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 approved; investigational
ATC Code L04AX05
DrugBank ID DB04951
KEGG ID D01583
MeSH ID C093844
PubChem ID 40632
TTD Drug ID D02WCI
NDC Product Code 0480-3610; 60862-005; 69766-030; 76072-1006; 42385-924; 69539-120; 42385-923; 42385-925; 42571-336; 69097-940; 72205-182; 0781-8085; 0480-3611; 65372-1197; 82920-705; 16729-468; 46708-479; 69238-1640; 62332-480; 0781-2158; 62207-004; 31722-872; 50228-442; 69539-119; 57297-140; 73309-052; 46708-480; 69097-988; 69238-1641; 42571-329; 46016-5312; 31722-873; 72205-181; 76282-716; 0781-8086; 53104-7712; 69037-0013; 60219-1640; 60219-1641; 47621-311; 59285-013; 59651-199; 50228-443; 50242-121; 60219-1642; 62332-479; 46016-5310; 16729-467; 42385-926; 42571-335; 50228-441; 50242-122; 69097-987; 76282-715; 76282-717; 11014-0214; 46438-0648; 62512-0070; 50242-123
UNII D7NLD2JX7U
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
*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)
Fibrosis08.03.01.0010.000772%Not Available
Flatulence07.01.04.0020.004171%
Food poisoning12.03.01.024; 11.07.02.001; 07.11.01.0070.000530%Not Available
Frequent bowel movements07.02.04.0020.001013%Not Available
Gamma-glutamyltransferase increased13.03.04.024--
Gastritis07.08.02.0010.001374%
Gastrooesophageal reflux disease07.02.02.0030.011549%
Gastrointestinal disorder07.11.01.0010.034720%Not Available
Gastrointestinal pain07.01.05.0050.001591%
Gout15.01.06.001; 14.09.01.001--Not Available
Guillain-Barre syndrome17.09.01.001; 11.07.01.001; 10.04.10.0050.000241%
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.003641%Not Available
Head discomfort17.02.05.0270.001350%Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001--Not Available
Hepatic failure09.01.03.002--
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000241%Not Available
Hepatitis09.01.07.0040.001447%Not Available
Hepatitis acute09.01.07.0050.000723%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.003737%Not Available
Hernia08.01.04.0010.000362%Not Available
Hiatus hernia22.09.02.004; 07.16.01.0010.001254%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.0040.000651%Not Available
Hyperchlorhydria07.11.03.0010.000820%Not Available
Hyperkeratosis23.01.01.0010.000530%
Hypersomnia17.15.01.001; 19.02.05.0010.003231%
Hyperventilation22.02.01.006; 19.01.02.0040.000241%Not Available
Hypocoagulable state01.01.02.0040.000241%Not Available
Hypogeusia17.02.07.004; 07.14.03.0020.000530%Not Available
Hypopnoea22.02.01.0210.000241%Not Available
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