"Patients with psoriatic arthritis (PsA) may be at increased risk for experiencing significant cardiovascular (CV) events, a new study suggests.
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Evoxac Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Evoxac (cevimeline hydrochloride) is a cholinergic agonist that works by stimulating certain nerves to increase the amount of saliva produced used to treat dry mouth in people with Sjogren's Syndrome. Evoxac is available in generic form. Common side effects of Evoxac include sweating, excessive salivating or drooling, nausea, loss of appetite, runny or stuffy nose, flushing, frequent urge to urinate, dizziness, weakness, diarrhea, constipation, blurred vision, dry eyes, dry mouth, muscle pain, or vaginal itching or discharge.
The recommended dose of Evoxac is 30 mg taken three times a day. Evoxac may interact with amiodarone, cimetidine, cyclosporine, metronidazole, antibiotics, antidepressants, asthma medicines, heart or blood pressure medications, or HIV /AIDS medicines. Tell your doctor all medications you use. During pregnancy, Evoxac should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Evoxac (cevimeline hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Evoxac in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking cevimeline and call your doctor at once if you have any of these serious side effects:
- shortness of breath, wheezing, or tightness in your chest;
- chest pain, uneven heart rate;
- attacks of severe stomach pain on the right side, extending up to your shoulder (sometimes worse after meals);
- nausea and vomiting, bloating, fever, chills, and jaundice (yellowing of the skin or eyes);
- swelling in your hands or feet;
- eye pain or drainage;
- fever, ear ache, flu symptoms; or
- white patches or sores inside your mouth or on your lips.
Less serious side effects may include:
- blurred vision, dry eyes;
- excessive sweating or salivating, drooling;
- runny or stuffy nose;
- nausea, diarrhea, constipation, loss of appetite;
- dry mouth;
- muscle pain;
- vaginal itching or discharge;
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Evoxac (Cevimeline HCL)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Evoxac Overview - Patient Information: Side Effects
Sweating, nausea, runny nose, flushing, frequent urge to urinate, dizziness, weakness, diarrhea, and blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause an increase in tears. This can be helpful if you have dry eyes. Tell your doctor if runny eyes become a problem.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/fast/irregular heartbeat, shakiness (tremor), fainting, lung problems (such as increased wheezing/cough/phlegm), mental/mood changes (such as confusion, agitation), severe stomach/abdominal pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Evoxac (Cevimeline HCL)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Evoxac 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.
The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline in Sjögren's syndrome patients:
|*n is the total number of patients exposed to the dose at any time during the study.|
In addition, the following adverse events (≥ 3% incidence) were reported in the Sjögren's clinical trials:
|Upper Respiratory Tract Infection||11.4%||9.1%|
|Urinary Tract Infection||6.1%||3.0%|
|*n is the total number of patients exposed to the dose at any time during the study.|
The following events were reported in Sjögren's patients at incidences of <3% and ≥ 1%: constipation, tremor, abnormal vision, hypertonia, peripheral edema, chest pain, myalgia, fever, anorexia, eye pain, earache, dry mouth, vertigo, salivary gland pain, pruritus, influenza-like symptoms, eye infection, post-operative pain, vaginitis, skin disorder, depression, hiccup, hyporeflexia, infection, fungal infection, sialoadenitis, otitis media, erythematous rash, pneumonia, edema, salivary gland enlargement, allergy, gastroesophageal reflux, eye abnormality, migraine, tooth disorder, epistaxis, flatulence, toothache, ulcerative stomatitis, anemia, hypoesthesia, cystitis, leg cramps, abscess, eructation, moniliasis, palpitation, increased amylase, xerophthalmia, allergic reaction.
The following events were reported rarely in treated Sjögren's patients (<1%): Causal relation is unknown:
Body as a Whole Disorders: aggravated allergy, precordial chest pain, abnormal crying, hematoma, leg pain, edema, periorbital edema, activated pain trauma, pallor, changed sensation temperature, weight decrease, weight increase, choking, mouth edema, syncope, malaise, face edema, substernal chest pain
Cardiovascular Disorders: abnormal ECG, heart disorder, heart murmur, aggravated hypertension, hypotension, arrhythmia, extrasystoles, t wave inversion, tachycardia, supraventric-ular tachycardia, angina pectoris, myocardial infarction, pericarditis, pulmonary embolism, peripheral ischemia, superficial phlebitis, purpura, deep thrombophlebitis, vascular disorder, vasculitis, hypertension
Digestive Disorders: appendicitis, increased appetite, ulcerative colitis, diverticulitis, duod-enitis, dysphagia, enterocolitis, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, gingivitis, glossitis, rectum hemorrhage, hemorrhoids, ileus, irritable bowel syndrome, melena, mucositis, esophageal stricture, esophagitis, oral hemorrhage, peptic ulcer, periodontal destruction, rectal disorder, stomatitis, tenesmus, tongue discoloration, tongue disorder, geographic tongue, tongue ulceration, dental caries
Hematologic Disorders: thrombocytopenic purpura, thrombocythemia, thrombocytopenia, hypochromic anemia, eosinophilia, granulocytopenia, leucopenia, leukocytosis, cervical lymphadenopathy, lymphadenopathy
Liver and Biliary System Disorders: cholelithiasis, increased gamma-glutamyl transferase, increased hepatic enzymes, abnormal hepatic function, viral hepatitis, increased serum glutamate oxaloacetic transaminase (SGOT) (also called AST-aspartate aminotransferase), increased serum glutamate pyruvate transaminase (SGPT) (also called ALT-alanine amino-transferase)
Metabolic and Nutritional Disorders: dehydration, diabetes mellitus, hypercalcemia, hyper-cholesterolemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, thirst
Musculoskeletal Disorders: arthritis, aggravated arthritis, arthropathy, femoral head avas-cular necrosis, bone disorder, bursitis, costochondritis, plantar fasciitis, muscle weakness, osteomyelitis, osteoporosis, synovitis, tendinitis, tenosynovitis
Nervous Disorders: carpal tunnel syndrome, coma, abnormal coordination, dysesthesia, dyskinesia, dysphonia, aggravated multiple sclerosis, involuntary muscle contractions, neuralgia, neuropathy, paresthesia, speech disorder, agitation, confusion, depersonalization, aggravated depression, abnormal dreaming, emotional lability, manic reaction, paroniria, somnolence, abnormal thinking, hyperkinesia, hallucination
Respiratory Disorders: asthma, bronchospasm, chronic obstructive airway disease, dyspnea, hemoptysis, laryngitis, nasal ulcer, pleural effusion, pleurisy, pulmonary congestion, pulmonary fibrosis, respiratory disorder
Skin and Appendages Disorders: acne, alopecia, burn, dermatitis, contact dermatitis, lichen-oid dermatitis, eczema, furunculosis, hyperkeratosis, lichen planus, nail discoloration, nail disorder, onychia, onychomycosis, paronychia, photosensitivity reaction, rosacea, sclero-derma, seborrhea, skin discoloration, dry skin, skin exfoliation, skin hypertrophy, skin ulceration, urticaria, verruca, bullous eruption, cold clammy skin
Special Senses Disorders: deafness, decreased hearing, motion sickness, parosmia, taste perversion, blepharitis, cataract, corneal opacity, corneal ulceration, diplopia, glaucoma, anterior chamber eye hemorrhage, keratitis, keratoconjunctivitis, mydriasis, myopia, photopsia, retinal deposits, retinal disorder, scleritis, vitreous detachment, tinnitus
Urogenital Disorders: epididymitis, prostatic disorder, abnormal sexual function, amenorrhea, female breast neoplasm, malignant female breast neoplasm, female breast pain, positive cervical smear test, dysmenorrhea, endometrial disorder, intermenstrual bleeding, leukorrhea, menorrhagia, menstrual disorder, ovarian cyst, ovarian disorder, genital pruritus, uterine hemorrhage, vaginal hemorrhage, atrophic vaginitis, albuminuria, bladder discomfort, increased blood urea nitrogen, dysuria, hematuria, micturition disorder, nephrosis, nocturia, increased nonprotein nitrogen, pyelonephritis, renal calculus, abnormal renal function, renal pain, strangury, urethral disorder, abnormal urine, urinary incontinence, decreased urine flow, pyuria
In one subject with lupus erythematosus receiving concomitant multiple drug therapy, a highly elevated ALT level was noted after the fourth week of cevimeline therapy. In two other subjects receiving cevimeline in the clinical trials, very high AST levels were noted. The significance of these findings is unknown.
Additional adverse events (relationship unknown) which occurred in other clinical studies (patient population different from Sjögren's patients) are as follows:
cholinergic syndrome, blood pressure fluctuation, cardiomegaly, postural hypotension, aphasia, convulsions, abnormal gait, hyperesthesia, paralysis, abnormal sexual function, enlarged abdomen, change in bowel habits, gum hyperplasia, intestinal obstruction, bundle branch block, increased creatine phosphokinase, electrolyte abnormality, glycosuria, gout, hyper-kalemia, hyperproteinemia, increased lactic dehydrogenase (LDH), increased alkaline phos-phatase, failure to thrive, abnormal platelets, aggressive reaction, amnesia, apathy, delirium, delusion, dementia, illusion, impotence, neurosis, paranoid reaction, personality disorder, hyperhemoglobinemia, apnea, atelectasis, yawning, oliguria, urinary retention, distended vein, lymphocytosis
The following adverse reaction has been identified during post-approval use of EVOXAC (cevimeline hcl) ®. Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
POST-MARKETING ADVERSE EVENTS
Liver and Biliary System Disorders: cholecystitis
Read the entire FDA prescribing information for Evoxac (Cevimeline HCL)
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