Opioid Analgesic (Weak) / SNRI Pregnancy: Tramadol drops should not be used in pregnant women - there is inadequate evidence on safety in human pregnancy and tramadol crosses the placenta. Regular use during pregnancy may cause drug dependence in the fetus leading to neonatal withdrawal symptoms, and administration during labour may depress respiration in the neonate (an antidote for the child should be readily available). Administration to nursing women is not recommended as tramadol may be secreted in breast milk and cause respiratory depression in the infant (about 0.1% of the maternal dose is excreted in breast milk); discontinuation of breast-feeding is generally not necessary following a single dose.

Tramadol 50–100mg

Brand names: Zamadol, Zydol, Mabron (MR)

Tramadol is a centrally acting opioid analgesic used here for moderate-to-severe acute pain following orthopaedic injury or surgery, often as a step beyond simple analgesics.

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: 50 to 100 mg (20 to 40 drops of the 100 mg/mL oral drops solution)

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

Frequency: 3 to 4 times a day (adults and adolescents above the age of 12 years)

Max: SPC section 4.4 states that the risk of convulsions may be increased when doses of tramadol hydrochloride exceed the recommended upper daily dose limit of 400 mg

Quoted exactly as the SPC words it: 'Adults and adolescents above the age of 12 years: The usual daily dose is 50 to 100 mg (20 to 40 drops), 3 to 4 times a day.' 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. For acute pain an initial dose of 100 mg is usually necessary (its activity is somewhat delayed compared with other analgesics); for pain associated with chronic conditions an initial dose of 50 mg is advised, and in chronic treatment the dose should be increased slowly to the final recommended dose with increments every 2 to 3 days to reduce adverse events. In children from 12 to 14 years, it is recommended to use the lowest dose. Elderly: dose adjustment is not usually necessary up to 75 years without clinically manifest hepatic or renal insufficiency; in patients over 75 years elimination may be prolonged so the dosage interval should be extended if necessary. Before starting, agree a treatment strategy including duration, goals and a plan for ending treatment; taper gradually on stopping to prevent withdrawal symptoms. Paediatric: the SPC states 'Tramadol drops is not suitable for children below the age of 12 years' — no per-kg paediatric dose is given. Product basis is the 100 mg/mL oral drops presentation; other tramadol formulations (capsules, modified-release tablets, solution for injection) have their own SPCs and different posology, so this record should not be used for a parenteral tramadol dose.

Dose adjustments

Renal

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

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
Patients with epilepsy not adequately controlled by treatment
Use in narcotic withdrawal treatment

Side effects

Nausea and dizziness (very common, both occurring in more than 10% of patients)
Headache, drowsiness, somnolence (common)
Constipation, dry mouth, vomiting, dyspepsia, abdominal pain, sweating, fatigue, asthenia, malaise (common)
Palpitation, tachycardia, postural hypotension or cardiovascular collapse (uncommon); dermal reactions - pruritus, rash, urticaria (uncommon)
Respiratory depression, epileptiform convulsions, serotonin syndrome, drug dependence and drug withdrawal syndrome

Interactions

Contraindicated in patients receiving MAO inhibitors or who have taken them within the last 14 days
Care should be taken with concomitant CNS depressant drugs, or in patients with respiratory depression, as the possibility of respiratory depression cannot be excluded
Tramadol may increase the seizure risk in patients taking other medicinal products that lower the seizure threshold
Serotonin syndrome, a potentially life-threatening condition, has been reported with tramadol combined with other serotonergic agents (and with tramadol alone) - observe carefully during initiation and dose escalation and consider dose reduction or discontinuation if suspected
(US labelling) CYP2D6 inhibitors alter tramadol and M1 exposure, which may reduce therapeutic effect, precipitate opioid withdrawal, or increase the risk of seizures and serotonin syndrome

Clinical monograph

How it works

It is a weak mu-opioid receptor agonist whose activity is augmented by inhibition of noradrenaline and serotonin reuptake, giving a dual analgesic mechanism.

Prescribing in practice

Lowers the seizure threshold and carries a meaningful serotonin syndrome risk, so avoid combining with other serotonergic agents and use cautiously in patients with epilepsy or head injury.
Analgesic response varies with CYP2D6 metaboliser status, and the combination of opioid and monoaminergic effects means respiratory depression and dependence remain possible.
Use the lowest effective dose for the shortest period, reassess regularly, and consider step-down to non-opioid analgesia as the injury settles.

Monitoring

Monitor pain scores, sedation and respiratory rate, and watch for signs of serotonin toxicity or dependence with continued use.

Counselling the patient

May cause drowsiness and dizziness, so avoid driving until you know how it affects you.
Do not take with other sedatives or alcohol, and report any agitation, tremor or confusion promptly.
Take only as prescribed and do not stop abruptly after prolonged use.

Evidence & guidelines

Tramadol is an established option in stepwise acute pain management, and MHRA advice reflects its seizure, serotonin and dependence risks.

Reference: NICE NG59 (Low Back Pain); WHO Analgesic Ladder; MHRA Drug Safety Update (tramadol in children); 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