What is the most important information I should know about vortioxetine?
Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. After you stop taking vortioxetine you must wait at least 21 days before you start taking an MAO inhibitor.
Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
What is vortioxetine?
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.
What should I discuss with my healthcare provider before taking vortioxetine?
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, rasagiline, selegiline, tranylcypromine, and others.
After you stop taking vortioxetine you must wait at least 21 days before you start taking an MAO inhibitor.
Be sure your doctor knows 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. These medicines may interact with vortioxetine and cause a serious condition called serotonin syndrome.
Vortioxetine is not approved for use by anyone younger than 18 years old.
Tell your doctor if you have ever had:
- bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;
- liver disease;
- narrow-angle glaucoma;
- seizures or epilepsy;
- bleeding or blood clotting disorder; 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.
Taking vortioxetine in the last 3 months of pregnancy may cause problems in the newborn, such as life-threatening withdrawal symptoms, serious lung problems or other complications in the baby. Tell your doctor if you are pregnant.
Do not start or stop taking vortioxetine during pregnancy without your doctor's advice. Vortioxetine may harm an unborn baby, but you may have a relapse of major depressive disorder or other problems if you stop taking this medicine during pregnancy. The benefit of continuing treatment with vortioxetine may outweigh any risks to the baby.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
How should I take vortioxetine?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
You may take vortioxetine with or without food.
Do not stop using vortioxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using vortioxetine.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking vortioxetine?
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
What are the possible side effects of vortioxetine?
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.
What other drugs will affect vortioxetine?
Tell your doctor about all your current medicines. Many drugs can affect vortioxetine, especially:
- medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia;
- any other antidepressant;
- a blood thinner (warfarin, Coumadin, Jantoven);
- a diuretic or "water pill";
- fentanyl, tramadol;
- quinidine;
- rifampin;
- St. John's wort, tryptophan (sometimes called L-tryptophan);
- migraine headache medicine (triptan);
-
NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
-
seizure medicine --carbamazepine, phenytoin.
This list is not complete and many other drugs may affect vortioxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your pharmacist can provide more information about vortioxetine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 4.01. Revision date: 8/13/2019.
