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Weak Opioid / Serotonin-Noradrenaline Reuptake Inhibitor (Analgesic) Pregnancy: SPC §4.6, verbatim: 'Animal studies with tramadol revealed at very high doses effects on organ development, ossification and neonatal mortality. Teratogenic effects were not observed. Tramadol crosses the placenta. There is inadequate evidence available on the safety of tramadol in human pregnancy. Therefore, Tramadol drops should not be used in pregnant women. Tramadol - administered before or during birth - does not affect uterine contractility. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.' BREAST-FEEDING (§4.6, verbatim): 'Approximately 0.1% of the maternal dose of tramadol is excreted in breast milk. In the immediate post-partum period, for maternal oral daily dosage up to 400 mg, this corresponds to a mean amount of tramadol ingested by breast-fed infants of 3% of the maternal weight-adjusted dosage. Administration to nursing women is not recommended as tramadol may be secreted in breast milk and may cause respiratory depression in the infant. Discontinuation of breast-feeding is generally not necessary following a single dose of tramadol.'

Tramadol (Post-Operative Pain)

Brand names: Tramacet (tramadol/paracetamol combination), Zydol, Tramadol hydrochloride

Tramadol is a centrally acting opioid analgesic used for moderate to severe post-operative pain, available as oral and parenteral preparations.

Adult dose

Dose: 50 to 100 mg (20 to 40 drops of the 100 mg/mL oral solution), 3 to 4 times a day; for acute pain an initial dose of 100 mg is usually necessary
Route: Oral — 100 mg/mL oral drops, solution; the drops are diluted with water before administration, independent of meals
Frequency: 3 to 4 times a day
Max: Maximum recommended upper daily dose limit 400 mg
SCOPE: the only product in this bundle is the 100 mg/mL ORAL DROPS solution, so the figures above are ORAL dosing only. This bundle contains NO IV or IM regimen and no dilution/infusion instruction. || ACUTE / POST-OPERATIVE PAIN — the indication of this page (SPC §4.2, verbatim): 'For acute pain an initial dose of 100 mg is usually necessary. In case TRAMADOL Drops is used for acute pain, it should be stressed that its activity is somewhat delayed in comparison to that of other analgesics.' || VERBATIM SPC §4.2: 'The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. ... 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. In children from 12 to 14 years, it is recommended to use the lowest dose. ... For pain associated with chronic conditions an initial dose of 50 mg is advised.' || CEILING (§4.4, verbatim): 'The risk may be increased when doses of tramadol hydrochloride exceed the recommended upper daily dose limit (400 mg).' || DISCONTINUATION (§4.2, verbatim): 'Before initiating treatment with Tramadol oral drops, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. ... When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.' || NOTE FOR THE REVIEWER: this oral-drops SPC contains no statement for or against use in acute post-operative pain; the US cross-check label is a once-daily extended-release TABLET whose numbers must not be applied to the oral drops above ('Do not exceed a daily dose of 300 mg tramadol' applies to that US product only).

Paediatric dose

Route: Oral — 100 mg/mL oral drops, solution (above 12 years only)
Frequency: 3 to 4 times a day in those above 12 years
Max: Maximum recommended upper daily dose limit 400 mg
SPC §4.2, verbatim: '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. In children from 12 to 14 years, it is recommended to use the lowest dose.' and 'Paediatric population: Tramadol drops is not suitable for children below the age of 12 years.' NO per-kg (mg/kg) paediatric figure appears anywhere in this bundle, so no weight-based dose is published and the weight calculator is deliberately left unfed. US cross-check labelling (extended-release tablets, a different product) contraindicates tramadol in 'all children younger than 12 years of age' and for 'post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy', and advises avoiding it in adolescents 12 to 18 years with other risk factors for respiratory depression. Verify any under-18 dose against a children's formulary before prescribing.

Dose adjustments

Renal

SPC §4.2, verbatim: 'In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patient's 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.' No creatinine-clearance bands or numeric reduced doses are given anywhere in this bundle.

Hepatic

SPC §4.2, verbatim: 'In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patient's 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.' No numeric hepatic dose reduction is given anywhere in this bundle.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients listed in section 6.1 (SPC §4.3)
  • Acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotropic medicinal products (SPC §4.3)
  • Patients who are receiving MAO inhibitors or who have taken them within the last 14 days (SPC §4.3, see §4.5)
  • Patients with epilepsy not adequately controlled by treatment (SPC §4.3)
  • For use in narcotic withdrawal treatment (SPC §4.3)
  • Not a UK contraindication but a US-label contraindication (cross-check, extended-release tablets): 'all children younger than 12 years of age' and 'post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy'; also significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus

Side effects

  • Very common (≥1/10), SPC §4.8: nausea; dizziness — 'The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients'
  • Common (≥1/100 to <1/10): headache, drowsiness, somnolence; constipation, dry mouth, vomiting, dyspepsia, abdominal pain; sweating; fatigue, asthenia, malaise; menopausal symptoms
  • Uncommon (≥1/1000 to <1/100): palpitation, tachycardia, postural hypotension or cardiovascular collapse; anorexia, retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea; dermal reactions (pruritus, rash, urticaria); drug withdrawal syndrome; toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), cross reactivity with non-steroidal anti-inflammatory drugs, allergic reaction
  • Rare (≥1/10 000 to <1/1000): epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope, hypertonia, dysgeusia, paraesthesia, tremor, respiratory depression; delirium, hallucinations, confusion, sleep disturbance, anxiety, nightmares, changes in mood and activity, suicidal ideation; bradycardia, increase in blood pressure; dyspnoea, worsening of asthma; miosis, blurred vision; motorial weakness; micturition disorders (difficulty in passing urine, dysuria and urinary retention); menstrual disorders; weight loss, allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema), anaphylaxis
  • Very rare (<1/10 000): elevated liver enzymes; panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus, CNS symptoms (confusion, delusions, depersonalization, derealization, paranoia)
  • Not known: hypoglycaemia, hyponatraemia; serotonin syndrome; speech disorders; mydriasis; drug dependence — SPC §4.8: 'Repeated use of Tramadol oral drops can lead to drug dependence, even at therapeutic doses'

Monitoring

  • SPC §4.2: 'During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed.'
  • SPC §4.2: 'In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).'
  • Respiratory depression — SPC §4.4: 'Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered ... or if the recommended dosage is significantly exceeded ... as the possibility of respiratory depression cannot be excluded in these situations.'
  • Seizures — SPC §4.4: 'Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol hydrochloride exceed the recommended upper daily dose limit (400 mg).'
  • Serotonin syndrome — SPC §4.4: 'If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose escalations. Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms.'
  • Tolerance, dependence and opioid use disorder — SPC §4.4: 'Before initiating treatment with Tramadol oral drops and during the treatment, treatment goals and a discontinuation plan should be agreed with the patient (see section 4.2).'
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

It is a weak mu-opioid receptor agonist whose active metabolite provides most of the opioid effect, and it additionally inhibits noradrenaline and serotonin reuptake, contributing to analgesia.

Prescribing in practice

  • It can cause respiratory depression and lowers the seizure threshold, so avoid in uncontrolled epilepsy and combine cautiously with other CNS depressants, while its serotonergic action risks serotonin syndrome with SSRIs, SNRIs, MAOIs and other serotonergic drugs.
  • Analgesic response varies with CYP2D6 metaboliser status, giving reduced effect in poor metabolisers and exaggerated opioid effects in ultra-rapid metabolisers.
  • Reduce exposure and lengthen the interval in renal or hepatic impairment and in the elderly, and review the continued need post-operatively to limit dependence.

Monitoring

Monitor pain control, sedation, respiratory rate and bowel function, watching for signs of serotonin toxicity when serotonergic drugs are co-prescribed.

Counselling the patient

  • It can make you drowsy and dizzy, so do not drive until you know how it affects you and avoid alcohol.
  • Report agitation, shivering, twitching, a fast heartbeat, or any difficulty breathing.
  • Use it only as prescribed and do not stop abruptly after prolonged use.

Evidence & guidelines

Tramadol is widely used for post-operative analgesia with efficacy and cautions documented in the SPC and UK pain-management guidance.

Reference: MHRA Drug Safety Update 2013 (tramadol children); RCoA Acute Pain Handbook; 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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