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Tolcapone

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: N04BX01

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4
Dyskinesia Dyskinesia 42% 20% x x x x
Nausea Nausea 30% 18% x x x x
Sleep disorder Sleep disorder 24% 18% x x x x
Abnormal dreams Dreaming excessive 21% 17% x x x
Decreased appetite Anorexia 19% 13% x x x x
Somnolence Somnolence 18% 13% x x x x
Muscle spasms Cramp muscle 17% 17% x x x
Diarrhoea Diarrhoea 16% 8% x x x x
Mental disorder Mental disorder very common x
Gastrointestinal disorder Gastrointestinal disorder very common x
Nervous system disorder Nervous system disorder very common x
Angiopathy Angiopathy very common x
Dizziness Dizziness 13% 10% x x x x
Syncope 4% 3% x x x x
Confusional state Confusional state 11% 9% x x x x
Feeling abnormal Confusional state 11% 9% x x x x
Malaise 1% 0% x x x
Headache Headache 10% 7% x x x x
Hallucination Hallucination 8% 5% x x x x
Vomiting Vomiting 8% 4% x x x x
Asthenia Fatigue 7% 6% x x x
Asthenia x x
Fatigue Fatigue 7% 6% x x x
Constipation Constipation 6% 5% x x x x
Abdominal pain Abdominal pain frequent, 5% 3% x x x x
Gastrointestinal pain Abdominal pain frequent, 5% 3% x x x x
Bronchitis Bronchitis frequent x x x
Infection Infection common, frequent x x x x
Dermatitis Rash frequent x x x
Rash Rash frequent x x x
Flank pain Flank pain frequent x x x
Hypoaesthesia Hypoaesthesia frequent x x x
Palpitations Palpitations frequent x x x
Pharyngitis Pharyngitis frequent x x x
Speech disorder Speech disorder frequent x x x
Tinnitus Tinnitus frequent x x x
Tooth disorder Tooth disorder frequent x x x
Tremor Tremor frequent x x x
Upper respiratory tract infection Upper respiratory tract infection 5% 3% x x x x
Urinary incontinence Urinary incontinence frequent x x x
Urinary tract infection Urinary tract infection 5% 4% x x x
Vertigo Vertigo frequent x x x
Dry mouth Dry mouth 5% 2% x x x x
Mood swings Mood swings frequent x x x
Affect lability Mood swings frequent x x x
Injury Accidental injury frequent x x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue common x
Skin disorder infrequent x x x
Myalgia Myalgia frequent x x x
Musculoskeletal discomfort Myalgia frequent x x x
Arthralgia x x
Erectile dysfunction Erectile dysfunction frequent x x x
Infestation Infestation NOS common x
Dyspepsia Dyspepsia 4% 2% x x x x
Shock Syncope 4% 3% x x x x
Syncope Syncope 4% 3% x x x x
Loss of consciousness Syncope 4% 3% x x x x
Fall Fall 4% 4% x x x
Hyperhidrosis Sweating increased 4% 2% x x x x
Sweating x
Chest pain Chest pain 3% 1% x x x x
Chest discomfort 1% 1% x x x
Dyspnoea Dyspnoea 3% 2% x x x
Influenza Influenza 3% 2% x x x x
Paraesthesia Paraesthesia 3% 2% x x x
Arthritis Arthritis 2% 1% x x x
Neck pain Neck pain 2% 1% x x x
Flatulence Flatulence 2% 2% x x x
Hypotension Hypotension 2% 1% x x x
Micturition disorder Micturition disorder 2% 1% x x x
Sinus congestion Sinus congestion 2% 0% x x x
Agitation Hyperkinesia 1% - 3% 0% - 1% x x x
Agitation 1% 0% x x x
Hyperkinesia Hyperkinesia 1% - 3% 0% - 1% x x x
Musculoskeletal stiffness Stiffness 2% 1% x x x
Chromaturia Urine color abnormal 2% 1% x x x x
Alopecia Alopecia 1% 0% x x x
Haemorrhage Haemorrhage 1% 0% x x x
Haemoglobin Haemorrhage 1% 0% x x x
Irritability Irritability 1% 0% x x x
Panic reaction Panic reaction 1% 0% x x x
Neoplasm skin Neoplasm skin 1% 0% x x x
Uterine neoplasm Uterine neoplasm 1% 0% x x x
Hypokinesia Hypokinesia 1% 1% x x x x
Cataract Cataract 1% 0% x x x
Endophthalmitis Ocular hyperaemia 1% 0% x x x
Ocular hyperaemia Ocular hyperaemia 1% 0% x x x
Malaise Malaise 1% 0% x x x
Discomfort Malaise 1% 0% x x x
Ill-defined disorder Malaise 1% 0% x x x
Euphoric mood Euphoric mood 1% 0% x x x
Chest discomfort Chest discomfort 1% 1% x x x
Mental retardation Mental deficiency 1% 0% x x x
Abscess Abscess infrequent x x x
Amnesia Amnesia infrequent x x x
Anaemia Anaemia infrequent x x x
Angina pectoris Angina pectoris infrequent x x x
Aortic valve stenosis Aortic valve stenosis infrequent x x x
Arrhythmia Arrhythmia infrequent x x x
Asthma Asthma infrequent x x x
Atrial fibrillation Atrial fibrillation infrequent x x x
Bacterial infection Bacterial infection infrequent x x x
Neoplasm malignant Carcinoma infrequent x x x
Cellulitis Cellulitis infrequent x x x
Cholelithiasis Cholelithiasis infrequent x x x
Colitis Colitis infrequent x x x
Libido decreased Libido decreased infrequent x x x
Disturbance in sexual arousal Libido decreased infrequent x x x
Libido increased infrequent x x x x
Dysphagia Dysphagia infrequent x x x
Dehydration Dehydration infrequent x x x
Delusion Delusion infrequent x x x
Diabetes mellitus Diabetes mellitus infrequent x x x
Diplopia Diplopia infrequent x x x
Dysuria Dysuria infrequent x x x
Ear pain Ear pain infrequent x x x
Eczema Eczema infrequent x x x
Oedema Oedema infrequent x x x
Epistaxis Epistaxis infrequent x x x
Erythema multiforme Erythema multiforme infrequent x x x
Oesophagitis Oesophagitis infrequent x x x
Extrapyramidal disorder Extrapyramidal disorder infrequent x x x
Eye haemorrhage Eye haemorrhage infrequent x x x
Furuncle Furunculosis infrequent x x x
Gastroenteritis Gastroenteritis infrequent x x x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage infrequent x x x
Cardiac arrest Cardiac arrest infrequent x x x
Cardiac failure Cardiac failure infrequent x x x
Haematuria Haematuria infrequent x x x
Hernia Hernia infrequent x x x
Herpes simplex Herpes simplex infrequent x x x
Herpes zoster Herpes zoster infrequent x x x
Hiccups Hiccups infrequent x x x
Hostility Hostility infrequent x x x
Hypercholesterolaemia Hypercholesterolaemia infrequent x x x
Hypersensitivity Hypersensitivity infrequent x x x
Hypertension Hypertension infrequent x x x
Hyperventilation Hyperventilation infrequent x x x
Libido increased Libido increased infrequent x x x x
Arthropathy Arthropathy infrequent x x x
Osteoarthritis Arthropathy infrequent x x x
Nephrolithiasis Calculus of kidney infrequent x x x
Lacrimal disorder Lacrimal disorder infrequent x x x
Lacrimal structural disorder Lacrimal disorder infrequent x x x
Laryngitis Laryngitis infrequent x x x
Fungal infection Fungal infection infrequent x x x
Myocardial infarction Myocardial infarction infrequent x x x
Acute coronary syndrome Myocardial infarction infrequent x x x
Myoclonus Myoclonus infrequent x x x
Neoplasm Neoplasm infrequent x x x
Nervousness Nervousness infrequent x x x
Tension Nervousness infrequent x x x
Neuralgia Neuralgia infrequent x x x
Nocturia Nocturia infrequent x x x
Oliguria Oliguria infrequent x x x
Otitis media Otitis media infrequent x x x
Pain Pain infrequent x x x
Polyuria Polyuria infrequent x x x
Urine output increased Polyuria infrequent x x x
Prostatic disorder Prostatic disorder infrequent x x x
Pruritus Pruritus infrequent x x x
Psychotic disorder Psychotic disorder infrequent x x x
Pulmonary embolism Pulmonary embolism infrequent x x x
Anorectal disorder Rectal disorder infrequent x x x
Rhinitis Rhinitis infrequent x x x
Seborrhoeic dermatitis Seborrhoeic dermatitis infrequent x x x
Salivary hypersecretion Salivary hypersecretion infrequent x x x
Cerebrovascular accident Cerebrovascular accident infrequent x x x
Tachycardia Tachycardia infrequent x x x
Tenosynovitis Tenosynovitis infrequent x x x
Thirst Thirst infrequent x x x
Tongue disorder Tongue disorder infrequent x x x
Urethral disorder Urinary tract disorder infrequent, common x x x x
Urinary tract disorder Urinary tract disorder infrequent, common x x x x
Urticaria Urticaria infrequent x x x
Uterine disorder Uterine disorder infrequent x x x
Uterine atony Uterine atony infrequent x x x
Uterine hypotonus Uterine atony infrequent x x x
Vaginal inflammation Vaginal inflammation infrequent x x x
Vaginal infection Vaginal inflammation infrequent x x x
Vasodilation procedure Vasodilation infrequent x x x
Viral infection Viral infection infrequent x x x
Urinary retention Urinary retention infrequent x x x
Choreoathetosis Choreoathetosis infrequent x x x
Chills Chills infrequent x x x
Arterial spasm Arterial spasm infrequent x x x
Apathy Apathy infrequent x x x
Flat affect Apathy infrequent x x x
Stomatitis Mouth ulceration infrequent x x x
Mouth ulceration Mouth ulceration infrequent x x x
Migraine Migraine infrequent x x x
Myocardial ischaemia Myocardial ischaemia infrequent x x x
Mania Manic psychosis infrequent x x x
Eye pain Eye pain infrequent x x x
Paranoia Paranoid reaction infrequent x x x
Skin discolouration Skin discolouration infrequent x x x
Abnormal faeces Abnormal faeces infrequent x x x
Muscle twitching Muscle twitching infrequent x x x
Thinking abnormal Thinking abnormal infrequent x x x
Mental disability Thinking abnormal infrequent x x x
Bradycardia Bradycardia infrequent x x x
Neuropathy peripheral Neuropathy infrequent x x x
Face oedema Face oedema infrequent x x x
Cough Cough increased infrequent x x x
Prostate cancer Prostate carcinoma infrequent x x x
Cerebral ischaemia Cerebral ischaemia infrequent x x x
Breast neoplasm Breast neoplasm infrequent x x x
Parosmia Parosmia infrequent x x x
Coronary artery disease Coronary artery disease infrequent x x x
Cerebral haemorrhage Cerebral haemorrhage infrequent x x x
Apnoea Apnoea rare x x x
Arteriosclerosis Arteriosclerosis rare x x x
Calculus bladder Calculus bladder rare x x x
Cardiovascular disorder Cardiovascular disorder rare x x x
Cholecystitis Cholecystitis rare x x x
Delirium Delirium rare x x x
Duodenal ulcer Duodenal ulcer rare x x x
Glaucoma Glaucoma rare x x x
Hemiplegia Hemiplegia rare x x x
Leukaemia Leukaemia rare x x x
Meningitis Meningitis rare x x x
Ovarian cancer Ovarian carcinoma rare x x x
Pericardial effusion Pericardial effusion rare x x x
Pulmonary oedema Pulmonary oedema rare x x x
Thrombocytopenia Thrombocytopenia rare x x x
Thrombosis Thrombosis rare x x x
Uterine haemorrhage Uterine haemorrhage rare x x x
Encephalopathy Encephalopathy rare x x x
Gastrointestinal carcinoma Gastrointestinal carcinoma rare x x x
Gastric atony Gastric atony rare x x x
Impaired gastric emptying Gastric atony rare x x x
Antisocial personality disorder Antisocial behaviour rare x x x
Antisocial behaviour Antisocial behaviour rare x x x
Asocial behaviour Antisocial behaviour rare x x x
Anxiety Anxiety x x
Arthralgia Arthralgia x x
Dysgeusia Dysgeusia x x
Body temperature increased Body temperature increased 0% 0% x x x
Multiple fractures Fracture x x
Fracture Fracture x x
Impulse-control disorder Impulse-control disorder x
Lethargy Lethargy x x
Mediastinal disorder Mediastinal disorder x
Hypertonia Hypertonia 0% 0% x x x
Neuroleptic malignant syndrome Neuroleptic malignant syndrome x
Paresis Paresis x x
Pathological gambling Pathological gambling x
Pneumonia Pneumonia x x
Rhabdomyolysis Rhabdomyolysis x
Sinusitis Sinusitis x x
Pollakiuria Pollakiuria x x
Hepatitis viral Hepatitis viral x x x
Weight decreased Weight decreased x x
Oedema peripheral Oedema peripheral x x
Hepatocellular injury Hepatocellular injury x x x x
Liver injury Hepatocellular injury x x x x
Alanine aminotransferase increased Alanine aminotransferase increased x x
Acute hepatic failure Acute hepatic failure x x x
Hypersexuality Hypersexuality x
Vision blurred Vision blurred x x
Gait disturbance Gait disturbance x x
Binge eating Binge eating x

Indications

Information about indications was extracted from the indications and usage sections of the labels.

tolcapone / tolcapone

Side effects:39
Source:EMA

Tolcapone

Side effects:200
Source:FDA Structured Product Label

TOLCAPONE / TASMAR

Side effects:212
Source:FDA

TOLCAPONE / TASMAR

Side effects:213
Source:FDA

Color scheme:

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    infrequent (0.1% to 1%)
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    postmarketing
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    not found on label