Evoxac (cevimeline)
An approved treatment for Sjögren's Syndrome.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Cevimeline wherever you encounter it, plus the key facts at a glance.
- Generic name
- Cevimeline
- Brand name
- Evoxac
- Development code
- SNI-2011
- Drug class
- Muscarinic agonist (M1/M3 selective)
- Manufacturer
- Cosette Pharmaceuticals (brand Evoxac); generics from several companies
- How it's taken
- Taken as a 30mg oral capsule, 3 times daily.
An oral muscarinic agonist approved specifically for dry mouth symptoms in Sjögren's syndrome.
Cevimeline is more selective than pilocarpine for the M1 and M3 receptors on salivary glands, which may result in fewer sweating and cardiovascular side effects.
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Where Cevimeline fits
One of 2 FDA-approved oral secretagogues for Sjögren's dry mouth (alongside pilocarpine).
- The M1/M3 selectivity may offer a better side effect profile for some patients, particularly those who experience excessive sweating with pilocarpine. Both are symptomatic treatments only; disease-modifying therapies remain in clinical development.
How Cevimeline works
Cevimeline works on the same principle as pilocarpine: stimulating the remaining functional salivary and lacrimal gland cells to produce more moisture. However, cevimeline is more selective for the M1 and M3 muscarinic receptors that are most abundant on salivary glands, rather than activating all muscarinic receptor subtypes equally.
This selectivity may provide two advantages: stronger stimulation of saliva production and fewer off-target effects like sweating (which is driven primarily by M2/M3 receptors on sweat glands). Patients who experience excessive sweating with pilocarpine sometimes tolerate cevimeline better.
Like pilocarpine, cevimeline is a symptomatic treatment only. It does not address the underlying autoimmune destruction of glands and must be taken continuously to maintain its effect.
Side effects and safety
The most common side effects include excessive sweating (though often less than with pilocarpine), nausea, diarrhea, rhinitis (runny nose), and upper respiratory infections. Visual disturbances and excessive tearing can occur. Cevimeline should not be used in patients with uncontrolled asthma, narrow-angle glaucoma, or acute iritis.
The label also warns that it can change heart rate and rhythm and can narrow the airways, so people with heart disease, controlled asthma, chronic bronchitis, or COPD need close medical supervision. It can blur vision, especially at night, so take care driving in the dark; people with a history of kidney stones or gallstones should use it with caution; and anyone who sweats heavily should drink extra water to avoid dehydration. Compared to pilocarpine, cevimeline may cause less sweating due to its greater M3 selectivity on salivary glands.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Cevimeline
Taken as a 30mg oral capsule, 3 times daily. Effects typically begin within 60-90 minutes and last approximately 4-6 hours. Should be taken with water. Food can delay absorption.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Help paying for Evoxac
Several companies make generic cevimeline, so no single drugmaker program covers every version. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE. Pick your insurance below to see which offers fit you.
No drugmaker assistance program for this medicine is published on the maker's official pages.
Good to know: Cevimeline is sold as a generic by several companies (e.g. Lupin). No manufacturer program for brand Evoxac was found on an official page.
Cevimeline treatment timeline for Sjögren's Syndrome
Tap how long you have been on Cevimeline to drop your pin on the road. Your answers stay on this device.
Stage 1 of 5 · Start to 1 mo
Starting cevimeline
You are starting cevimeline (Evoxac) for dry mouth caused by Sjögren's syndrome. Cevimeline is a muscarinic receptor agonist like pilocarpine, and both medicines act on the same kind of receptor on salivary and tear glands. The dose is 30mg three times daily. In the label's Sjögren's studies, 18.7% of people on 30mg three times a day had excessive sweating, against 2.4% on placebo. If you are switching from pilocarpine because of sweating, ask your doctor what to expect, since no trial has compared the 2 medicines directly. Like pilocarpine, cevimeline stimulates your remaining gland tissue to produce more saliva and tears. It treats symptoms only and does not modify the underlying autoimmune disease.
Coming up
Many people notice more saliva within the first few weeks, though this varies from person to person. Cevimeline stays in the body longer than pilocarpine, with a half-life of about 5 hours. Side effects to watch for include sweating, nausea, runny nose and stomach upset. Tell your doctor if they bother you, since 14.6% of people in the label's Sjögren's studies stopped cevimeline because of side effects. If cevimeline is not providing enough relief after 4 weeks, discuss with your doctor whether other measures or a switch to pilocarpine makes sense.
Get in touch with your rheumatologist if you notice
- Breathing difficulty, wheezing, or chest tightness (muscarinic agonists can trigger bronchospasm: contraindicated in uncontrolled asthma)
- Severe visual disturbances or eye pain (can worsen narrow-angle glaucoma or cause accommodation changes)
- Excessive diarrhea or vomiting preventing medication adherence: contact your doctor; dose adjustment, timing changes, or switching to pilocarpine may be needed
- Allergic reaction symptoms
- Heart palpitations or irregular heartbeat (muscarinic agonists can affect cardiac conduction in susceptible individuals)
- Why did you choose cevimeline over pilocarpine for me? (Or: I am switching from pilocarpine: what should I expect to be different?)
- How long should I give cevimeline before we know if it is working?
- Can I take cevimeline with or without food?
- Will cevimeline help my dry eyes too, or is it mainly for dry mouth?
- Are there any drug interactions I should know about?
- What dental care routine should I follow alongside this medication?
Every stage of Cevimeline treatment at a glance
Starting cevimeline Start to 1 mo
You are starting cevimeline (Evoxac) for dry mouth caused by Sjögren's syndrome. Cevimeline is a muscarinic receptor agonist like pilocarpine, and both medicines act on the same kind of receptor on salivary and tear glands. The dose is 30mg three times daily. In the label's Sjögren's studies, 18.7% of people on 30mg three times a day had excessive sweating, against 2.4% on placebo. If you are switching from pilocarpine because of sweating, ask your doctor what to expect, since no trial has compared the 2 medicines directly. Like pilocarpine, cevimeline stimulates your remaining gland tissue to produce more saliva and tears. It treats symptoms only and does not modify the underlying autoimmune disease.
Many people notice more saliva within the first few weeks, though this varies from person to person. Cevimeline stays in the body longer than pilocarpine, with a half-life of about 5 hours. Side effects to watch for include sweating, nausea, runny nose and stomach upset. Tell your doctor if they bother you, since 14.6% of people in the label's Sjögren's studies stopped cevimeline because of side effects. If cevimeline is not providing enough relief after 4 weeks, discuss with your doctor whether other measures or a switch to pilocarpine makes sense.
Optimization and adjustment 1 mo to 3 mo
You have been on cevimeline for 1-3 months and are settling into the treatment. If you switched from pilocarpine, you can now compare the two: is the sweating better? Is the saliva production comparable? If you started directly on cevimeline, you are learning what the medication can and cannot do for your symptoms. The label recommends only 1 dose, 30mg three times a day, so there is little room for dose changes. Your broader Sjögren's management should also be taking shape: dental care, dry eye treatment, and monitoring for systemic symptoms.
If cevimeline is helping and side effects are manageable, your doctor may keep the current plan. If the benefit is insufficient, your options include: switching to pilocarpine (some patients respond better to one than the other despite their similar mechanisms), combining cevimeline with supportive measures (saliva substitutes, prescription fluoride, sugar-free lozenges to stimulate natural secretion), or exploring clinical trials of disease-modifying therapies. If your dry eyes are not adequately addressed, coordinate with an ophthalmologist for dedicated eye treatment.
Treatment assessment 3 mo to 6 mo
By 3-6 months, you and your doctor can usually tell how much cevimeline is easing your symptoms. Your doctor should be assessing both your subjective experience (does your mouth feel less dry, can you eat more comfortably, is speaking easier) and any objective measures (salivary flow rate, dental health, Schirmer test for tears). Your doctor can compare how you feel now with how you felt before treatment. If the benefit is marginal, your doctor should be discussing what else can be done.
For people doing well, cevimeline stays one part of a wider Sjögren's care plan. Frequent dental visits (every 3-4 months) remain important even when saliva production has improved. For patients with limited benefit: consider whether combining secretagogue therapy with newer supportive measures, trying pilocarpine instead, or pursuing clinical trials of disease-modifying agents is the best path forward. For all patients: regular monitoring for Sjögren's systemic complications continues through your rheumatologist, including surveillance for lymphoma risk factors (persistent parotid swelling, low C4 complement, monoclonal gammopathy) since Sjögren's raises lymphoma risk compared with the general population, though most people never develop it.
Ongoing management 6 mo to 2 yr
Cevimeline is now an established part of your Sjögren's routine. The daily management of dry mouth includes the medication, dental care, hydration, and practical strategies you have developed over months of living with the condition. Your rheumatologist continues to monitor for systemic disease activity and complications. Your dentist is an equally important member of your care team.
Regular check-ups with your rheumatologist and dentist go on. Several Sjögren's medicines are in late-stage trials or under FDA review, and none is FDA approved for Sjögren's yet. If your symptoms change significantly (either better or worse), reassess the treatment plan. Watch for any new systemic manifestations of Sjögren's that may need additional treatment.
Long-term outlook 2 yr on
You have been managing Sjögren's with cevimeline for 2 years or more. The medication remains effective as long as you have functioning gland tissue, but Sjögren's is progressive, and some patients notice gradually declining benefit as glands undergo irreversible damage over the years. Your long-term care integrates symptom management, complication screening, and quality-of-life optimization.
Several Sjögren's medicines that target the immune process are in late-stage trials or under FDA review. If approved, adding a disease-modifying drug to your existing symptom management may help control disease activity, which researchers hope could protect gland function over time. Your rheumatologist can tell you about new options as they come.
This timeline shows typical patterns from the prescribing information, guidelines and published studies. Your own treatment may differ, and your rheumatologist is the source of truth for your plan. Last checked against the FDA label on .
Clinical trial results
Placebo-controlled trials demonstrated that cevimeline 30mg 3 times daily significantly improved salivary flow rate and patient-reported dry mouth symptoms compared to placebo in Sjögren's syndrome patients. The trials supported FDA approval specifically for dry mouth symptoms associated with Sjögren's syndrome.
Development history
Developed by Daiichi Sankyo (as SNI-2011), cevimeline received FDA approval in January 2000 specifically for dry mouth symptoms in Sjögren's syndrome. It was designed as a more selective alternative to pilocarpine with potentially improved tolerability. Generic versions are now available.
Explore Sjögren's Syndrome trials
Other Sjögren's Syndrome treatments
Common questions about Cevimeline
▸What is Cevimeline (Evoxac)?
An oral muscarinic agonist approved specifically for dry mouth symptoms in Sjögren's syndrome. Cevimeline is more selective than pilocarpine for the M1 and M3 receptors on salivary glands, which may result in fewer sweating and cardiovascular side effects.
▸How does Cevimeline work?
Cevimeline works on the same principle as pilocarpine: stimulating the remaining functional salivary and lacrimal gland cells to produce more moisture. However, cevimeline is more selective for the M1 and M3 muscarinic receptors that are most abundant on salivary glands, rather than activating all muscarinic receptor subtypes equally.
This selectivity may provide two advantages: stronger stimulation of saliva production and fewer off-target effects like sweating (which is driven primarily by M2/M3 receptors on sweat glands). Patients who experience excessive sweating with pilocarpine sometimes tolerate cevimeline better.
Like pilocarpine, cevimeline is a symptomatic treatment only. It does not address the underlying autoimmune destruction of glands and must be taken continuously to maintain its effect.
▸What are the side effects of Cevimeline?
The most common side effects include excessive sweating (though often less than with pilocarpine), nausea, diarrhea, rhinitis (runny nose), and upper respiratory infections. Visual disturbances and excessive tearing can occur. Cevimeline should not be used in patients with uncontrolled asthma, narrow-angle glaucoma, or acute iritis. The label also warns that it can change heart rate and rhythm and can narrow the airways, so people with heart disease, controlled asthma, chronic bronchitis, or COPD need close medical supervision. It can blur vision, especially at night, so take care driving in the dark; people with a history of kidney stones or gallstones should use it with caution; and anyone who sweats heavily should drink extra water to avoid dehydration. Compared to pilocarpine, cevimeline may cause less sweating due to its greater M3 selectivity on salivary glands.
▸How is Cevimeline taken?
Taken as a 30mg oral capsule, 3 times daily. Effects typically begin within 60-90 minutes and last approximately 4-6 hours. Should be taken with water. Food can delay absorption.
▸Is Cevimeline FDA approved?
Yes, Cevimeline (Evoxac) is FDA approved (2000) for the treatment of Sjögren's Syndrome.
▸What is Evoxac?
Evoxac is the brand name for cevimeline hydrochloride, an oral capsule approved by the FDA in January 2000 to treat dry mouth in people with Sjogren's syndrome.
About the disease: Sjogren's syndrome is an autoimmune disease in which the immune system attacks the glands that make saliva and tears.
Capsule: Each white capsule contains 30mg of cevimeline and is marked EVOXAC on the cap.
Maker and generics: The brand is marketed by Cosette Pharmaceuticals, and generic cevimeline capsules are also available.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸What is cevimeline used for?
Cevimeline is approved for 1 use: treating the symptoms of dry mouth in people with Sjogren's syndrome.
Symptom treatment only: It helps the glands you still have make more saliva but does not slow the underlying autoimmune damage. It must be taken continuously to keep working.
Other uses: Any other use, such as dry mouth from radiation or from other medicines, is outside the FDA-approved label.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸How does cevimeline work?
Cevimeline is a cholinergic agonist, meaning it mimics acetylcholine, the nerve signal that tells glands to secrete.
Receptors: It binds to muscarinic receptors, the docking sites on salivary and sweat glands and on smooth muscle in the gut and bladder.
Effect: Stimulating those receptors on the salivary glands increases saliva production.
Selectivity: It is more selective for the M1 and M3 receptor types that are most abundant on salivary glands, which is why it may cause less sweating than older drugs that activate all muscarinic receptor types equally.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸What drug class is cevimeline?
Cevimeline is a muscarinic agonist, also described as a cholinergic agonist or a secretagogue (a drug that stimulates secretion).
Approved secretagogues: It is 1 of 2 FDA-approved oral secretagogues for Sjogren's dry mouth, the other being pilocarpine.
Selectivity: Within the class it is considered selective for the M1 and M3 muscarinic receptor subtypes.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸What is the chemical structure of cevimeline? Why is it called a spiro compound?
The chemical name is cis-2'-methylspiro{1-azabicyclo[2.2.2]octane-3,5'-[1,3]oxathiolane} hydrochloride, hydrate (2:1).
Why spiro: A spiro compound is one in which 2 rings share a single atom, like 2 hoops joined at 1 point; in cevimeline a quinuclidine ring (the azabicyclo-octane) and an oxathiolane ring share 1 carbon.
Formula and weight: Its formula is C10H17NOS.HCl with a half molecule of water, and its molecular weight is 244.79.
Appearance: It is a white to off-white crystalline powder that dissolves readily in water.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸How is cevimeline taken, and what is the dose?
The recommended dose is 1 capsule of 30mg taken 3 times a day.
Higher doses: The label says there is not enough safety information to support doses above 30mg 3 times a day, and no evidence that higher doses work better.
With food: Taking it with food slows absorption, delaying the peak blood level from about 1.5 hours to about 2.9 hours and lowering it by 17.3%.
How to take: Swallow the capsule with water, and drink extra water if the drug makes you sweat heavily, since dehydration can develop.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸How long does cevimeline take to work, and how long does it last?
Effects on saliva typically begin within 60 to 90 minutes and last about 4 to 6 hours, which is why it is dosed 3 times a day.
Peak level: After a single 30mg capsule, cevimeline reaches its peak blood level in about 1.5 to 2 hours.
Half-life: The drug's half-life (the time for the blood level to fall by half) is about 5 hours, and it does not build up in the body with repeated dosing.
Elimination: Most of it leaves the body in the urine within 24 hours.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸What are the side effects of Evoxac?
The most common side effect tied to its gland-stimulating action is excessive sweating, followed by nausea and runny nose.
Trial size: In the Sjogren's trials, 533 people took cevimeline 30mg 3 times a day and 164 took placebo.
Gland-related effects: Excessive sweating (18.7% vs 2.4% on placebo), nausea (13.8% vs 7.9%), runny nose (11.2% vs 5.4%), diarrhea (10.3% vs 10.3%) and excessive saliva (2.2% vs 0.6%).
Other common events: Reported in at least 3% of people on cevimeline were headache (14.4%, which was lower than the 20.1% on placebo), sinus infection (12.3%), upper respiratory infection (11.4%), indigestion (7.8%), abdominal pain (7.6%), urinary tract infection (6.1%), cough (6.1%) and vomiting (4.6%).
Stopping and other reports: In the placebo-controlled US studies, 14.6% of people stopped cevimeline because of side effects. Blurred vision, especially at night, and gallbladder inflammation (cholecystitis) have also been reported.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸Who should not take cevimeline?
Evoxac should not be taken by anyone with uncontrolled asthma, by anyone who has had an allergic reaction to cevimeline, or by people in whom a constricted pupil would be harmful, such as those with acute iritis (inflammation of the colored part of the eye) or narrow-angle glaucoma.
Heart conditions: The label says it should be used with caution and close medical supervision in people with a history of angina or heart attack, because it can change heart rhythm or rate.
Lung conditions: The same caution applies to people with controlled asthma, chronic bronchitis or COPD, because it can tighten the airways.
Kidney stones or gallstones: People with a history of either should also use it with caution, since it can make the gallbladder and ureters contract.
Pregnancy and breastfeeding: There are no well-controlled studies in pregnant women, and it is not known whether it passes into breast milk.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸Does cevimeline interact with other medicines?
Yes.
Beta blockers: The label advises caution because of a possible effect on the heart's electrical conduction.
Nervous system drugs: Other drugs that stimulate the parasympathetic nervous system can add to cevimeline's effects, and cevimeline can cancel out the drying effect of anticholinergic drugs taken on purpose.
Liver enzymes: Cevimeline is broken down by the liver enzymes CYP2D6 and CYP3A4, so medicines that block those enzymes can raise its levels, and people with low CYP2D6 activity may be at higher risk of side effects.
What to do: Give your doctor and pharmacist a full list of what you take.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸What are the alternatives to cevimeline?
The main alternative is pilocarpine, the other oral secretagogue approved for Sjogren's dry mouth.
Pilocarpine: It acts on a broader range of muscarinic receptors and tends to cause more sweating.
Symptom relief only: Both drugs only relieve symptoms, and disease-modifying treatments for Sjogren's remain in clinical development.
Switching: People who sweat too much on pilocarpine sometimes tolerate cevimeline better, so switching between the 2 is something to discuss with your doctor.
If neither works: If you cannot take either because of uncontrolled asthma, narrow-angle glaucoma or heart disease, your rheumatologist or dentist can talk through other ways to manage dry mouth.
▸What is the difference between cevimeline and pilocarpine for Sjogren's?
Both stimulate saliva production.
Cevimeline: Evoxac is more selective for salivary gland receptors (M1/M3), which may cause less sweating than pilocarpine.
Pilocarpine: It acts on a broader range of receptors.
Disease effect: Neither modifies the underlying disease.
▸Does Evoxac work? What did the clinical trials and patient reviews show?
In the placebo-controlled trials, cevimeline improved dry mouth symptoms and measured saliva flow, though one study found higher saliva flow without a significant difference in patient ratings.
First trial: In a 6-week placebo-controlled trial of 75 people, 76% of those taking cevimeline 30mg 3 times a day said their dry mouth was better, compared with 35% on placebo.
Second trial: In a 12-week trial of 197 people, the 30mg dose again produced a statistically significant improvement in dry mouth symptoms and in measured saliva flow, while a 15mg dose improved saliva flow but not symptoms.
Third trial: In a second 12-week trial of 212 people, saliva flow rose significantly but patient ratings did not differ significantly, partly because the placebo response was high in that study.
Patient reviews: Trial Friend does not collect patient reviews, so the trial ratings above are the best available measure of how people felt on the drug.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸Is there a generic for Evoxac, and how much does it cost?
Yes, generic cevimeline hydrochloride 30mg capsules are available from several companies.
Cost: The FDA label does not list a price, and Trial Friend does not have a verified cost figure; what you pay depends on your insurance, your pharmacy and whether the brand or the generic is dispensed.
Assistance: No manufacturer assistance program is listed for Evoxac on Trial Friend, so ask your pharmacist about the generic and any discount options.
▸Who makes cevimeline, and when was it approved?
Cevimeline was developed by Daiichi Sankyo under the code SNI-2011 and received FDA approval in January 2000.
Current brand owner: The Evoxac brand is now marketed by Cosette Pharmaceuticals, Inc. of South Plainfield, New Jersey, and the current label was issued in February 2022.
Generics: Generic versions are made by several other companies.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
▸How should Evoxac be stored?
Store the capsules at room temperature, 77°F (25°C), with short trips between 59°F and 86°F (15°C to 30°C) allowed.
Packaging: Evoxac is supplied in child-resistant bottles of 100 capsules.
Keep away from children: Keep the bottle closed and out of reach of children, since an overdose can cause exaggerated effects such as sweating, vomiting, slow or fast heartbeat, low blood pressure and confusion.
Source: FDA label for Evoxac, DailyMed, effective 2022-09-07
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration. EVOXAC (cevimeline HCl) Capsules Label. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dac32a9b-05b8-42c2-9a29-d885a9279456
- Archives of Internal Medicine · 2002-06-10. Fife RS, et al. Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome: a randomized trial. https://pubmed.ncbi.nlm.nih.gov/12038948/