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What the label lists and what reports show

Cefixime side effects

Cefixime's FDA label: “Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting.” FAERS holds 2,959 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 (168 reports).

  • Generic listed

Check it at the source: the cefixime FDA label on DailyMed (effective August 5, 2026, REMEDYREPACK INC.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting.

From the label: adverse reactions, continued

Most common adverse reactions are gastrointestinal such as diarrhea (16%), nausea (7%), loose stools (6%), abdominal pain (3%), dyspepsia (3%), and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets. …

Source: FDA drug label, NDA203195 (Lupin Ltd), as published by REMEDYREPACK INC., effective August 5, 2026 (SPL set 3194433c-c04e-442b-9668-fbeb0a15bac7), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,959 reports list cefixime among the medicines taken, each a report of something that happened, not proof the medicine caused it; 197 are coded as a death and 1,372 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, 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

  • Drug Ineffective (a use or a product term, not a reaction)288
  • Off Label Use (a use or a product term, not a reaction)278
  • Pyrexia168
  • Diarrhoea (named in the label)165
  • Nausea (named in the label)164
  • Pain154
  • Malaise137
  • Fatigue136
  • Dyspnoea133
  • Headache (named in the label)132
  • Vomiting (named in the label)126
  • Condition Aggravated (a use or a product term, not a reaction)117
  • Abdominal Pain (named in the label)115
  • Asthenia91
  • Constipation89
  • Covid-1989
  • Anaemia (named in the label)88
  • Pneumonia (a use or a product term, not a reaction)87
  • Cough84
  • Arthralgia82
  • Erythema82
  • Febrile Neutropenia81
  • Chest Pain80
  • Pain In Extremity76
  • Back Pain75

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

What next?

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