Reboxetine

Pronunciation: reh-BOK-seh-teen.

Generic name: reboxetine
Brand names: Edronax, Norebox, Irenor
Drug class: Selective noradrenaline (norepinephrine) reuptake inhibitor (NRI/NARI) antidepressant
Form: Tablet (4 mg)
Route: Oral
Legal status: Prescription-only where authorised. Never approved by the US FDA; not found in the Health Canada Drug Product Database.

Supply Rules Vary

Trade names by country: United Kingdom · Australia · New Zealand

Australia: EDRONAX (4) (3) · Full directory

What reboxetine is and how it works

Reboxetine is a selective noradrenaline reuptake inhibitor (NRI), a type of antidepressant that works differently from the more commonly prescribed SSRIs. It is taken as an oral tablet, prescribed by a doctor, for adults with depressive illness. (1) (2) (6) (7)

Reboxetine is not available in the United States or Canada -- it was never approved by the US FDA and does not appear in Health Canada's drug database. It is authorised and prescribed in the United Kingdom, several other European countries, Australia, and New Zealand under the brand name Edronax (or Norebox/Irenor in Spain).

Mechanism of action: how reboxetine works

Reboxetine is a selective noradrenaline (norepinephrine) reuptake inhibitor with minimal effect on serotonin or dopamine reuptake. It is primarily metabolised by CYP3A4 and has no clinically significant effect on CYP1A2, 2C9, 2C19, or 2E1, and is not itself metabolised by CYP2D6. (1) (2)

What reboxetine is used for

Major depressive illness (acute treatment)

Reboxetine is indicated for the acute treatment of depressive illness/major depression in adults, in the countries where it is authorised (UK, several other EU/EEA countries, Australia, New Zealand). It is not approved in the United States or Canada. (1) (2) (3)

Maintaining clinical improvement

In patients who initially respond to reboxetine, it is also indicated to help maintain that clinical improvement and to help prevent relapse of depressive symptoms. (1) (3)

Before taking reboxetine

Do not take / not appropriate for

Do not take reboxetine if you are hypersensitive to reboxetine or any of the tablet's other ingredients. (all indications) (1) (2)
Do not take reboxetine together with monoamine oxidase inhibitors (MAOIs). At least one verified national label (New Zealand) states this combination is contraindicated outright; MAOIs must be stopped at least 2 weeks before starting reboxetine. (all indications) (1) (2)
Reboxetine is not recommended for use in patients with narrow-angle glaucoma, because it has a weak mydriatic (pupil-widening) effect. (all indications) (2)

Tell your clinician about

Tell your clinician about any history of seizures/convulsive disorders, since reboxetine should be used under close supervision in these patients and stopped if a seizure occurs.
Tell your clinician about any history of bipolar disorder, mania, or hypomania, since antidepressants including reboxetine can trigger a switch to mania/hypomania.
Tell your clinician about any heart disease, high blood pressure, heart failure, recent heart attack, hyperthyroidism, or tendency toward low blood pressure on standing, since reboxetine requires cardiovascular caution in these situations.
Tell your clinician about urinary retention, prostate enlargement, or narrow-angle glaucoma, since close supervision is advised.
Tell your clinician about all other medicines, including MAOIs, other antidepressants, lithium, triptans, tramadol/other opioids, St John's Wort, and any strong CYP3A4 inhibitors (e.g. certain antifungals, macrolide antibiotics) or inducers (e.g. carbamazepine, phenobarbital).
Tell your clinician if you are pregnant, planning pregnancy, or breastfeeding.
Reboxetine is not established as safe or effective in children and adolescents under 18, and is not recommended for this age group.

(1) (2)

How to take reboxetine

Reboxetine tablets are taken by mouth, with or without food.
The usual adult starting and therapeutic dose is 4 mg twice daily (8 mg/day), prescribed by a clinician. The clinical effect is usually seen after about 14 days.
If the response is incomplete after 3-4 weeks, your clinician may adjust the dose upward, up to a maximum of 12 mg/day in most verified labels.
Older adults (over 65) are usually started on a lower dose (2 mg twice daily), which a clinician may increase cautiously if needed.
People with kidney or liver problems are usually started on a lower dose (2 mg twice daily), adjusted by a clinician based on response and tolerance.
Any change in dose, or stopping treatment, should only be done on your clinician's advice.

(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

If a dose is missed, contact your clinician or pharmacist for advice on your specific dosing schedule rather than doubling the next dose. Do not take extra tablets to make up for a missed one without medical advice.

Overdose

Non-fatal overdoses have been reported in patients taking up to 240 mg of reboxetine. A fatal case has occurred when reboxetine was taken together with amitriptyline. Anyone who has taken more than the prescribed dose should seek urgent medical attention or contact emergency/poison-control services immediately; treatment includes cardiac monitoring and supportive care. (1)

Side effects

Reboxetine's side effects are related to its effect on noradrenaline reuptake. In clinical trials, adverse events occurred in about 80% of people taking reboxetine compared with about 70% taking placebo, and about 9% stopped treatment because of side effects.

Dry mouth, constipation, nausea

What to notice: These are among the most frequently reported effects.

What to do: Tell your clinician if these are bothersome or persistent; they can advise on management. (1)

Insomnia, agitation, anxiety, dizziness, headache

What to notice: These nervous-system effects are commonly reported, especially early in treatment.

What to do: Report new or worsening symptoms to your clinician, particularly at the start of treatment or after a dose change. (1)

Tachycardia and palpitations

What to notice: A faster heartbeat or noticeable palpitations may occur.

What to do: Tell your clinician promptly, especially if you have existing heart disease. (1)

Urinary retention or difficulty fully emptying the bladder

What to notice: Reported more often in men (about 31% in trials) than women (about 7%).

What to do: Tell your clinician if you notice difficulty urinating or incomplete bladder emptying. (1)

Erectile dysfunction, ejaculatory delay

What to notice: Sexual side effects have been reported in men.

What to do: Discuss with your clinician if this occurs; they can advise on options. (1)

Signs of serotonin syndrome

What to notice: Confusion or agitation, fast heartbeat, high temperature, sweating, muscle rigidity or twitching, tremor, nausea, vomiting, or diarrhoea, particularly if taking other serotonergic medicines.

What to do: Seek urgent medical attention; treatment with reboxetine and any other serotonergic medicine may need to be stopped immediately by your clinical team. (2)

Seizures

What to notice: A new convulsion or seizure.

What to do: Seek urgent medical attention. Reboxetine must be stopped if a seizure occurs. (1) (2)

New or worsening suicidal thoughts or self-harm

What to notice: Worsening mood, new suicidal thoughts, agitation, or unusual behaviour changes, especially early in treatment or after a dose change.

What to do: Seek medical advice immediately, or contact emergency services if there is immediate risk. Family and caregivers should also watch for these changes. (1) (2)

Serious warnings

Suicidal thoughts and behaviour — high

Symptoms: Worsening depression, new or worsening suicidal thoughts, self-harm, agitation, or unusual behaviour change, especially in the first weeks of treatment or around a dose change.

Action: Patients and caregivers should watch closely for these changes and seek medical advice immediately if they occur. The risk in patients under 18 is higher, and reboxetine is not recommended for this age group. (1) (2)

Serotonin syndrome — emergency

Symptoms: Confusion, agitation, fast heartbeat, unstable blood pressure, high temperature, sweating, muscle rigidity or twitching, tremor, nausea, vomiting, diarrhoea.

Action: This is potentially life-threatening. Seek urgent medical attention. It is more likely with concurrent serotonergic medicines (SSRIs, other SNRIs, triptans, tricyclic/tetracyclic antidepressants, lithium, opioids, tryptophan, buspirone, MAOIs, St John's Wort). (2)

MAOI interaction — emergency

Symptoms: Severe reactions, including serotonin syndrome, have occurred when serotonergic medicines are combined with MAOIs.

Action: MAOIs must be stopped at least 2 weeks before starting reboxetine. Concurrent use with MAOIs is contraindicated in at least one verified national label. (1) (2)

Seizures — high

Symptoms: New convulsions, more likely in patients with a history of convulsive disorders.

Action: Reboxetine should be used under close supervision in patients with a seizure history and must be stopped if a seizure occurs. (1) (2)

Cardiovascular effects (tachycardia, orthostatic hypotension) — moderate

Symptoms: Fast heartbeat, palpitations, dizziness on standing, especially in patients with existing heart disease or at doses above the recommended maximum.

Action: Close supervision is recommended in patients with heart disease, heart failure, hypertension, recent myocardial infarction, or hyperthyroidism. (1) (2)

Interactions

Medicine or test	Effect	Action
Monoamine oxidase inhibitors (MAOIs)	Risk of severe, potentially life-threatening reactions including serotonin syndrome.	MAOIs must be stopped at least 2 weeks before starting reboxetine. Concurrent use is contraindicated per at least one verified national label. (1) (2)
Other serotonergic medicines (SSRIs, other SNRIs, tricyclic/tetracyclic antidepressants, lithium, triptans, opioids, tryptophan, buspirone, St John's Wort)	Increased risk of serotonin syndrome.	Concurrent use should be avoided where possible; if unavoidable, the lowest effective reboxetine dose should be used with close monitoring, per clinician guidance. (2)
Potent CYP3A4 inhibitors (e.g. ketoconazole and other azole antifungals, macrolide antibiotics, fluvoxamine)	Can raise reboxetine plasma levels by roughly 50%, increasing the risk of side effects given reboxetine's narrow therapeutic margin.	Use with caution; a clinician may need to adjust the dose or monitor more closely. (1) (2)
CYP3A4 inducers (e.g. carbamazepine, phenobarbital)	May lower reboxetine plasma levels.	A clinician may need to increase the reboxetine dose if these are used concurrently. (2)
Lithium	Not formally evaluated in trials; no clinically significant effect on lithium clearance is expected, but monitoring is still recommended.	Lithium levels should be monitored if co-administered with reboxetine. (2)
Antihypertensive medicines	May increase the orthostatic hypotension (dizziness on standing) associated with reboxetine.	Use with caution and monitor blood pressure, per clinician guidance. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Reboxetine should be used in pregnancy only if the potential benefit justifies the potential risk, taking into account the risks of untreated depression. Animal studies have not shown clear evidence of a teratogenic effect, but effects on birth weight and skeletal development were seen at high doses. Discuss the balance of risks and benefits with your clinician. (2)

Breastfeeding

There is no human data on reboxetine excretion into breast milk, and it is not recommended during breastfeeding based on animal data showing effects on offspring survival and growth at high doses. (2)

Children and adolescents (under 18)

Reboxetine is not established as safe or effective in children and adolescents and is not recommended for this age group. Pooled data from antidepressant trials show an increased risk of suicidal thinking and behaviour in this age group during early treatment. (1) (2)

Older adults (over 65)

Older adults are usually started on a lower dose (2 mg twice daily) because drug exposure tends to be higher in this group, and they may be increased cautiously by a clinician if needed. Extra caution is advised in those with heart disease. (2)

Kidney or liver problems

A lower starting dose (2 mg twice daily) is usually recommended, increased cautiously based on tolerance and response. (2)

Monitoring

Before starting

Screen for a history of seizures, bipolar disorder/mania, heart disease, hypertension, hyperthyroidism, urinary retention, prostatic hypertrophy, and narrow-angle glaucoma.
Review all other medicines, especially MAOIs (which must be stopped at least 2 weeks beforehand), other serotonergic drugs, and CYP3A4 inhibitors/inducers.
Establish a baseline mental state and suicidality risk assessment, particularly in younger patients.

During treatment

Monitor for worsening depression or emerging suicidality, especially in the first weeks of treatment and after any dose change.
Monitor heart rate and blood pressure, particularly in patients with pre-existing cardiovascular disease.
Watch for signs of serotonin syndrome if other serotonergic medicines are used concurrently.
Monitor for urinary retention symptoms, especially in men.

(1) (2)

Storage

Store below 25 degrees Celsius, protected from light and moisture. Tablets are typically stable for up to 2 years when stored as directed. Refer to the specific product packaging for the exact storage conditions and expiry.

Study the drug class: SNRIs and other antidepressants

Professional information

This is clinician-facing context only. Always refer to the current local product information for dosing, administration, and safety guidance.

UK, EU/EEA, Australia, New Zealand

Indication: Major depressive illness

Dose summary: Adults: 4 mg twice daily (8 mg/day) initially; may increase to 10 mg/day after 3-4 weeks for incomplete response, maximum 12 mg/day in most verified labels. Elderly (>65): 2 mg twice daily (4 mg/day), may increase to 6 mg/day after 3 weeks. Renal/hepatic impairment: start 2 mg twice daily, titrate cautiously.

Renal context: Reduced starting dose (2 mg twice daily) recommended, titrated based on tolerance. (1) (2)

Mechanism of action

Hepatic guidance

Start at a lower dose (2 mg twice daily) in hepatic impairment and titrate cautiously based on tolerance.

Overdose note

Non-fatal overdoses reported up to 240 mg; one fatal case involved co-ingestion with amitriptyline. Manage with cardiac monitoring and supportive care. (1) (2)

Frequently asked questions

Is reboxetine available in the United States?

No. Reboxetine was never approved by the US FDA -- an early review did not result in marketing authorisation, and there is no US product or DailyMed label. It is not marketed or prescribed in the United States. (6)

Is reboxetine available in Canada?

No. Reboxetine does not appear in the Health Canada Drug Product Database under either its ingredient name or the brand name Edronax, based on a direct, live check of Health Canada's own database. (7)

Can I take reboxetine with an MAOI antidepressant?

No. MAOIs must be stopped at least 2 weeks before starting reboxetine, and at least one verified national label states that concurrent use with MAOIs is contraindicated because of the risk of severe reactions, including serotonin syndrome. (1) (2)

Is reboxetine the same as an SSRI?

No. Reboxetine is a selective noradrenaline reuptake inhibitor (NRI), which works mainly on noradrenaline rather than serotonin, unlike SSRIs such as fluoxetine or sertraline. It has a different side-effect profile as a result. (2)

What is the mechanism of action of reboxetine?

What is the generic name of Reboxetine?

The generic name is reboxetine. It is sold under brand names including Edronax, Norebox, Irenor. (1) (2) (3) (5) (6) (7)

What class of drug is reboxetine?

Reboxetine is classed as: Selective noradrenaline (norepinephrine) reuptake inhibitor (NRI/NARI) antidepressant. (1) (2) (3) (5) (6) (7)

References

Edronax 4mg Tablets - Summary of Product Characteristics (SmPC)electronic Medicines Compendium (UK), Pfizer · United Kingdom · accessed 2026-07-31 · source 1
New Zealand Data Sheet - EDRONAX 4 mg Tablet (version pfdedrot10126)Medsafe, New Zealand Medicines and Medical Devices Safety Authority · New Zealand · accessed 2026-07-31 · source 2
Edronax medicine finder entryhealthdirect Australia (Australian Government-funded consumer health information service) · Australia · accessed 2026-07-31 · source 3
EDRONAX reboxetine 4mg (as mesilate) tablet blister pack - ARTG entry 79745Therapeutic Goods Administration · Australia · accessed 2026-07-31 · source 4
List of nationally authorised medicinal products - Active substance: reboxetine (EURD list no. PSUSA/00002615/202504)European Medicines Agency · European Union / EEA · dated 2025-11-27 · accessed 2026-07-31 · source 5
Reboxetine FDA review history summarycross-referenced secondary reporting (no DailyMed/FDA primary source exists to cite directly, because none was ever issued) · United States · accessed 2026-07-31 · source 6
Health Canada Drug Product Database API query results for 'reboxetine' (active ingredient) and 'edronax' (brand name)Health Canada (Drug Product Database, official public API) · Canada · accessed 2026-07-31 · source 7

Brand names by country

Single-ingredient reboxetine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United Kingdom

EDRONAX (1)current regulator label · 4 mg tablet · Pfizer; see current EMC SmPC

Australia

EDRONAX (4) (3)current register product · 4 mg tablet (as reboxetine mesilate) · Pfizer Australia Pty Ltd -- ARTG 79745

New Zealand

EDRONAX (2)current regulator label · 4 mg tablet · See current Medsafe data sheet (version pfdedrot10126)

View brands in additional countries.

European Union / EEA (national authorisations)

EDRONAX (5), NOREBOX (5), IRENOR (5)