Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fosfomycin tromethamine
Drug ID BADD_D00966
Description Fosfomycin was discovered in 1969 by scientists at the Spanish Penicillin and Antibiotics Company and is produced by _Streptomyces fradiae_.[A229338,A230348] It may also be produced synthetically and is commercially available as the disodium salt for intravenous administration and as the calcium or trometamol salt for oral administration.[A230348] In terms of chemical structure, fosfomycin is a phosphoenolpyruvate analog and contains a phosphonic group and an epoxide ring.[A230348] Due to its ease of administration as a single 3-gram oral dose and desirable safety profile, fosfomycin has largely become a first-line therapeutic option for the treatment of uncomplicated urinary tract infections (UTIs) in females.[A230378] Despite being FDA approved only for urinary tract infections, fosfomycin actually has a broad spectrum of activity and is active against both gram-positive and gram-negative bacteria.[A230348] As such there is great interest in exploring the usefulness of fosfomycin for indications beyond the treatment of UTIs.[A230353,A230358]
Indications and Usage For the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.
Marketing Status Prescription
ATC Code J01XX01
DrugBank ID DB00828
KEGG ID D00925
MeSH ID D005578
PubChem ID 54331
TTD Drug ID D01GYT
NDC Product Code 67877-749; 0456-4300; 69097-579; 69037-0066; 53069-1080; 82036-4274; 12836-0318
Synonyms Fosfomycin | Phosphomycin | Phosphonomycin | Monuril | Fosfomycin Trometamol Salt | Fosfomycin Tromethamine | Tromethamine, Fosfomycin
Chemical Information
Molecular Formula C7H18NO7P
CAS Registry Number 78964-85-9
SMILES CC1C(O1)P(=O)(O)[O-].C(C(CO)(CO)[NH3+])O
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 pain07.01.05.002--
Abnormal faeces07.01.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Aplastic anaemia01.03.03.002--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Back pain15.03.04.005--
Blood bilirubin increased13.03.01.008--
Body temperature increased13.15.01.001--Not Available
Constipation07.02.02.001--
Deafness04.02.01.001--Not Available
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Eosinophil count increased13.01.06.004--Not Available
Eosinophilia01.02.04.001--
Flatulence07.01.04.002--
Gastrointestinal pain07.01.05.005--
Haematocrit decreased13.01.05.001--Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemoglobin decreased13.01.05.003--Not Available
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