Entacapone Side Effects

Please note - some side effects for Entacapone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Entacapone - for the Consumer

Entacapone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Entacapone:

Changes in the color of urine; constipation; diarrhea; dizziness; drowsiness; dry mouth; nausea; stomach pain; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fever; hallucinations; mental or mood changes; muscle pain, stiffness, or rigidity; severe or persistent dizziness; severe or persistent nausea or diarrhea; shortness of breath; uncontrolled muscle movements; unusual skin growths or change in the appearance of a mole.

Side Effects by Body System

Nervous system

Nervous system side effects have included dyskinesia (25%), hyperkinesia (10%), hypokinesia (9%), and dizziness (8%).

Gastrointestinal

Gastrointestinal side effects have included nausea (14%), diarrhea (10%), abdominal pain (8%), constipation (6%), vomiting (4%), dry mouth (3%), dyspepsia (2%), flatulence (2%), and gastritis (1%).

Genitourinary

Genitourinary side effects have included urinary discoloration (10%).

General

General side effects have included fatigue (6%), back pain (4%), and asthenia (2%).

Respiratory

Respiratory side effects have included dyspnea (3%).

Dermatologic

A 50-year-old male with an 8-year history of dilatative cardiomyopathy and a 5-year history of Parkinson's disease experienced a bullous skin eruption coincident with entacapone therapy. The patient was prescribed entacapone 200 mg five times a day due to progression of his extrapyramidal symptoms. After 15 days, bullous lesions were observed initially on the left leg and suddenly affected most of the body surface. During the first day of hospitalization, a dramatic deterioration of general conditions was noted with development of hyperpyrexia (39 degrees Celsius), severe hypotension (75/50 mmHg), pulmonary congestion, and acute renal failure with marked oliguria. Entacapone was discontinued and treatment with intramuscular cefazolin, intravenous corticosteroid, and cardio-respiratory therapy was initiated. General conditions improved after a few days, and the skin lesions completely disappeared after 10 days.

Dermatologic side effects have included increased sweating (2%). At least one case of bullous skin eruption has been reported.

Musculoskeletal

Musculoskeletal side effects have included back pain (2%).

Psychiatric

Psychiatric side effects have included anxiety (2%), somnolence (2%), and agitation (1%).

Hematologic

Hematologic side effects have included purpura (2%).

Other

Other side effects have included taste perversion (1%).

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