Section 06 · Monograph
Tapentadol ER
Reviewed Nov 2026FDA label
Nucynta EROpioid + NE reuptake inhibitor
- Forms
- ER tab: 50, 100, 150, 200, 250mg
- Dose
- DPN: start 50mg BID, titrate to 100-250mg BID (max 500mg/day)
- MOA
- Mu-opioid agonism + norepinephrine reuptake inhibition
Black Box Warning
- Addiction, abuse and misuse
- Life-threatening respiratory depression
- Accidental ingestion, especially by children, can be fatal
- Neonatal opioid withdrawal syndrome with prolonged use in pregnancy
- Concomitant use with benzodiazepines or other CNS depressants may cause profound sedation, respiratory depression, coma and death
Indications
- Pain severe enough to require daily around-the-clock long-term opioid treatmentFDA-labeled
- Neuropathic pain associated with diabetic peripheral neuropathy in adultsFDA-labeled
Mechanism of Action
- Mu-opioid receptor agonism combined with norepinephrine reuptake inhibition
Full Dosing
Adult / usual
- Diabetic peripheral neuropathy: start 50mg twice daily; titrate by 50mg twice daily no more often than every 3 days to an effective dose of 100-250mg twice daily; maximum 500mg/day
- Swallow whole; taper to discontinue
Contraindications
- Significant respiratory depression; acute or severe bronchial asthma
- Known or suspected GI obstruction including paralytic ileus
- MAOI use within 14 days
- Hypersensitivity
Drug Interactions
- MAOIs, SSRIs/SNRIs and tricyclics: serotonin syndrome risk
- Benzodiazepines and alcohol: respiratory depression
- May lower seizure threshold
Adverse Effects
- Nausea, constipation, dizziness, somnolence
- Respiratory depression
- Seizures, serotonin syndrome
- Withdrawal on abrupt discontinuation
Monitoring Parameters
- Pain, function and misuse risk (consider PDMP review)
- Respiratory status
- Naloxone co-prescribing per risk
Pregnancy & Lactation
- Neonatal opioid withdrawal syndrome with prolonged use
- Breastfeeding not recommended