FOSFOMYCIN TROMETHAMINE

Generic: FOSFOMYCIN TROMETHAMINE

Aucta PharmaceuticalsManufacturer
ORALRoute
FOSFOMYCIN TROMETHAMINEActive Substance
2026-04-09Original Approval

FOSFOMYCIN TROMETHAMINE is FDA application ANDA217772, sponsored by AUCTA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2023-07-18
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratorie

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic

Class II2024-01-16
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only,

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Top Reported Reactions

1
NAUSEA
60 reports
2
DIARRHOEA
54 reports
3
DIZZINESS
53 reports
4
DYSPNOEA
51 reports
5
OFF LABEL USE
51 reports
6
URINARY TRACT INFECTION
46 reports
7
VOMITING
42 reports
8
FATIGUE
41 reports
9
ASTHENIA
30 reports
10
HEADACHE
29 reports