Fidaxomicin (oral route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fidaxomicin in children 6 months and older. However, safety and efficacy have not been established in children younger than 6 months old.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fidaxomicin in the elderly.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin), history of—Allergic reactions are more likely to occur.

• Infection (systemic)—Should not be used to treat systemic infections.

Less common

• Abdominal or stomach pain
• bloating
• bloody or black, tarry stools
• chills
• confusion
• cough
• drowsiness
• fever
• loss of appetite
• lower back or side pain
• muscle tremors
• nausea
• painful or difficult urination
• pale skin
• rapid, deep breathing
• restlessness
• severe constipation
• shortness of breath
• sore throat
• 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

Less common

• Abdominal or stomach distension or tenderness
• acid or sour stomach
• belching
• blurred vision
• difficulty with swallowing
• dry mouth
• excess air or gas in the stomach or intestines
• flushed, dry skin
• fruit-like breath odor
• full feeling
• heartburn
• increased hunger
• increased thirst
• increased urination
• indigestion
• passing gas
• stomach discomfort or upset
• sweating
• troubled breathing
• unexplained weight loss