VIIBRYD^® (vilazodone HCI) is a prescription medicine indicated for the treatment of major depressive disorder (MDD) in adults.

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.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about suicide or dying; new or worse depression, anxiety, or panic attacks; feeling agitated, restless, angry or irritable; trouble sleeping; an increase in activity or talking more than normal (mania); or other unusual changes in behavior or mood

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.

Increased chance of bleeding: VIIBRYD and other antidepressant medicines may increase your chance of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin^®, Jantoven^®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.

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.

Discontinuation symptoms: Do not suddenly stop VIIBRYD without first talking to your healthcare provider. Stopping VIIBRYD suddenly may cause serious symptoms including: flu-like symptoms (eg, headache, sweating, nausea); anxiety, high or low mood, irritability, feeling restless or sleepy; dizziness, electric shock-like sensations, tremor, and confusion.

Seizures or convulsions.

Glaucoma (angle-closure glaucoma): Many antidepressants, including VIIBRYD, may cause an eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes in your vision or eye pain.

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.

• Do not take any drugs known as monoamine oxidase inhibitors (MAOIs), including linezolid (an antibiotic), with VIIBRYD or within 14 days of stopping VIIBRYD
• Do not start VIIBRYD if you started or stopped taking an MAOI in the last 14 days

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

• Tell your healthcare provider about any medical conditions or if you:
  • Have liver or kidney problems
  • Have or had mania, bipolar disorder (manic depression), seizures or convulsions
  • Have or had bleeding problems. VIIBRYD may increase your chance of bleeding or bruising
  • Have low salt (sodium) levels in your blood or are taking diuretics (water pills)
  • Drink alcohol
  • Are pregnant, breastfeeding or are planning to become pregnant or to breastfeed
• Tell your healthcare provider about all prescription, over-the-counter medications, vitamins, and herbal supplements you are taking or plan to take, especially:
  • Triptans used to treat migraine headaches; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, amphetamines, 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 (eg, warfarin, Coumadin, or Jantoven) because they may increase the risk of bleeding
  • Diuretics (water pills)

• 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.

• 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.

Please also see Medication Guide within the full Prescribing Information.