OLANZAPINE\SAMIDORPHAN L-MALATE: 1,301 Adverse Event Reports & Safety Profile

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1,301

Total FAERS Reports

14 (1.1%)

Deaths Reported

116

Hospitalizations

1,301

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20210101 · Latest Report: 20250801

What Are the Most Common OLANZAPINE\SAMIDORPHAN L-MALATE Side Effects?

#1 Most Reported

Off label use

259 reports (19.9%)

#2 Most Reported

Contraindicated product administered

86 reports (6.6%)

#3 Most Reported

Dizziness

80 reports (6.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Off label use	259	19.9%	2	14
Contraindicated product administered	86	6.6%	1	33
Dizziness	80	6.2%	0	3
Insomnia	60	4.6%	0	3
Weight decreased	59	4.5%	1	3
Weight increased	57	4.4%	0	1
Nausea	53	4.1%	0	0
Feeling abnormal	52	4.0%	0	2
Vomiting	51	3.9%	0	3
Decreased appetite	48	3.7%	0	2
Somnolence	48	3.7%	0	3
Sedation	47	3.6%	0	4
Fatigue	40	3.1%	0	2
Anxiety	37	2.8%	0	2
Drug screen false positive	36	2.8%	0	0
Withdrawal syndrome	35	2.7%	0	11
Tremor	33	2.5%	0	4
Drug withdrawal syndrome	32	2.5%	0	9
Hypersomnia	32	2.5%	0	3
Agitation	29	2.2%	0	1

Gender: 58.9% female, 41.1% male. Average age: 40.0 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2021	32	0	4
2022	82	1	13
2023	67	2	8
2024	110	1	28
2025	74	1	11

Indication	Reports
Product used for unknown indication	617
Bipolar disorder	167
Bipolar i disorder	165
Schizophrenia	133
Schizoaffective disorder bipolar type	31
Schizoaffective disorder	30
Psychotic disorder	26
Depression	25
Bipolar ii disorder	23
Affective disorder	18

Official prescribing information from the FDA-approved drug label.