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What the label lists and what reports show

Cefotaxime side effects

Cefotaxime's FDA label: “The most common adverse reactions have been local reactions following IM or IV injection.” FAERS holds 4,277 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 (281 reports).

  • Generic listed
  • In shortage

Check it at the source: the cefotaxime FDA label on DailyMed (effective April 11, 2024, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions have been local reactions following IM or IV injection.

From the label: adverse reactions, continued

Clinical Trials Experience Cefotaxime is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently. The most frequent adverse reactions (greater than 1%) are: Local (4.3%) - Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection. Hypersensitivity (2.4%) - Rash, pruritus, fever, eosinophilia. Gastrointestinal (1.4%) - Colitis, diarrhea, nausea, and vomiting. Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely. Less frequent adverse reactions (less than 1%) are: Hematologic System - Neutropenia, leukopenia, have been reported. Some individuals have developed positive direct Coombs Tests during treatment with cefotaxime and other cephalosporin antibiotics. Genitourinary System - Moniliasis, vaginitis. Central Nervous System - Headache. Liver - Transient elevations in AST, ALT, serum LDH, and serum alkaline phosphatase levels have been reported. Kidney - As with some other cephalosporins, transient elevations of BUN have been occasionally observed with cefotaxime. Post-Marketing Experience The following adverse reactions have been identified during post-approval use of cefotaxime. …

Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective April 11, 2024 (SPL set ed23b6bc-32c7-4c50-a53d-313ae78e5623), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,277 reports list cefotaxime among the medicines taken, each a report of something that happened, not proof the medicine caused it; 847 are coded as a death and 2,431 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 20 reactions below, 10 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

  • Drug Ineffective (a use or a product term, not a reaction)364
  • Off Label Use (a use or a product term, not a reaction)328
  • Pyrexia281
  • Drug Reaction With Eosinophilia And Systemic Symptoms240
  • Acute Kidney Injury195
  • Thrombocytopenia (named in the label)150
  • Neutropenia (named in the label)149
  • Condition Aggravated (a use or a product term, not a reaction)136
  • Sepsis129
  • Toxic Epidermal Necrolysis (named in the label)129
  • Diarrhoea (named in the label)125
  • Anaemia (named in the label)120
  • Rash (named in the label)120
  • Rash Maculo-Papular116
  • Hepatocellular Injury113
  • Drug Interaction (a use or a product term, not a reaction)105
  • Septic Shock105
  • Hypotension104
  • Vomiting (named in the label)103
  • Eosinophilia (named in the label)95
  • Pneumonia (a use or a product term, not a reaction)95
  • Renal Failure (named in the label)91
  • Dyspnoea81
  • Multiple Organ Dysfunction Syndrome78
  • Pancytopenia (named in the label)77

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

What next?

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