fidaxomicin
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
Side effects of Dificid (fidaxomicin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Adults
- Nausea (11%)
- Vomiting (7%)
- Stomach pain (6%)
- Stomach bleeding (4%)
Children
- Fever (13%)
- Stomach pain (8%)
- Vomiting (7%)
- Diarrhea (7%)
- Constipation (5%)
- Rash (5%)
- High liver enzyme levels in the blood (5%)
Less Common Side Effects
- Indigestion
- Itching
- Rash or hives
Dificid (fidaxomicin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: hives, rash, blisters, fever, swelling of the lips or tongue, difficulty breathing
The following Dificid (fidaxomicin) 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.
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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.
Common questions about Dificid
One study showed that Dificid cured C. diff infections about 90% of the time. A larger 2018 review of a collection of studies also found that Dificid can lower the risk of having a C. diff infection come back by almost 50% when compared to vancomycin capsules (Vancocin, Firvanq).
In studies of adults who took Dificid, it took about 3 days for diarrhea to go away after starting Dificid. Speak to your prescriber if you're concerned with how quickly Dificid is working for you.
It takes about 2 days for most of Dificid to leave your body after a dose. This time frame is estimated based on the half-life of Dificid. Talk with your healthcare team if you have specific concerns about how long this medication stays in your body.
Yes. Dificid and vancomycin capsules (Vancocin, Firvanq) don't interact with each other, so they can be taken together. But keep in mind that the treatment guidelines for C. diff generally recommend Dificid as a first-choice option and vancomycin capsules (Vancocin, Firvanq) as an alternative choice, rather than taking both medications together.
Diarrhea wasn't reported as a side effect in adults taking Dificid. But it was reported in about 7% of children who took the medication. Keep in mind that people take Dificid to treat diarrhea that's specifically caused by a C. diff infection. So it might be hard to tell whether the diarrhea is from the bacterial infection or whether it's a side effect from Dificid.
It's best to avoid alcohol while you're taking Dificid. Alcohol can worsen side effects from the antibiotic, like stomach pain and nausea. It can also make it more difficult for you to recover from an infection. Speak with a healthcare professional about your drinking habits and how to best avoid drinking alcohol while you're taking Dificid.
No, Dificid doesn't typically make you tired. This wasn't a side effect that people who took the medication reported during clinical trials. Keep in mind that tiredness can be a symptom of an active C. diff infection. Talk to your prescriber if you're feeling too tired to the point where you can't go about your day. They can help figure out what might be making you tired.
Some studies show that Dificid might have activity against some types of "good bacteria", like Lactobacillus. But other studies suggest that the medication doesn't make a significant impact on the good bacteria in your gut. This means that Dificid generally isn't considered harmful to good bacteria. The medication also doesn't typically cause side effects that are related to having too little good bacteria in the gut, such as stomach cramping or bloating. Since Dificid doesn't seem to affect your good bacteria too much, it might not be necessary to take a probiotic while you're getting treated. Talk to a healthcare professional if you have more questions on how Dificid affects good bacteria.
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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
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mg | 20 tablets | $1,292.69 | $64.63 |
Typical dosage 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
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
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
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