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Marketing Status approved; withdrawn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)
Paraesthesia23.03.03.094; 17.02.06.005--
Paranoia19.05.01.005--Not Available
Paresis17.01.04.008--Not Available
Parosmia22.04.03.007; 17.04.04.002--Not Available
Pericardial effusion02.06.01.002--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pollakiuria20.02.02.007--
Polyuria20.02.03.002--Not Available
Prostatic disorder21.04.01.001--Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.011--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rhabdomyolysis15.05.05.002--
Rhinitis22.07.03.006; 11.01.13.004--
Salivary hypersecretion07.06.01.009--Not Available
Seborrhoea23.02.07.001--Not Available
Seborrhoeic dermatitis23.03.04.018--Not Available
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Stomatitis07.05.06.005--
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