Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Opioid Analgesic (Weak) 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

Brand names: Zydol, Tramacet (combination)

Tramadol is a centrally acting opioid analgesic with additional monoaminergic action, used for moderate-to-severe pain; this page covers its use in older people.

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; for pain associated with chronic conditions an initial dose of 50 mg is advised
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, so the parenteral route shown elsewhere on this page is not supported by this source. || OLDER PEOPLE — the point of this page (SPC §4.2, verbatim): 'Elderly: A dose adjustment is not usually necessary in elderly patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary, the dosage interval is to be extended according to the patient's requirements.' || 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. ... 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. For pain associated with chronic conditions an initial dose of 50 mg is advised. It is recommended, when possible in case of chronic treatment, to slowly increase tramadol dosage to its final recommended dose (with increments every 2 to 3 days) in order to reduce the incidence of adverse events.' || 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): 'When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.' || US CROSS-CHECK (a different, once-daily extended-release TABLET — do not apply its numbers to the oral drops above): 'tramadol hydrochloride extended-release tablets should be used with caution in patients over 65 years of age, and with even greater caution in patients older than 75 years of age'; 'Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid tolerant or when opioids were co-administered with other agents that depress respiration'; 'Titrate the dosage ... slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression'; higher rates of constipation, fatigue, weakness, postural hypotension and dyspepsia were seen in those over 65.

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 that also inhibits reuptake of serotonin and noradrenaline, contributing to analgesia.

Prescribing in practice

  • In older people use cautiously at reduced dose with extended intervals, as they are more susceptible to confusion, sedation, falls, hyponatraemia and constipation, and reduced renal function prolongs exposure.
  • It lowers the seizure threshold and carries a serotonin-syndrome risk with serotonergic drugs such as SSRIs, SNRIs and certain antidepressants and triptans.
  • Like other opioids it can cause dependence and respiratory depression, with additive risk alongside benzodiazepines and other CNS depressants.

Monitoring

Monitor older patients for pain control, sedation, confusion, constipation and signs of serotonin toxicity, and review continued need.

Counselling the patient

  • It can cause drowsiness and dizziness; take care with driving and standing up.
  • Do not combine with alcohol or other sedatives, and report agitation, tremor or a fast heartbeat.

Evidence & guidelines

General prescribing guidance and the SPC highlight tramadol's seizure, serotonergic and CNS risks, supporting cautious reduced-dose use in older adults.

Reference: AGS Beers Criteria 2023; STOPP/START v3; MHRA 2015 (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).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Drugs
Pathways