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NRI (Selective Noradrenaline Reuptake Inhibitor) Pregnancy: §4.6 verbatim: 'No clinical trial data on exposure to reboxetine during pregnancy are available. However, postmarketing safety data on a very limited number of exposed pregnancies indicate no adverse effects of reboxetine on pregnancy or on the health of the foetus/newborn child. Animal studies in general do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition. Some impairment of growth and development has been noted in rat neonates. Reboxetine should only be used in pregnancy if the potential benefits of treatment to the mother outweigh the possible risks to the developing foetus.' Breast-feeding: 'Reboxetine is known to be excreted in breast milk. The level of active substance transferred in breast milk is anticipated to be very low, however there is insufficient information to exclude a risk to the nursing infant. The use of reboxetine during breast-feeding can be considered if the potential benefits outweigh the risk for the child.' Fertility: no clinical trial data; no effect on fertility parameters in animal studies.

Reboxetine

Brand names: Edronax

Reboxetine is a selective noradrenaline reuptake inhibitor antidepressant used in the treatment of major depression.

Adult dose

Dose: Depression, adults: 4 mg twice a day (b.i.d.), i.e. 8 mg/day orally. §4.2 verbatim: 'The recommended therapeutic dose is 4 mg twice a day (b.i.d.) i.e., 8 mg/day administered orally. The full therapeutic dose can be given upon starting treatment. After 3-4 weeks, this dose can be increased to 10 mg/day in case of incomplete clinical response.'
Route: Oral. §4.2: 'Reboxetine is for oral use.'
Frequency: Twice daily (b.i.d.)
Max: 12 mg/day. §4.2 verbatim: 'The maximum daily dose should not exceed 12 mg/day.'
SCOPE — this is the SPC's adult posology for the product's antidepressant indication, which is this page's primary and only indication. The §4.2 text does not restate the indication wording, but the label's own sections identify it: §4.4 'As with all antidepressants...' and §4.8 'In short-term controlled studies of patients with depression'. TITRATION: the full therapeutic dose (8 mg/day) may be given from the start; increase to 10 mg/day only after 3-4 weeks and only for incomplete clinical response; the ceiling is 12 mg/day. §4.2 also states 'The minimum effective dose has not yet been established.' ELDERLY — reboxetine is NOT recommended. §4.2 verbatim: 'Elderly patients have been studied in clinical trials at doses of 2 mg b.i.d. However, safety and efficacy have not been evaluated in placebo-controlled conditions. Therefore, as for other antidepressants that have not been studied in placebo-controlled conditions, reboxetine cannot be recommended.' Do not read the 2 mg b.i.d. figure as a recommended elderly dose — the label withholds a recommendation. §4.5 was not retrieved (§4.4 truncated before it), so no interactions array is published; §4.4 does state that concomitant MAO-inhibitors (including linezolid and methylene blue) 'should be avoided' and warns of serotonin syndrome — see the monitoring array.

Paediatric dose

Route: Oral
Frequency: Not applicable — not for use under 18 years
Max: Not applicable
NO PAEDIATRIC DOSE IS PUBLISHED — the SPC withholds one. §4.2 verbatim: 'Paediatric population: Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4).' §4.4 verbatim: 'Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.' If treatment under 18 is nevertheless contemplated, it is a specialist child and adolescent psychiatry decision and the dose must be verified against current prescribing references — no figure is derived here.

Dose adjustments

Renal

§4.2 verbatim: 'The starting dose in patients with renal or hepatic impairment should be 2 mg b.i.d which can be increased based on patient tolerance.' No eGFR threshold and no reduced maximum daily dose are stated in the retrieved text.

Hepatic

§4.2 verbatim: 'The starting dose in patients with renal or hepatic impairment should be 2 mg b.i.d which can be increased based on patient tolerance.' No Child-Pugh banding and no reduced maximum daily dose are stated in the retrieved text.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3 verbatim, and this is the whole of §4.3: 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.'
  • Not a §4.3 contraindication but a §4.4 avoidance: 'Concomitant use of MAO-inhibitors (including linezolid (an antibiotic which is a reversible non-selective MAOI) and methylene blue) and reboxetine should be avoided in view of the potential risk (tyramine-like effect) based on their mechanisms of action.'
  • Not a §4.3 contraindication but a §4.4 restriction: not for use in children and adolescents under 18 years
  • Not a §4.3 contraindication but a §4.4 caution: history of convulsive disorders — 'it should be given under close supervision to subjects with a history of convulsive disorders and it must be discontinued if the patient develops seizures'

Side effects

  • Common (§4.8): insomnia, dizziness, decreased appetite, dry mouth, constipation, nausea, hyperhidrosis, accommodation disorder, vertigo, tachycardia, palpitations, vasodilatation, hypotension, sensation of incomplete bladder emptying, urinary tract infection, dysuria, urinary retention, erectile dysfunction, ejaculatory pain, ejaculatory delay, chills, headache, paraesthesia, akathisia, dysgeusia, agitation, anxiety
  • Uncommon (§4.8): mydriasis, hypertension, vomiting, rash, testicular pain
  • Rare (§4.8): glaucoma
  • Frequency not known (§4.8): hyponatraemia, aggressive behaviour, hallucination, suicidal ideation/behaviour, serotonin syndrome, increased intraocular pressure, peripheral coldness, Raynaud's phenomenon, allergic dermatitis, irritability
  • §4.8: 'Cases of suicidal ideation and suicidal behaviours have been reported during reboxetine therapy or early after treatment discontinuation.'
  • §4.8 context: 'In placebo-controlled studies of 8 weeks duration or less, adverse events were reported in approximately 80% of reboxetine-treated patients and in approximately 70% of placebo-treated patients. Discontinuation rates for adverse events were approximately 9% and 5% for reboxetine- and placebo-treated patients, respectively.'
  • ⚠️ INCOMPLETE — the fetched §4.8 is truncated at the source-fetch limit part-way through the gender-difference paragraph; adverse reactions beyond that point were not retrieved.

Monitoring

  • Monitor for the emergence of serotonin syndrome, particularly during treatment initiation and dose increases and when any other serotonergic drug is co-prescribed. §4.4: 'Treatment with reboxetine and any concomitant serotonergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.'
  • Monitor for seizures — discontinue if the patient develops one (§4.4).
  • Monitor for suicidal ideation and behaviour, which have been reported during therapy and early after discontinuation (§4.8).
  • Watch for switches to mania/hypomania (§4.4 flags this; the sentence is cut off by the source-fetch limit, so read the full §4.4 before relying on it).
  • ⚠️ The fetched §4.4 is truncated at the source-fetch limit — cardiac, blood-pressure, urinary and glaucoma precautions that may follow were not retrieved. Read the full SPC at https://www.medicines.org.uk/emc/product/1578/smpc before prescribing.

Clinical monograph

How it works

It selectively inhibits the reuptake of noradrenaline at the presynaptic neuronal membrane, increasing noradrenergic neurotransmission, with little direct effect on serotonin or dopamine reuptake.

Prescribing in practice

  • As with all antidepressants, monitor for suicidal thoughts and clinical worsening, particularly early in treatment and in younger adults.
  • Common effects include insomnia, sweating, dizziness, dry mouth, constipation and urinary hesitancy, the latter warranting caution in prostatic disease.
  • Use caution in cardiac disease, epilepsy and the elderly, and avoid abrupt withdrawal.

Monitoring

Monitor mood, suicidal ideation and tolerability, with attention to blood pressure and urinary symptoms.

Counselling the patient

  • It may take a few weeks before you notice an improvement in mood.
  • Tell your doctor if you have difficulty passing urine or develop a fast heartbeat.
  • Do not stop the medicine suddenly; your doctor will reduce the dose gradually.

Evidence & guidelines

Reboxetine is a licensed antidepressant whose efficacy and place in therapy have been the subject of ongoing evidence review.

Reference: Cochrane Review (Reboxetine for Depression 2010); 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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