Trintellix Side Effects
Generic Name: vortioxetine
Note: This document contains side effect information about vortioxetine. Some of the dosage forms listed on this page may not apply to the brand name Trintellix.
Common side effects of Trintellix include: diarrhea, male sexual disorder, and nausea. Other side effects include: constipation, dizziness, and vomiting. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to vortioxetine: oral tablet
Oral route (Tablet)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. This risk must be balanced with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years or older. Monitor all patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Vortioxetine has not been evaluated for use in pediatric patients.
Side effects requiring immediate medical attention
Along with its needed effects, vortioxetine (the active ingredient contained in Trintellix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking vortioxetine:
Incidence not known
- blood in the stool or urine
- decreased urine output
- fast or irregular heartbeat
- increased thirst
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle pain or cramps
- nausea or vomiting
- nose bleeds
- overactive reflexes
- poor coordination
- red or purple spots on the skin
- shortness of breath
- swelling of the face, ankles, or hands
- talking or acting with excitement you cannot control
- trembling or shaking
- unusual bruising
- unusual tiredness or weakness
- vomiting blood
Side effects not requiring immediate medical attention
Some side effects of vortioxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Difficulty having a bowel movement (stool)
- dry mouth
- Bloated or full feeling
- excess air or gas in the stomach or intestines
- itching skin
- passing gas
- unusual dreams
Incidence not known
- Acid or sour stomach
- blurred vision
- change in taste
- dizziness or lightheadedness
- eye pain
- feeling of constant movement of self or surroundings
- feeling of warmth
- loss of taste
- redness of the face, neck, arms, and occasionally, upper chest
- sensation of spinning
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to vortioxetine: oral tablet
The most commonly reported side effects included nausea, sexual dysfunction, headache, diarrhea, and dry mouth.[Ref]
Nausea usually occurred during the first week of treatment, with up to 20% of patients reporting nausea within 1 to 2 days of starting treatment. Nausea occurred more frequently in female patients, and in patients 65 years and older.[Ref]
Very common (10% or more): Nausea (up to 42%), constipation (up to 15%)
Frequency not reported: Abdominal distention, epigastric discomfort, gastritis, salivary hypersecretion
Very common (10% or more): Sexual dysfunction (up to 34%)
Frequency not reported: Micturition urgency, nocturia, sexual desire, performance, and satisfaction[Ref]
Very common (10% or more): Headache (up to 14.7%)
Common (1% to 10%): Dizziness, sedation, somnolence
Postmarketing reports: Seizure
Common (1% to 10%): Accidental overdose, asthenia, fatigue
Frequency not reported: Malaise[Ref]
Common (1% to 10%): Abnormal dreams, insomnia
Uncommon (0.1% to 1%): Initial insomnia, middle insomnia, sleep disorder
Uncommon (0.1% to 1%): Flushing, night sweats
Frequency not reported: Rash
Postmarketing reports: Generalized rash[Ref]
Common (1% to 10%): Arthralgia, back pain
Frequency not reported: Bone fractures, muscle tension[Ref]
Common (1% to 10%): Decreased appetite
Common (1% to 10%): Nasopharyngitis[Ref]
Frequency not reported: Dry eye[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Trintellix (vortioxetine)." Takeda Pharmaceuticals America, Lincolnshire, IL.
3. Cerner Multum, Inc. "Australian Product Information." O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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More about Trintellix (vortioxetine)
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- Drug class: miscellaneous antidepressants
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