Nifuroxazide

Intestinal antimicrobial

ATC code: A07AX03(A07AX03)

Brand names: Ercefuryl, Bacifurane, Nifuroxazide

Updated 21 Jul 2026 · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Acute infectious diarrhea

Not recommended

International guidelines do not list nifuroxazide for adult acute infectious diarrhea. 2017, 2017, and CKS 2023 recommend rehydration (oral or intravenous), symptomatic loperamide in the absence of bloody stools or fever, and antibacterial therapy only in severe disease, dysentery, or sepsis – with azithromycin or ciprofloxacin. The 2019 Cochrane review found no high-quality RCTs supporting nifuroxazide efficacy. In 2019 restricted the drug in children under 2 years due to an unfavorable benefit-risk balance.

The drug is registered in Russia and a number of Eastern European countries. It is not registered in the United States or most EU countries. The evidence base for adult acute infectious diarrhea is absent.

Sources

ICD-10: A09 · ICD-11: 1A40

Functional non-infectious diarrhea

Not recommended

For functional (non-infectious) diarrhea, IBS-D, and post-infectious diarrhea, nifuroxazide is not used. An antimicrobial in the absence of infection is useless and potentially disrupts the gut microbiota. First-line options for IBS-D are symptomatic loperamide, antispasmodics, and in severe cases a short rifaximin course recommended by a gastroenterologist.

Sources

ICD-10: K59.1 · ICD-11: DD91.2

Travelers' diarrhea

Not recommended

For mild-to-moderate travelers' diarrhea, nifuroxazide is not prescribed. The drug is absent from international recommendations ( 2017, ISTM 2017, 2023) for this indication. First-line options for moderate disease are azithromycin 1000 mg as a single dose or rifaximin 200 mg three times daily for 3 days in the absence of fever and bloody stools. There is no evidence base for prescribing nifuroxazide to travelers.

Sources

ICD-10: A09 · ICD-11: 1A40

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

Nitrofuran derivative. Used in Russia for acute infectious diarrhea. EU restricted or withdrew registration due to weak evidence and granulocytopenia reports. Not mentioned in international guidelines, not on Essential Medicines List.

Safety

Contraindications

Hypersensitivity to nitrofurans in history
Age under 2 months
Age under 6 years for tablet formulations
Sucrase-isomaltase deficiency, fructose intolerance (for sucrose-containing suspension)

Serious adverse effects

Anaphylactoid reactions, angioedema (rare case reports)
Acute generalized exanthematous pustulosis

Common adverse effects

Gastrointestinal discomfort: nausea, bloating
Rash

Uncommon adverse effects

Skin flushing, urticaria
Eosinophilia

Pregnancy: can you take Nifuroxazide?

No FDA category assigned: the drug is not registered in the United States. Human safety data in pregnancy are limited. EMA in 2019 emphasized the limited data and unfavorable benefit-risk balance even in children. In pregnancy the drug is not used, because rehydration and supportive therapy on the obstetrician's recommendation are preferred for infectious diarrhea.

Breastfeeding: can you take Nifuroxazide?

Data on passage into breast milk are absent. The drug is not used during lactation. Alternatives are rehydration and symptomatic therapy compatible with breastfeeding.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Where the indication is justified per Russian labeling, tablets 200 mg are taken 4 times daily or suspension 200 mg 4 times daily. The course does not exceed 7 days. The drug is not absorbed systemically and acts locally in the intestinal lumen. Intake is independent of meals. Mandatory parallel rehydration (oral or intravenous in severe cases) is given.

Dose titration

The dose is set per Russian labeling. There is no evidence base for escalation, course extension, or use in additional indications. Persistent symptoms beyond 3 days require diagnostic reassessment and transition to evidence-based regimens per 2017 (azithromycin, ciprofloxacin in severe bacterial diarrhea) or an infectious disease consultation.

Monitoring

No specific laboratory monitoring is required. Key follow-up points are stool dynamics, hydration status, body temperature, and appearance of blood or pus in stools. With deterioration or persistence beyond 3 days, tactics are changed: stool culture, C. difficile testing, and an evidence-based antibiotic in confirmed bacterial infection.

Special situations

In children under 2 years, the drug is not used per 2019. The decision is based on lack of proven efficacy and reported allergic reactions. In children over 2 years, prescribing is at the physician's discretion in countries where the drug is registered, first and foremost with mandatory rehydration. Fever, blood in stools, or signs of dehydration require hospitalization and revision of therapy.

Common myths

Myth: "nifuroxazide is a safe intestinal antiseptic, fits any diarrhea". Fact: international guidelines (, , ) do not list the drug; the evidence base is limited. In 2019 withdrew pediatric forms in some EU countries due to an unfavorable benefit-risk balance.

Myth: "works faster than rehydration". Fact: the foundation of acute diarrhea management is rehydration. Antimicrobials, including nifuroxazide, do not shorten diarrhea in immunocompetent adults with viral etiology.

Myth: "can be used prophylactically while traveling". Fact: nifuroxazide is not recommended for travelers' diarrhea prophylaxis. Prophylactic antibiotics for travelers are not indicated in most cases.

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Frequently asked

What is Nifuroxazide used for?

Nifuroxazide is evaluated for the following indications with varying evidence strength: Functional non-infectious diarrhea (evidence tier F), Acute infectious diarrhea (evidence tier F), Travelers' diarrhea (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Nifuroxazide?

Common side effects of Nifuroxazide (≥ 1 in 100): Gastrointestinal discomfort: nausea, bloating, Rash. See the Safety section for uncommon and serious reactions.

Is Nifuroxazide safe during pregnancy?

Is Nifuroxazide compatible with breastfeeding?

Data on passage into breast milk are absent. The drug is not used during lactation. Alternatives are rehydration and symptomatic therapy compatible with breastfeeding.

Who should not take Nifuroxazide?

Nifuroxazide is contraindicated in: Hypersensitivity to nitrofurans in history; Age under 2 months; Age under 6 years for tablet formulations; Sucrase-isomaltase deficiency, fructose intolerance (for sucrose-containing suspension). Full list in the Safety section.

nifuroxazide is a safe intestinal antiseptic, fits any diarrhea

international guidelines (IDSA, WHO, NICE) do not list the drug; the evidence base is limited. In 2019 EMA withdrew pediatric forms in some EU countries due to an unfavorable benefit-risk balance.

works faster than rehydration

the foundation of acute diarrhea management is rehydration. Antimicrobials, including nifuroxazide, do not shorten diarrhea in immunocompetent adults with viral etiology.

can be used prophylactically while traveling

nifuroxazide is not recommended for travelers' diarrhea prophylaxis. Prophylactic antibiotics for travelers are not indicated in most cases.

Official sources

Direct links to regulator labels. Open in a new tab.

GRLS

Other drugs in this group

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