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Marketing Status approved; withdrawn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)
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Myoclonus17.02.05.008--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.009--
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Neoplasm skin23.08.02.003; 16.03.02.003--Not Available
Nephrolithiasis20.04.01.002--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neuralgia17.02.07.005--
Neuroleptic malignant syndrome17.05.02.003; 15.05.04.015; 12.03.01.003; 08.05.01.005--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nocturia20.02.03.001--Not Available
Ocular hyperaemia06.04.05.004--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophagitis07.08.05.001--
Oliguria20.01.03.004--Not Available
Osteoarthritis15.01.04.001--Not Available
Otitis media11.01.05.004; 04.05.01.001--
Ovarian cancer21.11.01.003; 16.12.04.001--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Panic reaction19.06.04.003--Not Available
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