Vortioxetine Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 5, 2023.

Applies to vortioxetine: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Warning: Suicidal Thoughts and Behaviors. Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants.Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors.Vortioxetine hydrobromide is not approved for use in pediatric patients.

Serious side effects of vortioxetine

Along with its needed effects, vortioxetine 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:

More common

• decreased interest in sexual intercourse
• delayed or inability to have an orgasm
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Incidence not known

• agitation
• blood in the stool or urine
• chest tightness
• confusion
• cough
• decreased urine output
• diarrhea
• difficulty swallowing
• dizziness
• fast or irregular heartbeat
• fever
• headache
• hives, itching
• hostility
• increased sweating
• increased thirst
• irritability
• 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
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or purple spots on the skin
• restlessness
• seizures
• shivering
• sweating
• swelling of the breasts or unusual milk production
• swelling of the face, ankles, or hands
• talking or acting with excitement you cannot control
• trembling or shaking
• trouble breathing
• twitching
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting blood

Other side effects of vortioxetine

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:

More common

• difficulty having a bowel movement (stool)
• dry mouth

Less common

• abnormal ejaculation
• 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
• belching
• blurred vision
• change in taste
• decrease in smell
• dizziness or lightheadedness
• eye pain
• feeling of constant movement of self or surroundings
• feeling of warmth
• heartburn
• indigestion
• loss of sense of smell
• 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.

General

The most commonly reported side effects included nausea, sexual dysfunction, headache, diarrhea, and dry mouth.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 42%), constipation (up to 15%)
• Common (1% to 10%): Abdominal discomfort, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, upper abdominal pain, vomiting
• Uncommon (0.1% to 1%): Abdominal distention, epigastric discomfort, gastritis, salivary hypersecretion
• Frequency not reported: Gastrointestinal bleeding
• Postmarketing reports: Acute pancreatitis^[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]

Genitourinary

• Very common (10% or more): Sexual dysfunction (up to 34%)
• Uncommon (0.1% to 1%): Micturition urgency, nocturia
• Frequency not reported: Sexual desire, performance, and satisfaction, vaginal bleeding^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 14.7%)
• Common (1% to 10%): Dizziness, sedation, somnolence
• Uncommon (0.1% to 1%): Dysgeusia, formication, lethargy, myoclonus, tremor, vertigo
• Frequency not reported: Serotonin syndrome
• Postmarketing reports: Seizure

Psychiatric

• Common (1% to 10%): Abnormal dreams, insomnia
• Uncommon (0.1% to 1%): Bruxism, derealization, initial insomnia, middle insomnia, restlessness, sleep disorder, tension
• Frequency not reported: Anger/sudden outbursts of anger, dyssomnia, mood swings, poor quality sleep, terminal insomnia, withdrawal symptoms
• Postmarketing reports: Aggression, agitation, hostility, irritation^[Ref]

Other

• Common (1% to 10%): Accidental overdose, asthenia, fatigue
• Uncommon (0.1% to 1%): Malaise^[Ref]

Dermatologic

• Common (1% to 10%): Generalized pruritus/pruritus, hyperhidrosis
• Uncommon (0.1% to 1%): Flushing, night sweats, rash
• Frequency not reported: Contusion, ecchymosis
• Postmarketing reports: Generalized rash, urticaria^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain
• Frequency not reported: Bone fractures, muscle tension^[Ref]

Metabolic

• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Increased low density lipoprotein/blood cholesterol/blood triglycerides, weight gain
• Frequency not reported: Hyponatremia^[Ref]

Respiratory

• Common (1% to 10%): Nasopharyngitis
• Frequency not reported: Epistaxis^[Ref]

Immunologic

• Common (1% to 10%): Influenza^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Chest discomfort, hypotension, increased heart rate, prolonged electrocardiogram QT
• Frequency not reported: Hemorrhage^[Ref]

Ocular

• Uncommon (0.1% to 1%): Dry eye
• Rare (0.01% to 0.1%): Mydriasis^[Ref]

Hypersensitivity

• Frequency not reported: Anaphylactic reaction, angioedema
• Postmarketing reports: Anaphylaxis, hypersensitivity reactions

Endocrine

• Postmarketing reports: Hyperprolactinemia

Frequently asked questions

• Is Trintellix the same as Brintellix?
• Does Trintellix (vortioxetine) cause weight gain or loss?
• How long does it take for Trintellix (vortioxetine) to start working?
• Is Trintellix (vortioxetine) good for anxiety?
• Shall I take Trintellix (vortioxetine) in the night or morning?
• Can I take Cymbalta (duloxetine) and Trintellix (vortioxetine) together?

Further information

Vortioxetine side effects can vary depending on the individual. 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.

Medical Disclaimer