• Descriptions:

Vortioxetine is used to treat major depressive disorder (MDD). It is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Vortioxetine works by increasing the activity of a chemical called serotonin in the brain.

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

This product is available in the following dosage forms:

Tablet

• Before Using:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of vortioxetine in the pediatric population. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vortioxetine in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution for patients receiving vortioxetine.

Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Isocarboxazid
Linezolid
Methylene Blue
Metoclopramide
Ozanimod
Phenelzine
Procarbazine
Rasagiline
Safinamide
Selegiline
Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab
Abiraterone Acetate
Aceclofenac
Acemetacin
Acenocoumarol
Alfentanil
Almotriptan
Amineptine
Amitriptyline
Amitriptylinoxide
Amoxapine
Amphetamine
Amtolmetin Guacil
Anagrelide
Anileridine
Apalutamide
Apixaban
Ardeparin
Argatroban
Aspirin
Atazanavir
Bemiparin
Benzhydrocodone
Benzphetamine
Betrixaban
Bivalirudin
Bromfenac
Brompheniramine
Bufexamac
Buprenorphine
Bupropion
Buspirone
Butorphanol
Cangrelor
Carbamazepine
Celecoxib
Certoparin
Chlorpheniramine
Choline Salicylate
Cilostazol
Citalopram
Clomipramine
Clonixin
Clopidogrel
Cobicistat
Cocaine
Codeine
Cyclobenzaprine
Dabigatran Etexilate
Dacomitinib
Dalteparin
Danaparoid
Darunavir
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexibuprofen
Dexketoprofen
Dextroamphetamine
Dextromethorphan
Dibenzepin
Diclofenac
Difenoxin
Diflunisal
Dihydrocodeine
Diphenoxylate
Dipyridamole
Dipyrone
Dolasetron
Doxepin
Drotrecogin Alfa
Droxicam
Duloxetine
Edoxaban
Eletriptan
Enoxaparin
Enzalutamide
Epoprostenol
Eptifibatide
Escitalopram
Eslicarbazepine Acetate
Ethylmorphine
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Fluvoxamine
Fondaparinux
Fosphenytoin
Frovatriptan
Gepirone
Granisetron
Heparin
Hydrocodone
Hydromorphone
Hydroxyamphetamine
Hydroxytryptophan
Ibuprofen
Iloprost
Imipramine
Indomethacin
Iobenguane I 131
Ivosidenib
Ketobemidone
Ketoprofen
Ketorolac
Lasmiditan
Lepirudin
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lorcaserin
Lornoxicam
Loxoprofen
Lumacaftor
Lumiracoxib
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Meperidine
Metaxalone
Methadone
Methamphetamine
Methylphenidate
Milnacipran
Mirtazapine
Mitotane
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nalbuphine
Naproxen
Naratriptan
Nefazodone
Nepafenac
Nicomorphine
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Nortriptyline
Oliceridine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Oxaprozin
Oxycodone
Oxymorphone
Oxyphenbutazone
Palonosetron
Papaveretum
Parecoxib
Paregoric
Parnaparin
Paroxetine
Pentazocine
Phenindione
Phenprocoumon
Phenylbutazone
Phenytoin
Piketoprofen
Piritramide
Piroxicam
Pixantrone
Pranoprofen
Prasugrel
Proglumetacin
Propyphenazone
Proquazone
Protein C
Protriptyline
Quinidine
Remifentanil
Reviparin
Rifampin
Rifapentine
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Salicylic Acid
Salsalate
Selexipag
Sertraline
Sibutramine
Sodium Salicylate
St John's Wort
Sufentanil
Sulfinpyrazone
Sulindac
Sulodexide
Sumatriptan
Tapentadol
Tenoxicam
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tirofiban
Tolfenamic Acid
Tolmetin
Tramadol
Trazodone
Treprostinil
Trimipramine
Tryptophan
Valdecoxib
Venlafaxine
Vilazodone
Vorapaxar
Warfarin
Ziprasidone
Zolmitriptan

Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Bipolar disorder (mood disorder with mania and depression), or risk of or
Bleeding problems or
Glaucoma, angle closure or
Hyponatremia (low sodium in the blood) or
Mania or hypomania, history of or
Seizures, history of—Use with caution. May make these conditions worse.

• Proper Use

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.

Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
For depression:

1. Adults—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 20 mg per day.
2. Children—Use and dose must be determined by your doctor.

Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Precautions

It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects. Blood and urine tests may be needed to check for unwanted effects.

Do not take vortioxetine if you have taken a monoamine oxidase (MAO) inhibitor (eg, Eldepryl®, Marplan®, Nardil®, Parnate®), methylene blue injection, or linezolid in the past 14 days. 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, including buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, other medicines for depression (eg, SNRIs, SSRIs, TCAs), or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, 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, including 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. This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. 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, including agitation, dizziness, headache, irritability, muscle tension, mood swings, nausea, runny nose, sudden outbursts of anger, or sweating.

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.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 (eg, St. John's wort) or vitamin supplements.

Description and Brand Names
Before Using
Proper Use
Precautions
Side Effects
Products and services
The Mayo Clinic Diet: What is your weight-loss goal? 5-10 lbs, 11-25 lbs, or 25+ lbs

• Side Effects

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:

More common:
Decreased interest in sexual intercourse
delayed or inability to have an orgasm
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
Incidence not known:
Agitation
blood in the stool or urine
chest tightness
confusion
cough
decreased urine output
diarrhea
difficulty swallowing
dizziness
fast or irregular heartbeat
fever
headache
hives, itching
hostility
increased sweating
increased thirst
irritability
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
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red or purple spots on the skin
restlessness
seizures
shivering
sweating
swelling of the breasts or unusual milk production
swelling of the face, ankles, or hands
talking or acting with excitement you cannot control
trembling or shaking
trouble breathing
twitching
unusual bleeding or 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:
Abnormal ejaculation
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
decrease in smell
dizziness or lightheadedness
eye pain
feeling of constant movement of self or surroundings
feeling of warmth
heartburn
indigestion
loss of sense of smell
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.