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Cevimeline Side Effects

For the Consumer

Applies to cevimeline: oral capsule

Along with its needed effects, cevimeline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cevimeline:

Less common
  • Difficulty breathing
  • fast heartbeat
  • itching
Rare
  • Chest pain
  • fainting or light-headedness when getting up from a lying or a sitting position
  • swelling of gums or tongue
Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur while taking cevimeline:

  • Blurring or loss of vision
  • chest pain
  • cold, clammy skin
  • diarrhea, continuous and severe
  • disturbed color vision
  • dizziness, faintness, or light-headedness when getting up from a lying or sitting position
  • difficult or labored breathing
  • fast, pounding, slow, or irregular heartbeat
  • fast, weak pulse
  • headache
  • mental confusion
  • nausea
  • pounding in ears
  • shaking or trembling of hands or feet
  • shortness of breath
  • stomach cramps or pain
  • sweating
  • tearing of the eyes

Check with your doctor as soon as possible if any of the following side effects occur while taking cevimeline:

Less common
  • Bloody or cloudy urine
  • blurred vision
  • chest pain
  • cough
  • cracks in skin
  • difficult, burning , or painful urination
  • dizziness
  • dry or itching eyes
  • earache
  • feeling of constant movement of self or surroundings
  • itching of vagina, genital, or other skin area
  • lower back pain
  • redness or pain in eye
  • ringing or buzzing in the ears
  • scaling of skin
  • shortness of breath
  • skin rash
  • soreness or redness of skin
  • sores, ulcers, or white spots on tongue, lips, or inside of mouth
  • stiffness of muscles
  • swelling of hands, ankles, feet, or lower legs
  • swelling on side of face and jaw, with or without pain
  • tense muscles

Some side effects of cevimeline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Excessive sweating
  • nausea
  • runny or stuffy nose
Less common
  • Abdominal pain
  • belching
  • bloating or swelling of face, hands, feet, or lower legs
  • bloody nose
  • bone or joint pain
  • burning, dry, or itching feeling in eye
  • change in vision
  • chills
  • constipation
  • cough, mucus-producing
  • decreased touch sensation
  • depression
  • diarrhea
  • dry mouth
  • eye pain
  • feelings of warmth in face, neck, arms, and occasionally, chest
  • fever
  • heartburn
  • hiccups
  • injury
  • itching
  • leg cramps
  • loss of appetite
  • migraine headache
  • mood or mental changes
  • muscle aches, pain, or stiffness
  • pain and swelling of eye, eyelid, or inner lining of eye
  • pain on side of face and jaw
  • pain, swelling, or redness of joints
  • postoperative pain
  • rapid weight gain
  • shortness of breath
  • skin disorder
  • tightness in chest
  • tooth disorders or pain
  • trembling or shaking of hands or feet
  • trouble in sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • watering of mouth
  • weight loss
Rare
  • Abnormal crying
  • deep, dark, purple bruise
  • swelling or puffiness of face
  • temperature sensation changes

For Healthcare Professionals

Applies to cevimeline: oral capsule

General

The most commonly reported side effects were excessive sweating, nausea, diarrhea, rhinitis, sinusitis, upper respiratory tract infection, and headache.[Ref]

Cardiovascular

Common (1% to 10%): Hot flushes
Uncommon (0.1% to 1%): Flushing, precordial chest pain, hematoma, pallor, substernal chest pain, abnormal ECG, heart disorder, heart murmur, aggravated hypertension, hypotension, arrhythmia, extrasystoles, t wave inversion, tachycardia, supraventricular tachycardia, angina pectoris, myocardial infarction, pericarditis, peripheral ischemia, superficial phlebitis, purpura, deep thrombophlebitis, vasculitis, vascular disorder, hypertension, post-operative hemorrhage
Frequency not reported: Blood pressure fluctuation, cardiomegaly, postural hypotension, bundle branch block, distended vein[Ref]

Hepatic

Uncommon (0.1% to 1%): Cholelithiasis, increased gamma-glutamyl transferase, increased hepatic enzymes, abnormal hepatic function, viral hepatitis, increased serum glutamate oxaloacetic transaminase (SGOT/AST), increased serum glutamate pyruvate transaminase (SGPT/ALT) Postmarketing reports: Cholecystitis[Ref]

Hematologic

Uncommon (0.1% to 1%): Cholelithiasis, increased gamma-glutamyl transferase, increased hepatic enzymes, abnormal hepatic function, viral hepatitis, increased serum glutamate oxaloacetic transaminase (SGOT/AST), increased serum glutamate pyruvate transaminase (SGPT/ALT) Postmarketing reports: Cholecystitis[Ref]

Gastrointestinal

Very common (10% or more): Nausea (13.8%), Diarrhea (10.3%)
Common (1% to 10%): Excessive salivation, dyspepsia, abdominal pain, vomiting
Uncommon (0.1% to 1%): Mouth edema, appendicitis, ulcerative colitis, diverticulitis, duodenitis, 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, food poisoning
Frequency not reported: Enlarged abdomen, change in bowel habits, gum hyperplasia, intestinal obstruction[Ref]

Nervous system

Very common (10% or more): Headache (14.4%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Syncope, 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, motion sickness, parosmia, taste perversion
Frequency not reported: Cholinergic syndrome, aphasia, convulsions, abnormal gait, hyperesthesia, paralysis, amnesia, neurosis[Ref]

Respiratory

Very common (10% or more): Sinusitis (12.3%), upper respiratory tract infection (11.4%), rhinitis (11.2%)
Common (1% to 10%): Coughing, pharyngitis, bronchitis
Uncommon (0.1% to 1%): Choking, pulmonary embolism, asthma, bronchospasm, chronic obstructive airway disease, dyspnea, hemoptysis, laryngitis, nasal ulcer, pleural effusion, pleurisy, pulmonary congestion, pulmonary fibrosis, respiratory disorder
Frequency not reported: Apnea, atelectasis, yawning[Ref]

Genitourinary

Uncommon (0.1% to 1%): Genital moniliasis, 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
Frequency not reported: Abnormal sexual function, impotence, oliguria, urinary retention[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, skeletal pain
Uncommon (0.1% to 1%): Leg pain, arthritis, aggravated arthritis, arthropathy, femoral head avascular necrosis, bone disorder, bursitis, costochondritis, plantar fasciitis, muscle weakness, osteomyelitis, osteoporosis, synovitis, tendinitis, tenosynovitis, joint dislocation, aggravated rheumatoid arthritis[Ref]

Dermatologic

Very common (10% or more): Excessive sweating (18.7%)
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Cellulitis, lupus erythematosus rash, lupus erythematosus syndrome, acne, alopecia, burn, dermatitis, contact dermatitis, lichenoid dermatitis, eczema, furunculosis, hyperkeratosis, lichen planus, nail discoloration, nail disorder, onychia, onychomycosis, paronychia, photosensitivity reaction, rosacea, scleroderma, seborrhea, skin discoloration, dry skin, skin exfoliation, skin hypertrophy, skin ulceration, urticaria, verruca, bullous eruption, cold clammy skin[Ref]

Ocular

Common (1% to 10%): Conjunctivitis, rigors
Uncommon (0.1% to 1%): Periorbital edema, blepharitis, cataract, corneal opacity, corneal ulceration, diplopia, glaucoma, anterior chamber eye hemorrhage, keratitis, keratoconjunctivitis, mydriasis, myopia, photopsia, retinal deposits, retinal disorder, scleritis, vitreous detachment[Ref]

Endocrine

Uncommon (0.1% to 1%): Increased glucocorticoids, goiter, hypothyroidism[Ref]

Immunologic

Uncommon (0.1% to 1%): Aggravated allergy, herpes simplex, herpes zoster, bacterial infection, viral infection, sepsis[Ref]

Metabolic

Uncommon (0.1% to 1%): Weight decrease, weight increase, increased appetite, dehydration, diabetes mellitus, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, thirst
Frequency not reported: Electrolyte abnormality, hyperkalemia, hyperproteinemia, failure to thrive, gout[Ref]

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma, squamous carcinoma[Ref]

Other

Common (1% to 10%): Injury, surgical intervention, fatigue, pain
Uncommon (0.1% to 1%): Asthenia, abnormal crying, edema, activated pain trauma, changed temperature sensation, malaise, face edema, fall, heat stroke, deafness, decreased hearing, tinnitus
Frequency not reported: Increased creatine phosphokinase, increased lactic dehydrogenase (LDH), increased alkaline phosphatase[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety
Frequency not reported: Aggressive reaction, apathy, delirium, delusion, dementia, illusion, paranoid reaction, personality disorder

Renal

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary frequency, polyuria, glycosuria[Ref]

References

1. "Product Information. Evoxac (cevimeline)" Daiichi Pharmaceuticals, Fort lee, NJ.

Some side effects of cevimeline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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