Dificid
Fidaxomicin, also known by its brand name, Dificid, is a macrolide antibiotic. It's used to treat adults and children 6 months and older with a type of infectious diarrhea called Clostridioides difficile (C. diff) diarrhea. Dificid (fidaxomicin) is available as a tablet and suspension (liquid), but it isn't available as a lower-cost generic yet. Dificid (fidaxomicin) is taken by mouth twice per day. Side effects include nausea, vomiting, and stomach pain.
What is Dificid (fidaxomicin)?
What is Dificid (fidaxomicin) used for?
Clostridioides difficile (C. diff) diarrhea in people ages 6 months and older
How Dificid (fidaxomicin) works
Dificid (fidaxomicin) is a macrolide antibiotic. It kills C. difficile bacteria by stopping them from making important nutrients that they need to grow and survive.
Drug Facts
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What are the side effects of Dificid (fidaxomicin)?
Common Side Effects
- Nausea (11%)
- Vomiting (7%)
- Stomach pain (6%)
- Stomach bleeding (4%)
- Fever (13%)
- Stomach pain (8%)
- Vomiting (7%)
- Diarrhea (7%)
- Constipation (5%)
- Rash (5%)
- High liver enzyme levels in the blood (5%)
Other Side Effects
- Indigestion
- Itching
- Rash or hives
Serious Side Effects
- Serious allergic reaction: hives, rash, blisters, fever, swelling of the lips or tongue, difficulty breathing
Source:Â DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
Abdominal or stomach pain
bloody or black, tarry stools
chills
confusion
drowsiness
loss of appetite
lower back or side pain
muscle tremors
painful or difficult urination
pale skin
rapid, deep breathing
restlessness
severe constipation
shortness of breath
stomach cramps
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
vomiting of blood or material that looks like coffee grounds
Incidence not known
Difficult or labored breathing
itching skin or rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
tightness in the chest
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Abdominal or stomach distension or tenderness
acid or sour stomach
belching
blurred vision
difficulty with swallowing
excess air or gas in the stomach or intestines
flushed, dry skin
fruit-like breath odor
full feeling
increased hunger
increased thirst
increased urination
indigestion
passing gas
stomach discomfort or upset
sweating
troubled breathing
unexplained weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Dificid (fidaxomicin)
Pros
First-choice option for treating C. diff diarrhea
Shown to work better than vancomycin capsules at preventing C. diff infection from coming back
Comes as a tablet and a liquid
Can be used in children as young as 6 months
Cons
Taken twice per day
Can cause nausea and vomiting as side effects
Must let the liquid sit out of the refrigerator for 15 minutes before you take a dose
No lower-cost generic available
Pharmacist tips for Dificid (fidaxomicin)
Take Dificid (fidaxomicin) exactly as prescribed. Make sure to finish your treatment course, even if you're feeling better. Stopping the medication earlier than prescribed can make your infection come back and become harder to treat.
You can take Dificid (fidaxomicin) with or without food. Taking the medication with food might help lessen or ease stomach upset from the antibiotic.
Tell your prescriber right away if you have unexplained vomiting or stomach pain or blood in your vomit or stool; you might need more medical attention. Although rare, some people who took Dificid (fidaxomicin) in clinical studies reported having mild stomach bleeding. But it's not completely clear whether the bleeding was due to Dificid (fidaxomicin) or other risk factors for bleeding.
Tell your healthcare provider (HCP) if you're pregnant. It isn't known whether this medication is safe to take while pregnant. Your HCP will discuss the risks and benefits of taking Dificid (fidaxomicin) during pregnancy to decide whether it's safe for you and your baby.
Ask your prescriber or your baby's primary care provider if it's safe for you to breastfeed while you're taking Dificid (fidaxomicin). It isn't known whether it's safe to breastfeed during treatment. But the medication doesn't seem to get absorbed into the body well, so it might not be expected to cause side effects to your baby.
More tips for the oral suspension (liquid)
The pharmacy will prepare the Dificid (fidaxomicin) suspension before giving it to you. Once prepared, the suspension is good for 12 days. After 12 days, throw away the bottle, even if there's still medication in it. The pharmacy staff typically writes this date on the bottle to help you remember when to throw it away.
Store the Dificid (fidaxomicin) suspension in the refrigerator in the original bottle that the pharmacy gave you.
When it's time to take your Dificid (fidaxomicin) dose, take the medication out of the refrigerator and let it sit for 15 minutes to warm up. Don't try to warm up the medication any other way (e.g., microwave, oven) because this can damage it.
Shake the bottle well before you measure out the Dificid (fidaxomicin) suspension. Make sure to only use an oral dosing syringe from the pharmacy to measure out your dose. Don't use household spoons because they aren't accurate and using them might cause you to take the wrong dose.
Frequently asked questions about Dificid (fidaxomicin)
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What are the risks and warnings for Dificid (fidaxomicin)?
Dificid (fidaxomicin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Allergic reactions
Risk factors: Allergy to other macrolide antibiotics
Severe allergic reactions to Dificid (fidaxomicin) are possible, including life-threatening reactions like facial swelling and anaphylaxis (e.g., closing of the throat). Let your prescriber know if you have an allergy to antibiotics, especially to other macrolide antibiotics like azithromycin (Zithromax). This is because you might be at greater risk for having an allergic reaction to Dificid (fidaxomicin).
Call 911 right away if you notice hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing after you take Dificid (fidaxomicin).
Dificid (fidaxomicin) dosage forms
Typical dosing for Dificid (fidaxomicin)
Adults and children weighing 27.5 lbs or more: The typical dose is 200 mg (or 5 mL of the suspension) by mouth two times a day for 10 days.
Children weighing between 20 lbs and 27.4 lbs: The typical dose is 160 mg (or 4 mL of the suspension) by mouth two times a day for 10 days.
Children weighing between 15.4 lbs and 19.9 lbs: The typical dose is 120 mg (or 3 mL of the suspension) by mouth two times a day for 10 days.
Children weighing between 9 lbs and 15.3 lbs: The typical dose is 80 mg (or 2 mL of the suspension) by mouth two times a day for 10 days.
Interactions between Dificid (fidaxomicin) and other drugs
More on Dificid (fidaxomicin) interactions
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cholera Vaccine, Live
How much does Dificid (fidaxomicin) cost?
What are alternatives to Dificid (fidaxomicin)?
Clostridioides difficile (C. diff) diarrhea in people ages 6 months and older
Infectious diarrhea caused by Clostridioides difficile (C. diff)
Gut inflammation (enterocolitis) caused by Staphylococcus aureus (S. aureus)
Amebiasis (parasitic gut infection)
Serious bacterial infections, such as:
Dificid (fidaxomicin) images
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References
Best studies we foundAl Momani, L. A., et al. (2018). Fidaxomicin vs vancomycin for the treatment of a first episode of Clostridium difficile infection: A meta-analysis and systematic review. Cureus.
Bishop, E. J., et al. (2022). Management of Clostridioides difficile infection in adults and challenges in clinical practice: Review and comparison of current IDSA/SHEA, ESCMID and ASID guidelines. The Journal of Antimicrobial Chemotherapy.
Cruz, M. P. (2012). Fidaxomicin (Dificid), a novel oral macrocyclic antibacterial agent for the treatment of Clostridium difficile-associated diarrhea in adults. Pharmacy and Therapeutics.
Drugs and Lactation Database (LactMed®). (2021). Fidaxomicin. National Institute of Child Health and Human Development.
Golan, Y., et al. (2012). Safety and efficacy of fidaxomicin in the treatment of Clostridium difficile-associated diarrhea. Therapeutic Advances in Gastroenterology.
Louie, T. J., et al. (2011). Fidaxomicin versus vancomycin for Clostridium difficile infection. The New England Journal of Medicine.
Louie, T. J., et al. (2012). Fidaxomicin preserves the intestinal microbiome during and after treatment of Clostridium difficile infection (CDI) and reduces both toxin reexpression and recurrence of CDI. Clinical Infectious Diseases.
Merck Sharp & Dohme LLC. (2023). Dificid- fidaxomicin tablet, film coated; Dificid- fidaxomicin granule, for suspension [package insert].
Song, J. H., et al. (2019). Recurrent Clostridium difficile infection: Risk factors, treatment, and prevention. Gut and Liver.
Weiss, K., et al. (2012). Safety analysis of fidaxomicin in comparison with oral vancomycin for Clostridium difficile infections. Clinical Infectious Diseases.
Zhanel, G. G., et al. (2015). Fidaxomicin: A novel agent for the treatment of Clostridium difficile infection. The Canadian Journal of Infectious Diseases & Medical Microbiology.
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