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fidaxomicin

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Brand names: Dificid

Macrocyclic Antibiotic Rx

Fidaxomicin is an antibiotic medicine. It is used to treat diarrhea caused by a bacteria called C. difficile.

Drug Pricing (NADAC)

Brand Price

$238.77/unit

Generic Available

Yes (3 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Fidaxomicin treats diarrhea caused by Clostridioides difficile (C.

Common side effects

Nausea, Vomiting, Abdominal pain

Key warnings

Do not take fidaxomicin if you are allergic to it or any of its ingredients.

How It Works

Fidaxomicin is a macrolide antibacterial drug. It works by stopping the growth of C. difficile bacteria in your gut. This helps to relieve diarrhea and other symptoms caused by the infection.

How to Take It

Take one 200 mg tablet twice a day. Take it by mouth for 10 days. You can take it with or without food.

Pregnancy & Breastfeeding

It is not known if fidaxomicin will harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if fidaxomicin passes into breast milk. Talk to your doctor about the best way to feed your baby if you take this medicine.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store fidaxomicin tablets at room temperature, between 68°F to 77°F, in the original bottle.

Side Effects (from patient reports)

Based on 2,065 FDA adverse event reports.

Clostridium Difficile Infection
461
Drug Ineffective
398
Diarrhoea
339
Disease Recurrence
178
Clostridium Difficile Colitis
156
Off Label Use
128
Nausea
120
Treatment Failure
119
Abdominal Pain
85
No Adverse Event
81

FDA Adverse Event Report Analysis

Detailed analysis of 2,273 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.

Total Reports

2,273

Death-Related Reports

248

Hospitalization Reports

699

Top Indication

Clostridium Difficile Infection

Gender Distribution

Female 1,221 (60%)
Male 738 (36%)

Age Distribution

0–17 61
18–44 200
45–64 412
65–74 326
75+ 422

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 CLOSTRIDIUM DIFFICILE INFECTION 461
2 DRUG INEFFECTIVE 398
3 DIARRHOEA 339
4 DISEASE RECURRENCE 178
5 CLOSTRIDIUM DIFFICILE COLITIS 156
6 OFF LABEL USE 128
7 NAUSEA 120
8 TREATMENT FAILURE 119
9 ABDOMINAL PAIN 85
10 NO ADVERSE EVENT 81
11 PYREXIA 74
12 DEATH 69
13 VOMITING 69
14 FATIGUE 55
15 ACUTE KIDNEY INJURY 52

Reactions in Death Reports

DEATH 69
CLOSTRIDIUM DIFFICILE INFECTION 45
DIARRHOEA 29
SEPTIC SHOCK 28
SEPSIS 25
RESPIRATORY FAILURE 24
DYSPNOEA 20
DRUG INEFFECTIVE 19
ANAEMIA 18
CLOSTRIDIUM DIFFICILE COLITIS 18

Reactions in Hospitalization Reports

CLOSTRIDIUM DIFFICILE INFECTION 191
DIARRHOEA 123
DRUG INEFFECTIVE 111
CLOSTRIDIUM DIFFICILE COLITIS 82
PYREXIA 55
NAUSEA 53
DISEASE RECURRENCE 51
ACUTE KIDNEY INJURY 41
OFF LABEL USE 37
VOMITING 37

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Do not take fidaxomicin if you are allergic to it or any of its ingredients. Allergic reactions can include trouble breathing, rash, itching, and swelling of the face, mouth, or throat. If you have a severe allergic reaction, stop taking fidaxomicin and get medical help right away.

Known Drug Interactions

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 )].

Mechanism: Cyclosporine blocks the proteins that help remove fidaxomicin from your system, which raises the amount of fidaxomicin in your blood.

What to do: Your doctor may monitor you for side effects, but no specific dose changes are usually required.

Common Questions

What is fidaxomicin used for?
It treats diarrhea caused by C. difficile.
How often do I take fidaxomicin?
You take one tablet twice a day for 10 days.
Can I take fidaxomicin with food?
Yes, you can take it with or without food.
What should I do if I miss a dose?
Take it as soon as you remember. If it's almost time for your next dose, skip the missed dose.
What are the common side effects?
Common side effects include nausea, vomiting, and abdominal pain.
Can I take fidaxomicin if I'm allergic to other antibiotics?
Tell your doctor if you are allergic to similar antibiotics. You may have an allergic reaction.
Is fidaxomicin safe during pregnancy?
Talk to your doctor if you are pregnant or plan to become pregnant.
Can I breastfeed while taking fidaxomicin?
Talk to your doctor about breastfeeding while taking this medicine.
How should I store fidaxomicin?
Store it at room temperature in the original bottle.
What if I have a severe allergic reaction?
Stop taking the medicine and get medical help right away.
What are the common side effects of fidaxomicin?
The most commonly reported side effects of fidaxomicin include Nausea, Vomiting, Abdominal pain, Gastrointestinal bleeding, Anemia. Based on 2,065 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does fidaxomicin interact with other medications?
Yes, fidaxomicin has 1 known drug interactions. Notable interactions include cyclosporine. Always inform your doctor about all medications you are taking.
What drug class is fidaxomicin?
fidaxomicin belongs to the Macrocyclic Antibiotic drug class. It requires a prescription (Rx). Fidaxomicin treats diarrhea caused by Clostridioides difficile (C.
Is fidaxomicin safe during pregnancy?
It is not known if fidaxomicin will harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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Medication Guides

Related Health & Safety Data

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What the FDA Data Shows for fidaxomicin

The FDA label for fidaxomicin (sold under brand names such as Dificid) classifies it as a prescription-only medication in the Macrocyclic Antibiotic class. Fidaxomicin treats diarrhea caused by Clostridioides difficile (C. Official labeling lists 6 commonly reported side effects, including Nausea, Vomiting, Abdominal pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,065 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: January 28, 2026

All federal data sources used on this page