{ "schema_version": 1, "kind": "drug_profile", "generic": "duloxetine", "review_status": "reviewed", "origin": "openfda", "sections": { "adult": [ { "text": "For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "The safety of doses above 120 mg/day has not been adequately evaluated [see Clinical Studies (14.1) ] .", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true } ], "child": [ { "text": "Safety and effectiveness in the pediatric population has not been established [see Boxed Warning and Warnings and Precautions (5.1) ] . Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as Duloxetine Delayed-release Capsules.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'pediatric use', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "2. DOSAGE AND ADMINISTRATION Duloxetine Delayed-release Capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Duloxetine Delayed-release Capsules can be given without regard to meals. • Duloxetine Delayed-release Capsules should generally be administered once daily without regard to meals.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "These effects were observed at the high dose of 45 mg/kg/day; the no-effect-level was 20 mg/kg/day.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'pediatric use', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true } ], "renal": [ { "text": "Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment [see Dosage and Administration (2.3) , Use in Specific Populations (8.10) , and Clinical Pharmacology (12.3) ].", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "Severe Renal Impairment — Duloxetine Delayed-release Capsules are not recommended for patients with end-stage renal disease or severe renal impairment (estimated creatinine clearance <30 mL/min) [see Warnings and Precautions (5.13) and Use in Specific Populations (8.10) ] .", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "Although C max was similar to normals in the cirrhotic patients, the half-life was about 3 times longer [see Dosage and Administration (2.3) and Warnings and Precautions (5.13) ] . 8.10 Severe Renal Impairment Limited data are available on the effects of duloxetine in patients with end-stage renal disease (ESRD).", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true } ], "hepatic": [ { "text": "Chronic Musculoskeletal Pain — The efficacy of Duloxetine Delayed-release Capsules has not been established in placebo-controlled studies beyond 13 weeks. 2.3 Dosing in Special Populations Hepatic Insufficiency — It is recommended that Duloxetine Delayed-release Capsules should ordinarily not be administered to patients with any hepatic insufficiency [see Warnings and Precautions (5.13) and Use in Specific Populations (8.9) ] .", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "Dosage modifications are not recommended for smokers. 8.8 Race No specific pharmacokinetic study was conducted to investigate the effects of race. 8.9 Hepatic Insufficiency Patients with clinically evident hepatic insufficiency have decreased duloxetine metabolism and elimination.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "After a single 20 mg dose of Duloxetine Delayed-release Capsules, 6 cirrhotic patients with moderate liver impairment (Child-Pugh Class B) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (AUC).", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true } ], "pregnancy": [ { "text": "Teratogenic Effects, Pregnancy Category C — In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (7 times the maximum recommended human dose [MRHD, 60 mg/day] and 4 times the human dose of 120 mg/day on a mg/m 2 basis, in rat; 15 times the MRHD and 7 times the human dose of 120 mg/day on a mg/m 2 basis in rabbit).", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "However, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day (2 times the MRHD and ≈1 times the human dose of 120 mg/day on a mg/m 2 basis in rat; 3 times the MRHD and 2 times the human dose of 120 mg/day on a mg/m 2 basis in rabbits).", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true } ], "lactation": [ { "text": "Duloxetine is excreted into the milk of lactating women.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true }, { "text": "Because the safety of duloxetine in infants is not known, nursing while on Duloxetine Delayed-release Capsules is not recommended.", "source": "US FDA label for duloxetine (DULOXETINE DELAYED-RELEASE), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/duloxetine.json", "verbatim": true } ] } }