhea
  • Nausea
  • Rash
  • Eosinophilia
  • Thrombocytosis

Pregnancy: can you take Ceftriaxone?

AEMPS summary of product characteristics (section 4.6): ceftriaxone crosses the placenta, and data on its use in pregnant women are limited. Animal studies found no direct or indirect harmful effects on embryo-fetal, perinatal or postnatal development. During pregnancy, especially in the first trimester, ceftriaxone is given only if the expected benefits outweigh the risks.

Breastfeeding: can you take Ceftriaxone?

Milk levels are low; infant risk minimal. Infant diarrhea or candidiasis possible.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Administered IM or IV once daily. IM injection is reconstituted in 1% lidocaine (painful without lidocaine); IV in normal saline or 5% dextrose. Do NOT mix in the same line with calcium-containing fluids (Hartmann's, Ringer's) – insoluble ceftriaxone-calcium precipitates, fatal respiratory embolism reported in neonates. In children over 28 days IV is safe with at least a 48-hour interval from calcium infusion.

Drug interactions

Calcium-containing fluids in neonates – absolute contraindication. Oral contraceptives – no clinically significant efficacy reduction with short courses (Cochrane meta-analysis 2017). Vitamin K antagonists (warfarin) – ceftriaxone suppresses gut flora and may raise INR; check 3–5 days after antibiotic start.
Label mentions6 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Moderateaminoglucósidosclass named in the label
    «No hay una evidencia clara en cuanto a un potencial aumento de la toxicidad renal de los aminoglucósidos cuando se utilizan con cefalosporinas. En tales casos se debe mantener una estrecha vigilancia…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «El uso concomitante con anticoagulantes orales puede aumentar el efecto anti-vitamina K y el riesgo de hemorragia. Se recomienda monitorizar con frecuencia la International Normalised Ratio (INR) y…»

    AEMPS, section 4.5 · Open on CIMA

  • «En un estudio in vitro , se han observado efectos antagonistas tras la combinación de cloranfenicol y ceftriaxona. Se desconoce la repercusión clínica.»

    AEMPS, section 4.5 · Open on CIMA

  • diuréticosclass named in the label
    «No se ha observado insuficiencia en la función renal tras la administración concomitante de dosis altas de ceftriaxona y diuréticos potentes (por ejemplo, furosemida).»

    AEMPS, section 4.5 · Open on CIMA

  • «No se ha observado insuficiencia en la función renal tras la administración concomitante de dosis altas de ceftriaxona y diuréticos potentes (por ejemplo, furosemida).»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Antibacterianos : Ceftriaxona: Hay estudios en los que se ha registrado un incremento de su eliminación por el diclofenaco.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Ceftriaxone used for?

Ceftriaxone is evaluated for the following indications with varying evidence strength: Community-acquired pneumonia (evidence tier A), Common cold (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Ceftriaxone?

Common side effects of Ceftriaxone (≥ 1 in 100): IM injection-site pain (without lidocaine), Diarrhea, Nausea, Rash, Eosinophilia, Thrombocytosis. See the Safety section for uncommon and serious reactions.

Is Ceftriaxone safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): ceftriaxone crosses the placenta, and data on its use in pregnant women are limited. Animal studies found no direct or indirect harmful effects on embryo-fetal, perinatal or postnatal development. During pregnancy, especially in the first trimester, ceftriaxone is given only if the expected benefits outweigh the risks.

Is Ceftriaxone compatible with breastfeeding?

Milk levels are low; infant risk minimal. Infant diarrhea or candidiasis possible.

Who should not take Ceftriaxone?

Ceftriaxone is contraindicated in: Cephalosporin hypersensitivity; Anaphylaxis to penicillins (cross-allergy 1–10%); Neonatal hyperbilirubinemia – kernicterus risk; Calcium-containing solutions in neonates. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Cefuroxime axetil, Chloramphenicol, Ciprofloxacin, Clarithromycin, Clindamycin, Flucloxacillin, Meropenem, Amoxicillin + Clavulanic Acid