Adverse Drug Reaction Classification System

ADR Ontology
ADR Term Focal nodular hyperplasia
ADR ID BADD_A08093
ADR Hierarchy
09      Hepatobiliary disorders
09.04      Hepatobiliary neoplasms
09.04.01      Hepatobiliary neoplasms benign
09.04.01.004      Focal nodular hyperplasia
16      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
16.06      Hepatic and biliary neoplasms benign
16.06.01      Hepatobiliary neoplasms benign
16.06.01.004      Focal nodular hyperplasia
Description Solitary or multiple benign hepatic vascular tumors, usually occurring in women of 20-50 years of age. The nodule, poorly encapsulated, consists of a central stellate fibrous scar and normal liver elements such as HEPATOCYTES, small BILE DUCTS, and KUPFFER CELLS among the intervening fibrous septa. The pale colored central scar represents large blood vessels with hyperplastic fibromuscular layer and narrowing lumen. [MeSH]
MedDRA Code 10052285
MeSH ID D020518
ADR Severity Grade (FAERS)
ADR Severity Grade (CTCAE) Not Available
Synonym
Focal nodular hyperplasia | Hepatic nodular hyperplasia | Focal Nodular Hyperplasia | Focal Nodular Hyperplasias | Hyperplasias, Focal Nodular | Hyperplasia, Focal Nodular
Drugs Leading to the ADR
Drug IDDrug NameADR Frequency (FAERS)ADR Severity Grade (FAERS)
BADD_D00195Azathioprine0.000313%
BADD_D00931Fluorouracil0.000184%
BADD_D01260Leuprolide acetate0.001434%
BADD_D01281Levonorgestrel0.002458%
BADD_D01633Oxaliplatin0.000336%
BADD_D02312Ulipristal--
BADD_D02464Fingolimod0.000241%
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