tramadol

tramadol is evaluated for the following indications with varying evidence strength: Neuropathic pain (evidence tier B), Acute moderate-to-severe pain (evidence tier B), Mild to moderate pain in adults (evidence tier F). See the full indication matrix with dosing and citations above on this page.

Common side effects of tramadol (≥ 1 in 100): Nausea, vomiting, Constipation, Dizziness, sedation, Dry mouth, Sweating, Headache. See the Safety section for uncommon and serious reactions.

FDA categories were retired in 2015 (historically C). Third-trimester exposure is associated with neonatal abstinence syndrome and respiratory depression. Manufacturer label states a contraindication. In pregnancy, prefer paracetamol and non-pharmacological measures.

Transfers into breast milk. In women with CYP2D6 ultra-rapid metabolism, milk concentrations of the active M1 metabolite are high — neonatal respiratory depression has been reported. Manufacturer label advises against breastfeeding.

tramadol is contraindicated in: Acute intoxication with alcohol, hypnotics, opioids, or psychotropics; Concurrent or recent (within 14 days) MAOI; Epilepsy with poor seizure control; Age under 12; Age under 18 after tonsillectomy or adenoidectomy (FDA black box). Full list in the Safety section.

FDA boxed warning: risk of addiction, abuse, life-threatening respiratory depression, and severe sedation when combined with benzodiazepines or alcohol. In children under 12, risk of severe respiratory depression in CYP2D6 ultra-rapid metabolizers. Contraindicated in children under 18 after tonsillectomy or adenoidectomy.

tramadol is an opioid with dependence risk. Schedule IV controlled substance in the US since 2014; restricted prescription in Russia since 2008.

the serotonergic component combined with SSRIs, SNRIs, MAOIs, or triptans risks serotonin syndrome — a severe and potentially lethal state. Such combinations require caution and risk assessment.

in CYP2D6 ultra-rapid metabolizers and when combined with alcohol or benzodiazepines, respiratory depression risk is significant.