Vortioxetine is used to treat depression. It works in the brain to help reduce depression symptoms and is an antidepressant.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food. Take this medicine at the same time each day.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Agitation

blood in the stool or urine

confusion

convulsions

decreased urine output

diarrhea

dizziness

fast or irregular heartbeat

fever

headache

increased thirst

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle pain or cramps

nausea or vomiting

nose bleeds

overactive reflexes

poor coordination

red or purple spots on the skin

restlessness

shivering

shortness of breath

sweating

swelling of the face, ankles, or hands

talking or acting with excitement you cannot control

trembling or shaking

twitching

unusual bruising

unusual tiredness or weakness

vomiting blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty having a bowel movement (stool)

dry mouth

Less common

Bloated or full feeling

excess air or gas in the stomach or intestines

itching skin

passing gas

unusual dreams

Incidence not known

Acid or sour stomach

belching

blurred vision

change in taste

dizziness or lightheadedness

eye pain

feeling of constant movement of self or surroundings

feeling of warmth

heartburn

indigestion

loss of taste

redness of the face, neck, arms, and occasionally, upper chest

sensation of spinning

stomach discomfort, upset, or pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects.

Do not take vortioxetine if you have taken a monoamine oxidase (MAO) inhibitor (such as Eldepryl®, Marplan®, Nardil®, Parnate®), methylene blue, or linezolid in the past 2 weeks. Do not start taking a MAO inhibitor within 21 days of stopping vortioxetine. If you do, you may develop confusion, agitation, restlessness, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Vortioxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Vortioxetine may cause a serious condition called serotonin syndrome if taken together with some medicines such as buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, other medicines for depression (such as amitriptyline, nortriptyline), or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with vortioxetine.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as headache, muscle tension, mood swings, dizziness, runny nose, or sudden outbursts of anger.

This medicine may cause some people to become dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.