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What the label lists and what reports show

Ceftriaxone side effects

Ceftriaxone's FDA label lists its adverse reactions in its own words. FAERS holds 38,242 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (2,055 reports).

  • Generic listed

Check it at the source: the ceftriaxone FDA label on DailyMed (effective February 4, 2026, Qilu Pharmaceutical Co., Ltd.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Ceftriaxone for injection is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Ceftriaxone for injection therapy or of uncertain etiology, were observed: LOCAL REACTIONS –pain, induration and tenderness was 1% overall. Phlebitis was reported in <1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL. GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS – injection site pain (0.6%). HYPERSENSITIVITY –rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills. INFECIONS AND INFESTATIONS –genital fungal infection (0.1%). HEMATOLOGIC –eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). …

Source: FDA drug label, Qilu Pharmaceutical Co., Ltd., effective February 4, 2026 (SPL set 4cdf0743-c62b-4969-b9c9-4c6400644f6c), via openFDA; the full label on DailyMed

What do FAERS reports show?

38,242 reports list ceftriaxone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,775 are coded as a death and 20,954 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)3,898
  • Drug Ineffective (a use or a product term, not a reaction)3,554
  • Pyrexia2,055
  • Acute Kidney Injury1,826
  • Dyspnoea1,592
  • Condition Aggravated (a use or a product term, not a reaction)1,585
  • Pneumonia (a use or a product term, not a reaction)1,337
  • Vomiting (named in the label)1,266
  • Nausea (named in the label)1,253
  • Drug Interaction (a use or a product term, not a reaction)1,155
  • Diarrhoea (named in the label)1,138
  • Sepsis1,091
  • Drug Reaction With Eosinophilia And Systemic Symptoms1,083
  • Rash (named in the label)1,082
  • Hypotension1,005
  • Anaemia (named in the label)966
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)966
  • Abdominal Pain (named in the label)912
  • Respiratory Failure864
  • Thrombocytopenia (named in the label)858
  • Multiple Organ Dysfunction Syndrome852
  • Drug Hypersensitivity841
  • Neutropenia (named in the label)798
  • Cough736
  • Septic Shock715

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ceftriaxone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions