Nifuroxazide

Intestinal antimicrobial

ATC code: A07AX03 (A07AX03)

Brand names

Ercefuryl, Bacifurane, Nifuroxazide

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.

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 or . 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.

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.

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), Mild-to-moderate travelers' diarrhea (evidence tier F), Acute infectious 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?

FDA category C. 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.

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.

Nifuroxazide

Mechanism of action

Marketing claims without evidence base

Acute infectious diarrhea

Functional non-infectious diarrhea

Mild-to-moderate travelers' diarrhea

Practical notes

Timing and administration

Dose titration

Monitoring

Special situations

Common myths

Check interaction with another drug

Official sources

Safety

Contraindications

Serious adverse effects

Common adverse effects

Uncommon adverse effects

PregnancyFDA C

Breastfeeding

Frequently asked