Brintellix (Vortioxetine)
Multimodal antidepressant for major depressive disorder in adults
Quick Facts About Brintellix
Key Takeaways About Brintellix
- Multimodal antidepressant: Brintellix works through a unique mechanism combining serotonin reuptake inhibition with direct activity at multiple serotonin receptors, distinguishing it from traditional SSRIs and SNRIs
- Proven effective for depression: Clinical trials demonstrate significant improvement in depressive symptoms, cognitive function, and overall functioning in adults with major depressive disorder
- Takes time to work: Allow at least 2–4 weeks for initial effects; continue treatment for a minimum of 6 months after symptom improvement to reduce relapse risk
- Nausea is the most common side effect: Usually mild, occurs in the first two weeks, and is generally transient; taking the tablet with food may help
- Do not stop abruptly: Gradual dose reduction under medical supervision is essential to avoid discontinuation symptoms such as dizziness, headache, and electric shock sensations
What Is Brintellix and What Is It Used For?
Brintellix contains the active substance vortioxetine, a multimodal antidepressant that acts on multiple serotonin targets in the brain. It is approved for the treatment of major depressive disorder (MDD) in adults and has been shown to reduce a broad range of depressive symptoms including low mood, anxiety, sleep disturbances, and difficulty concentrating.
Brintellix belongs to a class of medications commonly referred to as serotonin modulators and stimulators (SMS). Unlike traditional selective serotonin reuptake inhibitors (SSRIs), vortioxetine has a multimodal mechanism of action: it inhibits the serotonin transporter (SERT) while also directly modulating several serotonin receptor subtypes. Specifically, it acts as an antagonist at 5-HT3, 5-HT7, and 5-HT1D receptors, a partial agonist at 5-HT1B receptors, and a full agonist at 5-HT1A receptors.
This multimodal activity is believed to result in enhanced release of several neurotransmitters beyond serotonin, including noradrenaline, dopamine, acetylcholine, and histamine in certain brain regions. This broader neurochemical effect may contribute to its antidepressant and pro-cognitive properties. Clinical studies have demonstrated that vortioxetine improves not only core depressive symptoms but also cognitive function, including processing speed, executive function, and memory.
Major depressive disorder is one of the most common mental health conditions worldwide, affecting an estimated 280 million people globally according to the World Health Organization. It is characterized by persistent feelings of sadness, loss of interest or pleasure, disturbed sleep, changes in appetite, fatigue, difficulty concentrating, feelings of worthlessness or guilt, and in severe cases, thoughts of death or suicide. Brintellix addresses many of these symptoms through its broad pharmacological profile.
Brintellix was first approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in 2013. It is manufactured by H. Lundbeck A/S, a Danish pharmaceutical company specializing in brain diseases. The medication is available as film-coated tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, intended for once-daily oral administration.
Brintellix has shown particular benefit in improving cognitive symptoms of depression, such as difficulty concentrating, problems with memory, and slowed thinking. This is an area where it may offer advantages over some other antidepressants, as cognitive dysfunction often persists even after mood symptoms improve.
What Should You Know Before Taking Brintellix?
Before starting Brintellix, your doctor needs to know about all other medications you take, your medical history (especially seizures, bleeding disorders, or glaucoma), and whether you are pregnant or breastfeeding. Brintellix must not be taken with MAO inhibitors, and special caution is needed in young adults due to an increased risk of suicidal thoughts.
Contraindications
You must not take Brintellix if you are allergic to vortioxetine or any of the other ingredients in the tablet. More critically, Brintellix must not be used together with monoamine oxidase inhibitors (MAOIs), including non-selective MAOIs (such as phenelzine, tranylcypromine, and isocarboxazid) and selective MAO-A inhibitors (such as moclobemide). The combination can cause a dangerous condition called serotonin syndrome. If you have been taking an MAOI, you must wait at least 14 days after stopping it before starting Brintellix. Similarly, after stopping Brintellix, you must wait 14 days before starting an MAOI.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Brintellix if any of the following apply to you:
- Serotonergic medications: If you take other drugs that increase serotonin levels (such as tramadol, triptans for migraine, lithium, or tryptophan), the combination may increase the risk of serotonin syndrome. Symptoms include hallucinations, involuntary muscle twitching, rapid heartbeat, high blood pressure, fever, nausea, and diarrhea.
- Seizure history: If you have ever had seizures (convulsions) or have epilepsy, your doctor should monitor you carefully. Seizures are a potential risk with antidepressant treatment, and Brintellix should be discontinued if new seizures occur or seizure frequency increases.
- Mania: If you have a history of manic episodes, inform your doctor before starting treatment.
- Bleeding tendency: If you bruise easily, have a bleeding disorder, or take blood-thinning medications such as warfarin, aspirin, or NSAIDs, there may be an increased risk of bleeding.
- Low sodium levels: Antidepressants including vortioxetine can cause a condition called hyponatremia, particularly in elderly patients or those taking diuretics.
- Age 65 or older: The recommended starting dose is lower (5 mg daily) for elderly patients, and caution is needed regarding the risk of falls and hyponatremia.
- Severe kidney or liver disease: Dose adjustments may be necessary, and extra monitoring is recommended.
- Glaucoma or elevated eye pressure: Vortioxetine may cause pupil dilation (mydriasis), which can raise intraocular pressure. Contact your doctor immediately if you develop eye pain or blurred vision during treatment.
You may also experience feelings such as aggression, agitation, anger, and irritability while being treated with antidepressant medications including vortioxetine. If this occurs, speak to your doctor promptly.
If you are depressed or experience anxiety, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when starting antidepressant treatment, as it typically takes about 2 weeks or longer before the medication takes effect. Young adults (under 25 years) with psychiatric conditions treated with antidepressants have an increased risk of suicidal thoughts and self-harm. Contact your doctor or seek emergency medical care immediately if you have thoughts of harming yourself. Tell a relative or close friend about your depression and ask them to read this information.
Children and Adolescents
Brintellix is not recommended for children and adolescents under 18 years of age because efficacy has not been established in this population. Safety data from studies in children and adolescents aged 7 to 17 years showed that side effects were similar to those seen in adults, except that abdominal pain-related events were observed more frequently, and suicidal ideation was observed more frequently in adolescents than in adults.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking Brintellix. The medication should generally not be used during pregnancy unless your doctor considers it absolutely necessary after carefully weighing the benefits against the risks.
If you take Brintellix during the last three months of pregnancy, be aware that the following symptoms may occur in your newborn: breathing difficulties, bluish skin, seizures, difficulty regulating body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremors, jitteriness, irritability, lethargy, persistent crying, excessive sleepiness, and difficulty sleeping. Contact your doctor or midwife immediately if your baby develops any of these symptoms.
Taking medications like Brintellix during pregnancy, particularly during the last three months, may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. Symptoms usually appear within 24 hours of birth. Additionally, if you take Brintellix toward the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders.
A small amount of Brintellix passes into breast milk, but no harmful drug-related effects have been observed in infants in available data. However, Brintellix is generally not recommended during breastfeeding. Your doctor will help you decide whether to stop breastfeeding or stop the medication, considering the benefit of breastfeeding to your child and the benefit of treatment to you.
Driving and Operating Machinery
Brintellix has no or negligible effect on the ability to drive or use machines. However, since side effects such as dizziness have been reported, you should exercise caution when driving or operating machinery, especially at the start of treatment or when the dose is changed.
How Does Brintellix Interact with Other Drugs?
Brintellix has clinically significant interactions with several drug classes. The most dangerous interaction is with MAO inhibitors, which can cause life-threatening serotonin syndrome. Other important interactions include serotonergic drugs, anticoagulants, CYP enzyme inhibitors and inducers, and drugs that lower the seizure threshold.
Always inform your doctor about all medications you are currently taking, have recently taken, or might take. Drug interactions with Brintellix can affect the safety and effectiveness of your treatment. The following tables summarize the most important known interactions.
Major Interactions
| Drug / Drug Class | Risk | Action Required |
|---|---|---|
| Non-selective MAOIs (phenelzine, tranylcypromine, isocarboxazid) | Life-threatening serotonin syndrome | Contraindicated. Wait 14 days between stopping one and starting the other. |
| Selective MAO-A inhibitors (moclobemide) | Serotonin syndrome | Contraindicated. Do not use together. |
| MAO-B inhibitors (selegiline, rasagiline) | Increased serotonergic activity | Use with caution. Monitor for serotonin syndrome symptoms. |
| Linezolid (antibiotic) | MAO inhibition – serotonin syndrome risk | Avoid combination. If necessary, use with extreme caution and close monitoring. |
| Serotonergic drugs (tramadol, triptans, lithium, tryptophan, St. John’s wort) | Serotonin syndrome | Use with caution. Monitor for symptoms. Inform your doctor immediately if symptoms occur. |
Other Important Interactions
| Drug / Drug Class | Effect | Action Required |
|---|---|---|
| Warfarin, dipyridamol, NSAIDs, low-dose aspirin | Increased bleeding risk | Monitor for signs of bleeding. Use with caution. |
| Rifampicin, carbamazepine, phenytoin (CYP inducers) | Decreased vortioxetine levels | Dose increase of vortioxetine may be needed. Consult your doctor. |
| Bupropion, fluoxetine, paroxetine, quinidine (CYP2D6 inhibitors) | Increased vortioxetine levels | Dose reduction of vortioxetine may be needed. |
| Drugs that lower seizure threshold (tramadol, mefloquine, bupropion, triptans, antipsychotics) | Increased seizure risk | Use with caution. Inform your doctor about all medications. |
| Drugs that lower sodium levels (diuretics, desmopressin) | Increased risk of hyponatremia | Monitor sodium levels, especially in elderly patients. |
If you undergo a urine drug screening while taking Brintellix, certain test methods may produce a false-positive result for methadone, even if you are not taking methadone. If this happens, a more specific confirmatory test can be performed.
Alcohol
Although formal pharmacokinetic studies have not shown a direct interaction between vortioxetine and alcohol, it is strongly recommended to avoid alcohol during treatment. Both alcohol and vortioxetine affect brain chemistry, and combining them may increase the risk of side effects such as drowsiness, dizziness, and impaired cognitive function. Additionally, alcohol is a central nervous system depressant that can worsen depression symptoms and counteract the therapeutic benefits of antidepressant treatment.
What Is the Correct Dosage of Brintellix?
The recommended starting dose of Brintellix for adults under 65 is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg daily or decrease it to 5 mg daily depending on your response. For patients aged 65 and older, the starting dose is 5 mg once daily. Brintellix can be taken with or without food.
Always take Brintellix exactly as your doctor has told you. If you are unsure, check with your doctor or pharmacist. The tablet should be swallowed whole with a glass of water and can be taken at any time of day, with or without food. Many patients find it helpful to take the medication at the same time each day to establish a routine.
Adults (Under 65 Years)
Standard Adult Dosing
- Starting dose: 10 mg once daily
- Dose range: 5 mg to 20 mg once daily
- Maximum dose: 20 mg per day
- Your doctor may adjust the dose based on your response to treatment
- If you take strong CYP2D6 inhibitors (e.g., bupropion, fluoxetine), a dose reduction may be needed
- If you take CYP inducers (e.g., rifampicin, carbamazepine), a dose increase may be needed
Elderly Patients (65 Years and Older)
Elderly Dosing
- Starting dose: 5 mg once daily
- Dose range: 5 mg to 20 mg once daily
- Caution is advised with doses above 10 mg in patients over 65, as data in this group is limited
- Monitor for hyponatremia and fall risk
Children and Adolescents
Brintellix is not approved for use in patients under 18 years of age. Efficacy has not been demonstrated in pediatric clinical trials, and the safety profile in this age group is not fully established. Do not give Brintellix to children or adolescents.
Duration of Treatment
Continue taking Brintellix for as long as your doctor recommends. It is important to keep taking the medication even if it takes some time before you feel an improvement in your condition. Antidepressants typically require 2 to 4 weeks to produce noticeable therapeutic effects, and full benefits may not be apparent for up to 8 weeks. Treatment should continue for at least 6 months after you feel well again, as premature discontinuation is associated with a significant risk of relapse.
Missed Dose
If you forget to take a dose of Brintellix, take the next dose at the usual time. Do not take a double dose to make up for a missed dose. If you miss a dose and it is still well before the time for your next dose, you may take the missed dose when you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose entirely.
Overdose
If you have taken more than the prescribed dose of Brintellix, contact your doctor, go to the nearest emergency department, or call your local poison control center immediately. Keep the packaging and any remaining tablets available. Do this even if there are no signs of discomfort. Signs of overdose may include dizziness, nausea, diarrhea, stomach discomfort, itching all over the body, drowsiness, and flushing. At doses many times higher than the prescribed dose, seizures and serotonin syndrome have been reported.
Stopping Treatment
Do not stop taking Brintellix without first talking to your doctor. Your doctor may recommend gradually reducing your dose before completely stopping treatment. Some patients who stop taking Brintellix experience discontinuation symptoms such as dizziness, headache, tingling or a feeling of electric shocks (particularly in the head), difficulty sleeping, nausea or vomiting, anxiety, irritability or agitation, fatigue, or tremors. These symptoms may occur within the first week after Brintellix has been discontinued and usually resolve within 2 weeks.
What Are the Side Effects of Brintellix?
Like all medicines, Brintellix can cause side effects, although not everyone gets them. The most common side effect is nausea, which affects more than 1 in 10 users. Most side effects are mild to moderate, typically occur within the first two weeks of treatment, and tend to resolve on their own without the need to stop treatment.
Side effects observed in clinical trials were generally mild to moderate in intensity and occurred within the first two weeks of treatment. The reactions were usually transient and did not lead to discontinuation of therapy. Below is a comprehensive overview of reported side effects organized by frequency.
Very Common
Affects more than 1 in 10 users
- Nausea
Common
Affects up to 1 in 10 users
- Diarrhea
- Constipation
- Vomiting
- Dizziness
- Itching (pruritus) over the entire body
- Abnormal dreams
- Increased sweating
- Indigestion (dyspepsia)
Uncommon
Affects up to 1 in 100 users
- Flushing
- Night sweats
- Blurred vision
- Involuntary shaking (tremor)
- Hallucinations (seeing, hearing, or feeling things that are not there)
Rare
Affects up to 1 in 1,000 users
- Dilated pupils (mydriasis), which may increase the risk of glaucoma
Not Known
Frequency cannot be estimated from available data
- Low sodium levels in the blood (hyponatremia) – symptoms may include dizziness, weakness, confusion, drowsiness, nausea, or vomiting; severe cases may cause fainting or seizures
- Serotonin syndrome – a potentially life-threatening condition
- Severe allergic reactions (angioedema) – swelling of face, lips, tongue, or throat; difficulty breathing or swallowing; sudden drop in blood pressure
- Hives (urticaria)
- Unexplained or excessive bleeding, including bruising, nosebleeds, and gastrointestinal or vaginal bleeding
- Skin rash
- Sleep disturbances (insomnia)
- Agitation and aggression
- Headache
- Increased blood levels of prolactin
- Restlessness and inability to sit still (akathisia)
- Teeth grinding (bruxism)
- Inability to open the mouth (trismus)
- Restless legs syndrome
- Breast milk discharge (galactorrhea)
An increased risk of bone fractures has been observed in patients taking this type of medication. An increased risk of sexual dysfunction has been reported with the 20 mg dose, and some patients experienced this side effect at lower doses. If you experience agitation, aggression, or changes in behavior, contact your doctor immediately.
How Should You Store Brintellix?
Store Brintellix at room temperature, out of the reach and sight of children. No special storage conditions are required. Do not use the tablets after the expiry date printed on the packaging.
Keep this medicine out of the sight and reach of children. Do not use Brintellix after the expiry date stated on the carton after “EXP.” The expiry date refers to the last day of that month. This medicine does not require any special storage conditions – it can be stored at normal room temperature.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Proper disposal of pharmaceutical waste helps protect the environment and prevents accidental ingestion by children or animals.
What Does Brintellix Contain?
Each Brintellix 5 mg film-coated tablet contains 5 mg of vortioxetine (as hydrobromide). The tablets also contain inactive ingredients including mannitol, microcrystalline cellulose, and various excipients. The 5 mg tablets are pink, almond-shaped, and marked with “TL” on one side and “5” on the other.
The active substance is vortioxetine. Each film-coated tablet contains 5 mg of vortioxetine (as vortioxetine hydrobromide). The other ingredients (excipients) are:
- Tablet core: Mannitol (E421), microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate (Type A), magnesium stearate
- Film coating: Hypromellose, macrogol 400, titanium dioxide (E171), iron oxide red (E172)
The 5 mg tablets are pink, almond-shaped (5 × 8.4 mm) film-coated tablets debossed with “TL” on one side and “5” on the other side. Brintellix is available in blister packs of 14, 28, 56, 98, and 126 tablets, as well as bottles of 100 and 200 tablets. Not all pack sizes may be available in all countries.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets.
Frequently Asked Questions About Brintellix
Medical References and Sources
This article is based on current medical research and international regulatory documents. All claims are supported by scientific evidence from peer-reviewed sources and official prescribing information.
- European Medicines Agency (EMA). "Brintellix (vortioxetine) – Summary of Product Characteristics." EMA EPAR Official European product information and assessment report.
- U.S. Food and Drug Administration (FDA). "Trintellix (vortioxetine) – Prescribing Information." FDA Label U.S. prescribing information. Note: The brand name is Trintellix in the United States.
- McIntyre RS, et al. (2014). "A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults." International Journal of Neuropsychopharmacology. 17(10):1557-1567. DOI Landmark study demonstrating cognitive benefits of vortioxetine in depression.
- Sanchez C, et al. (2015). "Vortioxetine, a novel antidepressant with multimodal activity: Review of preclinical and clinical data." Pharmacology & Therapeutics. 145:43-57. Comprehensive review of the pharmacological profile and mechanism of action.
- World Health Organization (WHO). "Depression – Fact Sheet." 2023. WHO Fact Sheet Global epidemiology and burden of major depressive disorder.
- National Institute for Health and Care Excellence (NICE). "Depression in adults: treatment and management." NICE guideline [NG222]. 2022. NICE Guideline UK clinical guidelines for the management of depression in adults.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Drug information is based on official regulatory documents (EMA SmPC, FDA prescribing information) and peer-reviewed clinical trials.
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