Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pirfenidone
Drug ID BADD_D01783
Description Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney and liver. It is being investigated by InterMune.
Indications and Usage For the treatment of idiopathic pulmonary fibrosis (IPF).
Marketing Status Prescription; Discontinued
ATC Code L04AX05
DrugBank ID DB04951
KEGG ID D01583
MeSH ID C093844
PubChem ID 40632
TTD Drug ID D02WCI
NDC Product Code 65372-1197; 46708-907; 73309-052; 46016-5310; 62207-004; 62512-0070; 69037-0013; 53104-7712; 11014-0214; 59285-013; 76072-1006; 69766-030; 50242-122; 57297-140; 46016-5312; 46438-0648; 60219-1642; 50242-121; 50242-123; 59651-199; 60219-1640; 60219-1641; 60862-005; 42571-329; 63759-7005
Synonyms pirfenidone | 5-methyl-1-phenyl-2-(1H)-pyridone | Esbriet | deupirfenidone | 1-phenyl-5-(trideuteriomethyl)-1,2-dihydropyridin-2-one | Deskar
Chemical Information
Molecular Formula C12H11NO
CAS Registry Number 53179-13-8
SMILES CC1=CN(C(=O)C=C1)C2=CC=CC=C2
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.049793%Not Available
Abdominal distension07.01.04.0010.013317%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.037055%
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Acute hepatic failure09.01.03.0010.000906%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.000755%Not Available
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Acute psychosis19.03.01.0010.001158%Not Available
Acute pulmonary oedema02.05.02.004; 22.01.03.0050.000302%Not Available
Acute respiratory failure14.01.04.004; 22.02.06.0010.003474%Not Available
Adenocarcinoma16.16.01.0040.001158%Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.0040.001158%
Ageusia07.14.03.003; 17.02.07.0010.011580%Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Amnesia17.03.02.001; 19.20.01.0010.006948%
Anaemia01.03.02.001--
Anal fistula07.11.05.0020.001158%
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Anger19.04.02.001--Not Available
Angina pectoris02.02.02.002; 24.04.04.002--
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anosmia17.04.04.001; 22.04.03.0060.001737%
Anxiety19.06.02.002--
Aortic valve incompetence02.07.03.0010.001158%Not Available
Apathy19.04.04.0020.001737%Not Available
Aphasia17.02.03.001; 19.21.01.001--
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