Fidaxomicin is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile -associated diarrhea, among other approved uses. It is available as tablets and oral suspension. MedsAcross supplies Fidaxomicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
DIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile -associated diarrhea. To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
Source: US FDA prescribing information
Fidaxomicin is an antibacterial drug.
Source: US FDA prescribing information
DIFICID is administered orally with or without food. Adults One 200 mg tablet orally twice daily for 10 days. Pediatrics (6 Months to Less than 18 Years of Age) Tablets Pediatric patients weighing at least 12.5 kg and able to swallow tablets: One 200 mg tablet orally twice daily for 10 days. Oral Suspension Pediatric patients weighing at least 4 kg: Weight-based dosing of the oral suspension twice daily for 10 days using an oral dosing syringe, as specified in Table 1 in the full prescribing information. For instructions on preparation and administration of DIFICID oral suspension, see full prescribing information.
Source: US FDA prescribing information
DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
Source: US FDA prescribing information
Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue DIFICID. DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. DIFICID should only be used for the treatment of C. difficile -associated diarrhea. Development of drug-resistant bacteria: Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.
Source: US FDA prescribing information
The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. The most common adverse reactions in pediatric patients (incidence ≥5%) treated with DIFICID are pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash.
Source: US FDA prescribing information
Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract.
Source: US FDA prescribing information
Store DIFICID tablets at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). See USP controlled room temperature. Granules for oral suspension Store DIFICID granules for oral suspension at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). Store in the original bottle. Store in the original package. Once reconstituted, store DIFICID oral suspension refrigerated at 2°C-8°C (36°F-46°F) for up to 12 days. Store capped in the original bottle.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Fidaxomicin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fidaxomicin 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Dificid 200 mg tabletOral | Merck Sharp & Dohme | US FDA | Available on request |
| Dificid 200 mg/5 mL oral suspensionOral | Merck Sharp & Dohme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Fidaxomicin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Fidaxomicin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fidaxomicin, including Dificid.
Yes. The US FDA first approved Fidaxomicin on 27 May 2011, according to Drugs@FDA.
Yes. Fidaxomicin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Fidaxomicin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fidaxomicin is classified under ATC code A07AA12 (Fidaxomicin).
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