Nitrofurantoin
Furadantin Retard, Nitrofurantoin Agepha · ATC code J01XE01
Also known as: nitrofurantoin macrocrystals · Brand names: Furadantin Retard, Nitrofurantoin Agepha, Furadantin Rp, Nifurantin, Nifuretten, Piyeloseptyl, Ürineks
- Key facts
- Active substance
- Nitrofurantoin
- ATC code
- J01XE01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Nitrofurantoin is a urinary antibacterial. Per this US label (macrocrystal capsules), it is used to treat urinary tract infections caused by susceptible bacteria.
What it is used for
- Urinary tract infections due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain Klebsiella and Enterobacter species
- Not indicated for pyelonephritis or perinephric abscesses
Dosing
- Give with food
- Adults: 50 mg to 100 mg four times a day; the lower dosage for uncomplicated urinary tract infections
- Children: 5 mg/kg to 7 mg/kg per 24 hours in four divided doses (contraindicated under one month of age)
- Duration: one week or at least 3 days after urine sterility is obtained
- Long-term suppression: adults 50 mg to 100 mg at bedtime; children as low as 1 mg/kg per 24 hours may be adequate
Contraindications
- Anuria, oliguria or significant renal impairment (creatinine clearance under 60 mL per minute)
- Pregnant patients at term, during labor and delivery; neonates under one month (risk of hemolytic anemia)
- Previous cholestatic jaundice or hepatic dysfunction associated with nitrofurantoin
- Known hypersensitivity to nitrofurantoin
Important warnings
- Acute, subacute or chronic pulmonary reactions, some fatal; chronic forms (interstitial pneumonitis, pulmonary fibrosis) generally after six months or longer of therapy
- Hepatotoxicity including chronic active hepatitis and hepatic necrosis, rare, sometimes fatal
- Peripheral neuropathy, which may be severe or irreversible; risk increased by renal impairment, diabetes, vitamin B deficiency and other conditions
- Hemolytic anemia in glucose-6-phosphate dehydrogenase deficiency
Side effects
- Pulmonary reactions: fever, chills, cough, chest pain, dyspnea, infiltrates, eosinophilia (acute, usually within the first week)
- Chronic: malaise, dyspnea on exertion, cough, altered pulmonary function
- Others: hepatic reactions, peripheral neuropathy, hemolytic anemia
Interactions
- Antacids containing magnesium trisilicate should not be used while taking nitrofurantoin
Pregnancy and breastfeeding
- Pregnancy: contraindicated at term, during labor and delivery, or when labor is imminent
- Nursing: trace amounts in breast milk; because of possible serious reactions in infants under one month, decide whether to stop nursing or the drug
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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
- Furadantin RetardAmdipharm Limited · 1 register entry
- Nitrofurantoin AgephaAgepha Pharma S.R.O · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Furadantin RetardAmdipharm Limited · 1 register entry
- Furadantin RpAmdipharm Limited · 1 register entry
- NifurantinApogepha Arzneimittel Gmbh · 1 register entry
- NifurettenApogepha Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- PiyeloseptylBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- ÜrineksTOPRAK İLAÇ VE KİMYEVİ MADDELER SAN.VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 26 more European countries
- Belgium
- Furadantine Mc, Nitrofurantoin Activase, Nitrofurantoin Iasis Pharma
- Bulgaria
- Фуролин
- Croatia
- Ninur, Nitrofurantoin Galenika, Prevuro
- Cyprus
- Furolin, Macrodantin
- Czechia
- Nostiriazyn
- Denmark
- Foragen, Nitrofurantoin "eql Pharma", Nitrofurantoin Eql Pharma
- Estonia
- Magromag, Nitrofurantoin Auxilia, Nitrofurantoin Orifarm
- Finland
- Foragen, Furuti
- France
- Furadantine
- Greece
- Furolin, Nitrofurantoin Iasis
- Hungary
- Nitrofurantoin-Chinoin, Nitrofurantoin Pharmsol
- Iceland
- Furadantin
- Ireland
- Macrobid, Macrodantin, Nitrofurantoin Activase Pharmaceuticals, Nitrofurantoin Kora Healthcare
- Italy
- Furedan, Nitrofurantoina Doc, Nitrofurantoina Mylan Pharma
- Latvia
- Furadonīns, Magromag, Uvamin Retard
- Lithuania
- Furadonins, Magromag, Nitrofurantoin Sanoswiss, Nitrofurantoin Sanus, Uvamin Retard
- Luxembourg
- Furadantine Mc
- Malta
- Furolin, Macrodantin, Nitrofurantoin Iasis
- Netherlands
- Foragen, Furabid, Furadantine Mc, Nitrofurantoin Activase, Nitrofurantoin Aurobindo, Nitrofurantoïne Activase, Nitrofurantoïne Focus Care, Nitrofurantoïne Glenmark, Nitrofurantoïne Mc Viatris, Nitrofurantoïne Prolepha
- Norway
- Foragen, Furadantin
- Portugal
- Furadantina Mc, Nitrofurantoin Activase, Nitrofurantoína Generis, Nitrofutantoína Generis
- Romania
- Furolin, Nitrofurantoina Arena
- Slovakia
- Nitrofurantoin Olikla, Nitrofurantoin Pharmevid, Nostiriazyn
- Slovenia
- Macrobid, Nitrofurantoin Activase
- Spain
- Furantoína
- Sweden
- Foragen, Furadantin, Nitrofurantoin Alternova
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. nitrofurantoin macrocrystals (BluePoint Laboratories) – Prescribing Information, 2026-06-24. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cfa20cfd-478f-48c6-9b59-3c425abd766a
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.