Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tolcapone
Drug ID BADD_D02241
Description Tolcapone is a drug that inhibits the enzyme catechol-O-methyl transferase (COMT). It is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa medication. It is a yellow, odorless, non-hygroscopic, crystalline compound. Tolcapone is associated with a risk of hepatotoxicity.
Indications and Usage Used as an adjunct to levodopa/carbidopa therapy for the symptomatic treatment of Parkinson's Disease. This drug is generally reserved for patients with parkinsonian syndrome receiving levodopa/carbidopa who are experiencing symptom fluctuations and are not responding adequately to or are not candidates for other adjunctive therapies.
Marketing Status approved; withdrawn
ATC Code N04BX01
DrugBank ID DB00323
KEGG ID D00786
MeSH ID D000077867
PubChem ID 4659569
TTD Drug ID D0Y7PG
NDC Product Code 50742-193; 0187-0938; 68682-938; 17511-119; 65085-0032; 76438-001
UNII CIF6334OLY
Synonyms Tolcapone | 3,4-Dihydroxy-5'-methyl-5-nitrobenzophenone | 3,4 Dihydroxy 5' methyl 5 nitrobenzophenone | SOM0226 | Ro 40-7592 | Ro 40 7592 | Ro 407592 | Ro-40-7592 | Ro407592 | Tasmar
Chemical Information
Molecular Formula C14H11NO5
CAS Registry Number 134308-13-7
SMILES CC1=CC=C(C=C1)C(=O)C2=CC(=C(C(=C2)O)O)[N+](=O)[O-]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Body temperature increased13.15.01.001---
Bradycardia02.03.02.002---
Breast neoplasm16.10.02.001; 21.05.01.004---
Bronchitis11.01.09.001; 22.07.01.001--
Burning sensation08.01.09.029; 17.02.06.001---
Calculus bladder20.04.03.001---
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiovascular disorder02.11.01.010; 24.03.02.009---
Cataract06.06.01.001--
Cellulitis11.02.01.001; 23.11.02.004---
Cerebral haemorrhage17.08.01.003; 24.07.04.001---
Cerebral ischaemia17.08.01.005; 24.04.06.003--
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.002---
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Chills08.01.09.001; 15.05.03.016--
Cholecystitis09.03.01.001--
Cholelithiasis09.03.01.002---
Choreoathetosis17.01.01.003---
Chromaturia20.02.01.002--
Colitis07.08.01.001--
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Coronary artery disease02.02.01.001; 24.04.04.006---
Cough22.02.03.001--
Death08.04.01.001--
Dehydration14.05.05.001--
Delirium19.13.02.001--
Delusion19.10.01.001--
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