Cevimeline: Side Effects, Uses & Monitoring
Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
- Data source
- FDA labeling via NIH DailyMed (label 0f15cb50…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Headache | 20.1% |
| Excessive sweating | 18.7% |
| Nausea | 13.8% |
| Sinusitis | 12.3% |
| Upper respiratory tract infection | 11.4% |
| Rhinitis | 11.2% |
| Diarrhea | 10.3% |
| Dyspepsia | 8.5% |
| Abdominal pain | 7.6% |
| Dizziness | 7.3% |
| Urinary tract infection | 6.1% |
| Coughing | 6.1% |
| Rash | 6% |
| Pharyngitis | 5.4% |
| Vomiting | 4.6% |
| Injury | 4.5% |
| Back pain | 4.5% |
| Conjunctivitis | 4.3% |
| Bronchitis | 4.1% |
| Arthralgia | 3.7% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
Frequently Asked Questions
What is Cevimeline used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Cevimeline?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Cevimeline. Individual risk varies.
Does Cevimeline require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Cevimeline.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.