{ "schema_version": 1, "kind": "drug_profile", "generic": "oseltamivir", "review_status": "reviewed", "origin": "openfda", "sections": { "adult": [ { "text": "During emergency situations and when neither the oral suspension or the age-appropriate strengths of oseltamivir phosphate capsules to mix with sweetened liquids are available, then a pharmacist may prepare an emergency supply of oral suspension from oseltamivir phosphate 75 mg capsules [see Dosage and Administration (2.6) ].", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Adults and Adolescents (13 years of age and older) The recommended oral dosage of oseltamivir phosphate capsules for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (one 75 mg capsule or 12.5 mL of oral suspension twice daily) for 5 days.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Adults and Adolescents (13 years of age and older) The recommended dosage of oseltamivir phosphate capsules for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (one 75 mg capsule or 12.5 mL of oral suspension once daily) for at least 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true } ], "child": [ { "text": "Efficacy could not be established in pediatric patients with asthma. 2 weeks to less than 1 year of age: Safety and efficacy in pediatric patients 2 weeks to less than 1 year of age is supported by adequate and well-controlled trials in adults and older pediatric patients and two open-label trials of oseltamivir phosphate capsules (2 to 3.5 mg per kg twice daily for 5 days) in 136 pediatric subjects 2 weeks to less than 1 year of age.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'pediatric use', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Adults and Adolescents (13 years of age and older) The recommended oral dosage of oseltamivir phosphate capsules for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily (one 75 mg capsule or 12.5 mL of oral suspension twice daily) for 5 days.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Adults and Adolescents (13 years of age and older) The recommended dosage of oseltamivir phosphate capsules for prophylaxis of influenza in adults and adolescents 13 years and older is 75 mg orally once daily (one 75 mg capsule or 12.5 mL of oral suspension once daily) for at least 10 days following close contact with an infected individual and up to 6 weeks during a community outbreak.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true } ], "renal": [ { "text": "Adjust the oseltamivir phosphate capsules dosage in patients with moderate or severe renal impairment [see Dosage and Administration (2.4) ].", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Patients from 2 Weeks to less than 1 Year of Age Any weight 3 mg/kg twice daily Not applicable 0.5 mL/kg For patients less than 1 year of age, provide an appropriate dosing device that can accurately measure and administer small volumes.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Dosage modifications are recommended in adults with an estimated creatinine clearance less than or equal to 60 mL per minute [see Use in Specific Population (8.6) and Clinical Pharmacology (12.3) ] .", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true } ], "hepatic": [ { "text": "Oseltamivir phosphate capsules are not recommended for patients with ESRD not undergoing dialysis [see Indications and Usage (1.3) and Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment No dosage adjustment is required in patients with mild to moderate hepatic impairment.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "The safety and pharmacokinetics in patients with severe hepatic impairment have not been evaluated [see Clinical Pharmacology (12.3) ] . 8.8 Use in Patients with Chronic Conditions Efficacy of oseltamivir phosphate capsules in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease was evaluated in one randomized, placebo-controlled clinical trial.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true } ], "pregnancy": [ { "text": "Risk Summary There are no adequate and well-controlled studies with oseltamivir phosphate in pregnant women to inform a drug-associated risk of adverse developmental outcomes.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Available published epidemiological data suggest that oseltamivir phosphate capsules, taken in any trimester, is not associated with an increased risk of birth defects.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "However, these studies individually are limited by small sample sizes, use of different comparison groups, and some lacked information on dose, which preclude a definitive assessment of the risk [see Data and Clinical Pharmacology (12.3) ] .", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true } ], "lactation": [ { "text": "Risk Summary Based on limited published data, oseltamivir and oseltamivir carboxylate have been shown to be present in human milk at low levels considered unlikely to lead to toxicity in the breastfed infant.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "Postmarketing experience has not reported any information to suggest serious adverse effects of oseltamivir exposure via breast milk in infants.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true }, { "text": "It is not known if oseltamivir affects human milk production.", "source": "US FDA label for oseltamivir (Oseltamivir Phosphate), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/oseltamivir.json", "verbatim": true } ] } }