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Zulresso Side Effects

Generic name: brexanolone

Medically reviewed by Last updated on Mar 15, 2024.

Note: This document contains side effect information about brexanolone. Some dosage forms listed on this page may not apply to the brand name Zulresso.

Applies to brexanolone: intravenous solution.


Intravenous route (Solution)

Warning: Excessive Sedation and Sudden Loss of ConsciousnessPatients are at risk of excessive sedation or sudden loss of consciousness during administration of brexanolone.Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren).Brexanolone is available only through a restricted program called the ZULRESSO REMS.

Serious side effects of Zulresso

Along with its needed effects, brexanolone (the active ingredient contained in Zulresso) 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:

More common

Less common

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

Symptom of overdose

Other side effects of Zulresso

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:

More common

Less common

For Healthcare Professionals

Applies to brexanolone: intravenous solution.


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]


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]


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

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


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


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


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

Frequently asked questions


1. (2019) "Product Information. Zulresso (brexanolone)." Sage Therapeutics, Inc.

2. (2022) "Product Information. Zulresso (brexanolone)." Sage Therapeutics, Inc., SUPPL-7

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.