What it isWeak mu-opioid agonist that also inhibits serotonin and norepinephrine reuptake; moderate pain.
Why this oneIts analgesia depends partly on a CYP2D6-generated opioid metabolite, making response unusually variable.
What limits itSeizures, serotonin syndrome and respiratory depression are the traps; CYP2D6 inhibitors can blunt analgesia.
FDA-approved for
Off-label
FDA label
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BOXED WARNING Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion can be fatal; risks with benzodiazepines/CNS depressants; neonatal opioid withdrawal syndrome; ultra-rapid metabolism risk in children.
| FDA dosing | Population | Start | Target | Max |
| Pain (moderate to moderately severe) | Adult | 25 mg QAM, titrate +25 mg q3days to 25 mg QID | 50-100 mg q4-6h PRN after titration | 400 mg/day (300 mg/day if >75 yr) |
Titration Increase every 3 days during titration
Renal CrCl <30 mL/min: dosing interval q12h, max 200 mg/day
Hepatic Severe impairment: 50 mg q12h
Max 400 mg/day (300 mg/day if >75 yr)
Instructions
- Do not use with other tramadol-containing products.
- Do not abruptly discontinue in physically dependent patients - taper gradually.
- Dialysis patients may receive their regular dose on the day of dialysis.
Contraindications
- Children younger than 12 years
- Post-operative management after tonsillectomy/adenoidectomy in children <18 years
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
- Known or suspected GI obstruction, including paralytic ileus
- MAOIs (concurrently or within 14 days) due to risk of serotonin syndrome
Cautions
- Serotonin syndrome (alone or with serotonergic drugs)
- Seizure risk
- Suicide risk - avoid in suicidal/addiction-prone patients
- Adrenal insufficiency
- Respiratory depression in COPD/elderly/cachectic/debilitated
- Severe hypotension
- Opioid-induced hyperalgesia
- Withdrawal on abrupt discontinuation
Adverse reactions
- Dizziness/vertigo
- Nausea
- Constipation
- Headache
- Somnolence
- Vomiting
- Pruritus
Pregnancy Prolonged use may cause neonatal opioid withdrawal syndrome; insufficient data on birth defects
Lactation Breastfeeding not recommended
⚠ BOXED WARNINGS
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Ultra-rapid metabolism and death in children
- Risk from concomitant use with benzodiazepines
Cost, est. cash$10–$300/month
Generic entry2002
Classes and tags
Clinical profile
Therapeutic safety burden3 / 4
Overdose danger4 / 4
Weight-gain liability0 / 4
Sedation liability2 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk2 / 4
Legacy pregnancy categoryC
Defining liabilityRespiratory depression, dependence and overdose; risk rises sharply with sedatives or impaired clearance.
Active metabolites
Mechanism of action: Tramadol ballicule
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Memory aids: mascots and interaction avatars
“Ultra-ram Trauma doll”
Open Tramadol in the interactive console ↗