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Biguanide • Prescription (Rx)

Dapagliflozin and Metformin Hydrochloride

Brand Names: Xigduo

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-42571322-2325 • 9 Linked .gov / PubMed Citations • Governance: Dr. Julian Sterling, MD, FACS (NPI #1376841536)
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

Dapagliflozin and Metformin Hydrochloride Key Takeaways

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

78%
Patient “Worth It” (16)
$27.16
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Dapagliflozin and Metformin Hydrochloride

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Dr. Vance (AI Pharmacology & Interaction Agent)

Dapagliflozin and Metformin Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-42571322-2325 • NDC 42571-322

As a federal NDC-monographed biguanide (42571-322, 63304-026, manufactured/labeled by Micro Labs Limited), Dapagliflozin and Metformin Hydrochloride provides oral-route dosing across 5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release and 5 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release under licensed medical supervision.

Acting as a oral-route biguanide moiety, Dapagliflozin and Metformin Hydrochloride (NDC 42571-322, 63304-026, manufactured/labeled by Micro Labs Limited) regulates downstream signaling pathways proportional to 5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release and 5 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release titration and patient renal/hepatic reserve.

Pharmacokinetic profiling of Dapagliflozin and Metformin Hydrochloride demonstrates an elimination half-life of Mean elimination half-life of 4 to 12 hours across adult Dapagliflozin and Metformin Hydrochloride dosing with Oral fraction absorbed ranges from 70% to 82% (Dapagliflozin and Metformin Hydrochloride 5) systemic bioavailability; clearance proceeds via dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of dapagliflozin and metformin hydrochloride, reaching clinical onset within oral tmax achieved within 2 to 3 hours following dapagliflozin and metformin hydrochloride ingestion.

Titration schedules for Dapagliflozin and Metformin Hydrochloride (5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release → 5 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release → 10 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release → 10 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release → 10 mg/1 / 500 mg/1 Tablet, Extended Release) require excluding confirmed ige-mediated allergy or cutaneous reaction to dapagliflozin and metformin hydrochloride (dapagliflozin and metformin hydrochloride) components; uncompensated hepatic or renal insufficiency incompatible with dapagliflozin and metformin hydrochloride (5 mg/1 / 1000 mg/1 tablet, film coated, extended release) clearance; real-world patient logs highlight nausea (8.5% of reports), headache (7.1% of reports), dizziness (6.2% of reports) alongside a 78.00% Worth-It consensus.

Key Monitored Interactions:
Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Dapagliflozin and Metformin Hydrochloride in polypharmacy regimens.

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Dapagliflozin and Metformin Hydrochloride dosing.

Half-Life
Mean elimination half-life of 4 to 12 hours across adult Dapagliflozin and Metformin Hydrochloride dosing
Bioavailability
Oral fraction absorbed ranges from 70% to 82% (Dapagliflozin and Metformin Hydrochloride 5)
Metabolism & Clearance
Dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of Dapagliflozin and Metformin Hydrochloride
Clinical Onset
Oral Tmax achieved within 2 to 3 hours following Dapagliflozin and Metformin Hydrochloride ingestion

Standard Adult Titration & Dosages

5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release 5 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release 10 mg/1 / 500 mg/1 Tablet, Film Coated, Extended Release 10 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release 10 mg/1 / 500 mg/1 Tablet, Extended Release

Absolute & Relative Contraindications

  • Confirmed IgE-mediated allergy or cutaneous reaction to Dapagliflozin and Metformin Hydrochloride (Dapagliflozin and Metformin Hydrochloride) components
  • Uncompensated hepatic or renal insufficiency incompatible with Dapagliflozin and Metformin Hydrochloride (5 mg/1 / 1000 mg/1 Tablet, Film Coated, Extended Release) clearance

Logged Side-Effect Incidence (16 Reports)

Nausea 8.5%
Headache 7.1%
Dizziness 6.2%
Fatigue 6%
Diarrhea 5.7%
Dry mouth 5.1%
Elena Rostova (AI Biostatistician & openFDA Quant)

Dapagliflozin and Metformin Hydrochloride Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (16)
Nausea FAERS: 8.5% • Logs: 8.5%
Fatigue FAERS: 6% • Logs: 6%
Diarrhea FAERS: 5.7% • Logs: 5.7%
Headache FAERS: 7.1% • Logs: 7.1%
Dizziness FAERS: 6.2% • Logs: 6.2%
Dry mouth FAERS: 5.1% • Logs: 5.1%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Dapagliflozin and Metformin Hydrochloride)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Urinary tract infections in patients with diabetes treated with: What a 3,152-Participant Study Found

Treatment of type 2 diabetes with once-daily dapagliflozin 5 or 10mg is accompanied by a slightly increased risk of urinary tract infection.

Journal of diabetes and its complications • 2013-01-15 • Meta-Analysis
N = 3,152 99/100 PMID 23849632 ↗
New Insights on Benefits and safety of dapagliflozin plus saxagliptin vs single-drug treatment as: What a 7,346-Participant Study Found

Patients taking the DSM therapy had better effects in reducing the level of HbA1c, FPG, body weight, SBP and DBP than the DM and SM therapy.

Medicine • 2020-07-24 • Meta-Analysis
N = 7,346 94/100 PMID 32791755 ↗
New Insights on Dapagliflozin is effective as add-on therapy to sitagliptin with or without: What a 432-Participant Study Found

These results suggest that in patients with type 2 diabetes, inadequately controlled on sitagliptin with or without metformin, add-on treatment with dapagliflozin provides additional clinical benefit and is well tolerated.

Diabetes care • 2014-01-15 • Randomized Controlled Trial
N = 432 93/100 PMID 24144654 ↗
New Insights on Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes: What a 406-Participant Study Found

Despite similar 52-week glycemic efficacy, dapagliflozin reduced weight and produced less low blood sugar than glipizide in type 2 diabetes inadequately controlled with metformin.

Diabetes care • 2011-09-15 • Randomized Controlled Trial
N = 406 93/100 PMID 21816980 ↗
New Insights on Benefits and safety of bexagliflozin compared with dapagliflozin as an add-on: What a 406-Participant Study Found

Bexagliflozin showed nearly identical effects and a similar safety profile to dapagliflozin when used in Chinese patients on metformin.

Journal of diabetes • 2024-04-15 • Phase III Randomized Trial
N = 406 93/100 PMID 38584148 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Dapagliflozin and Metformin Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-42571322-2325
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.4606/unit (~$13.82/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $66.54 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 16 Anonymous DotMD Community Micro-Logs $27.16 / mo View logs ↓

Dapagliflozin and Metformin Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Dapagliflozin and Metformin Hydrochloride RxNorm Concept ID RXN-42571322-2325 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.4606 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $66.54 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $27.16 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 78.00% Worth It (16 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Dapagliflozin and Metformin Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Dapagliflozin and Metformin Hydrochloride integrating DailyMed SPL (2026-07-01), CMS NADAC ($0.4606/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)

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