Tramadol ER

ULTRAM ER

Open Tramadol ER in the interactive console ↗

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 ↗

BOXED WARNING Addiction, abuse, and misuse (overdose and death); life-threatening respiratory depression; accidental ingestion (fatal in children); neonatal opioid withdrawal syndrome; risks from concomitant benzodiazepines/CNS depressants; ultra-rapid metabolism risk in children (contraindicated <12 y and after tonsillectomy/adenoidectomy <18 y); complex CYP3A4/2D6 interactions; REMS.

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)

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)

⚠ BOXED WARNINGS