Commonly reported side effects of tolcapone include: diarrhea, dyskinesia, insomnia, nausea, orthostatic hypotension, vomiting, confusion, dizziness, dystonia, headache, muscle cramps, anorexia, and increased dream activity. Other side effects include: syncope, abdominal pain, constipation, falling, fatigue, diaphoresis, urine discoloration, and xerostomia. See below for a comprehensive list of adverse effects.
Applies to tolcapone: oral tablet
Oral route (Tablet)
Tolcapone use has been associated with a risk of potentially fatal, acute fulminant liver failure. Avoid use in patients with liver disease and monitor liver enzymes before starting treatment with tolcapone and periodically during therapy. Discontinue therapy if liver dysfunction develops or if a patient fails to show substantial clinical benefit within 3 weeks of initiation of treatment. Use caution in patients with severe baseline dyskinesia or dystonia.
Along with its needed effects, tolcapone 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 tolcapone:
Incidence not known
Check with your doctor as soon as possible if any of the following side effects occur while taking tolcapone:
Some side effects of tolcapone 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:
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Applies to tolcapone: oral tablet
The more commonly reported adverse events have included dyskinesia, nausea, sleep disorder, orthostatic complaints, and diarrhea.
Cases of severe hepatocellular injury, including fulminant liver failure resulting in death, have been reported. As of 5-2005, 3 cases of fulminant hepatic failure had been reported from more than 40,000 patient years of worldwide use. This incidence may be 10 to 100-fold higher than the incidence in the general population. All 3 cases were reported within the first 6 months of treatment initiation. Analysis of laboratory monitoring indicates that when present, transaminase elevations generally occur within the first 6 months. It is not clear whether periodic monitoring will prevent the occurrence of fulminant liver failure, but it is believed that early detection and immediate withdrawal enhances the likelihood for recovery.
During clinical trials, transaminase elevations to greater than 3 times the upper limit of normal (3 x ULN) occurred in 1% and 3% of patients receiving 100 mg or 200 mg three times a day, respectively. Females were more likely than males to have elevated liver enzymes (5% vs 2%). Approximately 33% of patients with elevated liver enzymes had diarrhea. Liver enzyme elevations to greater than 8 x ULN occurred in 0.3% and 0.7% of patients receiving 100 mg or 200 mg three times a day, respectively.
Common (1% to 10%): ALT increases
Uncommon (0.1% to 1%): Hepatocellular injury
In clinical trials, diarrhea developed in approximately 16%, and 18%, of patients receiving 100 mg or 200 mg three times a day, respectively. Diarrhea was generally regarded as mild to moderate, however, severe diarrhea occurred in 3% to 4% of patients and hospitalization was needed in 0.7% and 1.7% of patients receiving 100 mg or 200 mg, respectively. Diarrhea was the most common adverse reaction resulting in discontinuation. No consistent mechanism for tolcapone-induced diarrhea is known.
Very common (10% or more): Nausea (up to 35%), diarrhea (up to 18%), vomiting (up to 10%)
Common (1% to 10%): Constipation, xerostomia, abdominal pain, dyspepsia, flatulence, tooth disorder
Uncommon (0.1% to 1%): Dysphagia, gastrointestinal hemorrhage, gastroenteritis, mouth ulceration, increased salivation, abnormal stools, esophagitis, cholelithiasis, colitis, tongue disorder
Rare (0.01% to 0.1%): Cholecystitis, duodenal ulcer, gastrointestinal carcinoma, stomach atony
Very common (10% or more): Muscle cramps (up to 18%)
Common (1% to 10%): Neck pain, flank pain, myalgia
Uncommon (0.1% to 1%): Tenosynovitis, arthrosis, joint disorder
Very common (10% or more): Orthostatic complaints (up to 17%)
Common (1% to 10%): Syncope, palpitation
Uncommon (0.1% to 1%): Hypertension, vasodilation, angina pectoris, heart failure, atrial fibrillation, tachycardia, migraine, aortic stenosis, arrhythmia, arteriospasm, bradycardia, coronary artery disorder, heart arrest, myocardial infarct, myocardial ischemia, edema
Rare (less than 0.1%): Arteriosclerosis, cardiovascular disorder, pericardial effusion, thrombosis
This drug enhances levodopa bioavailability and therefore can increase the occurrence of orthostatic hypotension. During clinical trials, orthostatic hypotension occurred at least once in 14% and 13% of patients receiving 100 mg or 200 mg three times a day, respectively. At least one episode of syncope was reported in 4% and 3% of patients, respectively. Approximately 0.7% of patients discontinued therapy due to events related to hypotension.
Hallucinations occurred in 8% to 10% of patients receiving this drug in clinical trials compared to 5% in placebo. Hallucinations generally present shortly after therapy initiation and appeared to be responsive to levodopa dose reduction. Postmarketing reports of new or worsening mental status and behavioral changes have included paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium.
Very common (10% or more): Sleep disorder (up to 25%), excessive dreaming (up to 21%), confusion (up to 11%), hallucinations (up to 10%)
Common (1% to 10%): Agitation, irritability, mental deficiency, hyperactivity, panic reaction, euphoria, depression, emotional lability
Uncommon (0.1% to 1%): Amnesia, hostility, increased libido, manic reaction, nervousness, paranoid reaction, elusions, libido decreased, apathy, psychosis, abnormal thinking
Rare (less than 0.1%): Antisocial reaction, impulse control disorders
Postmarketing reports: New or worsening mental status and behavioral changes
Female patients may be more likely to develop somnolence than males. Dyskinesia may occur or be exacerbated as this drug potentiates the dopaminergic side effects of levodopa.
Very common (10% or more): Dyskinesia (up to 51%), dystonia (up to 22%), somnolence (up to 18%), dizziness (up to 13%), headache (up to 11%),
Common (1% to 10%): Hyperkinesia, hypertonia, hypesthesia, tremor, speech disorder,
Uncommon (0.1% to 1%): Neuralgia, extrapyramidal syndrome, cerebral ischemia, cerebrovascular accident, neuropathy, choreoathetosis, myoclonus, twitching, cerebral hemorrhage
Rare (less than 0.1%): Encephalopathy, hemiplegia, meningitis, delirium, neuroleptic malignant syndrome symptom complex
Common (1% to 10%): Upper respiratory tract infection, dyspnea, sinus congestion, bronchitis, pharyngitis
Uncommon (0.1% to 1%): Pulmonary embolus, increased cough, rhinitis, asthma, epistaxis, hyperventilation, laryngitis, hiccup
Rare (less than 0.1%): Apnea, hypoxia, lung edema
This drug and its metabolites are yellow and can cause a harmless intensification in the color of the urine.
Common (1% to 10%): Urinary tract infection, urine discoloration, micturition, urinary incontinence, impotence
Uncommon (0.1% to 1%): Rectal disorder, prostatic disorder, dysuria, nocturia, polyuria, urinary retention, urinary tract disorder, hematuria, kidney calculus, oliguria, uterine atony, uterine disorder, vaginitis
Rare (less than 0.1%): Bladder calculus, uterine hemorrhage
Common (1% to 10%): Increased sweating, alopecia, rash
Uncommon (0.1% to 1%): Cellulitis, face edema, herpes zoster, pruritus, seborrhea skin discoloration, eczema, erythema multiforme, skin disorder, furunculosis, herpes simplex, urticaria
Common (1% to 10%): Skin tumor, uterine tumor
Uncommon (0.1% to 1%): Carcinoma, neoplasm, prostatic carcinoma, breast neoplasm
Rare (less than 0.1%): Ovarian carcinoma
Common (1% to 10%): Cataract, inflamed eye
Uncommon (0.1% to 1%): Diplopia, eye hemorrhage, eye pain, lacrimation disorder,
Rare (less than 0.1%): Glaucoma
Common (1% to 10%): Fatigue, falling, loss of balance, malaise, fever, vertigo, accidental injury, tinnitus , ear pain, otitis media, parosmia
Uncommon (0.1% to 1%): Hernia, chills
Rare (0.01% to 0.1%): Death
Uncommon (0.1% to 1%): Allergic reaction
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Fungal infection, viral infection, bacterial infection, abscess
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Tolcapone