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Samidorphan Side Effects

The most commonly reported side effects of samidorphan include off label use, contraindicated product administered, and dizziness, based on 1,432 FDA adverse event reports from 2011 to 2025.

Samidorphan side effects

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

1
Off Label Use19.0%272
2
Contraindicated Product Administered6.7%96
3
Dizziness5.8%83
4
Weight Increased4.9%70
5
Insomnia4.7%67
6
Weight Decreased4.3%62
7
Nausea4.2%60
8
Vomiting4.1%58
9
Feeling Abnormal3.8%54
10
Decreased Appetite3.5%50
11
Sedation3.4%49
12
Somnolence3.4%49
13
Fatigue3.3%47
14
Anxiety2.9%41
15
Drug Withdrawal Syndrome2.7%39

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

Report severity

20.6%Serious295 reports
10.4%Hospitalizations149 reports
1.0%Fatal14 reports

Seriousness is determined by the reporter, not by OpenClaim.

Samidorphan drug interactions

Other drugs that appear in adverse event reports alongside samidorphan. 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
Olanzapine96.2%1,377
2
Buprenorphine3.1%44
3
Naloxone-hydrochloride2.5%36
4
Methadone-hydrochloride1.3%19
5
Divalproex-sodium0.8%12
6
Paliperidone0.6%9
7
Fentanyl0.6%9
8
Aripiprazole0.6%8
9
Lumateperone0.6%8
10
Trospium-chloride0.6%8
11
Xanomeline-tartrate0.6%8
12
Amphetamine0.6%8
13
Sodium-oxybate0.5%7
14
Quetiapine-fumarate0.4%6
15
Naltrexone0.3%5

Taken alongside

1
Olanzapine20.8%298
2
Lamotrigine3.6%51
3
Lithium2.6%37
4
Trazodone-hydrochloride2.4%35
5
Divalproex-sodium2.3%33
6
Buspirone-hydrochloride2.3%33
7
Gabapentin2.2%32
8
Clonazepam2.2%32
9
Hydroxyzine2.0%29
10
Benztropine-mesylate2.0%29
11
Metformin2.0%28
12
Ergocalciferol1.9%27
13
Quetiapine-fumarate1.9%27
14
Fluoxetine-hydrochloride1.8%26
15
Bupropion1.7%24

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 samidorphan side effects

49.3% of samidorphan adverse event reports involve female patients and 34.0% involve male patients. The largest age group is adult at 88%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.3%
Male34.0%
Unknown16.7%

Age group

< 20.2%
2–111.0%
12–173.4%
18–6487.7%
65+7.7%

What is samidorphan used for

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

Abnormal Weight GainAdverse Drug ReactionAffective DisorderAggressionAgitationAlcohol Use DisorderAlcoholismAngerAntipsychotic TherapyAnxietyAnxiety DisorderArthritisAttention Deficit Hyperactivity DisorderAutism Spectrum DisorderBehaviour Disorder

Showing 15 of 69 indications

Samidorphan brand names and reporting trend

Samidorphan is sold under the brand name Lybalvi.

Brand names

Lybalvi7

Quarterly reports (20112025)

201120242025

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

Taking samidorphan with another medication?

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