Summary

Commonly reported side effects of vortioxetine include: diarrhea, male sexual disorder, and nausea. Other side effects include: constipation, dizziness, and vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to vortioxetine: oral tablet.

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
• dizziness or lightheadedness
• eye pain
• feeling of constant movement of self or surroundings
• feeling of warmth
• heartburn
• indigestion
• 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

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%)

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]

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