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Marketing Status approved; withdrawn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)
Hyperkinesia17.01.02.008--Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hyperventilation22.02.01.006; 19.01.02.004--Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypokinesia17.01.02.009--Not Available
Hypotension24.06.03.002--
Hypoxia22.02.02.003--
Impaired gastric emptying07.02.02.004--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Irritability19.04.02.013; 08.01.03.011--
Lacrimation disorder06.08.02.010--Not Available
Laryngitis22.07.03.001; 11.01.13.001--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukaemia16.01.03.001; 01.10.03.001--
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Loss of consciousness17.02.04.004--Not Available
Malaise08.01.01.003--
Mania19.16.02.002--
Meningitis17.06.03.001; 11.01.03.001--
Mental disability26.01.01.001--Not Available
Micturition disorder20.02.02.005--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
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