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What the label lists and what reports show

Cefprozil side effects

Cefprozil's FDA label: “The most common adverse effects observed in patients treated with cefprozil are: Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).” FAERS holds 780 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 chronic kidney disease (89 reports).

  • Generic listed

Check it at the source: the cefprozil FDA label on DailyMed (effective May 5, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse effects observed in patients treated with cefprozil are: Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).

From the label: adverse reactions, continued

The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued cefprozil therapy due to adverse events. The most common adverse effects observed in patients treated with cefprozil are: Gastrointestinal: Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%). Hepatobiliary: Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely. Hypersensitivity: Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy. CNS: Dizziness (1%), hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible. Hematopoietic: Decreased leukocyte count (0.2%), eosinophilia (2.3%). Renal: Elevated BUN (0.1%), serum creatinine (0.1%). Other: Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).

Source: FDA drug label, Aurobindo Pharma Limited, effective May 5, 2024 (SPL set b9111a81-07c4-4458-b994-a4ad504986d8), via openFDA; the full label on DailyMed

What do FAERS reports show?

780 reports list cefprozil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 306 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 21 reactions below, 7 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

  • Chronic Kidney Disease89
  • Drug Hypersensitivity73
  • Cough64
  • Acute Kidney Injury59
  • Dyspnoea59
  • Rash (named in the label)57
  • Pneumonia (a use or a product term, not a reaction)56
  • Pyrexia55
  • Fatigue52
  • Renal Failure52
  • Diarrhoea (named in the label)49
  • Urticaria (named in the label)49
  • Arthralgia43
  • Drug Ineffective (a use or a product term, not a reaction)42
  • Abdominal Pain (named in the label)41
  • Off Label Use (a use or a product term, not a reaction)41
  • Vomiting (named in the label)40
  • Oropharyngeal Pain39
  • Sinusitis (a use or a product term, not a reaction)36
  • Nausea (named in the label)35
  • Asthma34
  • Pruritus (named in the label)34
  • Wheezing33
  • Pain32
  • Erythema31

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

What next?

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