Prescription medicine

Fosfomycin Brand names: Contepo; first approved as Monurol

Fosfomycin (Monurol) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $26.22 per unit (Fosfomycin 3 g sachet) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the fosfomycin FDA label on DailyMed (effective April 9, 2026, Aucta Pharmaceuticals, Inc.); the NDA 50717 record on Drugs@FDA; every fosfomycin label on DailyMed.

Highlights of the record

FDA label of April 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.

Forms and strengths

Granule for solution; powder; granule; injection (powder) for solution.

On the market

Earliest approval on file: December 19, 1996 Monurol, Zambon Spa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 8 first October 6, 2020; 8 with a marketed status in Drugs@FDA
Labelers listed (NDC): 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Last listed patent: January 30, 2039 Contepo injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): $26.22 per unit Fosfomycin 3 g sachet
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2023 0 Class I among all firms' recalls; latest January 16, 2024
FAERS reports: 598 through July 30, 2026

What is fosfomycin used for?

From the label: indications and usage
Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)

Conditions named in the indications of fosfomycin's FDA labels, with every medicine labeled for each:

Urinary tract infections

From other fosfomycin labels
Urinary tract infections: INDICATIONS AND USAGE Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and …

Source: FDA drug label (Fosfomycin Tromethamine), Aucta Pharmaceuticals, Inc., effective April 9, 2026 (SPL set 4f206750-8126-99a3-e063-6294a90ade4c), via openFDA; the full label on DailyMed

Is there a generic for fosfomycin (Monurol)?

The FDA approved the first generic fosfomycin on October 6, 2020. 8 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists fosfomycin from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Monurol for solution; a patent listed only for Contepo injection runs to January 30, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

1996 earliest approval on file
2020 first generic approved
2039 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for fosfomycin (Monurol)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $26.22 per unit (Fosfomycin 3 g sachet), down 29% from $37.03 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Fosfomycin 3 g sachet (generic)

$55.96

$26.22

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Fosfomycin 3 g sachet	Generic	$26.22 per unit	n/a	-29%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has fosfomycin been recalled?

The FDA's Enforcement Report lists 2 recalls naming fosfomycin since 2023: 0 Class I (the most serious), 1 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
January 16, 2024	Class II	Ascend Laboratories, LLC	Failed Impurities/Degradation Specification: Out of specification for organic impurities
July 18, 2023	Class III	Ascend Laboratories, LLC	Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the fosfomycin label say about other medicines?

The fosfomycin label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name fosfomycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Cimetidine	drug interactions	Cimetidine does not affect the pharmacokinetics of fosfomycin when coadministered with fosfomycin tromethamine.
Metoclopramide	drug interactions	Drug Interactions Metoclopramide: When coadministered with fosfomycin tromethamine, metoclopramide, a drug which increases gastrointestinal motility, lowers the serum concentration and urinary excretion of fosfomycin.
Piperacillin and tazobactam	warnings and precautions	Hypophosphatemia with serum phosphate concentrations less than 1.0 mg/dL occurred in 2.1% of patients receiving CONTEPO and none of the patients receiving piperacillin/tazobactam.
Tromethamine	contraindications	CONTRAINDICATIONS Fosfomycin tromethamine granules for oral solution is contraindicated in patients with known hypersensitivity to the drug.

Check fosfomycin against other medicines

Source: FDA drug label (Fosfomycin Tromethamine), Aucta Pharmaceuticals, Inc., effective April 9, 2026 (SPL set 4f206750-8126-99a3-e063-6294a90ade4c), via openFDA; the full label on DailyMed

What do FAERS reports show for fosfomycin?

The FDA Adverse Event Reporting System holds 598 reports that list fosfomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 284 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Nausea (named in the label)62
Diarrhoea (named in the label)54
Dizziness (named in the label)53
Dyspnoea51
Off Label Use (a use or a product term, not a reaction)51
Urinary Tract Infection (a use or a product term, not a reaction)46
Fatigue43
Vomiting (named in the label)42

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as fosfomycin?

9 other medicines are given the same way (oral) and in the same FDA class as fosfomycin or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Doxycycline	Urinary tract infections	71 labelers	$0.118 per tablet 100 mg tablet	A presentation being discontinued
Amoxicillin and clavulanate	Urinary tract infections	31 labelers	$0.0693 per mL 600-42.9 mg/5 mL sus	No current entry
Nitrofurantoin	Urinary tract infections	47 labelers	$0.165 per capsule 50 mg capsule	A presentation being discontinued
Minocycline	Urinary tract infections	21 labelers	$0.343 per capsule 100 mg capsule	No current entry
Methenamine	Urinary tract infections	10 labelers	$0.313 per tablet 1 g tablet	No current entry
Sulfadiazine	Urinary tract infections	2 labelers	$15.06 per tablet 500 mg tablet	No current entry
Gepotidacin	Urinary tract infections	none listed	$91.40 per tablet 750 mg tablet	No current entry
Pivmecillinam	Urinary tract infections	none listed	n/a	No current entry

Every medicine labeled for the same conditions as fosfomycin

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does fosfomycin compare with medicines for the same use?

5 side-by-side pages set fosfomycin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to fosfomycin: 9 medicines for the same use
Fosfomycin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other