Cevimeline Side Effects

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.

For the Consumer

Applies to cevimeline: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking cevimeline: 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 of cevimeline 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.

For Healthcare Professionals

Applies to cevimeline: oral capsule

Nervous system

Nervous system side effects have included excess sweating (19%) and excessive salivation (2%).

Gastrointestinal

Gastrointestinal side effects have included nausea (14%), diarrhea (10%), dyspepsia (8%), abdominal pain (8%), vomiting (4.6%) and cholecystitis.

General

General side effects have included headache (14%), injury (5%), dizziness (4%), surgical intervention (3%), fatigue (3%), pain (3%), hot flushes (2%), and insomnia (2%).

Respiratory

Respiratory side effects have included sinusitis (12%), upper respiratory tract infection (11%), rhinitis (11%), coughing (6%), pharyngitis (5%), and bronchitis (4%).

Genitourinary

Genitourinary side effects have included urinary tract infection (6%) and urinary frequency (1%).

Musculoskeletal

Musculoskeletal side effects have included back pain (5%), arthralgia (4%), skeletal pain (3%), and rigors (1%).

Dermatologic

Dermatologic side effects have included rash (4%).

Ocular

Ocular side effects have included conjunctivitis (4%).

Hepatic

Hepatic side effects including liver and biliary systems disorders and cholecystitis have been reported.

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