Zuranolone Side Effects

Applies to zuranolone: oral capsule.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that this medicine is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some people 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. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may make you less alert and aware, which can affect your ability to drive and do other dangerous activities safely. Do not drive or do anything else that could be dangerous for at least 12 hours after taking each dose.

This medicine may cause confusion, dizziness, drowsiness, sleepiness, slow thinking, or trouble with walking, which may lead to falls.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using 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 or vitamin supplements.

Serious side effects of zuranolone

Along with its needed effects, zuranolone 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 zuranolone:

Other side effects of zuranolone

Some side effects of zuranolone 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 zuranolone: oral capsule.

General adverse events

The most common adverse reactions in patients treated with this drug were somnolence, dizziness, diarrhea, fatigue, and urinary tract infections.^[Ref]

Dermatologic

• Common (1% to 10%): Rash^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, abdominal pain, dry mouth, toothache^[Ref]

Abdominal pain includes upper abdominal pain^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle twitching, myalgia^[Ref]

Nervous system

• Very common (10% or more): Somnolence (up to 36%), dizziness (up to 13%)
• Common (1% to 10%): Memory impairment, tremor, hypoesthesia

Somnolence includes sedation and hypersomnia

Other

• Common (1% to 10%): Fatigue^[Ref]

Fatigue includes asthenia and lethargy^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, confusional state^[Ref]

Respiratory

• Common (1% to 10%): COVID-19, nasopharyngitis, sinus congestion^[Ref]

Nasopharyngitis includes upper respiratory tract infection^[Ref]

See also:

Further information

Zuranolone 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