{"id":"ceftibuten","rwe":[{"pmid":"41724364","year":"2026","title":"New-generation antibiotics and nonantibiotic strategies against carbapenemase-producing Enterobacterales: More focus on metallo-β-lactamase producers.","finding":"","journal":"International journal of antimicrobial agents","studyType":"Clinical Study"},{"pmid":"41432447","year":"2026","title":"Exploring the activity of a novel orally bioavailable β-lactam-β-lactamase inhibitor combination, ceftibuten-ledaborbactam, against Enterobacterales-carrying bla(OXA-48).","finding":"","journal":"Microbiology spectrum","studyType":"Clinical Study"},{"pmid":"41117553","year":"2025","title":"Dilution susceptibility testing method evaluation for the combination of ceftibuten and avibactam against Enterobacterales.","finding":"","journal":"Journal of clinical microbiology","studyType":"Clinical Study"},{"pmid":"41050220","year":"2024","title":"ETIOLOGY OF URINARY TRACT INFECTIONS IN NEONATES AND BACTERIAL RESISTANCE IN CROATIA.","finding":"","journal":"Acta clinica Croatica","studyType":"Clinical Study"},{"pmid":"41009847","year":"2025","title":"Human Antimicrobial Use in Bangladesh: Five-Year Trend Analysis Including COVID-19 Pandemic Era.","finding":"","journal":"Antibiotics (Basel, Switzerland)","studyType":"Clinical Study"}],"tags":[{"label":"Cephalosporin Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01DD14","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Suspension","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Acute bacterial bronchitis","category":"indication"},{"label":"Acute otitis media","category":"indication"},{"label":"Haemophilus Influenzae Acute Otitis Media","category":"indication"},{"label":"Haemophilus Influenzae Chronic Bronchitis","category":"indication"},{"label":"Infective otitis media","category":"indication"},{"label":"Moraxella Catarrhalis Acute Otitis Media","category":"indication"},{"label":"Burke Therap","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Nausea","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"1%","severity":"common","organSystem":""},{"effect":"Anorexia","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Dry mouth","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Dysuria","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Eructation","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Flatulence","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Loose stools","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Moniliasis","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Nasal congestion","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Paresthesia","drugRate":"0.5%","severity":"common","organSystem":""},{"effect":"Pruritus","drugRate":"0.5%","severity":"common","organSystem":""}],"contraindications":["Colitis","Impaired renal function disorder","Pseudomembranous enterocolitis"],"specialPopulations":{"Pregnancy":"Ceftibuten was not teratogenic in the pregnant rat at oral doses up to 400 mg/kg/day (approximately 8.6 times the human dose based on mg/m2/day). Ceftibuten was not teratogenic in the pregnant rabbit at oral doses up to 40 mg/kg/day (approximately 1.5 times the human dose based on mg/m2/day) and has revealed no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studi","Geriatric use":"The usual adult dosage recommendation may be followed for patients in this age group. However, these patients should be monitored closely, particularly their renal function, as dosage adjustment may be required.","Paediatric use":"The safety and efficacy of ceftibuten in infants less than months of age has not been established."},"seriousAdverseEvents":[{"effect":"Seizures","drugRate":"","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Stevens-Johnson syndrome","drugRate":"","severity":"serious"},{"effect":"Toxic epidermal necrolysis","drugRate":"","severity":"serious"},{"effect":"Pseudomembranous colitis","drugRate":"","severity":"serious"},{"effect":"Aplastic anemia","drugRate":"","severity":"serious"},{"effect":"Hemolytic anemia","drugRate":"","severity":"serious"},{"effect":"Agranulocytosis","drugRate":"","severity":"serious"},{"effect":"Hepatic cholestasis","drugRate":"","severity":"serious"},{"effect":"Toxic nephropathy","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Burke Therap","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ceftibuten","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:47:54.244718+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ceftibuten","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:48:02.087861+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:48:00.704416+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ceftibuten","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:48:01.480033+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial penicillin-binding protein inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:48:02.087432+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1605/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:48:01.960353+00:00"}},"allNames":"cedax","offLabel":[],"synonyms":["ceftibuten","ceftibuten dihydrate","cedax"],"timeline":[{"date":"1995-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PERNIX THERAP to Burke Therap"},{"date":"1995-12-20","type":"positive","source":"DrugCentral","milestone":"FDA approval (Pernix Therap)"}],"aiSummary":"Cedax (ceftibuten) is a cephalosporin antibacterial drug, a type of small molecule antibiotic. It was originally developed by Pernix Therapeutics and is currently owned by Burke Therapeutics. Cedax is used to treat various bacterial infections, including acute bacterial bronchitis, acute otitis media, and streptococcal tonsillitis. The drug is off-patent and has no active Orange Book patents, allowing for generic manufacturing. Key safety considerations include the potential for allergic reactions and gastrointestinal side effects.","brandName":"Cedax","ecosystem":[{"indication":"Acute bacterial bronchitis","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefixime","slug":"cefixime","company":""}],"globalPrevalence":null},{"indication":"Acute otitis media","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"benzylpenicillin","slug":"benzylpenicillin","company":"Pfizer"},{"name":"cefalexin","slug":"cefalexin","company":"Shionogi Inc"}],"globalPrevalence":null},{"indication":"Haemophilus Influenzae Acute Otitis Media","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefalexin","slug":"cefalexin","company":"Shionogi Inc"}],"globalPrevalence":null},{"indication":"Haemophilus Influenzae Chronic Bronchitis","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefditoren pivoxil","slug":"cefditoren-pivoxil","company":"Vansen Pharma"}],"globalPrevalence":null},{"indication":"Infective otitis media","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Moraxella Catarrhalis Acute Otitis Media","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"cefalexin","slug":"cefalexin","company":"Shionogi Inc"},{"name":"cefixime","slug":"cefixime","company":""}],"globalPrevalence":709000000},{"indication":"Moraxella Catarrhalis Chronic Bronchitis","otherDrugs":[{"name":"cefaclor","slug":"cefaclor","company":""},{"name":"cefditoren pivoxil","slug":"cefditoren-pivoxil","company":"Vansen Pharma"},{"name":"cefprozil","slug":"cefprozil","company":""},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":null},{"indication":"Streptococcal tonsillitis","otherDrugs":[{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"benzylpenicillin","slug":"benzylpenicillin","company":"Pfizer"}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Cephalosporin Antibacterial","explanation":"","oneSentence":"","technicalDetail":"Cedax (ceftibuten) is a second-generation cephalosporin antibiotic that exerts its antibacterial effects by inhibiting the synthesis of the bacterial cell wall through the inhibition of penicillin-binding proteins (PBPs). This results in the disruption of the bacterial cell wall, ultimately leading to cell lysis and death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ceftibuten","title":"Ceftibuten","extract":"Ceftibuten is a third-generation cephalosporin antibiotic. It is an orally administered agent, with two dosage forms, capsule or oral suspension. It is marketed by Pernix Therapeutics under the trade name Cedax."},"commercial":{"launchDate":"1995","_launchSource":"DrugCentral (FDA 1995-12-20, PERNIX THERAP)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/562","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ceftibuten","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ceftibuten","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Ceftibuten","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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