Tramadol ER
ULTRAM ER
Pronunciation: TRA-ma-doel (UL-tram)
“Ultra-ram Trauma doll”
What it isExtended-release mu-opioid agonist and serotonin-norepinephrine reuptake inhibitor (ULTRAM ER, 2005); around-the-clock chronic pain.
Why this oneOnce-daily delivery is unsuitable for as-needed pain or rapid titration; apparent half-life ~8 h (vs ~6 h IR).
What limits itCYP2D6 inhibition can blunt analgesia while seizures and serotonin toxicity remain. It retains full opioid dependence and respiratory risk.
FDA-approved for
- chronic pain (around-the-clock) (2005)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Management of severe and persistent pain requiring an opioid analgesic and not adequately treated by alternatives | Adults | 100 mg QD (or convert from tramadol IR, rounded down to next lower 100 mg) | Titrate by 100 mg every 5 days to effect | 300 mg/day |
Titration Increase by 100 mg no more often than every 5 days
Renal Not recommended (not studied; limited dose-strength flexibility)
Hepatic Not recommended (not studied; reduced metabolism in cirrhosis; limited dose-strength flexibility)
Maximum 300 mg/day
Instructions
- Swallow capsules whole; do not split, chew, crush, or dissolve
- Once daily; may take without regard to food, in a consistent manner
- Do not exceed 300 mg/day; do not use with other tramadol products
- Do not abruptly discontinue — taper by 10–25% of daily dose every 2–4 weeks
- Discuss access to an opioid overdose reversal agent (e.g., naloxone)
Available strengths
- ER tab 100, 200, 300 mg
- cap 100, 200, 300 mg
- tab 25, 50, 75, 100 mg
- ER cap 100, 200, 300 mg
- sol 5 mg/mL
Contraindications
- Children younger than 12 years of age
- Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days
Cautions
- Addiction, abuse, and misuse
- Life-threatening respiratory depression
- Neonatal opioid withdrawal syndrome
- Serotonin syndrome
- Seizures
- Ultra-rapid metabolism risk in children
- Adrenal insufficiency
- Severe hypotension
- Risk with benzodiazepines/other CNS depressants
- Opioid-induced hyperalgesia and allodynia
Adverse reactions
- Nausea
- Constipation
- Dry mouth
- Somnolence
- Dizziness
- Vomiting
Pregnancy Prolonged use may cause neonatal opioid withdrawal syndrome; not recommended for use during pregnancy
Lactation Tramadol and M1 present in milk; breastfeeding not recommended (risk of excess sedation/respiratory depression, especially in ultra-rapid metabolizers)
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 100 mg | ER tab | 30 qd | $26.83 | not offered |
| 200 mg | ER tab | 30 qd | $37.52 | not offered |
| 300 mg | ER tab | 30 qd | $64.81 | not offered |
Other forms: Tramadol (ULTRAM)
⚠ BOXED WARNINGS
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Risk from concomitant use with benzodiazepines
Classes and tags
Clinical profile
Serotonin and MAOI
Provisional washout figures
Elevating mechanismSRI
Exposure dependenceTherapeutic exposure; severe toxicity requires meaningful MAO-A inhibition
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 ER in the interactive console ↗
