Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fidaxomicin
Drug ID BADD_D00896
Description Fidaxomicin is a novel macrolide antibiotic used in the treatment of diarrhea caused by _Clostridioides_ (formerly _Clostridium_) _difficile_ in adult and pediatric patients over the age of 6 months.[L11575] Fidaxomicin is a naturally-occurring 18-member macrocycle derived from fermentation.[A190501] Because fidaxomicin contains an 18-membered lactone ring in its structure, it is referred to as a macrocyclic lactone antibiotic drug.[A190492] The antibacterial activity of fidaxomicin is distinct from macrolides and rifamycins, as the bactericidal activity is time-dependent, and not concentration-dependent.[A190492] Fidaxomicin was the first macrocyclic lactone antibiotic with activity against _C. difficile_,[A190486] and it displays a narrow spectrum of activity against gram-positive anaerobes.[A7445] It mediates its potent bactericidal action on the bacteria by inhibiting the bacterial RNA synthase, thereby disrupting bacterial transcription.[A190486] The minimum inhibitory concentration (MIC90) for fidaxomicin is four times less than that of [vancomycin], which was the primary drug of choice for _C. difficile_ infection before the approval of fidaxomicin.[A190492] Unlike vancomycin, however, fidaxomicin has a negligible effect on normal colonic microflora.[A190516] The FDA initially approved fidaxomicin in May 2011 for the treatment of _C. difficile_-associated diarrhea in adult patients over the age of 18.[A190492] Later that year in December, the drug was also approved by the European Medicine Agency.[A190492] In June 2012, fidaxomicin was also granted approval by Health Canada.[A190486] The approved indication of fidaxomicin was expanded by the FDA in January 2020 to include pediatric patients over the age of 6 months in the treatment population.[L11575]
Indications and Usage Treatment of Clostridium difficile-associated diarrhea
Marketing Status Prescription
ATC Code A07AA12
DrugBank ID DB08874
KEGG ID D09394
MeSH ID D000077732
PubChem ID 151383
TTD Drug ID D06LNW
NDC Product Code 52015-700; 52015-080; 65727-027; 55500-0007; 62227-003
Synonyms Fidaxomicin | Lipiarmycin A3 | Lipiarmycin | Tiacumicin B | PAR 101 | PAR101 | PAR-101 | Dificid | Lipiarmycin B4 | Tiacumicin C | Lipiarmycin B | Lipiarmycin A4 | Lipiarmycin B3
Chemical Information
Molecular Formula C52H74Cl2O18
CAS Registry Number 873857-62-6
SMILES CCC1C=C(C(CC=CC=C(C(=O)OC(CC=C(C=C(C1OC2C(C(C(C(O2)(C)C)OC(=O)C(C)C)O)O)C)C)C(C) O)COC3C(C(C(C(O3)C)OC(=O)C4=C(C(=C(C(=C4O)Cl)O)Cl)CC)O)OC)O)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.001431%
Abdominal pain upper07.01.05.0030.000409%
Abdominal tenderness07.01.05.004--Not Available
Alanine aminotransferase increased13.03.01.003--
Anaemia01.03.02.001--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Blood bicarbonate decreased13.11.01.019--
Cardiac failure02.05.01.0010.000160%
Clostridium difficile colitis07.19.01.004; 11.02.02.0040.001840%Not Available
Colitis ulcerative10.02.01.004; 07.08.01.0050.000107%Not Available
Constipation07.02.02.0010.000409%
Cough22.02.03.0010.000409%
Death08.04.01.001--
Dehydration14.05.05.0010.000613%
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.0010.004702%
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.003--
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.015--Not Available
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.000107%
Dyspnoea22.02.01.004; 02.01.03.002--
Faeces discoloured07.01.03.0020.000409%Not Available
Feeling abnormal08.01.09.0140.000409%Not Available
Flatulence07.01.04.002--
Gastrointestinal disorder07.11.01.0010.000409%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
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