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Brexanolone Side Effects

Medically reviewed by Drugs.com. Last updated on March 31, 2020.

For the Consumer

Applies to brexanolone: intravenous solution

Warning

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.

Side effects requiring immediate medical attention

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:

More common

  • Dizziness or lightheadedness
  • drowsiness
  • fainting
  • feeling of constant movement of self or surroundings
  • relaxed and calm feeling
  • sensation of spinning
  • sleepiness or unusual drowsiness

Less common

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

Symptom of overdose

  • Prolonged drowsiness

Side effects not requiring immediate medical attention

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

  • Dry mouth

Less common

For Healthcare Professionals

Applies to brexanolone: intravenous solution

General

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

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

Very common (10% or more): Dry mouth (up to 11%)

Common (1% to 10%): Diarrhea, dyspepsia[Ref]

Cardiovascular

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

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

References

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

Frequently asked questions

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.