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What the label lists and what reports show

Cefoxitin side effects

Cefoxitin's FDA label: “The most common adverse reactions have been local reactions following intravenous injection.” FAERS holds 1,373 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 drug resistance (90 reports).

  • Generic listed

Check it at the source: the cefoxitin 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 intravenous injection.

From the label: adverse reactions, continued

Cefoxitin for injection is generally well tolerated. The most common adverse reactions have been local reactions following intravenous injection. Other adverse reactions have been encountered infrequently. Local Reactions Thrombophlebitis has occurred with intravenous administration. Allergic Reactions Rash (including exfoliative dermatitis and toxic epidermal necrolysis), urticaria, flushing, pruritus, eosinophilia, fever, dyspnea, and other allergic reactions including anaphylaxis, interstitial nephritis and angioedema have been noted. Cardiovascular Hypotension. Gastrointestinal Diarrhea, including documented pseudomembranous colitis which can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely. Neuromuscular Possible exacerbation of myasthenia gravis. Blood Eosinophilia, leukopenia including granulocytopenia, neutropenia, anemia, including hemolytic anemia, thrombocytopenia, and bone marrow depression. A positive direct Coombs test may develop in some individuals, especially those with azotemia. Liver Function Transient elevations in SGOT, SGPT, serum LDH, and serum alkaline phosphatase; and jaundice have been reported. Renal Function Elevations in serum creatinine and/or blood urea nitrogen levels have been observed. As with the cephalosporins, acute renal failure has been reported rarely. …

Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective April 11, 2024 (SPL set d2c449b9-5624-4166-95b1-d7813b3d0445), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,373 reports list cefoxitin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 126 are coded as a death and 541 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, 6 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)93
  • Drug Resistance90
  • Nausea (named in the label)80
  • Drug Reaction With Eosinophilia And Systemic Symptoms79
  • Rash (named in the label)77
  • Drug Ineffective (a use or a product term, not a reaction)63
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)63
  • Thrombocytopenia62
  • Condition Aggravated (a use or a product term, not a reaction)56
  • Dyspnoea (named in the label)51
  • Pyrexia50
  • Diarrhoea (named in the label)49
  • Hypotension (named in the label)44
  • Acute Kidney Injury43
  • Vomiting (named in the label)42
  • Mycobacterium Abscessus Infection41
  • Anaphylactic Reaction39
  • Rash Maculo-Papular39
  • Treatment Failure (a use or a product term, not a reaction)37
  • Pneumonia (a use or a product term, not a reaction)35
  • Anaphylactic Shock33
  • Drug Intolerance33
  • Ototoxicity33
  • Drug Hypersensitivity32
  • Pathogen Resistance32

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

What next?

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