Uses
Cevimeline is indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.
Source: US FDA prescribing information
- Presentations
- 2
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Cevimeline is a cholinergic receptor agonist indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome. It is available as capsules for oral use. MedsAcross supplies Cevimeline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cholinergic Receptor Agonist, Cholinergic Muscarinic Agonists
- ATC classification
- N07AX03 Cevimeline · Parasympathomimetic drug, subgroup N07AX
- US FDA first approval
- 11 January 2000
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Capsule
- Identifiers
- UNII P81Q6V85NPRxCUI 44281CAS 107233-08-9DrugBank DB00185Q3665683
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
The recommended dose of cevimeline hydrochloride capsules is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.
Source: US FDA prescribing information
Contraindications
Cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.
Source: US FDA prescribing information
Warnings and precautions
Cardiovascular Disease: Cevimeline can potentially alter cardiac conduction and/or heart rate. Patients with significant cardiovascular disease may potentially be unable to compensate for transient changes in hemodynamics or rhythm induced by cevimeline. Cevimeline should be used with caution and under close medical supervision in patients with a history of cardiovascular disease evidenced by angina pectoris or myocardial infarction. Pulmonary Disease: Cevimeline can potentially increase airway resistance, bronchial smooth muscle tone, and bronchial secretions. Cevimeline should be administered with caution and with close medical supervision to patients with controlled asthma, chronic bronchitis, or chronic obstructive pulmonary disease.
Source: US FDA prescribing information
Side effects
Cevimeline 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.
Source: US FDA prescribing information
Storage
Store at 25°C (77°F) excursion permitted to 15°-30°C (59°-86°F) Rx only Marketed by: Cosette Pharmaceuticals, Inc.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Cevimeline, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cevimeline 30 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Evoxac 30 mg capsuleOral | Cosette Pharmaceuticals | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 11 January 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Cevimeline in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Cevimeline available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Cevimeline and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Cevimeline have?
The catalogue lists 1 brand names for Cevimeline, including Evoxac.
Is Cevimeline approved by the US FDA?
Yes. The US FDA first approved Cevimeline on 11 January 2000, according to Drugs@FDA.
Does Cevimeline need cold chain shipping?
No listed presentation of Cevimeline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Cevimeline in?
Cevimeline is classified under ATC code N07AX03 (Cevimeline).
References
- cevimeline hydrochloride prescribing information (Cosette Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 5 January 2023
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