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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.
TRINTELLIX and some other antidepressant medications carry a Boxed Warning due to risk for suicidal thoughts and actions. Specifically, you should know:
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.
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.
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:
*Based on an average change from the overall score on a standardized sexual functioning questionnaire
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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Suicidal Thoughts and Actions and Antidepressant DrugsAntidepressants may increase suicidal thoughts or actions in some children, teens or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. People who have (or have a family history of) bipolar illness, or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. TRINTELLIX has not been evaluated for use in patients under 18.Do not take TRINTELLIX if you:Are allergic to vortioxetine or any of the ingredients in TRINTELLIXTake a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid; do not take an MAOI within 21 days of stopping TRINTELLIX; do not start TRINTELLIX if you stopped taking an MAOI in the last 14 daysTRINTELLIX may cause serious side effects including:Serotonin Syndrome: A potentially life-threatening problem that can happen when medicines such as TRINTELLIX are taken with certain other medicines. Symptoms may include agitation, hallucinations, coma or other changes in mental status; problems controlling movements or muscle twitching, stiffness or tightness; fast heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting or diarrhea.Abnormal bleeding or bruising: TRINTELLIX and other serotonergic 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.Manic episode: 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.Visual problems: May include eye pain, changes in vision, swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.Low salt (sodium) levels in the blood: Symptoms may include headache; difficulty concentrating, memory changes or confusion; weakness and unsteadiness on your feet; and in severe or sudden cases hallucinations, fainting, seizures or coma. If not treated, severe low sodium levels can cause death.Before starting TRINTELLIX, tell your healthcare provider if you have or had liver problems, seizures or convulsions, bipolar disorder (manic depression) or mania, low salt (sodium) levels in your blood, bleeding problems, drink alcohol, have any other medical conditions or if you are pregnant, nursing, plan to become pregnant, or plan to nurse.TRINTELLIX and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together. Tell your healthcare provider if you plan on or are taking any other prescription and non-prescription medicines, vitamins and herbal supplements including medicines for migraine headaches, such as triptans; medicines used to treat mood, anxiety, psychotic or thought disorders such as tricyclics, lithium, SSRIs, SNRIs, bupropion, buspirone or antipsychotics; MAOIs including linezolid (a specific antibiotic); over-the-counter supplements such as tryptophan or St. John's wort; and the following medicines: aspirin, NSAIDs, warfarin (Coumadin®, Jantoven®), diuretics, rifampin, carbamazepine, phenytoin, quinidine, tramadol or fentanyl.Common side effects of TRINTELLIX include: nausea, constipation or vomiting. These are not all the possible side effects of TRINTELLIX.Do not start or stop taking TRINTELLIX without talking to your healthcare provider first. Suddenly stopping TRINTELLIX when you take higher doses may cause you to have side effects including headache, stiff muscles, mood swings, sudden outbursts of anger, dizziness or feeling lightheaded, or runny nose.Talk to your healthcare provider.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.
Indication for TRINTELLIXTRINTELLIX is a prescription medicine used to treat Major Depressive Disorder (MDD) in adults.
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:
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:
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:
The most common side effects of TRINTELLIX include:
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.
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.