Reboxetine, commonly known as Edronax, is an antidepressant used to treat major depression in adults. However, its use has the potential for many side effects, ranging from mild insomnia and dizziness to severe symptoms like glaucoma and suicidal ideation.

Reboxetine brand names

Reboxetine brand names include Edronax (primarily in English-speaking countries), Irenor and Norebox in Spain, and Davedax in Italy. It’s available as Solvex in Germany, Prolift in several South American countries, and in China, it’s known as Yeluoshu or Zuolexin.[1]

What is reboxetine prescribed for?

Reboxetine is not available or approved for use in the United States. It is, however, approved for use in many European nations to address major depression.

This drug was developed as the first selective norepinephrine reuptake inhibitor (SNRI) in the treatment of depression.[2] Since its introduction in the late 1990s, reboxetine has shown promise in some studies for treating other psychiatric disorders, namely panic disorder and attention-deficit hyperactivity disorder (ADHD).

For example, a 2002 study showed that reboxetine effectively reduced the number of panic attacks and symptoms compared to a placebo. Additionally, patients receiving reboxetine showed improved scores on various clinical assessments, including the Hamilton Rating Scale for Depression, compared to the placebo group.[3]

Additional studies have shown promise for reboxetine as a treatment for ADHD. A 2011 study demonstrated that a twice-daily dose of reboxetine was a well-tolerated and effective treatment for adults with ADHD.[4]

How does reboxetine work?

As noted earlier, reboxetine is a selective norepinephrine reuptake inhibitor (SNRI). It works by binding to norepinephrine transporters in the brain, thereby blocking the reuptake of the neurotransmitter. [5] By preventing this action, the amount of norepinephrine in the brain increases, reducing depressive symptoms. 

Reboxetine has shown the ability to reduce depressive symptoms with minimal drug-drug interactions. Moreover, it works only on specific norepinephrine transmitters while leaving serotonin and dopamine levels unchanged.[6]

Additionally, some clinical studies show that reboxetine does not affect receptors associated with the mild to severe side effects of other antidepressant drugs. This is particularly true for adverse events in the sedative, cardiovascular, and anticholinergic realms.[7] As a result, reboxetine has relatively few significant side effects.

How is reboxetine usually taken?

Edronax is taken orally in tablet form. Each tablet contains 4 mg of the drug. The standard dosage is two daily tablets for a total of 8 mg.[7]

Unlike other antidepressants, there is no need to increase the dosage slowly - the full 8 mg daily dose can begin immediately. If the desired effect isn’t achieved after 3-4 weeks, the dosage might increase to 10 mg daily. The maximum daily dosage is 12 mg for adults.[7]

Edronax can be taken with or without food. However, it’s recommended to take this medication at the same time each day, not because of ill effects, but to improve the patient’s ability to remember to take their pills.

If a dose is forgotten, it can be taken as soon as the patient remembers. However, if a patient remembers the missed dose close to the next time a dosage is needed, the missed dose should be omitted altogether. Never “double up.”

How long does reboxetine stay in your system?

A 4 mg dose of reboxetine absorbs to peak levels approximately two hours after dosing. Its half-life is approximately 13 hours. A steady-state condition is achieved within five days, at which point the amount of drug absorbed matches the amount of drug cleared from the body.[7]

Reboxetine side effects

The reboxetine side effects run the gamut from very common, such as headache, to rare, such as glaucoma.[7] The type of side effects between these extremes ranges widely, too.

Highly common side effects include:

  • Dizziness
  • Insomnia
  • Dry mouth
  • Constipation
  • Nausea

Hyperhidrosis, or excessive sweating, is another common side effect of this drug. There are several less common side effects as well. These include agitation, anxiety, and decreased appetite. Difficulties with the heart, including palpitations, hypertension, and hypotension, are also common, though not to the extent of the reboxetine side effects listed earlier.

Among the most concerning side effects of reboxetine is the potential for aggressive behavior and suicidal ideation, though the potential for these behaviors exists with many antidepressants.[7]

Additionally, as with any drug therapy, you must contact your doctor if you experience side effects, especially if they are severe or rare. If you find that you’re in a dangerous situation (e.g., potential overdose or experiencing suicidal ideation), call 911 immediately.

Reboxetine precautions

Taking reboxetine or any drug requires that you be mindful of precautions to ensure your safety. This begins with a frank conversation with your mental health provider and pharmacist about any substances you’re currently taking. Your doctor and pharmacist should also know what herbal supplements and vitamins you take, as these substances might cause unwanted effects when mixed with reboxetine.

Additionally, tell your doctor if you have any medical or mental health conditions, in particular, if you have glaucoma, heart problems, urinary problems, or bipolar disorder.[7] This is necessary to ensure that reboxetine doesn’t exacerbate your symptoms or cause side effects that worsen your existing conditions.

Given that dizziness and insomnia are highly common reboxetine side effects, take care when driving or operating equipment. Additionally, take precautions if you’re pregnant or breastfeeding, as reboxetine can be passed from the mother to the fetus via the umbilical cord and to an infant through breast milk.[7]

Reboxetine is not recommended for children under the age of 18. Clinical trials show that children are more susceptible to hostility and suicidal ideation than adults when on antidepressants.[7]

Reboxetine interactions

Reboxetine metabolizes via an isozyme called CYP3A4. As such, you should avoid other substances that inhibit this isozyme.[7] This includes:

  • Fluvoxamine, which is a selective serotonin reuptake inhibitor (SSRI) used to treat obsessive-compulsive disorder
  • Azole antifungals, which treat fungal infections
  • Macrolide antibiotics, which treat bacterial infections

Likewise, take care when prescribing reboxetine with CYP3A4 inducers, such as:[7]

  • Rifampicin, an antimycobacterial drug that treats bacterial infections
  • Phenytoin and phenobarbital, both of which are anti-seizure medications
  • Carbamazepine, which treats nerve pain, seizures, and bipolar disorder
  • John’s wort, which has evidence of depressive disorders and other mental health conditions

Reboxetine storage

Keep reboxetine in its original packaging in a cool, dry place away from heat and light. Also, ensure this medication is stored out of sight and out of reach of children.

If reboxetine isn’t stored correctly, you run the risk of reducing its shelf life, which is three years.[7] Furthermore, improper storage of this drug might enable children to accidentally ingest it and cause poisoning.

What to do if you overdose on reboxetine

Very limited studies have shown that reboxetine has relatively mild overdose effects, including anxiety, hypertension, and postural hypotension. These symptoms seem to be especially acute in elderly populations.[7]

Again, in limited studies, a reboxetine overdose is typically not fatal, even when taken with large doses of other substances.[7] Nevertheless, extreme care should always be taken when ingesting medications to minimize the chance of an overdose.

If you or someone you know overdoses on reboxetine, call a physician to get instructions on proper care. If overdose symptoms are severe, get yourself or your loved one to the hospital immediately for observation and treatment.

FAQ's

Why is reboxetine not available in the U.S.?

Reboxetine gained preliminary approval for use in the U.S. by the Federal Drug Administration (FDA) in 1999. However, after the FDA ordered additional clinical testing, the agency tendered a letter of non-approval to reboxetine’s manufacturer in the early 2000s. It’s still unclear why the FDA stopped the development of reboxetine in the U.S.[1]

What alternatives to reboxetine are there?

There are many different antidepressant treatments available that have similar effects on reducing symptoms of depression. These include popular options like other SNRIs (e.g., venlafaxine, duloxetine), tricyclic antidepressants (e.g., clomipramine, dosulepin, imipramine), and SSRIs (e.g., fluoxetine, citalopram, sertraline).[8]

Resources:

  1. Page M. E. (2006). The Promises and Pitfalls of Reboxetine. CNS Drug Reviews, 9(4), 327–342. https://doi.org/10.1111/j.1527-3458.2003.tb00258.x
  2. Hajós, M., Fleishaker, J. C., Filipiak-Reisner, J. K., Brown, M. T., & Wong, E. H. (2006). The Selective Norepinephrine Reuptake Inhibitor Antidepressant Reboxetine: Pharmacological and Clinical Profile. CNS Drug Reviews, 10(1), 23–44. https://doi.org/10.1111/j.1527-3458.2004.tb00002.x
  3. Versiani, M., Cassano, G., Perugi, Gl, Benedetti, A., Mastalli, L., Nardi, A., & Savino, M. (2002). Reboxetine, A Selective Norepinephrine Reuptake Inhibitor, Is an Effective and Well-Tolerated Treatment for Panic Disorder. The Journal of Clinical Psychiatry, 63(1), 31–7. https://doi.org/10.4088/jcp.v63n0107
  4. Riahi, F., Tehrani-Doost, M., Shahrivar, Z., & Alaghband-Rad, J. (2010). Efficacy of reboxetine in adults with attention-deficit/hyperactivity disorder: A randomized, placebo-controlled clinical trial. Human Psychopharmacology: Clinical & Experimental, 25(7-8), 570-576. https://doi.org/10.1002/hup.1158
  5. Page M. E. (2006). The Promises and Pitfalls of Reboxetine. CNS Drug Reviews, 9(4), 327–342. https://doi.org/10.1111/j.1527-3458.2003.tb00258.x
  6. Hajós, M., Fleishaker, J. C., Filipiak-Reisner, J. K., Brown, M. T., & Wong, E. H. (2006). The Selective Norepinephrine Reuptake Inhibitor Antidepressant Reboxetine: Pharmacological and Clinical Profile. CNS Drug Reviews, 10(1), 23–44. https://doi.org/10.1111/j.1527-3458.2004.tb00002.x
  7. Edronax 4mg Tablets – Summary of Product Characteristics (SmPC). (2022, March 18). Pfizer Limited. Retrieved November 7, 2022, from https://www.medicines.org.uk/emc/product/1578/
  8. National Health Service. (2022, February 18). Overview - Antidepressants. Retrieved November 9, 2022, from https://www.nhs.uk/mental-health/talking-therapies-medicine-treatments/medicines-and-psychiatry/antidepressants/overview/