Fidaxomicin Side Effects

Some side effects of fidaxomicin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fidaxomicin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fidaxomicin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• black, bloody, or tarry stools; or

• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects of fidaxomicin may include:

• nausea, vomiting, stomach pain;

• bloating or gas; or

• mild rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fidaxomicin: oral tablet

Dermatologic

Dermatologic side effects have included drug eruption (less than 2%), pruritus (less than 2%), and rash (less than 2%).

Gastrointestinal

Gastrointestinal side effects have included nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), abdominal distension (less than 2%), abdominal tenderness (less than 2%), dyspepsia (less than 2%), dysphagia (less than 2%), flatulence (less than 2%), intestinal obstruction (less than 2%), and megacolon (less than 2%).

Hematologic

Hematologic side effects have included anemia (2%), neutropenia (2%) and decreased platelet count (less than 2%).

Hepatic

Hepatic side effects have included increased hepatic enzymes (less than 2%).

Metabolic

Metabolic side effects have included hyperglycemia (less than 2%), and metabolic acidosis (less than 2%).

Laboratory abnormalities have included increased blood alkaline phosphatase (less than 2%), and decreased blood bicarbonate (less than 2%).

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