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Serotonin and Norepinephrine Reuptake Inhibitor • Prescription (Rx)

Duloxetine Hydrochloride

Brand Names: Duloxetine Delayed-Release, Cymbalta

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-09-29 • RxNorm RxCUI 596926 • 10 Linked .gov / PubMed Citations • Governance: Dr. Hannah Lindqvist, MD, PhD (NPI #1457952647)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Duloxetine Hydrochloride Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

90%
Patient “Worth It” (16)
$5.89
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Duloxetine Hydrochloride

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Dr. Vance (AI Pharmacology & Interaction Agent)

Duloxetine Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 596926 • NDC 33342-160

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 ).

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.

Following administration (20 mg/1 Capsule, Delayed Release Pellets), Duloxetine Hydrochloride achieves F ≈ 75%–87% systemic availability after standard oral Duloxetine Hydrochloride administration bioavailability and time to peak concentration spans 1 to 2 hrs under duloxetine hydrochloride maintenance onset, governed by a 12 hours terminal elimination (Duloxetine Hydrochloride SPL) terminal half-life through duloxetine hydrochloride undergoes cyp2d6/cyp1a2-mediated hepatic metabolism prior to excretion.

Before initiating Duloxetine Hydrochloride at 20 mg/1 Capsule, Delayed Release Pellets, clinical safety checklists rule out documented intolerance or hypersensitivity reaction involving duloxetine hydrochloride (serotonin and norepinephrine reuptake inhibitor); concurrent restricted medications flagged in section 4/7 of the duloxetine hydrochloride dailymed monograph (596926). Logged tolerability patterns center on nausea (9.2% of reports), headache (8.5% of reports), dizziness (6.9% of reports).

CYP450 & Metabolic Pathways: CYP2D6 CYP1A2
Key Monitored Interactions:
CYP2D6 Metabolic Inhibitors & Inducers Moderate

Review concurrent CYP2D6 substrates and inhibitors when titrating Duloxetine Hydrochloride maintenance doses.

Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Duloxetine Hydrochloride (serotonin and norepinephrine reuptake inhibitor).

Half-Life
12 hours terminal elimination (Duloxetine Hydrochloride SPL)
Bioavailability
F ≈ 75%–87% systemic availability after standard oral Duloxetine Hydrochloride administration
Metabolism & Clearance
Duloxetine Hydrochloride undergoes CYP2D6/CYP1A2-mediated hepatic metabolism prior to excretion
Clinical Onset
Time to peak concentration spans 1 to 2 hrs under Duloxetine Hydrochloride maintenance

Standard Adult Titration & Dosages

20 mg/1 Capsule, Delayed Release Pellets 60 mg/1 Capsule, Delayed Release Pellets 40 mg/1 Capsule, Delayed Release Pellets 60 mg/1 Capsule, Delayed Release 20 mg/1 Capsule, Delayed Release

Absolute & Relative Contraindications

  • Documented intolerance or hypersensitivity reaction involving Duloxetine Hydrochloride (serotonin and norepinephrine reuptake inhibitor)
  • Concurrent restricted medications flagged in Section 4/7 of the Duloxetine Hydrochloride DailyMed monograph (596926)

Logged Side-Effect Incidence (16 Reports)

Nausea 9.2%
Headache 8.5%
Dizziness 6.9%
Fatigue 5.2%
Orthostatic hypotension 3.3%
Restlessness 3.2%
Elena Rostova (AI Biostatistician & openFDA Quant)

Duloxetine Hydrochloride Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (16)
Nausea FAERS: 9.2% • Logs: 9.2%
Fatigue FAERS: 5.2% • Logs: 5.2%
Headache FAERS: 8.5% • Logs: 8.5%
Dizziness FAERS: 6.9% • Logs: 6.9%
Restlessness FAERS: 3.2% • Logs: 3.2%
Orthostatic hypotension FAERS: 3.3% • Logs: 3.3%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Duloxetine Hydrochloride)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Efficacy and tolerability of antidepressant drugs in treatment of depression in: What a 6,949-Participant Study Found

A total of 33 RCTs were included in 32 articles, involving 6949 patients.

Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences • 2022-08-01 • Meta-Analysis
N = 6,949 99/100 PMID 37202104 ↗
New Insights on Antidepressants for the treatment of adults with depression in the maintenance: What a 9,384-Participant Study Found

Compared to placebo, venlafaxine was associated with a lower incidence of dizziness, while desvenlafaxine, sertraline, and vortioxetine were associated with a higher incidence of nausea/vomiting.

Molecular psychiatry • 2023-01-15 • Meta-Analysis
N = 9,384 99/100 PMID 36253442 ↗
New Insights on Efficacy of duloxetine for multisite pain in patients with knee pain due to: What a 353-Participant Study Found

These results are consistent with duloxetine enhancing the activity of descending inhibitory pain pathways that are dysfunctional in patients with central sensitization and multisite pain.

Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association • 2021-01-15 • Phase III Randomized Trial
N = 353 93/100 PMID 32245696 ↗
Can This Approach Help? Inside the Latest Research on Efficacy of duloxetine in patients with knee wear-and-tear joint pain or chronic

These results suggest that patients with knee wear-and-tear joint pain who respond well to duloxetine in the first month might experience sustained, long-term pain relief with generally greater quality-of-life improvement than.

Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association • 2022-05-15 • Phase III Randomized Trial
N = 43 88/100 PMID 33958268 ↗
Can This Approach Help? Inside the Latest Research on Fixed dose combination of low dose pregabalin and duloxetine, or pregabalin

Conclusions: A FDC of low doses of pregabalin and duloxetine and high dose of pregabalin single-drug treatment achieved similar pain-relieving with dizziness, and somnolence as the most frequent adverse event.

F1000Research • 2023-01-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 38618021 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Duloxetine Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 596926
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.1120/unit (~$3.36/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $5.89 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $34.50 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 16 Anonymous DotMD Community Micro-Logs $7.50 / mo View logs ↓
Hims & Hers Direct Cash Pharmacy (Licensed Telehealth Cash Program) State-licensed clinician review • ~2d mail fulfillment $49.00/mo program Program details
Sesame Direct Cash-Pay Prescriber Network (Licensed Telehealth Cash Program) State-licensed clinician review • ~1d mail fulfillment $29.00 consult Program details

Duloxetine Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Duloxetine Hydrochloride RxNorm Concept ID 596926 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.1120 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $34.50 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $5.89 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 90.00% Worth It (16 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Duloxetine Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Duloxetine Hydrochloride integrating DailyMed SPL (2025-09-29), CMS NADAC ($0.1120/unit), and 16 Zero-PHI patient logs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Duloxetine Hydrochloride community threads and patient logs by age, biological sex, dosage, and treatment duration.

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Recent Verified Anonymous Patient Micro-Logs (0)