What the label lists and what reports show
Cevimeline side effects
Cevimeline's FDA label lists its adverse reactions in its own words. FAERS holds 2,694 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (176 reports).
- Generic listed
Check it at the source: the cevimeline FDA label on DailyMed (effective January 5, 2023, Cosette Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsCevimeline was administered to 1777 patients during clinical trials worldwide, including Sjögren’s patients and patients with other conditions. In placebo-controlled Sjögren’s studies in the U.S., 320 patients received cevimeline doses ranging from 15 mg tid to 60 mg tid, of whom 93% were women and 7% were men. Demographic distribution was 90% Caucasian, 5% Hispanic, 3% Black and 2% of other origin. In these studies, 14.6% of patients discontinued treatment with cevimeline due to adverse events. The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline in Sjögren’s syndrome patients: Adverse Event Cevimeline 30 mg (tid) n*=533 Placebo (tid) n=164 Excessive Sweating 18.7% 2.4% Nausea 13.8% 7.9% Rhinitis 11.2% 5.4% Diarrhea 10.3% 10.3% Excessive Salivation 2.2% 0.6% Urinary Frequency 0.9% 1.8% Asthenia 0.5% 0.0% Flushing 0.3% 0.6% …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Event | Cevimeline 30 mg (tid) n*=533 | Placebo (tid) n=164 |
|---|---|---|
| Headache | 14.4% | 20.1% |
| Sinusitis | 12.3% | 10.9% |
| Upper Respiratory Tract Infection | 11.4% | 9.1% |
| Dyspepsia | 7.8% | 8.5% |
| Abdominal Pain | 7.6% | 6.7% |
| Urinary Tract Infection | 6.1% | 3.0% |
| Coughing | 6.1% | 3.0% |
| Pharyngitis | 5.2% | 5.4% |
| Vomiting | 4.6% | 2.4% |
| Injury | 4.5% | 2.4% |
| Back Pain | 4.5% | 4.2% |
| Rash | 4.3% | 6.0% |
| Conjunctivitis | 4.3% | 3.6% |
| Dizziness | 4.1% | 7.3% |
| Bronchitis | 4.1% | 1.2% |
| Arthralgia | 3.7% | 1.8% |
| Surgical Intervention | 3.3% | 3.0% |
| Fatigue | 3.3% | 1.2% |
| Pain | 3.3% | 3.0% |
| Skeletal Pain | 2.8% | 1.8% |
| Insomnia | 2.4% | 1.2% |
| Hot Flushes | 2.4% | 0.0% |
| Rigors | 1.3% | 1.2% |
| Anxiety | 1.3% | 1.2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Cosette Pharmaceuticals, Inc., effective January 5, 2023 (SPL set efc2bb24-4dda-4781-bef5-fcd9abf082dd), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,694 reports list cevimeline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 105 are coded as a death and 660 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cevimeline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions