Tramadol + Paracetamol

Tramadol + Paracetamol is evaluated for the following indications with varying evidence strength: Acute pain (evidence tier A), Chronic pain (evidence tier D). See the full indication matrix with dosing and citations above on this page.

Common side effects of Tramadol + Paracetamol (≥ 1 in 100): Nausea, vomiting, Constipation, Drowsiness, dizziness, Dry mouth, Sweating, Headache. See the Safety section for uncommon and serious reactions.

FDA category C. Not first-line in pregnancy. Paracetamol can be used short-term as indicated; tramadol can cause neonatal withdrawal and potentially neonatal seizures. If an opioid is necessary, prefer paracetamol + codeine for a short course or epidural methods.

Single doses are compatible (tramadol RID 2.9%, Hale L3). Long courses and high doses are not recommended – risk of infant sedation, especially in ultra-rapid metabolizer mothers (FDA Safety Communication 2017). Paracetamol – Hale L1, RID 6.4%, fully compatible. Monitor infant for sedation, poor feeding, respiratory depression.

Tramadol + Paracetamol is contraindicated in: Hypersensitivity to tramadol or paracetamol; Acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic drugs; Concomitant or <2-week prior MAOI use; Severe hepatic or renal impairment; Uncontrolled epilepsy. Full list in the Safety section.

FDA Black Box: severe respiratory depression and fatal cases in CYP2D6 ultra-rapid metabolizers (up to 6% of Europeans, up to 35% of North Africans). Contraindicated in children <18 after tonsillectomy/adenoidectomy.