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

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, new or worse anxiety; panic attacks; feeling agitated or restless; new or worse irritability; trouble sleeping; an extreme increase in activity or talking (mania); or other unusual changes in behavior or mood

Do not take VIIBRYD if you take a monoamine oxidase inhibitor (MAOI), have taken or will take an MAOI within 14 days of taking VIIBRYD, or are being treated with the antibiotic linezolid or intravenous methylene blue.

Serotonin Syndrome: A potentially life-threatening problem that can happen when VIIBRYD is taken with certain other medicines. Stop taking VIIBRYD and call your healthcare provider or go to the nearest emergency room right away if you have any of the following: agitation; hallucinations; confusion, coma; fast heart beat; blood pressure changes; dizziness; sweating; flushing; high body temperature; tremors, stiff muscles, or muscle twitching; loss of coordination; seizures; nausea, vomiting or diarrhea

Increased chance of bleeding: Taking VIIBRYD with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, or blood thinners may add to this risk. Tell your healthcare provider right away about unusual bleeding or bruising

Manic episodes: Symptoms may include 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 side effects including: nausea; sweating; changes in mood; headache; irritability and agitation; tiredness; dizziness; problems sleeping; electric shock sensation; hypomania; anxiety; ringing in your ears; confusion; seizures

Seizures or convulsions

Glaucoma (angle-closure glaucoma): 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: May be serious and may cause death. Elderly people may be at greater risk for this. Symptoms may include headache; difficulty concentrating; memory changes; confusion; weakness and unsteadiness which can lead to falls

In severe or more sudden cases, symptoms include hallucinations; fainting; seizures; coma; respiratory arrest; death.

• Tell your healthcare provider about any medical conditions or if you:
  • Have or have a family history of suicide, depression, bipolar disorder, mania or hypomania
  • Have or had bleeding problems
  • Have or had seizures or convulsions
  • Have high pressure in the eye (glaucoma)
  • Have low salt (sodium) levels in your blood
  • Drink alcohol
  • Are pregnant or plan to become pregnant. Taking VIIBRYD late in pregnancy may lead to an increased risk of certain problems in your newborn. Talk to your healthcare provider about the risks to your baby if you take VIIBRYD during pregnancy. If you become pregnant during treatment with VIIBRYD, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185
  • Are breastfeeding or plan to breastfeed. It is not known if VIIBRYD passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VIIBRYD
• Tell your healthcare provider about all prescription and over-the-counter medications, vitamins, and herbal supplements you are taking or plan to take, especially:
  • MAOIs; triptans (medicines used to treat migraines); tricyclic antidepressants; fentanyl; lithium; tramadol; tryptophan; buspirone; amphetamines; St. John’s Wort; medicines that can affect blood clotting such as aspirin, NSAIDs, and warfarin; diuretics; medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
  VIIBRYD may affect the way other medicines work, and other medicines may affect how VIIBRYD works. Do not start or stop any medicines while taking VIIBRYD without talking to your healthcare provider.

• Do not drive, operate heavy machinery, or engage in other dangerous activities until you know how VIIBRYD affects you. VIIBRYD can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Avoid drinking alcohol while taking VIIBRYD.

• The most common side effects of VIIBRYD include diarrhea, nausea or vomiting, and trouble sleeping. These are not all the possible side effects of VIIBRYD.

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.