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Cevimeline Side Effects

The most commonly reported side effects of cevimeline include diarrhoea, headache, and nausea, based on 3,200 FDA adverse event reports from 2004 to 2025. 6.4% of reports found the drug to be ineffective.

Cevimeline side effects

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

1
Drug Ineffective6.4%204
2
Diarrhoea5.2%166
3
Headache5.0%159
4
Nausea4.4%142
5
Fatigue4.4%141
6
Dyspnoea4.1%132
7
Pain3.6%115
8
Off Label Use3.5%113
9
Arthralgia3.4%110
10
Fall3.1%99
11
Dizziness3.0%95
12
Malaise2.9%94
13
Pneumonia2.6%82
14
Dry Mouth2.5%81
15
Vomiting2.5%79

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

Report severity

58.7%Serious1,879 reports
28.8%Hospitalizations922 reports
4.8%Fatal152 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cevimeline drug interactions

Other drugs that appear in adverse event reports alongside cevimeline. 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
Adalimumab7.4%238
2
Sodium-oxybate7.2%230
3
Etanercept4.0%127
4
Lenalidomide2.8%89
5
Tofacitinib2.7%87
6
Treprostinil2.5%79
7
Apremilast2.2%69
8
Cenegermin-bkbj2.0%63
9
Ambrisentan1.8%59
10
Dupilumab1.7%55
11
Belimumab1.5%48
12
Pregabalin1.5%47
13
Prednisone1.3%43
14
Esomeprazole1.2%38
15
Certolizumab-pegol1.2%37

Taken alongside

1
Ergocalciferol23.3%747
2
Levothyroxine-sodium21.2%678
3
Acetaminophen18.4%588
4
Hydroxychloroquine-sulfate18.2%583
5
Omeprazole18.2%582
6
Gabapentin16.4%524
7
Aspirin16.3%521
8
Prednisone16.2%519
9
Folic-acid14.7%469
10
Furosemide13.7%438
11
Albuterol12.3%394
12
Fluticasone11.6%372
13
Duloxetine-hydrochloride11.6%372
14
Methotrexate11.5%368
15
Atorvastatin-calcium11.3%362

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 cevimeline side effects

77.7% of cevimeline adverse event reports involve female patients and 16.1% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female77.7%
Male16.1%
Unknown6.2%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6455.6%
65+44.2%

What is cevimeline used for

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

Acute Respiratory Distress SyndromeAdverse EventAntibiotic ProphylaxisAntibiotic TherapyAntifungal ProphylaxisAntiviral ProphylaxisAptyalismArthritisArthropod BiteAsthmaAtypical Mycobacterial InfectionAutonomic NeuropathyAnhidrosisAptyalismAutonomic Nervous System Imbalance

Showing 15 of 131 indications

Cevimeline brand names and reporting trend

Cevimeline is sold under the brand name Cevimeline Hydrochloride.

Brand names

Cevimeline Hydrochloride5

Quarterly reports (20042025)

20052010201520202025

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

Taking cevimeline with another medication?

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