BREXANOLONE for Major depression: Side Effects & Safety Data

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There are 5 adverse event reports in the FDA FAERS database where BREXANOLONE was used for Major depression.

Most Reported Side Effects for BREXANOLONE

Side Effect	Reports	%	Deaths	Hosp.
Product administration error	36	13.8%	0	1
Anxiety	34	13.0%	0	0
Drug ineffective	26	10.0%	1	4
Off label use	24	9.2%	0	1
Drug monitoring procedure incorrectly performed	19	7.3%	0	0
Fatigue	17	6.5%	0	1
Dizziness	16	6.1%	0	0
Perinatal depression	15	5.8%	0	1
Crying	14	5.4%	0	0
Product administration interrupted	14	5.4%	0	1
Feeling abnormal	13	5.0%	0	0
Incorrect product administration duration	12	4.6%	0	1
Therapeutic product effect incomplete	12	4.6%	0	0
Headache	11	4.2%	0	0
Somnolence	11	4.2%	0	0