Brexanolone Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 12, 2025.

Applies to brexanolone: intravenous solution.

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.

This medicine may cause excessive drowsiness or sleepiness and sudden loss of consciousness. Do not drive or do anything else that could be dangerous after your infusion until your feeling of sleepiness has completely gone away. You must have a caregiver or family member with you to help care for your child or children during treatment with this medicine.

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.

Check with your doctor before receiving this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with brexanolone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Serious side effects of brexanolone

Along with its needed effects, brexanolone 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 or nurse immediately if any of the following side effects occur while taking brexanolone:

Get emergency help immediately if any of the following symptoms of overdose occur while taking brexanolone:

Symptom of overdose

• prolonged drowsiness

Other side effects of brexanolone

Some side effects of brexanolone 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 brexanolone: intravenous solution.

General adverse events

The most commonly reported side effects included sedation, somnolence, dizziness, presyncope, and vertigo.^[Ref]

Nervous system

• Very common (10% or more): Sedation (up to 21%), somnolence (up to 21%), dizziness (up to 13%), presyncope (up to 13%), vertigo (up to 13%)
• Common (1% to 10%): Loss of consciousness, syncope^[Ref]

Gastrointestinal

• Very common (10% or more): Dry mouth (up to 11%)
• Common (1% to 10%): Diarrhea, dyspepsia^[Ref]

Dyspepsia was a dose-related side effect.^[Ref]

Cardiovascular

• Common (1% to 10%): Changes in blood pressure, flushing, hot flush, tachycardia^[Ref]

Tachycardia was a dose-related side effect.^[Ref]

Local

• Common (1% to 10%): Infusion site events, infusion site pain^[Ref]

Other

• Common (1% to 10%): Fatigue, medication error (due to infusion pump malfunction)^[Ref]

Respiratory

• Common (1% to 10%): Oropharyngeal pain^[Ref]

See also:

Frequently asked questions

• How is Zulresso administered for the treatment of Postpartum Depression?

Further information

Brexanolone 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