Xifaxan Side Effects

Generic Name: rifaximin

Note: This page contains side effects data for the generic drug rifaximin. It is possible that some of the dosage forms included below may not apply to the brand name Xifaxan.

It is possible that some side effects of Xifaxan may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to rifaximin: oral tablet

As well as its needed effects, rifaximin (the active ingredient contained in Xifaxan) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rifaximin, check with your doctor immediately:

More common
  • Black, tarry stools
  • dizziness or lightheadedness
  • muscle spasm
  • rapid breathing
  • shortness of breath
  • sleeplessness
  • trouble sleeping
  • unable to sleep
Less common
  • Blood in urine
  • bloody nose
  • chest pain
  • continuing ringing or buzzing or other unexplained noise in the ears
  • fainting
  • feeling of constant movement of self or surroundings
  • increased heart rate
  • sensation of spinning
  • sunken eyes
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Cracks in the skin
  • hives or welts
  • itching skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of heat from the body
  • rash
  • red, swollen skin scaly skin
  • redness of skin

Some rifaximin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Bloated
  • difficulty in moving
  • dizziness
  • excess air or gas in the stomach or intestines
  • fever
  • frequent urge to defecate
  • full feeling
  • headache
  • lower back or side pain
  • muscle pain or stiffness
  • pain in joints
  • passing gas
  • stomach pain
  • straining while passing stool
  • swelling of the hands, ankles, feet, or lower legs
Less common
  • Abnormal dreams
  • blurred vision
  • chills
  • confusion
  • cough
  • decreased urination
  • difficulty having a bowel movement (stool)
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry lips
  • dry mouth
  • ear pain
  • feeling of warmth
  • hearing loss
  • lightheadedness
  • loss of appetite
  • loss of taste
  • nausea
  • painful or difficult urination
  • pale skin
  • redness of the face, neck, arms and occasionally, upper chest
  • sore throat
  • sweating
  • swollen glands
  • thirst
  • vomiting
  • wrinkled skin

For Healthcare Professionals

Applies to rifaximin: oral tablet

General

The most common side effects in travelers' diarrhea were flatulence, headache, abdominal pain, rectal tenesmus, defecation urgency, and nausea. This drug was discontinued due to side effects in 0.4% of patients; such side effects were taste loss, dysentery, decreased weight, anorexia, nausea, and nasal passage irritation.

The most common side effects in hepatic encephalopathy were peripheral edema, nausea, dizziness, fatigue, and ascites.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 14.3%), ascites (11.4%), flatulence (up to 11%)
Common (1% to 10%): Abdominal pain, abdominal distension, rectal tenesmus, upper abdominal pain, defecation urgency, constipation, stomach discomfort, vomiting, lower abdominal pain, abdominal tenderness, dry mouth, esophageal variceal bleed, diarrhea, bloating and distension, nausea and vomiting symptoms
Uncommon (0.1% to 1%): Dry lips, dyspepsia, gastrointestinal motility disorder, hard feces, hematochezia, mucous stools, taste disorders
Frequency not reported: Blood in stool, dysentery, fecal abnormality, gingival disorder, inguinal hernia, straining, bad taste in mouth
Postmarketing reports: Clostridium difficile associated colitis[Ref]

Other

Very common (10% or more): Peripheral edema (15%), fatigue (up to 12.1%)
Common (1% to 10%): Pyrexia, chest pain, pain, generalized edema, influenza-like illness, contusion, fall, procedural pain
Uncommon (0.1% to 1%): Ear pain, clostridial infection, candidiasis, hot flush, edema, herpes simplex, asthenic conditions, chills, pain and discomfort
Rare (less than 0.1%): Asthenia
Frequency not reported: Motion sickness, malaise, hot flashes
Postmarketing reports: Clostridial infections (Clostridium difficile)[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 13%), headache (10%)
Common (1% to 10%): Vertigo, amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor
Uncommon (0.1% to 1%): Balance disorders, convulsion, attention disorders, migraine, paresthesia, sinus headache, somnolence
Frequency not reported: Syncope, tinnitus, loss of taste
Postmarketing reports: Presyncope, syncope[Ref]

Hypersensitivity

Hypersensitivity reactions have occurred as early as within 15 minutes of drug administration.[Ref]

Frequency not reported: Anaphylactic reactions
Postmarketing reports: Hypersensitivity reactions (including exfoliative dermatitis, rash, angioneurotic edema [swelling of face and tongue and difficulty swallowing], urticaria, pruritus, flushing, anaphylaxis), anaphylactic responses, angioedemas, hypersensitivity[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, cellulitis
Uncommon (0.1% to 1%): Eruptions and exanthemas, sunburn, hyperhidrosis/increased sweating, cold sweat
Frequency not reported: Clamminess
Postmarketing reports: Dermatitis, eczema, erythemas, pruritus, purpura, urticarias[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms, arthralgia, back pain, myalgia, pain in extremity
Uncommon (0.1% to 1%): Neck pain, muscular weakness[Ref]

Hematologic

Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Lymphocytosis, monocytosis, neutropenia
Postmarketing reports: Thrombocytopenia, INR abnormalities[Ref]

Respiratory

Common (1% to 10%): Cough, nasopharyngitis, dyspnea, upper respiratory tract infection, rhinitis, pneumonia, epistaxis
Uncommon (0.1% to 1%): Pleural effusion, pharyngitis, oropharyngeal pain, rhinorrhea, dry throat, nasal congestion
Rare (less than 0.1%): Chronic obstructive pulmonary disease
Frequency not reported: Respiratory tract infection, nasal passage irritation, pharyngolaryngeal pain[Ref]

Psychiatric

Common (1% to 10%): Depression, insomnia, confusional state
Uncommon (0.1% to 1%): Anxiety, hypersomnia, abnormal dreams, depressed mood, nervousness[Ref]

Metabolic

Common (1% to 10%): Increased weight, anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia
Uncommon (0.1% to 1%): Decreased appetite
Frequency not reported: Decreased weight[Ref]

Cardiovascular

Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Palpitations, increased blood pressure
Rare (less than 0.1%): Hypertension[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection, dysuria, polyuria, proteinuria, pollakiuria, blood in urine present, glycosuria, polymenorrhea
Frequency not reported: Choluria, hematuria, urinary frequency[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased AST
Postmarketing reports: Liver function test abnormalities[Ref]

Ocular

Uncommon (0.1% to 1%): Diplopia[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Xifaxan (rifaximin)." Salix Pharmaceuticals, Raleigh, NC.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Rifaximin (Xifaxan 550) for hepatic encephalopathy." Med Lett Drugs Ther 52 (2010): 87

5. Pimentel M, Park S, Mirocha J, Kane SV, Kong Y "The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial." Ann Intern Med 145 (2006): 557-63

6. Juillerat P, Pittet V, Felley C, et al. "Drug safety in Crohn's disease therapy." Digestion 76 (2007): 161-8

7. Garey KW, Salazar M, Shah D, Rodrigue R, Dupont HL "Rifamycin antibiotics for treatment of Clostridium difficile-associated diarrhea." Ann Pharmacother 42 (2008): 827-35

8. Trapnell CB, Connolly M, Pentikis H, Forbes B, Bettenhausen DK "Absence of effect of oral rifaximin on the pharmacokinetics of ethinyl estradiol/norgestimate in healthy females." Ann Pharmacother 41 (2007): 222-8

9. Hynicka LM, Silva KN "Probable rifaximin-induced neutropenia." Am J Health Syst Pharm 69 (2012): 583-6

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