Vortioxetine Side Effects

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

Applies to vortioxetine: oral tablet.

Precautions

It is important that your doctor check your progress at regular visits to allow changes in your dose and help reduce any side effects. Blood and urine tests may be needed to check for unwanted effects.

Do not take vortioxetine if you have taken a monoamine oxidase (MAO) inhibitor (eg, Eldepryl®, Marplan®, Nardil®, Parnate®), methylene blue injection, or linezolid in the past 14 days. Do not start taking a MAO inhibitor within 21 days of stopping vortioxetine. If you do, you may develop confusion, agitation, restlessness, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Vortioxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Vortioxetine may cause a serious condition called serotonin syndrome if taken together with some medicines, including buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, other medicines for depression (eg, SNRIs, SSRIs, TCAs), or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with vortioxetine.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Hyponatremia (low sodium in the blood) may occur with this medicine. This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Do not suddenly Stop taking vortioxetine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms, including agitation, dizziness, headache, irritability, muscle tension, mood swings, nausea, runny nose, sudden outbursts of anger, or sweating.

This medicine may cause some people to become dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

For healthcare professionals

Applies to vortioxetine: oral tablet.

General adverse events

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

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer