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Brexanolone Side Effects

The most commonly reported side effects of brexanolone include product administration error, anxiety, and off label use, based on 260 FDA adverse event reports from 2019 to 2025. 9.2% of reports found the drug to be ineffective.

#1 Reported: Product Administration ErrorAll side effects ↓Top Co-Medication: Escitalopram-oxalateDrug interactions ↓83% of Reports Are AdultDemographics ↓

Brexanolone side effects

Percentages show how often each reaction appears relative to total reports for brexanolone.

1
Product Administration Error13.8%36
2
Anxiety13.1%34
3
Off Label Use9.6%25
4
Drug Ineffective9.2%24
5
Fatigue7.3%19
6
Drug Monitoring Procedure Incorrectly Performed7.3%19
7
Dizziness6.2%16
8
Perinatal Depression5.8%15
9
Crying5.4%14
10
Product Administration Interrupted5.4%14
11
Somnolence5.0%13
12
Feeling Abnormal5.0%13
13
Therapeutic Product Effect Incomplete4.6%12
14
Incorrect Product Administration Duration4.6%12
15
Headache4.2%11

These are voluntary reports and do not establish that brexanolone caused these reactions.

Report severity

10.4%Serious27 reports
2.7%Hospitalizations7 reports
0.4%Fatal1 reports

Seriousness is determined by the reporter, not by OpenClaim.

Brexanolone drug interactions

Other drugs that appear in adverse event reports alongside brexanolone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Escitalopram-oxalate2.7%7
2
Quetiapine-fumarate2.7%7
3
Aripiprazole1.9%5
4
Venlafaxine1.5%4
5
Ziprasidone1.5%4
6
Sertraline-hydrochloride1.2%3
7
Lorazepam1.2%3
8
Doxepin-hydrochloride1.2%3
9
Atropine1.2%3
10
Tramadol-hydrochloride1.2%3
11
Clonazepam0.8%2
12
Levothyroxine-sodium0.8%2
13
Propofol0.8%2
14
Midazolam0.8%2
15
Thiopental-sodium0.8%2

Taken alongside

1
Clonazepam3.1%8
2
Sertraline-hydrochloride2.7%7
3
Ergocalciferol2.3%6
4
Acetaminophen2.3%6
5
Buspirone-hydrochloride2.3%6
6
Lamotrigine1.9%5
7
Bupropion1.9%5
8
Hydroxyzine1.9%5
9
Ibuprofen1.5%4
10
Cyanocobalamin1.5%4
11
Lorazepam1.5%4
12
Phenobarbital-sodium1.5%4
13
Levetiracetam1.5%4
14
Escitalopram-oxalate1.5%4
15
Trazodone-hydrochloride1.2%3

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports brexanolone side effects

60.0% of brexanolone adverse event reports involve female patients and 2.3% involve male patients. The largest age group is adult at 83%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.0%
Male2.3%
Unknown37.7%

Age group

< 24.3%
2–116.4%
12–176.4%
18–6482.9%
65+0.0%

What is brexanolone used for

Conditions and purposes for which patients were taking brexanolone when the adverse event was reported.

Affective DisorderAnxietyBrief Psychotic Disorder, With Postpartum OnsetCortical DysplasiaDepressionEpilepsyFebrile Infection-related Epilepsy SyndromeMajor DepressionMajor DepressionNew Onset Refractory Status EpilepticusPerinatal DepressionProduct Used For Unknown IndicationPerinatal DepressionPostpartum DisorderProduct Used For Unknown Indication

Showing 15 of 18 indications

Brexanolone brand names and reporting trend

Brexanolone is sold under the brand name Zulresso.

Brand names

Zulresso15

Quarterly reports (2019–2025)

20192020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking brexanolone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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