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Opioid Agonist • Prescription (Rx)

Tramadol Hydrochloride

Brand Names: Conzip

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-12-29 • RxNorm RxCUI 1148478 • 9 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

Tramadol Hydrochloride Key Takeaways

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

92%
Patient “Worth It” (5)
$45.34
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Tramadol Hydrochloride Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 1148478 • NDC 68025-071

1 Indications and usage conzip: is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. CONZIP is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.

12.1 Mechanism of Action CONZIP contains tramadol, an opioid agonist, and an inhibitor of reuptake of norepinephrine and serotonin. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to mu-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity of tramadol is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to mu-opioid receptors.

Systemic exposure to Tramadol Hydrochloride reflects Approximately 49% to 61% enteral uptake across labeled Tramadol Hydrochloride strengths absorption kinetics and predominantly hepatic biotransformation with renal elimination of polar tramadol hydrochloride conjugates, sustaining receptor engagement across a Steady-state plasma equilibrium reached over 6–16 hour t½ intervals for Tramadol Hydrochloride half-life window (maximum serum exposure occurs 2–3 hours after tramadol hydrochloride dosing response profile).

Dosing protocols (300 mg/1 Tablet, Extended Release or 200 mg/1 Tablet, Extended Release or 50 mg/1 Tablet, Coated or 100 mg/1 Tablet, Film Coated, Extended Release or 50 mg/1 Tablet, Film Coated) balance efficacy (92.00% patient satisfaction across 5 logs) against nausea (7.8% of reports), headache (6.7% of reports), dizziness (6% of reports), with strict avoidance in history of severe allergic sensitivity to tramadol hydrochloride active moiety or formulation vehicle; acute clinical instability or interacting polypharmacy excluded under 2025-12-29 tramadol hydrochloride labeling.

Key Monitored Interactions:
CNS Depressants, Sedatives & Opioids Major

Synergistic sedative pharmacodynamics between Tramadol Hydrochloride and hypnotic agents elevate fall and respiratory risks.

Overlapping Therapeutic Class Formulations Moderate

Verify medication reconciliation lists so Tramadol Hydrochloride is not inadvertently duplicated with another opioid agonist.

Half-Life
Steady-state plasma equilibrium reached over 6–16 hour t½ intervals for Tramadol Hydrochloride
Bioavailability
Approximately 49% to 61% enteral uptake across labeled Tramadol Hydrochloride strengths
Metabolism & Clearance
Predominantly hepatic biotransformation with renal elimination of polar Tramadol Hydrochloride conjugates
Clinical Onset
Maximum serum exposure occurs 2–3 hours after Tramadol Hydrochloride dosing

Standard Adult Titration & Dosages

300 mg/1 Tablet, Extended Release 200 mg/1 Tablet, Extended Release 50 mg/1 Tablet, Coated 100 mg/1 Tablet, Film Coated, Extended Release 50 mg/1 Tablet, Film Coated

Absolute & Relative Contraindications

  • History of severe allergic sensitivity to Tramadol Hydrochloride active moiety or formulation vehicle
  • Acute clinical instability or interacting polypharmacy excluded under 2025-12-29 Tramadol Hydrochloride labeling

Logged Side-Effect Incidence (5 Reports)

Nausea 7.8%
Headache 6.7%
Dizziness 6%
Orthostatic hypotension 5%
Fatigue 4.8%
Diarrhea 4%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (5)
Nausea FAERS: 7.8% • Logs: 7.8%
Fatigue FAERS: 4.8% • Logs: 4.8%
Diarrhea FAERS: 4% • Logs: 4%
Headache FAERS: 6.7% • Logs: 6.7%
Dizziness FAERS: 6% • Logs: 6%
Orthostatic hypotension FAERS: 5% • Logs: 5%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Efficacy of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute: What a 344-Participant Study Found

This pooled analysis reinforces the efficacy profile of CTC versus tramadol and, given that CTC permits lower daily tramadol dosing and thereby reduces unnecessary opioid use, this highlights its improved benefit/risk profile...

Drugs in R&D • 2024-06-15 • Phase III Randomized Trial
N = 344 93/100 PMID 38874739 ↗
New Insights on Celecoxib-tramadol co-crystal in patients with moderate-to-severe pain following: What a 637-Participant Study Found

Celecoxib-tramadol co-crystal was associated with reduced rescue medication use and an acceptable tolerability profile compared with tramadol or celecoxib alone in adults with acute, moderate-to-severe, postoperative pain.

Pain practice : the official journal of World Institute of Pain • 2024-11-15 • Phase III Randomized Trial
N = 637 93/100 PMID 38956758 ↗
Managing Postoperative pain: Can HSK21542 Make a Real Difference? (What New Research Reveals)

Grade ≥3 treatment-emergent side effects occurred in eight (5.9%) and three (2.3%) patients in the HSK21542 arm of HSK21542-301 and HSK21542-303, respectively.

Nature communications • 2025-05-24 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 40413233 ↗
Can This Approach Help? Inside the Latest Research on Benefits and safety of twice-daily tramadol hydrochloride bilayer

Sustained-release tramadol tablets with an immediate-release component are effective and well tolerated for managing postherpetic neuralgia.

Pain practice : the official journal of World Institute of Pain • 2023-03-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 36478501 ↗
Can This Approach Help? Inside the Latest Research on Benefits and safety of co-crystal of tramadol-celecoxib (CTC) in acute

Although the study did not meet its primary endpoint, CTC 200 mg showed a clinically relevant improvement in overall.

European journal of pain (London, England) • 2022-11-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 35974668 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Tramadol Hydrochloride Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 1148478
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.9096/unit (~$27.29/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $111.08 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 5 Anonymous DotMD Community Micro-Logs $45.34 / mo View logs ↓

Tramadol Hydrochloride Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Tramadol Hydrochloride RxNorm Concept ID 1148478 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.9096 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $111.08 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $45.34 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 92.00% Worth It (5 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Tramadol Hydrochloride Patient Community, Cohort Filters & Dosage Logs

Evidence synthesis for Tramadol Hydrochloride: FDA labeling (2025-12-29, NDC 68025-071), CYP/interaction screening, and public pharmacy acquisition costs.

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

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