Fidaxomicin
Fidaxomicin is an antibiotic (a macrolide) used to treat C. difficile-associated diarrhea, an infection of the gut that causes diarrhea.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Fidaxomicin (Dificid) is a targeted antibiotic for C. difficile-associated diarrhea that works right in the gut, with very little absorbed, and guidelines now favor it as a first choice; it has been on the market since about 2009 and is available as a generic. Most people tolerate it well, and nausea, vomiting or belly pain are what people notice most. Watch for a serious allergic reaction, such as trouble breathing or swelling of the mouth, throat or face, and get help right away. Finish all 10 days of twice-daily doses, and tell your prescriber if the diarrhea is not easing or you see signs of bleeding.
Clinical pearls
- It treats only C. difficile and will not cover other infections; take it with or without food.
- Mention any past reaction to a macrolide antibiotic, such as azithromycin or erythromycin, before your first dose.
- The Dificid liquid, made from granules, suits children who cannot swallow tablets; generic tablets are approved only for adults.
- Wash hands with soap and water at home, because alcohol gel does not kill C. difficile spores.
Patient information guide A plain-language walkthrough of Fidaxomicin, written from its FDA label.
What Fidaxomicin is used for
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Fidaxomicin is used for one infection across its products.
- C. difficile-associated diarrhea in adults (Dificid tablets, Dificid oral suspension and fidaxomicin tablets).
- C. difficile-associated diarrhea in children 6 months and older (Dificid only).
How Fidaxomicin works
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Fidaxomicin is a macrolide antibacterial. It acts locally in the gut on C. difficile. Very little is absorbed into the blood, so it stays mostly in the digestive tract where the infection is.
Fidaxomicin dosage
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Fidaxomicin is taken by mouth twice a day for 10 days, with or without food.
- Adults take a tablet.
- Children who can swallow tablets and meet the weight requirement may take Dificid tablets.
- Dificid oral suspension is for children who can't swallow tablets. It is dosed by weight with an oral syringe.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Fidaxomicin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults
- One 200 mg tablet orally twice daily for 10 days
- With or without food
- Pediatric patients (6 months to less than 18 years) weighing at least 12.5 kg and able to swallow tablets
- One 200 mg tablet orally twice daily for 10 days
- With or without food; if unable to swallow tablets, use the oral suspension
- Pediatric patients 4 kg to less than 7 kg (oral suspension)
- 80 mg (2 mL of 40 mg/mL suspension) twice daily for 10 days using an oral dosing syringe
- Weight-based dosing
- Pediatric patients 7 kg to less than 9 kg (oral suspension)
- 120 mg (3 mL of 40 mg/mL suspension) twice daily for 10 days using an oral dosing syringe
- Weight-based dosing
- Pediatric patients 9 kg to less than 12.5 kg (oral suspension)
- 160 mg (4 mL of 40 mg/mL suspension) twice daily for 10 days using an oral dosing syringe
- Weight-based dosing
- Pediatric patients 12.5 kg and above (oral suspension)
- 200 mg (5 mL of 40 mg/mL suspension) twice daily for 10 days using an oral dosing syringe
- Weight-based dosing
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION DIFICID is administered orally with or without food. ( 2.1 ) Adults One 200 mg tablet orally twice daily for 10 days. ( 2.2 ) 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. ( 2.3 ) 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. ( 2.3 ) For instructions on preparation and administration of DIFICID oral suspension, see full prescribing information. ( 2.4 ) 2.1 Important Administration Instructions DIFICID is available for oral administration as 200 mg tablets and as granules for oral suspension (40 mg/mL (200 mg/5 mL) when reconstituted). DIFICID is administered orally with or without food. 2.2 Adult Patients The recommended dosage for adults is one 200 mg DIFICID tablet orally twice daily for 10 days. 2.3 Pediatric Patients (6 Months to Less than 18 Years of Age) Tablets The recommended dosage for pediatric patients weighing at least 12.5 kg and able to swallow tablets is one 200 mg DIFICID tablet administered orally twice daily for 10 days. If unable to swallow tablets, pediatric patients may be dosed with DIFICID oral suspension as recommended in Table 1 below. Oral Suspension The recommended dosage for pediatric patients based on weight are shown in Table 1. Administer DIFICID oral suspension orally twice daily for 10 days using an oral dosing syringe [see Dosage and Administration (2.4) ] . Table 1: Recommended Dosage of DIFICID Oral Suspension in Pediatric Patients, Based on Weight Body Weight Dose Administered Twice Daily Volume of 40 mg/mL Suspension to be Administered Orally Twice Daily 4 kg to less than 7 kg 80 mg 2 mL 7 kg to less than 9 kg 120 mg 3 mL 9 kg to less than 12.5 kg 160 mg 4 mL 12.5 kg and above 200 mg 5 mL 2.4 Preparation and Administration of DIFICID Oral Suspension Preparation Shake the glass bottle to ensure the granules move around freely and no caking has occurred. Measure 130 mL of purified water, add to the glass bottle, and cap tightly. Hold bottle in a horizontal position and shake bottle vigorously in that position for at least 2 minutes. Verify that a homogeneous suspension is obtained.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fidaxomicin side effects
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The most common side effects in adults are:
Common side effects
- Nausea
- Vomiting
- Abdominal (belly) pain
- Gastrointestinal bleeding
- Anemia (low red blood cells)
- Neutropenia (low white blood cells)
- In children: fever, diarrhea, constipation, rash, raised liver tests
When to get medical help
- Get help right away for signs of a serious allergic reaction, such as trouble breathing or swelling of the mouth, throat or face.
- Call your doctor if you develop a rash or itching.
- Stop the medicine and get medical help if a severe allergic reaction happens.
- Tell your doctor if your diarrhea doesn't improve or you have signs of bleeding.
Fidaxomicin warnings and precautions
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- Serious allergic reactions (trouble breathing, rash, itching, swelling of the mouth, throat and face) have been reported. Stop the drug and get help if severe.
- It works only for C. difficile diarrhea, not other infections.
- Using it without proven or strongly suspected C. difficile infection increases the risk of drug-resistant bacteria.
Fidaxomicin interactions
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Few interactions are noted.
- Cyclosporine: raises fidaxomicin blood levels, though they stay very low.
- P-glycoprotein blockers: can be used together with fidaxomicin, and no dose change is recommended.
Interactions listed in the FDA-approved label
From the Fidaxomicin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Cyclosporine (P-gp inhibitor): When co-administered with fidaxomicin tablets, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range. Fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended.
Read the label’s full interactions text
7 DRUG INTERACTIONS Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract. 7.1 Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with fidaxomicin tablets, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range [see Clinical Pharmacology ( 12.3 )]. Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of fidaxomicin-treated adult patients in controlled clinical trials. Based on these results, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fidaxomicin
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- Don't use it if you have a known allergy to fidaxomicin or its ingredients.
- Tell your doctor about any allergy to macrolide antibiotics.
- Pregnancy: human data are limited, and animal studies showed no harm.
- Breastfeeding: it isn't known whether it passes into milk, so discuss it with your doctor.
- Children: not established under 6 months of age.
- Older adults: blood levels were higher, but safety and effectiveness were similar.
Fidaxomicin overdose
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No cases of acute overdose have been reported in humans. Dogs given more than 100 times the human dose for 3 months had no drug-related harm.
What Fidaxomicin does in the body
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Fidaxomicin acts locally in the gut on C. difficile. In a dose-ranging trial, higher doses worked better, showing a dose-response relationship.
How your body processes Fidaxomicin
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Very little fidaxomicin is absorbed into the blood, and it stays mainly in the gut. Your body converts it to an active metabolite called OP-1118, without using CYP enzymes. Food doesn't meaningfully change how it works. Over 92% of a dose was found in stool, and its half-life is about 11 to 12 hours. Older adults had higher blood levels.
How to store Fidaxomicin
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Tablets Store DIFICID tablets 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 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).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Fidaxomicin
92 supplements and herbal products have documented interactions with Fidaxomicin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 71
- Minor · 18
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Fidaxomicin has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Fidaxomicin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Fidaxomicin — the kind of thing our pharmacy team would talk through with you at the counter.
What am I taking this for?
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How do I take it?
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What side effects should I expect?
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When should I call for help?
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Can I take it with my other medicines?
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Is it safe in pregnancy or breastfeeding?
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Is Fidaxomicin available over the counter?
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When was Fidaxomicin first available?
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Who makes Fidaxomicin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fidaxomicin on HelloPharmacist
Fidaxomicin forms and strengths (how it comes)
Fidaxomicin is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fidaxomicin inactive ingredients by manufacturer.
Tablet
How this form is used
- Dificid tablets are used for C. difficile-associated diarrhea in adults and in children 6 months and older.
- Fidaxomicin tablets are used for C. difficile-associated diarrhea in adults.
- Dificid tablets are taken by mouth twice daily for 10 days, with or without food.
- Fidaxomicin tablets are taken by mouth twice daily for 10 days, with or without food.
- Dificid tablets are for children who weigh at least 12.5 kg and can swallow tablets.
Oral suspension
How this form is used
- Dificid oral suspension is used in children for C. difficile-associated diarrhea, including those weighing at least 4 kg.
- Dificid oral suspension is given by mouth twice daily for 10 days using an oral dosing syringe.
- Dificid oral suspension dosing is based on a child's weight.
- Dificid oral suspension is mixed with water from granules, kept in the refrigerator and discarded after 12 days.
- Take Dificid oral suspension out of the refrigerator 15 minutes before each dose and shake it well.
Fidaxomicin on the U.S. market: products, makers and brands
How Fidaxomicin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
5 companies list 6 Fidaxomicin product records with the FDA, mostly as tablet, oral suspension; the earliest marketing or approval year on record is 2009. Brand names on the directory include Dificid; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Fidaxomicin is used (Medicaid data)
A general measure of how commonly Fidaxomicin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fidaxomicin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fidaxomicin prescribed? Of the 1,601 medications we measure, Fidaxomicin ranks #1,065 by Medicaid prescriptions — more than 33% of them.
Utilization by Fidaxomicin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fidaxomicin 200 MG Oral Tablet Most dispensed
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1111106
fidaxomicin 40 MG/ML Oral Suspension
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2279843
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fidaxomicin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 7 listed Fidaxomicin NDCs with Medicaid activity.
Compare Fidaxomicin products
A representative set of FDA-listed product records for Fidaxomicin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral suspension | ||||
| 200 mg/5 mL | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 💊Tablet | ||||
| 200 mg | Oral | Apotex Corp. | ANDA | View NDC → |
| 200 mg | Oral | Merck Sharp & Dohme LLC | NDA | View NDC → |
| 200 mg | Oral | Sandoz Inc | ANDA | View NDC → |
| 200 mg | Oral | Teva Pharmaceuticals, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Fidaxomicin NDCs →
Fidaxomicin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fidaxomicin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fidaxomicin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fidaxomicin FDA approval history
How Fidaxomicin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fidaxomicin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Fidaxomicin recalls since July 2021.
✅No Fidaxomicin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1111103 2 dose forms · 2 strengths
Look up RxCUI 1111103 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Fidaxomicin supply and shortage status
Whether Fidaxomicin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fidaxomicin costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 200 mg | $90.50 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Fidaxomicin brand names
Fidaxomicin is sold under one brand name in the FDA directory — Dificid. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fidaxomicin: manufacturers and labelers
5 companies list Fidaxomicin products with the FDA. By number of product records, the largest are Merck Sharp & Dohme LLC, Apotex Corp., Sandoz Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Fidaxomicin drug class (RxNorm)
Fidaxomicin belongs to the Macrolide Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fidaxomicin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →