Vortioxetine is an antidepressant that is used to treat major depressive disorder in adults.

Vortioxetine may also be used for purposes not listed in this medication guide.

You should not use vortioxetine if you are allergic to it.

Do not use vortioxetine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

After you stop taking vortioxetine you must wait at least 21 days before you start taking an MAO inhibitor.

Tell your doctor if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with vortioxetine could cause a serious condition called serotonin syndrome.

Tell your doctor if you have ever had:

• bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;
• glaucoma;
• seizures or epilepsy;
• bleeding problems; or
• low levels of sodium in your blood.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Not approved for use by anyone younger than 18 years old.

Taking vortioxetine in the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, serious lung problems, or other complications in the baby. However, stopping the medicine may not be safe for you. Do not start or stop vortioxetine without asking your doctor.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Brintellix (Vortioxetine) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
• vision changes, eye pain, eye redness or swelling;
• easy bruising, unusual bleeding, coughing up blood; or
• low sodium level (may be more likely to occur in older adults--confusion, memory problems, hallucinations, slurred speech, severe weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

• nausea;
• constipation; or
• vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.