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Tramadol: Difference between revisions

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{{MedTemplate
{{MedTemplate
| generic           = Tramadol
| generic           = Tramadol
| brand             = Ultram
| brand             = Ultram (IR), Ultram ER, ConZip ER
| structure         =  
| structure         =
| classes           = Opioid, Analgesic
| classes           = [[:Category:Opioid analgesics|Opioid analgesic (atypical, weak μ-agonist with serotonin/norepinephrine reuptake inhibition)]], [[:Category:Schedule IV controlled substances|Schedule IV controlled substance]], [[:Category:Analgesics|Analgesic]]
| mechanism          = Mu-opioid agonist; serotonin–norepinephrine reuptake inhibitor
| uses              = <vote slug="moderate-severe-pain-use">Moderate to moderately severe pain (FDA)</vote>, <vote slug="chronic-pain-tramadol-use">Chronic pain in opioid-sparing regimens (off-label)</vote>, <vote slug="restless-legs-syndrome-use">Restless legs syndrome (off-label, second-line)</vote>, <vote slug="neuropathic-pain-broad-use">Neuropathic pain (off-label)</vote>
| uses              =  
| starting_dose    = IR: 25-50 mg PO every 4-6 hours as needed, titrate as tolerated. ER: 100 mg PO once daily, titrate by 100 mg every 5 days
| starting_dose     =  
| preparations     = IR tablets 50 mg; ER tablets 100, 200, 300 mg (Ultram ER, ConZip); oral solution 5 mg/mL; combination products with acetaminophen (Ultracet)
| preparations      =  
| fda_max          = 400 mg/day (IR, adult); 300 mg/day (ER); 300 mg/day in elderly >75 years
| fda_max           =  
| pill_id           =
| routes             =  
| routes           = Oral
| onset             =  
| onset             = 30-60 minutes (IR)
| duration           =  
| duration         = 4-6 hours (IR); 24 hours (ER)
| halflife           =
| halflife          = Tramadol 6-7 hours; M1 active metabolite 7-9 hours<ref name="ultram-label">FDA Prescribing Information, Ultram (tramadol hydrochloride), Janssen, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s048lbl.pdf</ref>
| bioavailability    =
| bioavailability   = ~75% (IR, rises with multi-dose administration due to saturable first-pass)<ref name="ultram-label" />
| pregnancy         =  
| pregnancy        = Chronic third-trimester exposure produces neonatal opioid withdrawal syndrome and respiratory depression at delivery.{{citation needed}}
| legal              =  
| legal             = [[USLegal:Schedule IV|Schedule IV controlled substance]] in US (federally scheduled 2014); some states schedule higher<ref name="ultram-label" />
| intro              =
| mechanism         = <vote slug="tramadol-mech-claim">Weak μ-opioid receptor agonist whose major analgesic activity comes from CYP2D6 conversion to O-desmethyltramadol (M1), a ~6-fold more potent μ-agonist. Tramadol also inhibits serotonin and norepinephrine reuptake (the SNRI-like component), which contributes meaningfully to analgesia and distinguishes the agent from traditional opioids. CYP2D6 ultra-rapid metabolizers produce dangerously high M1 levels with risk of fatal respiratory depression, particularly in children; CYP2D6 poor metabolizers get reduced opioid analgesic benefit and rely on the SNRI component.</vote> '''Serotonin syndrome''' risk with SSRIs, SNRIs, MAOIs, and other serotonergic agents. '''Seizure''' risk is dose-dependent and elevated in patients with epilepsy, head trauma, or concurrent serotonergic medicines. CPIC provides CYP2D6 genotype-guided opioid selection guidance<ref name="cpic-opioid-cyp2d6">CPIC Guideline for CYP2D6, OPRM1, and COMT and Opioid Use, 2021. https://cpicpgx.org/guidelines/cpic-guideline-for-codeine-and-cyp2d6/</ref>.
| pharmacokinetics   =  
| pharmacodynamics  =  
| indications        =  
| dosing             =  
| effects            =  
| interactions      = <pharmaInteractions/>
| pregnancy_details  =
| monitoring         =  
| counseling        =  
| anecdotes          =
| seealso            =
| references        =  
}}
}}


== References ==
<references />


[[Category:Opioids]]
[[Category:Opioid analgesics]]
[[Category:Synthetic opioids]]
[[Category:Schedule IV controlled substances]]
[[Category:Analgesics]]
[[Category:Analgesics]]

Latest revision as of 06:31, 23 May 2026

Opioid analgesic (atypical, weak μ-agonist with serotonin/norepinephrine reuptake inhibition), Schedule IV controlled substance, Analgesic
Tramadol
Ultram (IR), Ultram ER, ConZip ER

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Summary
Classes
Opioid analgesic (atypical, weak μ-agonist with serotonin/norepinephrine reuptake inhibition), Schedule IV controlled substance, Analgesic
Common uses
Moderate to moderately severe pain (FDA)0, Chronic pain in opioid-sparing regimens (off-label)0, Restless legs syndrome (off-label, second-line)0, Neuropathic pain (off-label)0
Pharmacy
Starting dose
IR: 25-50 mg PO every 4-6 hours as needed, titrate as tolerated. ER: 100 mg PO once daily, titrate by 100 mg every 5 days
Preparations
IR tablets 50 mg; ER tablets 100, 200, 300 mg (Ultram ER, ConZip); oral solution 5 mg/mL; combination products with acetaminophen (Ultracet)
US FDA Max
400 mg/day (IR, adult); 300 mg/day (ER); 300 mg/day in elderly >75 years
Pharmacology
Routes
Oral
Onset
30-60 minutes (IR)
Duration
4-6 hours (IR); 24 hours (ER)
Half-life
Tramadol 6-7 hours; M1 active metabolite 7-9 hours[2]
Bioavailability
~75% (IR, rises with multi-dose administration due to saturable first-pass)[2]
Pregnancy
Chronic third-trimester exposure produces neonatal opioid withdrawal syndrome and respiratory depression at delivery.[citation needed]
Legal status
Schedule IV controlled substance in US (federally scheduled 2014); some states schedule higher[2]
Purported mechanism
Weak μ-opioid receptor agonist whose major analgesic activity comes from CYP2D6 conversion to O-desmethyltramadol (M1), a ~6-fold more potent μ-agonist. Tramadol also inhibits serotonin and norepinephrine reuptake (the SNRI-like component), which contributes meaningfully to analgesia and distinguishes the agent from traditional opioids. CYP2D6 ultra-rapid metabolizers produce dangerously high M1 levels with risk of fatal respiratory depression, particularly in children; CYP2D6 poor metabolizers get reduced opioid analgesic benefit and rely on the SNRI component.0 Serotonin syndrome risk with SSRIs, SNRIs, MAOIs, and other serotonergic agents. Seizure risk is dose-dependent and elevated in patients with epilepsy, head trauma, or concurrent serotonergic medicines. CPIC provides CYP2D6 genotype-guided opioid selection guidance[1].

References

  1. ↑ CPIC Guideline for CYP2D6, OPRM1, and COMT and Opioid Use, 2021. https://cpicpgx.org/guidelines/cpic-guideline-for-codeine-and-cyp2d6/
  2. ↑ 2.0 2.1 2.2 FDA Prescribing Information, Ultram (tramadol hydrochloride), Janssen, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020281s048lbl.pdf
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