IMPORTANT RISK INFORMATION ABOUT VIIBRYD Prescribing Information | Medication Guide

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. VIIBRYD is not approved for use in patients under 18. For more information on this risk, please read the VIIBRYD Medication Guide in the accompanying full Prescribing Information. See additional Important Risk Information below.

Focus on Treating Your Depression Symptoms With VIIBRYD®

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VIIBRYD Side Effect Profile

Patients taking VIIBRYD may
experience side effects.

VIIBRYD^® (vilazodone HCl) is indicated for the treatment of major depressive disorder (MDD) in adults.

IMPORTANT RISK INFORMATION

What is the most important information I should know about VIIBRYD?

VIIBRYD and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the symptoms described below, or call 911 if there is an emergency.

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. VIIBRYD is not approved for use in patients under 18. For more information on this risk, please read the VIIBRYD Medication Guide in the accompanying full Prescribing Information.

Serotonin Syndrome: Agitation, hallucinations, coma or other changes in mental status; coordination problems or muscle twitching; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea; muscle stiffness or tightness.

Abnormal bleeding: VIIBRYD and other antidepressant medicines 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.

Seizures or convulsions.

Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this. Symptoms may include headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or memory problems.

Who should not take VIIBRYD?

Do not take any drugs known as MAOIs within 14 days of stopping VIIBRYD
Do not start VIIBRYD if you stopped taking an MAOI in the last 14 days
Do not start VIIBRYD if you are taking linezolid (a specific antibiotic) or are receiving intravenous methylene blue

People who take VIIBRYD close in time to taking an MAOI may have serious or even life-threatening side effects.

What should I tell my healthcare provider before starting VIIBRYD?

Tell your healthcare provider about all prescription, over-the-counter medications, vitamins and herbal supplements you are taking or plan to take, including:

Triptans used to treat migraine headaches; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics; tramadol, mephenytoin (Mesantoin) or over-the-counter supplements such as tryptophan or St. John’s Wort; this is necessary to avoid a potentially life-threatening condition
Aspirin, NSAID pain relievers, or blood thinners (warfarin, Coumadin, or Jantoven) because they may increase the risk of bleeding

Speak with your doctor if you:

Have kidney or liver problems
Have or had mania, bipolar disorder (manic depression), seizures or convulsions
Have or had bleeding problems. VIIBRYD may increase your risk of bleeding or bruising
Have low salt (sodium) levels in your blood or are taking diuretics (water pills)
Are nursing, pregnant, or are planning to become pregnant or to breastfeed

Do not stop VIIBRYD without first talking to your healthcare provider.

Stopping VIIBRYD suddenly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or sleepy; headache, sweating, nausea, dizziness; electric shock-like sensations, tremor, and confusion.

What should I avoid when taking VIIBRYD?

Until you know how VIIBRYD affects you, you should not drive, operate heavy machinery, or engage in other dangerous activities. Avoid drinking alcohol while taking VIIBRYD.

What are the most common side effects of VIIBRYD?

The most common side effects in people taking VIIBRYD include diarrhea, nausea or vomiting, and trouble sleeping.
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 VIIBRYD. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Please also see Medication Guide within the full Prescribing Information.