{"id":"telithromycin","rwe":[],"tags":[{"label":"Ketolide Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Potassium voltage-gated channel subfamily H member 2","category":"target"},{"label":"KCNH2","category":"gene"},{"label":"J01FA15","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Chlamydial pneumonia","category":"indication"},{"label":"Haemophilus influenzae pneumonia","category":"indication"},{"label":"Moraxella Catarrhalis Pneumonia","category":"indication"},{"label":"Pneumococcal pneumonia","category":"indication"},{"label":"Pneumonia due to Mycoplasma pneumoniae","category":"indication"},{"label":"Streptococcus pyogenes infection","category":"indication"},{"label":"Sanofi Aventis Us","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"drugInteractions":[{"url":"/drug/cyp3a4-substrates","drug":"CYP3A4 Substrates","action":"Use caution","effect":"Strong CYP3A4 Inhibitors - CYP3A4 Substrates","source":"DrugCentral","drugSlug":"cyp3a4-substrates"},{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"},{"url":"/drug/alfentanil","drug":"alfentanil","action":"Avoid combination","effect":"May interact with Alfentanil","source":"DrugCentral","drugSlug":"alfentanil"},{"url":"/drug/alfuzosin","drug":"alfuzosin","action":"Monitor closely","effect":"May interact with Alfuzosin","source":"DrugCentral","drugSlug":"alfuzosin"},{"url":"/drug/conivaptan","drug":"conivaptan","action":"Avoid combination","effect":"May interact with Conivaptan","source":"DrugCentral","drugSlug":"conivaptan"},{"url":"/drug/dasatinib","drug":"dasatinib","action":"Monitor closely","effect":"May interact with Dasatinib","source":"DrugCentral","drugSlug":"dasatinib"},{"url":"/drug/diltiazem","drug":"diltiazem","action":"Monitor closely","effect":"May interact with Diltiazem","source":"DrugCentral","drugSlug":"diltiazem"},{"url":"/drug/fentanyl","drug":"fentanyl","action":"Avoid combination","effect":"May interact with Fentanyl","source":"DrugCentral","drugSlug":"fentanyl"},{"url":"/drug/isradipine","drug":"isradipine","action":"Monitor closely","effect":"May interact with Isradipine","source":"DrugCentral","drugSlug":"isradipine"},{"url":"/drug/itraconazole","drug":"itraconazole","action":"Monitor closely","effect":"May interact with Itraconazole","source":"DrugCentral","drugSlug":"itraconazole"},{"url":"/drug/ketoconazole","drug":"ketoconazole","action":"Monitor closely","effect":"May interact with Ketoconazole","source":"DrugCentral","drugSlug":"ketoconazole"},{"url":"/drug/nicardipine","drug":"nicardipine","action":"Monitor closely","effect":"May interact with Nicardipine","source":"DrugCentral","drugSlug":"nicardipine"},{"url":"/drug/nilotinib","drug":"nilotinib","action":"Monitor closely","effect":"May interact with Nilotinib","source":"DrugCentral","drugSlug":"nilotinib"},{"url":"/drug/nimodipine","drug":"nimodipine","action":"Monitor closely","effect":"May interact with Nimodipine","source":"DrugCentral","drugSlug":"nimodipine"},{"url":"/drug/pazopanib","drug":"pazopanib","action":"Monitor closely","effect":"May interact with Pazopanib","source":"DrugCentral","drugSlug":"pazopanib"},{"url":"/drug/tamsulosin","drug":"tamsulosin","action":"Monitor closely","effect":"May interact with Tamsulosin 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Pregnancy Category C. Telithromycin was not teratogenic in the rat or rabbit. Reproduction studies have been performed in rats and rabbits, with effect on pre-post natal development studied in the rat. At doses estimated to be 1.8 times (900 mg/m2) and 0.49 times (240 mg/m2) the daily human dose of 800 mg (492 mg/m2) in the rat and rabbit, respectively, no evidence of fetal terata was found. At doses higher than the 900 mg/m2 and 240 mg/m2 in rats and rabbits, respectively, respe","Geriatric use":"In all Phase III clinical trials (n=4,780), KETEK was administered to 694 patients who were 65 years and older, including 231 patients who were 75 years and older. Efficacy and safety in elderly patients >= 65 years were generally similar to that observed in younger patients; however, greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is required based on age alone.","Paediatric use":"The safety and effectiveness of KETEK in pediatric patients has not been established."},"seriousAdverseEvents":[{"effect":"Hepatotoxicity (severe/fatal)","drugRate":"","severity":"serious"},{"effect":"Fulminant hepatitis","drugRate":"","severity":"serious"},{"effect":"Hepatic necrosis","drugRate":"","severity":"serious"},{"effect":"Hepatic failure","drugRate":"","severity":"serious"},{"effect":"Hepatitis","drugRate":"0.07%","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Angioedema","drugRate":"","severity":"serious"},{"effect":"Pancreatitis","drugRate":"","severity":"serious"},{"effect":"Atrial arrhythmias","drugRate":"","severity":"serious"},{"effect":"Erythema multiforme","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Sanofi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TELITHROMYCIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:37:22.961401+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:37:28.854906+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TELITHROMYCIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:37:29.173843+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial 70S ribosome inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:37:30.415270+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1136/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:37:29.958366+00:00"}},"allNames":"ketek","offLabel":[],"synonyms":["HMR3647","HMR-3647","RU-66647","RU 66647","HMR 3647","telithromycin","Ketek"],"timeline":[{"date":"2004-04-01","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sanofi Aventis Us)"}],"aiSummary":"Ketek (Telithromycin) is a ketolide antibacterial drug developed by Sanofi Aventis US, targeting the potassium voltage-gated channel subfamily H member 2. It was approved by the FDA in 2004 for various bacterial infections, including pneumonia and tonsillitis. As a small molecule, Ketek works by inhibiting bacterial protein synthesis, making it difficult for bacteria to multiply. Currently, Ketek is off-patent with no active Orange Book patents, but it is still owned by Sanofi Aventis US. Key safety considerations include its potential to cause liver damage and interact with other medications.","approvals":[{"date":"2004-04-01","orphan":false,"company":"SANOFI AVENTIS US","regulator":"FDA"}],"brandName":"Ketek","ecosystem":[{"indication":"Chlamydial pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"azithromycin","slug":"azithromycin","company":""},{"name":"clarithromycin","slug":"clarithromycin","company":"Abbvie"},{"name":"erythromycin","slug":"erythromycin","company":"Arbor Pharms Llc"}],"globalPrevalence":null},{"indication":"Haemophilus influenzae pneumonia","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"azithromycin","slug":"azithromycin","company":""}],"globalPrevalence":null},{"indication":"Moraxella Catarrhalis 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