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Quick facts
- How it is given
- oral
- Type
- human prescription drug
- Brand names
- DULOXETINE HYDROCHLORIDE
- RxNorm ID
- 596926
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults (1) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1) Diabetic peripheral neuropathic pain (DPNP) in adults (1) Fibromyalgia (FM) in adults Chronic musculoskeletal pain in adults (1)
About this medicine
Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients: 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide duloxetine-structure
How it works
12.1 Mechanism of Action Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Who should not take it
The use of MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsule or within 5 days of stopping treatment with duloxetine delayed-release capsule is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)]. Starting duloxetine delayed-release capsule in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)]. Concomitant use of an MAOI antidepressant with duloxetine delayed-release capsule is contraindicated Use of duloxetine delayed-release capsule within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid-or intravenous methylene blue-treated patients, initiation of duloxetine delayed-release capsule is contraindicated (4)
Warnings and cautions
Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue duloxetine delayed-release capsule in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease (5.2) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur (5.3) Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also when taken alone. If it occurs, discontinue duloxetine delayed-release capsules (5.4) Increased Risk of Bleeding : May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk (5.5, 7.4, 8.1) Severe Skin Reactions : Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur; Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified (5.6) Activation of Mania or Hypomania : Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania (5.8) Angle-Closure Glaucoma : Has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.9) Seizures : Prescribe with care in patients with a history of seizure disorder (5.10) Blood Pressure Increases : Monitor blood pressure prior to initiating treatment and periodically throughout treatment (5.11) Inhibitors of CYP1A2 or Thioridazine : Avoid co-administration with duloxetine hydrochloride (5.12) Hyponatremia : Can occur in association with SIADH; consider discontinuation(5.13) Glucose Control in Diabetes : In DPNP patients, increases in fasting blood glucose, HbA 1c have been observed (5.14) Conditions that Slow Gastric Emptying : Use cautiously in these patients (5.14) Sexual Dysfunction : Duloxetine delayed-release capsules may cause symptoms of sexual dysfunction (5.16) 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Y […]
Reported side effects
The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3)] Serotonin Syndrome [see Warnings and Precautions (5.4)] Increased Risk of Bleeding [see Warnings and Precautions (5.5)] Severe Skin Reactions [see Warnings and Precautions (5.6)] Discontinuation Syndrome [see Warnings and Precautions (5.7)] Activation of Mania/Hypomania [see Warnings and Precautions (5.8)] Angle-Closure Glaucoma [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Increases in Blood Pressure [see Warnings and Precautions (5.11)] Clinically Important Drug Interactions [see Warnings and Precautions (5.12)] Hyponatremia [see Warnings and Precautions (5.13)] Urinary Hesitation and Retention [see Warnings and Precautions (5.15)] Sexual Dysfunction [see Warnings and Precautions (5.16)] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): (6.1) Adults : nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients : decreased weight, decreased appetite, nausea, vomiting, fatigue, and diarrhea To report SUSPECTED ADVERSE REACTIONS, contact 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 stated frequencies of adverse reactions represent the proportion of patients who experienced, at least once, one treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. […]
Interactions with other medicines
Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potent inhibitors of CYP1A2 should be avoided (7.1). Potent inhibitors of CYP2D6 may increase duloxetine concentrations (7.2). Duloxetine is a moderate inhibitor of CYP2D6 (7.9). 7.1 Inhibitors of CYP1A2 When duloxetine delayed-release capsules 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t 1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions (5.12)] . 7.2 Inhibitors of CYP2D6 Concomitant use of duloxetine delayed-release capsules (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12)] . 7.3 Dual Inhibition of CYP1A2 and CYP2D6 Concomitant administration of duloxetine delayed-release capsules 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and C max . 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are co-administered with warfarin. […]
Use in specific groups
Pregnancy : Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate (8.1) Hepatic Impairment : Avoid use in patients with chronic liver disease or cirrhosis (5.14) Renal Impairment : Avoid use in patients with severe renal impairment, GFR <30 mL/minute (5.14) 8.1 Pregnancy Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data) . There are risks associated with untreated depression and fibromyalgia in pregnancy, and with exposure to SNRIs and SSRIs, including duloxetine delayed-release capsules, during pregnancy (see Clinical Considerations) . In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m 2 basis. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD given to adolescents on a mg/m 2 basis. At this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. Post-weaning growth was not adversely affected. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. […]
If too much is taken
10.1 Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute duloxetine delayed-release capsules overdoses, primarily with mixed overdoses, but also with duloxetine delayed-release capsules only, including 1000 mg of duloxetine delayed-release capsules (approximately 8.3 times the maximum recommended dosage). Signs and symptoms of overdose (duloxetine delayed-release capsules alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting. 10.2 Management of Overdose There is no specific antidote to a duloxetine delayed-release capsules overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose with duloxetine delayed-release capsules, treatment should consist of those general measures employed in the management of overdose with any drug, such as assuring an adequate airway, oxygenation, and ventilation and monitoring cardiac rhythm and vital signs. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Induction of emesis is not recommended. Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease duloxetine AUC and C max by an average of one-third, although some patients had a limited effect of activated charcoal. Due to the large volume of distribution of duloxetine, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial. In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who overdose with duloxetine delayed-release capsules and tricyclic antidepressants. […]
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 22 April 2026. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.