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Vortioxetine Side Effects

In Summary

Commonly reported side effects of vortioxetine 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

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:

Incidence not known
  • Agitation
  • blood in the stool or urine
  • confusion
  • convulsions
  • decreased urine output
  • diarrhea
  • dizziness
  • fast or irregular heartbeat
  • fever
  • headache
  • 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
  • restlessness
  • shivering
  • shortness of breath
  • sweating
  • swelling of the face, ankles, or hands
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • twitching
  • unusual bruising
  • unusual tiredness or weakness
  • vomiting blood

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
  • 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

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
Frequency not reported: Abdominal distention, epigastric discomfort, gastritis, salivary hypersecretion
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%)
Frequency not reported: Micturition urgency, nocturia, sexual desire, performance, and satisfaction[Ref]

Nervous system

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

Other

Common (1% to 10%): Accidental overdose, asthenia, fatigue
Frequency not reported: Malaise[Ref]

Psychiatric

Common (1% to 10%): Abnormal dreams, insomnia
Uncommon (0.1% to 1%): Initial insomnia, middle insomnia, sleep disorder
Frequency not reported: Bruxism, derealization, dyssomnia, mood swings, poor quality sleep, restlessness, sudden outbursts of anger, tension, terminal insomnia, withdrawal symptoms[Ref]

Dermatologic

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

Musculoskeletal

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

Metabolic

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

Respiratory

Common (1% to 10%): Nasopharyngitis[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Cardiovascular

Frequency not reported: Chest discomfort, hypotension, increased heart rate, prolonged electrocardiogram QT[Ref]

Ocular

Frequency not reported: Dry eye[Ref]

References

1. "Product Information. Trintellix (vortioxetine)." Takeda Pharmaceuticals America, Lincolnshire, IL.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of vortioxetine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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