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What the label lists and what reports show

Cefaclor side effects

Cefaclor's FDA label lists its adverse reactions in its own words. FAERS holds 1,535 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 hypersensitivity (252 reports).

  • Generic listed

Check it at the source: the cefaclor FDA label on DailyMed (effective November 1, 2022, Azorian Pharma, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse effects considered to be related to therapy with cefaclor are listed below: Hypersensitivity reactions have been reported in about 1.5% of patients and include morbilliform eruptions (1 in 100). Pruritus, urticaria, and positive Coombs' tests each occur in less than 1 in 200 patients. Cases of serum-sickness-like reactions have been reported with the use of cefaclor. These are characterized by findings of erythema multiforme, rashes, and other skin manifestations accompanied by arthritis/arthralgia, with or without fever, and differ from classic serum sickness in that there is infrequently associated lymphadenopathy and proteinuria, no circulating immune complexes, and no evidence to date of sequelae of the reaction. Occasionally, solitary symptoms may occur, but do not represent a serum-sickness-like reaction. …

Source: FDA drug label, Azorian Pharma, LLC, effective November 1, 2022 (SPL set 224af904-38f3-4210-a750-e21006db4c66), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,535 reports list cefaclor among the medicines taken, each a report of something that happened, not proof the medicine caused it; 148 are coded as a death and 695 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, 9 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 Hypersensitivity252
  • Nausea (named in the label)159
  • Vomiting (named in the label)159
  • Fatigue137
  • Pyrexia121
  • Dizziness (named in the label)111
  • Infection (a use or a product term, not a reaction)106
  • Diarrhoea (named in the label)103
  • Drug Ineffective (a use or a product term, not a reaction)98
  • Drug Intolerance96
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)95
  • Rash (named in the label)93
  • International Normalised Ratio Fluctuation90
  • Dyspnoea (named in the label)87
  • Malaise81
  • Pneumonia (a use or a product term, not a reaction)74
  • Abdominal Pain (named in the label)72
  • Bloody Discharge72
  • Lyme Disease72
  • Urticaria (named in the label)71
  • Headache70
  • Pruritus (named in the label)66
  • Off Label Use (a use or a product term, not a reaction)65
  • Chronic Kidney Disease64
  • Hypoaesthesia64

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

What next?

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