Brintellix Side Effects Center

Last updated on RxList: 8/27/2020
Brintellix Side Effects Center

What Is Brintellix?

Brintellix (vortioxetine) is an antidepressant used to treat major depressive disorder (MDD).

What Are Side Effects of Brintellix?

Common side effects of Brintellix include:

  • nausea,
  • diarrhea,
  • constipation,
  • vomiting,
  • sexual dysfunction,
  • dry mouth,
  • gas,
  • dizziness,
  • abnormal dreams, and
  • itching.

Antidepressants such as Brintellix can raise the risk of suicidal thoughts among some users, especially among children, adolescents, and adults aged 18 to 24. Tell your doctor if you experience any thoughts of suicide or worsening depression while taking Brintellix

Dosage for Brintellix

The recommended starting dose of Brintellix is 10 mg taken orally once daily. Dosage should then be increased to 20 mg/day, as recommended by your doctor.

What Drugs, Substances, or Supplements Interact with Brintellix?

Brintellix may interact with monoamine oxidase inhibitors (MAOIs), SSRIs, SNRIs, triptans, buspirone, tramadol, tryptophan, bupropion, fluoxetine, paroxetine, quinidine, rifampicin, carbamazepine, or phenytoin. Tell your doctor all medications and supplements you use.

Brintellix During Pregnancy and Breastfeeding

Tell your doctor if you become pregnant or intend to become pregnant during therapy with Brintellix. Consult your doctor before breastfeeding.

Additional Information

Our Brintellix (vortioxetine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Brintellix Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
  • vision changes, eye pain, eye redness or swelling;
  • easy bruising, unusual bleeding, coughing up blood; or
  • low sodium level (may be more likely to occur in older adults--confusion, memory problems, hallucinations, slurred speech, severe weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • nausea;
  • constipation; or
  • vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Depression is a(n) __________ . See Answer
Brintellix Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Patient Exposure

BRINTELLIX was evaluated for safety in 4746 patients (18 years to 88 years of age) diagnosed with MDD who participated in pre-marketing clinical studies; 2616 of those patients were exposed to BRINTELLIX in 6 to 8 week, placebo-controlled studies at doses ranging from 5 mg to 20 mg once daily and 204 patients were exposed to BRINTELLIX in a 24 week to 64 week placebo-controlled maintenance study at doses of 5 mg to 10 mg once daily. Patients from the 6 to 8 week studies continued into 12-month open-label studies. A total of 2586 patients were exposed to at least one dose of BRINTELLIX in open-label studies, 1727 were exposed to BRINTELLIX for six months and 885 were exposed for at least one year.

Adverse Reactions Reported as Reasons for Discontinuation of Treatment

In pooled 6 to 8 week placebo-controlled studies the incidence of patients who received BRINTELLIX 5 mg/day, 10 mg/day, 15 mg/day and 20 mg/day and discontinued treatment because of an adverse reaction was 5%, 6%, 8% and 8%, respectively, compared to 4% of placebo-treated patients. Nausea was the most common adverse reaction reported as a reason for discontinuation.

Common Adverse Reactions in Placebo-Controlled MDD Studies

The most commonly observed adverse reactions in MDD patients treated with BRINTELLIX in 6 to 8 week placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were nausea, constipation and vomiting.

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of MDD patients treated with any BRINTELLIX dose and at least 2% more frequently than in placebo-treated patients in the 6 to 8 week placebo-controlled studies.

Table 2: Common Adverse Reactions Occurring in ≥ 2% of Patients Treated with any BRINTELLIX Dose and at Least 2% Greater than the Incidence in Placebo-treated Patients

System Organ Class Preferred Term BRINTELLIX 5 mg/day
N=1013 %
BRINTELLIX 10 mg/day
N=699 %
BRINTELLIX 15 mg/day
N=449 %
BRINTELLIX 20 mg/day
N=455 %
Placebo
N=1621 %
Gastrointestinal disorders
  Nausea 21 26 32 32 9
  Diarrhea 7 7 10 7 6
  Dry mouth 7 7 6 8 6
  Constipation 3 5 6 6 3
  Vomiting 3 5 6 6 1
  Flatulence 1 3 2 1 1
Nervous system disorders
  Dizziness 6 6 8 9 6
Psychiatric disorders
  Abnormal dreams < 1 < 1 2 3 1
Skin and subcutaneous tissue disorders
  Pruritus* 1 2 3 3 1
*includes pruritus generalized

Nausea

Nausea was the most common adverse reaction and its frequency was dose-related (Table 2). It was usually considered mild or moderate in intensity and the median duration was 2 weeks. Nausea was more common in females than males. Nausea most commonly occurred in the first week of BRINTELLIX treatment with 15 to 20% of patients experiencing nausea after 1 to 2 days of treatment. Approximately 10% of patients taking BRINTELLIX 10 mg/day to 20 mg/day had nausea at the end of the 6 to 8 week placebo-controlled studies.

Sexual Dysfunction

Difficulties in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders, but they may also be consequences of pharmacologic treatment.

In the MDD 6 to 8 week controlled trials of BRINTELLIX, voluntarily reported adverse reactions related to sexual dysfunction were captured as individual event terms. These event terms have been aggregated and the overall incidence was as follows. In male patients the overall incidence was 3%, 4%, 4%, 5% in BRINTELLIX 5 mg/day, 10 mg/day, 15 mg/day, 20 mg/day, respectively, compared to 2% in placebo. In female patients, the overall incidence was < 1%, 1%, < 1%, 2% in BRINTELLIX 5 mg/day, 10 mg/day, 15 mg/day, 20 mg/day, respectively, compared to < 1% in placebo.

Because voluntarily reported adverse sexual reactions are known to be underreported, in part because patients and physicians may be reluctant to discuss them, the Arizona Sexual Experiences Scale (ASEX), a validated measure designed to identify sexual side effects, was used prospectively in seven placebo-controlled trials. The ASEX scale includes five questions that pertain to the following aspects of sexual function: 1) sex drive, 2) ease of arousal, 3) ability to achieve erection (men) or lubrication (women), 4) ease of reaching orgasm, and 5) orgasm satisfaction.

The presence or absence of sexual dysfunction among patients entering clinical studies was based on their ASEX scores. For patients without sexual dysfunction at baseline (approximately 1/3 of the population across all treatment groups in each study), Table 3 shows the incidence of patients that developed treatment-emergent sexual dysfunction when treated with BRINTELLIX or placebo in any fixed dose group. Physicians should routinely inquire about possible sexual side effects.

Table 3: ASEX Incidence of Treatment Emergent Sexual Dysfunction*

  BRINTELLIX 5 mg/day
N=65:67†
BRINTELLIX 10 mg/day
N=94:86†
BRINTELLIX 15 mg/day
N=57:67†
BRINTELLIX 20 mg/day
N=67:59†
Placebo
N=135:162†
Females 22% 23% 33% 34% 20%
Males 16% 20% 19% 29% 14%
*Incidence based on number of subjects with sexual dysfunction during the study / number of subjects without sexual dysfunction at baseline. Sexual dysfunction was defined as a subject scoring any of the following on the ASEX scale at two consecutive visits during the study: 1) total score ≥ 19; 2) any single item ≥ 5; 3) three or more items each with a score ≥ 4
†Sample size for each dose group is the number of patients (females:males) without sexual dysfunction at baseline

Adverse Reactions Following Abrupt Discontinuation of BRINTELLIX Treatment

Discontinuation symptoms have been prospectively evaluated in patients taking BRINTELLIX 10 mg/day, 15 mg/day, and 20 mg/day using the Discontinuation-Emergent Signs and Symptoms (DESS) scale in clinical trials. Some patients experienced discontinuation symptoms such as headache, muscle tension, mood swings, sudden outbursts of anger, dizziness, and runny nose in the first week of abrupt discontinuation of BRINTELLIX 15 mg/day and 20 mg/day.

Laboratory Tests

BRINTELLIX has not been associated with any clinically important changes in laboratory test parameters in serum chemistry (except sodium), hematology and urinalysis as measured in the 6 to 8 week placebo-controlled studies. Hyponatremia has been reported with the treatment of BRINTELLIX [see WARNINGS AND PRECAUTIONS]. In the 6-month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to BRINTELLIX during the initial 12-week, open-label phase, there were no clinically important changes in lab test parameters between BRINTELLIX and placebo-treated patients.

Weight

BRINTELLIX had no significant effect on body weight as measured by the mean change from baseline in the 6 to 8 week placebo-controlled studies. In the 6-month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to BRINTELLIX during the initial 12-week, open-label phase, there was no significant effect on body weight between BRINTELLIX and placebo-treated patients.

Vital Signs

BRINTELLIX has not been associated with any clinically significant effects on vital signs, including systolic and diastolic blood pressure and heart rate, as measured in placebo-controlled studies.

Other Adverse Reactions Observed in Clinical Studies

The following listing does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

Ear and labyrinth disorders — vertigo

Gastrointestinal disorders — dyspepsia

Nervous system disorders — dysgeusia

Vascular disorders — flushing

Read the entire FDA prescribing information for Brintellix (Vortioxetine Tablets)

© Brintellix Patient Information is supplied by Cerner Multum, Inc. and Brintellix Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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