OpenClaim

Xanomeline Side Effects

The most commonly reported side effects of xanomeline include nausea, vomiting, and constipation, based on 1,423 FDA adverse event reports from 2004 to 2025. 2.3% of reports found the drug to be ineffective.

Xanomeline side effects

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

1
Nausea22.0%313
2
Vomiting16.7%238
3
Constipation7.4%106
4
Off Label Use6.8%97
5
Urinary Retention6.1%87
6
Dizziness4.3%61
7
Vision Blurred3.5%50
8
Dyspepsia3.5%50
9
Hyperhidrosis3.2%46
10
Treatment Noncompliance2.6%37
11
Dry Mouth2.5%35
12
Drug Ineffective2.3%33
13
Somnolence2.2%32
14
Gastrooesophageal Reflux Disease2.2%32
15
Drooling2.2%31

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

Report severity

23.1%Serious329 reports
7.7%Hospitalizations109 reports
1.4%Fatal20 reports

Seriousness is determined by the reporter, not by OpenClaim.

Xanomeline drug interactions

Other drugs that appear in adverse event reports alongside xanomeline. 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
Trospium-chloride98.9%1,408
2
Clozapine1.5%21
3
Olanzapine0.9%13
4
Risperidone0.8%11
5
Bupropion0.4%6
6
Haloperidol0.4%6
7
Paliperidone0.4%5
8
Ondansetron0.4%5
9
Lithium0.3%4
10
Aripiprazole0.3%4
11
Divalproex-sodium0.2%3
12
Hydroxyzine0.2%3
13
Samidorphan-l-malate0.2%3
14
Lorazepam0.2%3
15
Lumateperone0.1%2

Taken alongside

1
Clozapine3.0%42
2
Olanzapine2.2%31
3
Aripiprazole2.0%28
4
Paliperidone1.8%25
5
Risperidone1.4%20
6
Divalproex-sodium1.3%19
7
Haloperidol1.3%19
8
Lamotrigine1.3%19
9
Quetiapine-fumarate1.2%17
10
Lithium1.2%17
11
Benztropine-mesylate1.1%15
12
Trazodone-hydrochloride0.9%13
13
Hydroxyzine0.9%13
14
Clonazepam0.9%13
15
Ondansetron0.8%12

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 xanomeline side effects

31.0% of xanomeline adverse event reports involve female patients and 46.1% involve male patients. The largest age group is adult at 91%. These figures reflect who reports side effects, not underlying risk.

Sex

Female31.0%
Male46.1%
Unknown22.9%

Age group

< 20.0%
2–110.0%
12–170.9%
18–6491.0%
65+8.1%

What is xanomeline used for

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

Affective DisorderAggressionAnxietyAutism Spectrum DisorderBipolar I DisorderBipolar DisorderCerebral DisorderDelusionDelusional Disorder, Unspecified TypeDementiaDepressionHallucinationIntellectual DisabilityManiaMental Disorder

Showing 15 of 28 indications

Xanomeline brand names and reporting trend

Xanomeline is sold under the brand name Cobenfy.

Brand names

Cobenfy7

Quarterly reports (20042025)

20042025

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

Taking xanomeline with another medication?

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