Opioid Analgesic (Weak-Moderate) / SNRI Pregnancy: There is inadequate evidence on the safety of tramadol in human pregnancy and it should not be used in pregnant women. Tramadol crosses the placenta; regular use during pregnancy may cause drug dependence in the foetus, leading to neonatal withdrawal symptoms, and administration during labour may depress respiration in the neonate. Administration to nursing women is not recommended (approximately 0.1% of the maternal dose is excreted in breast milk), although discontinuation of breast-feeding is generally not necessary after a single dose.

Tramadol

Brand names: Zamadol, Tramquel, Tilodol SR

Tramadol is a centrally acting opioid analgesic used for moderate-to-severe pain, combining weak opioid activity with effects on monoamine pathways.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Adults and adolescents above the age of 12 years: usual daily dose 50 to 100 mg (20 to 40 drops), 3 to 4 times a day. For acute pain an initial dose of 100 mg is usually necessary; for pain associated with chronic conditions an initial dose of 50 mg is advised

Route: Oral — the drops should be administered orally and diluted with water before administration, independent of meals

Frequency: Three to four times a day

Max: The SPC (§4.4) refers to a recommended upper daily dose limit of 400 mg — the risk of convulsions may be increased when this is exceeded

eMC SPC for Tramadol 100 mg/ml oral drops, solution. The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient, and the lowest effective dose for analgesia should generally be selected. In children from 12 to 14 years it is recommended to use the lowest dose. When possible in chronic treatment, tramadol dosage should be increased slowly to its final recommended dose (increments every 2 to 3 days) to reduce the incidence of adverse events. Its activity in acute pain is somewhat delayed compared with other analgesics. Before starting, agree a treatment strategy including duration, treatment goals and a plan for ending treatment, in order to minimise the risk of addiction and drug withdrawal syndrome; when therapy is no longer required it may be advisable to taper the dose gradually. Elderly: dose adjustment is not usually necessary up to 75 years without clinically manifest hepatic or renal insufficiency; over 75 years elimination may be prolonged and the dosage interval should be extended if necessary. Paediatric population: not suitable for children below the age of 12 years — clinician to verify paediatric analgesia against a children's formulary.

Dose adjustments

Renal

In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed; prolongation of the dosage intervals should be carefully considered according to the patient's requirements. In cases of severe renal and/or severe hepatic insufficiency Tramadol drops are not recommended.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotropic medicinal products
Patients who are receiving MAO inhibitors or who have taken them within the last 14 days
Epilepsy not adequately controlled by treatment
Use in narcotic withdrawal treatment
Not suitable for children below the age of 12 years (§4.2)

Side effects

Dizziness (very common)
Nausea (very common)
Headache, drowsiness, somnolence (common)
Constipation, dry mouth, vomiting, dyspepsia, abdominal pain (common)
Sweating; fatigue, asthenia, malaise (common)
Serious reactions include respiratory depression, epileptiform convulsions, serotonin syndrome, anaphylaxis and drug dependence

Interactions

MAO inhibitors — contraindicated during treatment or within the last 14 days (§4.3)
Other serotonergic agents — risk of serotonin syndrome, a potentially life-threatening condition; careful observation is advised particularly during initiation and dose escalation, and dose reduction or discontinuation should be considered if it is suspected (§4.4)
CNS depressant drugs — care should be taken because the possibility of respiratory depression cannot be excluded (§4.4)
Medicinal products that lower the seizure threshold — tramadol may increase the seizure risk in patients taking these (§4.4)
Alcohol, hypnotics, analgesics, opioids and other psychotropic medicinal products — acute intoxication with these is a contraindication (§4.3). Note: eMC §4.5 was not captured in the fetched source bundle; the full interactions section must be checked on the SPC.

Clinical monograph

How it works

It is a weak mu-opioid receptor agonist that also inhibits the reuptake of serotonin and noradrenaline, contributing to its analgesic effect.

Prescribing in practice

It lowers the seizure threshold and can cause serotonin syndrome, so use with particular caution alongside antidepressants and other serotonergic or seizure-threshold-lowering drugs.
It is a controlled drug with potential for dependence and misuse, and effect can be unpredictable in poor or ultra-rapid CYP2D6 metabolisers.
Reduce the dose in renal and hepatic impairment and in the elderly, and counsel on drowsiness, nausea and constipation.

Monitoring

Monitor analgesic response, sedation and signs of serotonin toxicity or seizures, and review the ongoing need for treatment to limit dependence.

Counselling the patient

This medicine can cause drowsiness and dizziness, so take care when driving.
Tell your doctor about any antidepressants or other medicines, as combinations can be harmful.
Do not exceed the prescribed dose and avoid alcohol.

Evidence & guidelines

Tramadol is recommended for moderate-to-severe pain as a step on the analgesic ladder in NICE and pain management guidance.

Reference: MHRA Drug Safety Update on Serotonin Syndrome; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways