Skip to main content

What the label lists and what reports show

Cefpodoxime side effects

Cefpodoxime's FDA label lists its adverse reactions in its own words. FAERS holds 976 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 diarrhoea (80 reports).

  • Generic listed

Check it at the source: the cefpodoxime FDA label on DailyMed (effective July 30, 2026, Sandoz Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Clinical Trials Film-coated Tablets (Multiple dose) In clinical trials using multiple doses of cefpodoxime proxetil filmcoated tablets, 4696 patients were treated with the recommended dosages of cefpodoxime (100 to 400 mg Q 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. One-hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity. Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or diarrhea. The percentage of cefpodoxime proxetil-treated patients who discontinued study drug because of adverse events was significantly greater at a dose of 800 mg daily than at a dose of 400 mg daily or at a dose of 200 mg daily. …

Source: FDA drug label, Sandoz Inc, effective July 30, 2026 (SPL set 8519a9d8-7106-4545-bc58-859ee9a6708e), via openFDA; the full label on DailyMed

What do FAERS reports show?

976 reports list cefpodoxime among the medicines taken, each a report of something that happened, not proof the medicine caused it; 107 are coded as a death and 551 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, 13 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

  • Diarrhoea (named in the label)80
  • Pyrexia77
  • Pneumonia (a use or a product term, not a reaction)69
  • Dyspnoea (named in the label)50
  • Fatigue (named in the label)47
  • Cough (named in the label)46
  • Nausea (named in the label)43
  • Death (an outcome recorded in the report)41
  • Vomiting (named in the label)40
  • Pain38
  • Off Label Use (a use or a product term, not a reaction)37
  • Asthenia (named in the label)36
  • Rash (named in the label)35
  • Urinary Tract Infection (a use or a product term, not a reaction)34
  • Headache (named in the label)33
  • Condition Aggravated (a use or a product term, not a reaction)32
  • Drug Ineffective (a use or a product term, not a reaction)30
  • Dizziness (named in the label)29
  • Pruritus (named in the label)29
  • Fall25
  • Anaemia (named in the label)24
  • Dehydration (named in the label)24
  • Drug Hypersensitivity23
  • Weight Decreased23
  • Bladder Transitional Cell Carcinoma21

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

What next?

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