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Fosfomycin

Cystium, Fomicyt, Fosfomycin Sandoz · ATC code J01XX01

Also known as: Fosfomisin, Fosfomycin Tromethamine · Brand names: Cystium, Fomicyt, Fosfomycin Sandoz, Fosfomycin Al, Fosfomycin Aristo, Fosfomycin Eberth, Fosfomycin Hexal, Infectofos, Dispari, Fosday, Fosit, Monomisin, Monurol, Monusin, Phosmycin …

Key facts
Active substance
Fosfomycin
ATC code
J01XX01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Fosfomycin (as fosfomycin tromethamine) is an oral antibiotic. Per the US prescribing information, it is used as a single dose for uncomplicated urinary tract infection (acute cystitis) in women.

What it is used for

  • Uncomplicated urinary tract infection (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis
  • Not indicated for pyelonephritis or perinephric abscess
  • If bacteriuria persists or reappears, other agents should be selected

Dosing

  • Women 18 years of age and older: one sachet of granules as a single dose, with or without food
  • Do not take in dry form; always mix with water before ingesting
  • Do not use more than one single dose per episode of acute cystitis; repeated daily doses did not improve success but increased adverse events
  • Obtain urine culture before and after therapy

Contraindications

  • Known hypersensitivity to fosfomycin

Important warnings

  • Clostridioides difficile-associated diarrhea, from mild diarrhea to fatal colitis, can occur even over two months after use
  • If CDAD is suspected, other antibiotics may need to be stopped and specific treatment started
  • If symptoms do not improve in two to three days, the patient should contact her health care provider

Side effects

  • Diarrhea (9.0%), vaginitis (5.5%), nausea (4.1%), headache (3.9%)
  • Dizziness, asthenia, dyspepsia
  • Rare postmarketing reports: angioedema, aplastic anemia, cholestatic jaundice, hepatic necrosis, toxic megacolon; also anaphylaxis and hearing loss

Interactions

  • Metoclopramide and other drugs increasing gastrointestinal motility: lower fosfomycin serum concentration and urinary excretion

Pregnancy and breastfeeding

  • Fosfomycin crosses the placenta; no teratogenic effects in rat studies

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • CystiumAristo Pharma Gmbh (Art 57) · 1 register entry
  • FomicytInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry
  • Fosfomycin SandozSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Fosfomycin AlAliud Pharma Gmbh · 1 register entry
  • Fosfomycin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Fosfomycin EberthDr. Friedrich Eberth Arzneimittel Gmbh · 1 register entry
  • Fosfomycin HexalHexal Ag · 1 register entry
  • InfectofosInfectopharm Arzneimittel Und Consilium Gmbh, De, Heppenheim · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • DispariHELBA İLAÇ İÇ VE DIŞ SAN. TİC. A.Ş. · 2 register entries
  • FosdayNEUTEC İLAÇ SAN. TİC. A.Ş · 2 register entries
  • FositKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
  • MonomisinEMKAR İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MonurolBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • MonusinHÜSNÜ ARSAN İLAÇLARI A.Ş. · 1 register entry
  • PhosmycinWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • UrobelNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 1 register entry
  • UrocareDROGSAN İLAÇLARI SAN. VE TİC. A.Ş. · 1 register entry
  • UrodayNEUTEC İLAÇ SAN. TİC. A.Ş · 2 register entries
  • Uromisin SaseKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • ZeronatTRİOZER İLAÇ KİM. KOZMETİK SAĞ. HİZM. SAN. VE TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • ContepoMeitheal Pharmaceuticals Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 23 more European countries
Belgium
Fomicyt
Bulgaria
Цистомицин
Croatia
Fomicyt, Urifos
Czechia
Fomicyt, Welnur
Denmark
Fosfomycin Infectopharm
Estonia
Uridoz
Finland
Fosfomycin Infectopharm, Monuril
France
Fomicyt I.V., Fosfomycine Adultes Zentiva, Fosfomycine Panpharma, Fosfomycine Viatris
Greece
Fomicyt
Hungary
Afosfol, Fomicyt
Iceland
Monuril
Ireland
Fomicyt
Italy
Danifos Adulti, Fosfomicina Adulti Pensa, Fosfomicina Adulti Ratiopharm, Fosfomicina Aurobindo Italia, Fosfomicina Eg, Infectofos, Urofos Adulti
Latvia
Uridoz
Lithuania
Fosfomycin Zentiva, Uridoz
Netherlands
Fomicyt, Fosfomycine Focus
Norway
Fosfomycin Infectopharm, Monuril
Poland
Fosfomycin Aurovitas, Infectofos
Portugal
Fosfomicina Generis, Fosfomicina Pharmakern, Fosfusiv
Romania
Fomicyt
Slovakia
Fomicyt
Spain
Fosfocina, Fosfomicina Abamed, Fosfomicina Aurovitas, Fosfomicina Cinfa, Fosfomicina Labiana, Fosfomicina Level, Fosfomicina Pharmacare, Fosfomicina Stada, Fosfomicina Tarbis, Monurol, Solufos
Sweden
Fosfomycin Infectopharm, Monuril

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Fosfomycin Tromethamine (Aucta Pharmaceuticals, Inc.) – Prescribing Information, 2026-04-09. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4f206750-8126-99a3-e063-6294a90ade4c
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.