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Marketing Status approved; withdrawn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)
Weight decreased13.15.01.005--
Balance disorder08.01.03.081; 17.02.02.007---
Acute coronary syndrome02.02.02.015; 24.04.04.011---
Musculoskeletal stiffness15.03.05.027---
Musculoskeletal discomfort15.03.04.001---
Affect lability19.04.01.001---
Haemorrhage24.07.01.002---
Vasodilation procedure25.03.01.001---
Disturbance in sexual arousal19.08.04.003---
Angiopathy24.03.02.007---
Urine output increased13.13.03.002---
Prostate cancer16.25.01.001; 21.04.02.002---
Bacterial infection11.02.01.005---
Impulse-control disorder19.18.01.002---
Infestation11.09.01.001; 23.11.01.002---
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.002---
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Ill-defined disorder08.01.03.049---
Lacrimal disorder06.08.02.005---
Psychotic disorder19.03.01.002--
Orthostatic intolerance02.11.01.019; 17.05.01.007; 24.06.01.003---
Hypersexuality19.08.03.005---
Liver injury09.01.07.022; 12.01.17.012---
Intellectual disability17.03.07.001; 19.21.06.001---
Lacrimal structural disorder06.06.04.013---
Gambling disorder19.07.06.015---
Vulvovaginal inflammation21.14.02.014---
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