CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE: 7,419 Adverse Event Reports & Safety Profile

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7,419

Total FAERS Reports

68 (0.9%)

Deaths Reported

1,357

Hospitalizations

7,419

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 19950101 · Latest Report: 20250917

What Are the Most Common CALCIUM OXYBATE\MAGNESIUM OXYBATE\POTASSIUM OXYBATE\SODIUM OXYBATE Side Effects?

#1 Most Reported

Product administration interrupted

1,446 reports (19.5%)

#2 Most Reported

Surgery

908 reports (12.2%)

#3 Most Reported

Nausea

820 reports (11.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Product administration interrupted	1,446	19.5%	9	362
Surgery	908	12.2%	0	96
Nausea	820	11.1%	1	144
Product dose omission issue	763	10.3%	2	192
Anxiety	590	8.0%	1	117
Intentional dose omission	518	7.0%	2	119
Intentional product use issue	454	6.1%	0	106
Headache	450	6.1%	0	90
Dizziness	429	5.8%	1	72
Somnolence	404	5.5%	1	73
Vomiting	384	5.2%	0	86
Depression	367	5.0%	4	69
Feeling abnormal	367	5.0%	1	69
Weight decreased	359	4.8%	2	62
Hospitalisation	337	4.5%	5	335
Drug ineffective	335	4.5%	2	60
Fall	335	4.5%	1	123
Illness	335	4.5%	0	81
Suicidal ideation	308	4.2%	0	64
Covid-19	304	4.1%	1	85

Gender: 73.9% female, 26.1% male. Average age: 43.3 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2001	1	0	0
2004	1	0	1
2007	1	0	1
2008	2	0	0
2010	2	0	0
2012	4	1	1
2014	3	0	1
2015	5	0	1
2016	3	0	1
2017	3	0	2
2018	9	0	4
2019	9	0	1
2020	35	0	6
2021	520	5	108
2022	673	10	148
2023	946	15	239
2024	817	4	185
2025	387	6	85

Indication	Reports
Narcolepsy	4,932
Cataplexy	3,826
Somnolence	3,257
Hypersomnia	1,752
Product used for unknown indication	898
Insomnia	20
Fibromyalgia	11
Obstructive sleep apnoea syndrome	11
Sleep disorder	11
Muscular weakness	6

Official prescribing information from the FDA-approved drug label.