Rifaximin Side Effects

Some side effects of rifaximin 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 rifaximin: oral tablet

Along with its needed effects, rifaximin 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 while taking rifaximin:

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 side effects of rifaximin 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:

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.

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

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)

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

Hypersensitivity

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

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

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

Musculoskeletal

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

Hematologic

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

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

Psychiatric

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

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

Cardiovascular

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

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

Hepatic

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

Ocular

Uncommon (0.1% to 1%): Diplopia

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