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Marketing Status approved; withdrawn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--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.002--Not Available
Vasodilation procedure25.03.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Urine output increased13.13.03.002--Not Available
Prostate cancer21.04.02.002; 16.25.01.001--Not Available
Bacterial infection11.02.01.005--Not Available
Impulse-control disorder19.18.01.002--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Ill-defined disorder08.01.03.049--Not Available
Lacrimal disorder06.08.02.005--Not Available
Psychotic disorder19.03.01.002--
Orthostatic intolerance02.11.01.019; 24.06.01.003; 17.05.01.007--Not Available
Hypersexuality19.08.03.005--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
Intellectual disability19.21.06.001; 17.03.07.001--Not Available
Lacrimal structural disorder06.06.04.013--Not Available
Gambling disorder19.07.06.015--Not Available
Vulvovaginal inflammation21.14.02.014--Not Available
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