Tramadol
ULTRAM
Pronunciation: TRA-ma-doel (UL-tram)
“Ultra-ram Trauma doll”
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
- pain (1995)
Off-label
- premature ejaculation
FDA label
Read the full label on DailyMed ↗
| 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.
Available strengths
- tab 50, 100 mg
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
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 50 mg | tab | 30 qd | $0.74 | not offered |
| 100 mg | tab | 30 qd | $32.48 | not offered |
Other forms: Tramadol ER (ULTRAM ER)
Generic entry2002
⚠ BOXED WARNINGS
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Ultra-rapid metabolism and death in children
- Risk from concomitant use with benzodiazepines
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityRespiratory depression, dependence and overdose; risk rises sharply with sedatives or impaired clearance.
Serotonin and MAOI
Provisional washout figures
Elevating mechanismSRI
Non-elevating actionNone recorded
Exposure dependenceTherapeutic exposure; severe toxicity requires meaningful MAO-A inhibition
Washout BEFORE an MAOI14 days
Evidence confidenceHigh
InterpretationOpioid with clinically significant SRI activity; dangerous with meaningful MAO-A inhibition. A second SRI generally represents therapeutic duplication/additive adverse effects, not the classic life-threatening interaction.
Active metabolites
Open Tramadol in the interactive console ↗
