Adverse Drug Reaction Classification System

ADR Ontology
ADR Term Fibrocystic breast disease
ADR ID BADD_A01654
ADR Hierarchy
16      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
16.14      Breast neoplasms benign (incl nipple)
16.14.01      Breast and nipple neoplasms benign
16.14.01.003      Fibrocystic breast disease
21      Reproductive system and breast disorders
21.05      Breast disorders
21.05.04      Breast disorders NEC
21.05.04.018      Fibrocystic breast disease
Description A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency. | A benign lesion of the BREAST, characterized by a proliferation of disorganized small glands lined by EPITHELIAL CELLS without apparent myoepithelial cells. These glands usually have enlarged lumens, and lie in adipose or fibrous tissue. [MeSH]
MedDRA Code 10016621
MeSH ID D005348
ADR Severity Grade (FAERS)
ADR Severity Grade (CTCAE) Not Available
Synonym
Adenosis sclerosing | Breast cystic fibrosis | Breast fibrocystic | Breast fibrocystic change | Breast fibrocystic disorder | Breast mass fibrocystic | Cystic disease of breast (benign) | Diffuse cystic mastopathy | Disease cystic breast | Disease fibrocystic breast | Fibrocystic breast | Fibrocystic breast disease | Fibrocystic disease of breast | Mass breast fibrocystic | Fibrocystic disease | Reclus disease | Fibrocystic Breast Disease | Breast Disease, Fibrocystic | Disease, Fibrocystic Breast | Mammary Dysplasia | Dysplasia, Mammary | Fibrocystic Disease of Breast | Breast Fibrocystic Disease | Fibrocystic Mastopathy | Mastopathy, Fibrocystic | Breast Dysplasia | Dysplasia, Breast | Fibrocystic Changes of Breast | Breast Fibrocystic Change | Breast Fibrocystic Changes | Microglandular Adenosis | Adenoses, Microglandular | Adenosis, Microglandular | Microglandular Adenoses | Adenosis of Breast | Breast Adenosis | Chronic Cystic Mastitis | Cystic Mastitis, Chronic | Cystic Breast Disease | Breast Disease, Cystic | Disease, Cystic Breast | Cystic Disease of Breast | Breast Cystic Disease | Breast Cystic Diseases
Drugs Leading to the ADR
Drug IDDrug NameADR Frequency (FAERS)ADR Severity Grade (FAERS)
BADD_D01680Paroxetine hydrochloride--
BADD_D01681Paroxetine hydrochloride hemihydrate--
BADD_D01682Paroxetine impurity a--
BADD_D01683Paroxetine mesylate--
BADD_D01735Pergolide--
BADD_D01736Pergolide mesylate--
BADD_D01835Pregabalin--
BADD_D01951Risperidone0.000182%
BADD_D02210Tiagabine--
BADD_D02211Tiagabine hydrochloride--
BADD_D02236Tofacitinib0.000651%
BADD_D02346Venlafaxine--
BADD_D02464Fingolimod0.000482%
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