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Dificid

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Dificid

Dificid Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Dificid (fidaxomicin) is a macrolide antibacterial drug used to reduce the development of drug-resistant bacteria and to treat Clostridium difficile-associated diarrhea (CDAD) in adults over the age of 18. A generic form is not available in the US. Dificid should only be used to treat infections that are proven or strongly suspected to be caused by Clostridium difficile. Dificid is not an effective treatment for systemic infections. Common side effects are nausea, vomiting, and diarrhea.

Dificid (fidaxomicin) is available only as 200 mg strength tablets. The recommended dose is one 200 mg Dificid tablet orally twice daily for 10 days with or without food. Reported bothersome side effects of Dificid are gastrointestinal disorders such as flatulence and indigestion. Other side effects can include itching skin and rash. Serious side effects are GI bleeding and intestinal obstruction. Dificid is known to react with Cyclosporine. There are no adequate and well-controlled studies in pregnant women or in children under age 18. This drug should be used during pregnancy only if clearly needed. It is not known whether fidaxomicin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dificid is administered to a nursing woman.

Our Dificid (fidaxomicin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Dificid in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dificid (Fidaxomicin Tablets for Oral Administration) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Dificid FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of any other drug and may not reflect the rates observed in practice.

The safety of DIFICID 200 mg tablets taken twice a day for 10 days was evaluated in 564 patients with CDAD in two active-comparator controlled trials with 86.7% of patients receiving a full course of treatment.

Thirty-three patients receiving DIFICID (5.9%) withdrew from trials as a result of adverse reactions (AR). The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the fidaxomicin and vancomycin patients in Phase 3 studies.

Table 1: Selected Adverse Reactions with an Incidence of ≥ 2% Reported in DIFICID Patients in Controlled Trials

  DIFICID (N=564) Vancomycin (N=583)
System Organ Class Preferred Term n (%) n (%)
Blood and Lymphatic System Disorders
  Anemia 14 (2%) 12 (2%)
  Neutropenia 14 (2%) 6 (1%)
Gastrointestinal Disorders
  Nausea 62 (11%) 66 (11%)
  Vomiting 41 (7%) 37 (6%)
  Abdominal Pain 33 (6%) 23 (4%)
  Gastrointestinal Hemorrhage 20 (4%) 12 (2%)

The following adverse reactions were reported in < 2% of patients taking DIFICID tablets in controlled trials:

Gastrointestinal Disorders: abdominal distension, abdominal tenderness, dyspepsia, dysphagia, flatulence, intestinal obstruction, megacolon

Investigations: increased blood alkaline phosphatase, decreased blood bicarbonate, increased hepatic enzymes, decreased platelet count

Metabolism and Nutrition Disorders: hyperglycemia, metabolic acidosis

Skin and Subcutaneous Tissue Disorders: drug eruption, pruritus, rash

Post Marketing Experience

Adverse reactions reported in the post marketing setting arise from a population of unknown size and are voluntary in nature. As such, reliability in estimating their frequency or in establishing a causal relationship to drug exposure is not always possible.

Hypersensitivity reactions (dyspnea, angioedema, rash, and pruritus) have been reported.

Read the entire FDA prescribing information for Dificid (Fidaxomicin Tablets for Oral Administration) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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