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Fidaxomicin

Fidaxomicin is an antibiotic (a macrolide) used to treat C. difficile-associated diarrhea, an infection of the gut that causes diarrhea.

Brand name Dificid
Drug class Macrolide Antibacterial
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 7, 2026
Fidaxomicin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

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.
How you get itPrescription only
Comes asTablet, Oral suspension
Earliest FDA record2009
Companies listing it with the FDA5
FDA label last updatedOct 16, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Fidaxomicin, written from its FDA label.

What Fidaxomicin is used for

▾

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

▾

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

▾

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

▾

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

▾
  • 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

▾

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.

Read the full Drug Interactions section on DailyMed →

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

▾
  • 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

▾

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

▾

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

▾

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 →

92

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.

Severity mix
  • Major · 3
  • Moderate · 71
  • Minor · 18
Every supplement checked against Fidaxomicin — ranked by severity The full interaction hub: 3 major · 71 moderate · 18 minor · every one linked to its full report. Check Fidaxomicin against your exact supplements

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.

7

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.

Evidence & significance mix
  • Higher significance · 6
  • Moderate · 1
See the full Fidaxomicin nutrient depletion report

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?

▾
Fidaxomicin treats diarrhea caused by a C. difficile infection in your gut. It only works for this infection, not for other kinds.

How do I take it?

▾
Take it by mouth twice a day for 10 days, with or without food. Finish the full course as your prescriber directs, even if you start feeling better.

What side effects should I expect?

▾
The most common are nausea, vomiting and belly pain. Some people also have gut bleeding, anemia or low white blood cells. Let your doctor know if anything bothers you or worsens.

When should I call for help?

▾
Get help right away if you have trouble breathing or swelling of your face, mouth or throat. Also call if you get a rash or itching. These could be signs of an allergic reaction.

Can I take it with my other medicines?

▾
Fidaxomicin has few interactions. Cyclosporine raises its levels in the blood, but they stay low. Medicines that block P-glycoprotein can be used with it without a dose change. Still, tell me everything you take.

Is it safe in pregnancy or breastfeeding?

▾
There isn't enough human data to know the risk in pregnancy, though animal studies showed no harm to the fetus. It's unknown whether it gets into breast milk. Talk with your doctor about the benefits and risks.

Is Fidaxomicin available over the counter?

▾
No. Fidaxomicin is a prescription medicine: every Fidaxomicin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Fidaxomicin first available?

▾
The earliest FDA record we hold for Fidaxomicin is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Fidaxomicin was first used.

Who makes Fidaxomicin?

▾
5 companies currently list Fidaxomicin products in the FDA's NDC Directory, including Merck Sharp & Dohme LLC, Apotex Corp., Sandoz Inc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Fidaxomicin on HelloPharmacist

Detailed data & references for Fidaxomicin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

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

By mouth
Brands Dificid
How this form is used
What it may be used for
  • 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.
Important instructions
  • 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.
Available strengths 1 strength
8 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Dificid
How this form is used
What it may be used for
  • Dificid oral suspension is used in children for C. difficile-associated diarrhea, including those weighing at least 4 kg.
Important instructions
  • 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.
Available strengths 1 strength
3 FDA-listed product records ⓘ

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.

2
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
2
Brand names
6
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

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.

Merck Sharp & Dohme LLC33%
Apotex Corp.17%
Sandoz Inc17%
Teva Pharmaceuticals, Inc.17%
Torrent Pharmaceuticals Limited17%

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.

4,446
Medicaid prescriptions filled (Q1–Q4 2025)
$18.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fidaxomicin prescribed? Of the 1,601 medications we measure, Fidaxomicin ranks #1,065 by Medicaid prescriptions — more than 33% of them.

Where Fidaxomicin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

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.

The 200 mg oral tablet is the most-dispensed Fidaxomicin product — about 99% of these Medicaid prescriptions.

fidaxomicin 200 MG Oral Tablet Most dispensed

4,420 Medicaid prescriptions (Q1–Q4 2025) 99% of Fidaxomicin prescriptions shown $18.8M gross reimbursement (before rebates) ≈ $4,255 per prescription (gross)

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

26 Medicaid prescriptions (Q1–Q4 2025) <1% of Fidaxomicin prescriptions shown $93,907 gross reimbursement (before rebates) ≈ $3,612 per prescription (gross)

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 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 2021

Source: 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.

Ingredient (IN) Fidaxomicin RxCUI 1111103 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 2279842 In current FDA listings
    Clinical drug / strength (SCD) 40 MG/ML RxCUI 2279843
  2. Dose form (SCDF) Oral Tablet RxCUI 1111105 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 1111106

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.

💵 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.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 200 mg $90.50 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full 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.

Dificid

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.

Merck Sharp & Dohme LLC 2 Apotex Corp. 1 Sandoz Inc 1 Teva Pharmaceuticals, Inc. 1 Torrent Pharmaceuticals Limited 1

Fidaxomicin drug class (RxNorm)

Fidaxomicin belongs to the Macrolide Antibacterial class.

Pharmacologic class Macrolide Antibacterial
Drug family (ATC) Antibiotics

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 16, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fidaxomicin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fidaxomicin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
Finished products in the current FDA directory
6
Companies listing them (makers, repackagers, distributors)
5
FDA labeler codes behind them ⓘ
5
Linked representative label ⓘ
Merck Sharp & Dohme LLC
Linked label effective
Oct 16, 2024
Composite sections available
22
Linked SPL Set ID
dd966338-c820-4270-b704-09ef75fa3ceb
Linked SPL Document ID
21c95e9f-0a3d-4fb8-90b5-934bad817d00
Open the linked representative label on DailyMed ↗

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 →