Tolcapone Side Effects

Some side effects of tolcapone 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 tolcapone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tolcapone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• feeling like you might pass out;

• fever, stiff muscles, confusion, and sweating (especially when you first start taking tolcapone);

• hallucinations;

• tremors (uncontrolled shaking);

• tight feeling in your chest, trouble breathing;

• pain or burning when you urinate;

• severe or ongoing diarrhea; or

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects of tolcapone may include:

• diarrhea or constipation;

• dry mouth;

• headache, tired feeling;

• unusual skin changes;

• dizziness, drowsiness;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• sleep problems (insomnia), dreaming more than usual; or

• agitation or anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tolcapone: oral tablet

General

In general, tolcapone was well tolerated in clinical trials with most adverse events being mild to moderate in severity. Dyskinesia and other dopaminergic-related effects were the most frequently reported adverse events in patients with motor fluctuations. Diarrhea was the most common nondopaminergic adverse event, occurring in up to 26% of patients who received tolcapone, and necessitating discontinuation of treatment in approximately 5% to 10% of patients.

Hepatic

Hepatic side effects have included severe liver damage, including fulminant liver failure resulting in death. Three cases of fatal fulminant hepatic failure have been reported from more than 40,000 patient years of worldwide use. Increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea (30% to 35%), anorexia (19% to 23%), diarrhea (16% to 18%), vomiting (8% to 10%), constipation (6% to 8%), xerostomia (5% to 6%), abdominal pain (5% to 6%), dyspepsia (3% to 4%), flatulence (2% to 4%), and dry mouth.

Musculoskeletal

Musculoskeletal side effects have included dystonia (19% to 22%), muscle cramps (17% to 18%), stiffness (2%), arthritis (1% to 2%), and hypertonia (1%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (5% to 7%), dyspnea (3%), and sinus congestion (1% to 2%).

Genitourinary

Genitourinary side effects have included urine discoloration (2% to 7%), urinary tract infection (5%), and micturition disorder (1% to 2%).

Cardiovascular

Cardiovascular side effects have included chest pain (1% to 3%), hypotension (2%), chest discomfort (1% to 2%), and orthostatic symptoms.

Dermatologic

A case report of vitiligo has been reported in a 50-year-old man with Parkinson's disease one week after the start of therapy with tolcapone 300 mg per day.

Dermatologic side effects have included dermal bleeding (1%), alopecia (1%), and increased sweating. At least one case of vitiligo has also been reported.

Oncologic

Oncologic side effects have included tumors of the skin (1%) and tumors of the uterus (1%).

Ocular

Ocular side effects have included cataracts (1%) and inflamed eyes (1%).

Nervous system

Nervous system side effects have included dyskinesia (42% to 51%), sleep disorder (24% to 25%), excessive dreaming (16% to 21%), somnolence (14% to 18%), orthostatic complaints (17%), dizziness (6% to 13%), confusion (10% to 11%), headache (10% to 11%), hallucination (8% to 10%), syncope (4% to 5%), hyperkinesia (2% to 3%), paresthesia (1% to 3%), hypokinesia (1% to 3%), loss of balance (2% to 3%), mental deficiency (1%), agitation (1%), hyperactivity (1%), and neuroleptic malignant-like syndrome. Akathisia, insomnia and sleep disturbances have also been reported.

The neuroleptic malignant-like syndrome was reported in an elderly patient. It was caused by abrupt withdrawal of tolcapone.

Other

Other side effects have included fatigue (3% to 7%), falling (4% to 6%), increased sweating (4% to 7%), influenza (3% to 4%), neck pain (2%), burning (1% to 2%), irritability (1%), malaise (1%), panic reaction (1%), euphoria (1%), and fever (1%).

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