Patient portrayal.
Individual results may vary.
Side effects
TRINTELLIX® (vortioxetine) is a prescription medicine used in adults to treat a certain type of depression called Major Depressive Disorder (MDD). TRINTELLIX has not been shown to be safe and effective for use in children.
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.
Constipation
Vomiting
Nausea was usually considered to be mild or moderate, and its frequency was dose-related. Nausea generally occurred in the first week and became less frequent over time, usually lasting for about 2 weeks. Nausea may continue in some people.
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 increase the risk of suicidal thoughts and actions in 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.
- 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.
For more information on side effects, visit our full FAQ.
Concerned about weight gain?
TRINTELLIX did not have a 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 and also in a separate long-term study.
Sexual side effects caused by antidepressants are a common problem.
You're not alone. Many common and frequently used antidepressants have sexual side effects. In fact, patients who experience sexual side effects report it as one of the most troublesome side effects of their depression treatment.
Antidepressants may cause sexual side effects, including:
Lack of
sexual drive
Lack of sexual drive
Difficulty becoming
aroused
Difficulty becoming aroused
Difficulty achieving
orgasm
Difficulty achieving orgasm
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 patients with MDD 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, and 20 mg were 16%, 20%, and 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 people may be reluctant to discuss them. A patient questionnaire designed to identify sexual side effects was used in TRINTELLIX studies to determine how many people experienced sexual side effects while taking TRINTELLIX.
Sexual problems: Taking antidepressants like TRINTELLIX may cause sexual problems. Symptoms in males may include: delayed ejaculation or inability to have an ejaculation, decreased sex drive, or problems getting or keeping an erection. Symptoms in females may include: decreased sex drive, or delayed orgasm or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with TRINTELLIX.
See below for Important Safety Information, including Boxed WARNING for Suicidal Thoughts and Actions.
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 and patients switched to escitalopram (LEXAPRO®) both maintained improvement in depression from their previous antidepressant therapy
Individual results may vary.
*Based on an average change from the overall score on a standardized sexual functioning questionnaire.
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, low levels of salt in your blood, or sexual problems. 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). TRINTELLIX has not been shown to be safe and effective for use in children.
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.
Don’t be afraid to talk to your doctor.
Many people are reluctant to talk to their doctors about their antidepressant sexual side effects. While it can be an uncomfortable topic, you shouldn’t struggle in silence. Let your healthcare professional know about any side effects you’re experiencing.
Frequently Asked Questions
Before taking TRINTELLIX, tell your healthcare professional:
- 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
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