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Side effects. Hmmm.

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Side Effects

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Common side effects of TRINTELLIX

You may experience side effects with TRINTELLIX. The most common side effects in short-term studies were nausea, constipation, and vomiting.

Nausea was mild or moderate, and its frequency was related to the dose. Nausea generally occurred in the first week, and became less frequent over time. Nausea may continue in some people. Generally, nausea lasted for about two weeks.

Suicidal Thoughts and Actions and Antidepressant Drugs

TRINTELLIX and some other antidepressant medications carry a Boxed Warning due to risk for suicidal thoughts and actions. Specifically, you should know:

  • TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger.
  • TRINTELLIX is not for use in children under 18.
  • Patients taking TRINTELLIX should call their doctor or get emergency help right away if they have new or sudden changes in mood, behavior, thoughts or feelings, or symptoms that are new, worse or worry them; or if they develop suicidal thoughts or actions.

So you're wondering about weight gain?

TRINTELLIX did not have significant impact on weight in short-term studies and during a 6-month phase of a long-term study of patients who responded to TRINTELLIX when compared to patients taking a sugar pill.

Some reports of weight gain have been received since product approval.

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Can TRINTELLIX cause antidepressant sexual side effects?

As with other antidepressants, TRINTELLIX can be associated with sexual side effects during treatment. In 6- to 8-week clinical studies, up to 5% of Major Depressive Disorder (MDD) patients taking TRINTELLIX voluntarily reported sexual side effects. When proactively assessed in MDD patients with normal sexual functioning in seven studies using a self-rated questionnaire, reports of sexual side effects from doses of TRINTELLIX 5 mg, 10 mg, 20 mg were 16%, 20%, 29% in men (N=212) respectively and 22%, 23% and 34% in females (N=226) respectively, compared to placebo rates of 14% in males (N=162) and 20% in females (N=135).

Voluntary reports of sexual side effects with antidepressants are known to be underreported in part because patients may be reluctant to discuss them. A self-rated questionnaire designed to identify sexual side effects was used in TRINTELLIX clinical trials to determine how many people actually experienced sexual side effects with TRINTELLIX.

Can changing to TRINTELLIX from certain antidepressants help improve their sexual side effects? 

In an 8-week clinical study, patients whose depression improved on sertraline (ZOLOFT®), citalopram (CELEXA®), or paroxetine (PAXIL®) but who were experiencing sexual side effects from their treatment were switched to either TRINTELLIX or escitalopram (LEXAPRO®).

Results from this study showed:

  • Patients switched to TRINTELLIX showed greater improvement in antidepressant sexual side effects compared to those who switched to escitalopram (LEXAPRO®)*
  • Patients switched to TRINTELLIX or escitalopram (LEXAPRO®) also maintained improvement in depression from their previous antidepressant therapy

*Based on an average change from the overall score on a standardized sexual functioning questionnaire

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Important Safety Information

TRINTELLIX may cause serious side effects including Serotonin Syndrome, increased risk of bleeding, hypomania (manic episodes), discontinuation syndrome (side effects if you suddenly stop taking TRINTELLIX), visual problems, or low levels of salt in your blood. Please see additional Important Safety Information below.

TRINTELLIX is a prescription medication used in adults to treat a type of depression called Major Depressive Disorder (MDD). 

In multiple 6-8 week studies and one maintenance study vs. sugar pill, TRINTELLIX was shown to help reduce the multiple symptoms of MDD based on an overall score on a standardized depression rating scale.

Individual results may vary.

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IMPORTANT SAFETY INFORMATION About TRINTELLIX

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Suicidal Thoughts & Actions

TRINTELLIX and other antidepressants may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. TRINTELLIX is not for use in children under 18. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. Pay close attention to any changes, especially new or sudden changes in mood, behavior, thoughts, or feelings. Call your doctor or get emergency help right away if you have symptoms such as suicidal thoughts or actions, impulsivity, aggressive or violent actions, depression, anxiety or panic attacks, agitation, restlessness, anger, irritability, trouble sleeping, an increase in activity or talking, or other unusual changes in behavior or mood; especially if they are new, worse, or worry you.

Who should not take TRINTELLIX?

Do not start or take TRINTELLIX if you:

  • are allergic to vortioxetine or any of the ingredients in TRINTELLIX
  • take a Monoamine Oxidase Inhibitor (MAOI)
  • have stopped taking an MAOI in the last 14 days
  • are being treated with the antibiotic linezolid or intravenous methylene blue

Do not start taking an MAOI for at least 21 days after you stop treatment with TRINTELLIX.

What should I tell my doctor before taking TRINTELLIX?

Before taking TRINTELLIX, tell your doctor:

  • about all your medical and other health conditions
  • if you are pregnant or plan to become pregnant, since TRINTELLIX may harm your unborn baby. Taking TRINTELLIX during your third trimester may cause your baby to have withdrawal symptoms after birth or to be at increased risk for a serious lung problem at birth. Tell your doctor right away if you become or think you are pregnant while taking TRINTELLIX.
  • if you are breastfeeding or plan to breastfeed, since it is not known if TRINTELLIX passes into your breast milk

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, since TRINTELLIX and some medicines may cause serious side effects (or may not work as well) when taken together. Especially tell your doctor if you take: medicines for migraine headache called triptans; tricyclic antidepressants; fentanyl; lithium; tramadol; tryptophan; buspirone; St. John’s Wort; medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin; and diuretics.

What are the possible side effects of TRINTELLIX?

TRINTELLIX may cause serious side effects, including:

  • Serotonin syndrome: A potentially life‐threatening problem that can happen when you take TRINTELLIX with certain other medicines. Call your doctor or go to the nearest emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: agitation; seeing or hearing things that are not real; confusion; coma; fast heart beat; changes in blood pressure; dizziness; sweating; flushing; high body temperature; shaking, stiff muscles, or muscle twitching; loss of coordination; seizures; nausea, vomiting, diarrhea.
  • Increased risk of bleeding: Taking TRINTELLIX with aspirin, NSAIDs, warfarin or blood thinners may add to this risk. Tell your doctor right away about any unusual bleeding or bruising.
  • Manic episodes: Manic episodes may happen in people with bipolar disorder who take TRINTELLIX. Symptoms may include: greatly increased energy; racing thoughts; unusually grand ideas; talking more or faster than usual; severe problems sleeping; reckless behavior; excessive happiness or irritability.
  • Discontinuation syndrome: Suddenly stopping TRINTELLIX may cause you to have serious side effects including: nausea; sweating; changes in your mood; irritability and agitation; dizziness; electric shock feeling; tremor; anxiety; confusion; headache; tiredness; problems sleeping; hypomania; ringing in your ears; seizures.
  • Eye problems: TRINTELLIX may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your doctor if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
  • Low levels of salt (sodium) in your blood: Low sodium levels in your blood that may be serious and may cause death can happen during treatment with TRINTELLIX. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include headache; difficulty concentrating; memory changes; confusion; weakness and unsteadiness on your feet which can lead to falls. In more severe or more sudden cases, signs and symptoms include: seeing or hearing things that are not real; fainting; seizures; coma; stopping breathing.

The most common side effects of TRINTELLIX include:

  • nausea
  • constipation
  • vomiting

These are not all the possible side effects of TRINTELLIX. Tell your doctor if you have any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is TRINTELLIX (vortioxetine)?

TRINTELLIX is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD).

There is a pregnancy registry for females who are exposed to antidepressants during pregnancy. The purpose of the registry is to collect information about the health of females exposed to antidepressants and their babies. If you become pregnant during treatment with TRINTELLIX, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

For additional Important Safety Information, click here for Medication Guide, and discuss with your doctor.