Tell your doctor if you:
- have liver problems
- have or had seizures or convulsions
- have mania or bipolar disorder (manic depression)
- have low salt (sodium) levels in your blood
- have or had bleeding problems
- drink alcohol
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if Brintellix will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Brintellix passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Brintellix.
Tell your doctor about all of the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements.
Brintellix is a prescription medication used to treat depression in adults.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Brintellix falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Brintellix and other antidepressant medicines may cause serious side effects.
Suicidal thoughts or actions. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
- Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
- Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive, being angry or violent
- thoughts about suicide or dying
- new or worse depression
- new or worse anxiety
- feeling agitated, restless, angry or irritable
- acting on dangerous impulses
- acting aggressive, being angry or violent
- thoughts about suicide or dying
- new or worse depression
- new or worse anxiety
- feeling agitated, restless, angry or irritable
- trouble sleeping
- extreme increase in activity or talking (mania)
- other unusual changes in behavior or mood
- panic attacks
- new or worse irritability
Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as Brintellix are taken with certain other medicines. Symptoms of serotonin syndrome may include:
- agitation, hallucinations, coma or other changes in mental status
- problems controlling your movements or muscle twitching
- fast heartbeat
- high or low blood pressure
- sweating or fever
- nausea or vomiting
- diarrhea
- muscle stiffness or tightness
Abnormal bleeding or bruising. Brintellix may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.
Hypomania (manic episodes). Symptoms of manic episodes include:
- greatly increased energy
- severe problems sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
Low levels of salt (sodium) in your blood. Symptoms of this may include: headache, difficulty concentrating, memory changes, confusion, weakness and unsteadiness on your feet. Symptoms of severe or sudden cases of low salt levels in your blood may include: hallucinations (seeing or hearing things that are not real), fainting, seizures and coma. If not treated, severe low sodium levels can cause death.
Do not take Brintellix if you:
- are allergic to vortioxetine, or any of the ingredients in Brintellix.
- take a Monoamine Oxidase Inhibitor (MAOI).
- Do not take an MAOI within 21 days of stopping Brintellix.
- Do not start Brintellix if you stopped taking an MAOI in the last 14 days.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known if Brintellix crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Brintellix.
Tell your doctor about all of the medications you take including prescription and non-prescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:
- medicines used to treat migraine headache (e.g. triptans)
- medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), buspirone, or antipsychotics
- MAOIs (including linezolid, an antibiotic)
- Tramadol or fentanyl
- over-the-counter supplements such as tryptophan or St. John’s Wort
- nonsteroidal anti-inflammatory drugs (NSAIDs)
- aspirin
- warfarin (Coumadin, Jantoven)
- diuretics
- rifampicin
- carbamazepine
- phenytoin
- quinidine
This is not a complete list of Brintellix drug interactions. Ask your doctor or pharmacist for more information.
If you take too much Brintellix call your doctor or local Poison Control Center or seek emergency medical treatment right away.
- Take Brintellix exactly as your healthcare providers tells you to take it.
- Take Brintellix at about the same time each day.
- Your healthcare provider may need to change the dose of Brintellix until it is the right dose for you.
- Do not start or stop taking Brintellix without talking to your healthcare provider first.
- Brintellix may be taken with or without food.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Brintellix affects you.
- Avoid drinking alcohol while taking Brintellix.
Brintellix (generic: vortioxetine) is a prescription medication used to treat depression in adults. This medication is the first in a new class of drugs called serotonin modulator/stimulators. The exact way it works to treat depression is unknown.
Brintellix comes in tablet form. It is usually taken once daily, with or without food.
Common side effects include nausea, constipation and vomiting. Brintellix may cause drowsiness. Do not drive or operate heavy machinery until you know how it affects you. Avoid alcohol while taking this medication.
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Brintellix, there are no specific foods that you must exclude from your diet when receiving this medication.
Serious side effects have been reported. See “Drug Precautions”.
Common side effects in people who take Brintellix include:
- nausea
- constipation
- vomiting
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Brintellix.
For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Brintellix has not been evaluated for use in pediatric patients.
- Store Brintellix at room temperature between 59°F to 86°F (15°C to 30°C).
- Keep Brintellix and all medicines out of the reach of children.
Take Brintellix exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The recommended starting dose is 10 mg once daily.
The dose is increased to 20 mg daily, as tolerated.