Tramadol
Regulatory sources consulted
- openfda-label-a994e116-d201-47f9-baaf-dd76a84eba7e
- aemps-cima-ft-61784
- ansm-bdpm-rcp-69995434
- PubMed PMID:38641202 ↗
- PubMed PMID:36414224 ↗
- PubMed PMID:39465454 ↗
- PubMed PMID:37005099 ↗
- PubMed PMID:34264611 ↗
- CredibleMeds.org
- OpenFDA · N02AX02
- RxNorm rxcui 10689 ↗
Approved indications
- Management of moderate to severe pain.
- Management of severe and persistent pain that requires an opioid analgesic and for which alternative treatment options are inadequate (extended-release formulations).
- Neuropathic pain (second-line treatment). · off-label
Contraindications
Absolute
- Hypersensitivity to tramadol; acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs.
- Concomitant use of MAO inhibitors or within 2 weeks after their discontinuation.
- Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting.
- Children younger than 12 years of age; post-operative management in children younger than 18 years following tonsillectomy and/or adenoidectomy.
- Severe hepatic impairment; epilepsy not controlled by treatment.
Clinical warnings
- Boxed warning · Addiction, Abuse, and Misuse: Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death. — FDA
- Boxed warning · Life-Threatening Respiratory Depression: Serious respiratory depression may occur, especially during initiation or following a dosage increase. — FDA
- Major warning · Seizure Risk: May induce or increase the risk of seizures, especially with other drugs that lower the seizure threshold. — EMA SPC
- Major warning · Serotonin Syndrome: Risk of life-threatening serotonin syndrome when co-administered with other serotonergic drugs. — FDA
Drug interactions
- HighMonoamine Oxidase Inhibitors (MAOIs)N06A
Mechanism: Increased risk of serotonin syndrome and CNS toxicity due to inhibition of monoamine metabolism.
Recommendation: Contraindicated. Do not use concomitantly or within 2 weeks of discontinuing the MAOI.
FDA labelEMA SPC
- HighCYP2D6 Inhibitors (e.g., Bupropion, Fluoxetine, Paroxetine)N06AX12
Mechanism: Inhibit conversion of tramadol to its active M1 metabolite (more potent), reducing analgesic efficacy and increasing tramadol concentrations (risk of seizures and serotonin syndrome).
Recommendation: Monitor for response and adverse effects. Consider an alternative analgesic or adjust tramadol dose.
FDA label
- HighBenzodiazepines and other CNS depressantsN05BA
Mechanism: Additive CNS depression, which can result in profound sedation, respiratory depression, coma, and death.
Recommendation: Avoid concomitant use. If necessary, use the lowest effective dose for the shortest possible duration and monitor closely.
FDA label Boxed Warning
Adverse events
Common (≥1%)
dizziness · nausea · constipation · headache · somnolence · vomiting · dry mouth
Rare but serious
respiratory depression · serotonin syndrome · seizures · anaphylaxis · adrenal insufficiency · hypoglycemia
Pregnancy and lactation
FDA category: C
Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome. Not recommended during breastfeeding due to potential excretion into breast milk and risk of serious adverse effects in the infant.
Recent literature (PubMed)
Revisión por expertos europeos sobre el manejo del dolor en ancianos. Tramadol se prescribe para dolor moderado a severo, destacando la necesidad de ajustar dosis por función renal y comorbilidades.
Revisión de las guías de dolor neuropático. Las guías francesas de 2020 posicionan al tramadol como tratamiento de segunda línea, a menudo en combinación, debido al riesgo de mal uso.
Revisión sobre el manejo del dolor agudo. Tramadol se considera una opción para dolor agudo severo o refractario tras el fracaso de AINEs y paracetamol, con énfasis en el uso a corto plazo.
Revisión narrativa sobre el tratamiento de la artrosis. Señala que el tramadol es un tratamiento controvertido y las guías recientes ofrecen recomendaciones dispares sobre su uso en esta indicación.
Revisión sobre el alivio del dolor durante el parto. Menciona el tramadol como uno de los agentes farmacológicos sistémicos utilizados, aunque la evidencia sobre su eficacia varía.