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Xifaxan (Rifaximin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Studies Experience

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


         Travelers’ Diarrhea

        The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers’ diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.

        Discontinuations due to adverse reactions occurred in 0.4% of patients.  The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation.

        All adverse reactions for XIFAXAN 200 mg three times daily that occurred at a frequency ≥ 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.)

Table 1. All Adverse Reactions With an Incidence ≥2% Among Patients Receiving XIFAXAN Tablets, 200 mg Three Times Daily, in Placebo-Controlled Studies
MedDRA Preferred Term
Number (%) of Patients 
XIFAXAN
Tablets, 600 mg/day

(N = 320)

Placebo

N = 228
 

*NOS: Not otherwise specified

 

Flatulence

 

36 (11%)

 

45 (20%)

 

Headache

 

31 (10%)

 

21 (9%)

 

Abdominal Pain NOS*

 

23 (7%)

 

23 (10%)

 

Rectal Tenesmus

 

23 (7%)

 

20 (9%)

 

Defecation Urgency

 

19 (6%)

 

21 (9%)

 

Nausea

 

17 (5%)

 

19 (8%)

 

Constipation

 

12 (4%)

 

8 (4%)

 

Pyrexia

 

10 (3%)

 

10 (4%)

 

Vomiting NOS

 

7 (2%)

 

4 (2%)

        The following adverse reactions, presented by body system, have also been reported in <2% of patients taking XIFAXAN in the two placebo-controlled clinical trials where the 200 mg tablet was taken three times a day for travelers’ diarrhea.  The following includes adverse reactions regardless of causal relationship to drug exposure.

        Blood and Lymphatic System Disorders: Lymphocytosis, monocytosis, neutropenia

        Ear and Labyrinth Disorders: Ear pain, motion sickness, tinnitus

        Gastrointestinal Disorders: Abdominal distension, diarrhea NOS, dry throat, fecal abnormality NOS, gingival disorder NOS, inguinal hernia NOS, dry lips, stomach discomfort

        General Disorders and Administration Site Conditions: Chest pain, fatigue, malaise, pain NOS, weakness

        Infections and Infestations: Dysentery NOS, respiratory tract infection NOS, upper respiratory tract infection NOS

        Injury and Poisoning: Sunburn

        Investigations: Aspartate aminotransferase increased, blood in stool, blood in urine, weight decreased

        Metabolic and Nutritional Disorders: Anorexia, dehydration

        Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, muscle spasms, myalgia, neck pain

        Nervous System Disorders: Abnormal dreams, dizziness, migraine NOS, syncope, loss of taste

        Psychiatric Disorders: Insomnia

        Renal and Urinary Disorders: Choluria, dysuria, hematuria, polyuria, proteinuria, urinary frequency

        Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea NOS, nasal passage irritation, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, rhinitis NOS, rhinorrhea

        Skin and Subcutaneous Tissue Disorders: Clamminess, rash NOS, sweating increased

        Vascular Disorders: Hot flashes NOS

         Hepatic Encephalopathy

        The data described below reflect exposure to XIFAXAN 550 mg in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days).  The safety of XIFAXAN 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n = 140) and in a long term follow-up study (n = 280).  The population studied had a mean age of 56.26 (range: 21-82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black.  Ninety-one percent of patients in the trial were taking lactulose concomitantly. All adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN 550 mg-treated subjects than in the placebo group in the 6-month trial are provided in Table 2. (These include adverse events that may be attributable to the underlying disease).

Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Receiving XIFAXAN and at a Higher Incidence Than Placebo
 
Number (%) of Patients

  MedDRA Preferred Term   
XIFAXAN Tablets
550 mg TWICE
DAILY  
N = 140


Pla
cebo
N = 159
 

    Edema peripheral

 

21 (15%)

 

13 (8%)

 

    Nausea

 

20 (14%)

 

   21 (13%)   

 

    Dizziness

 

18 (13%)

 

13 (8%)

 

    Fatigue

 

17 (12%)

 

18 (11%)

 

    Ascites

 

16 (11%)

 

15 (9%)

 

    Muscle spasms

 

13 (9%)

 

11 (7%)

 

    Pruritus

 

13 (9%)

 

10 (6%)

 

    Abdominal pain

 

12 (9%)

 

13 (8%)

 

    Abdominal distension

 

11 (8%)

 

12 (8%)

 

    Anemia

 

11 (8%)

 

6 (4%)

 

    Cough

 

10 (7%)

 

11 (7%)

 

    Depression

 

10 (7%)

 

8 (5%)

 

    Insomnia

 

10 (7%)

 

11 (7%)

 

    Nasopharyngitis

 

10 (7%)

 

10 (6%)

 

    Abdominal pain upper

 

9 (6%)

 

8 (5%)

 

    Arthralgia

 

9 (6%)

 

4 (3%)

 

    Back pain

 

9 (6%)

 

10 (6%)

 

    Constipation

 

9 (6%)

 

10 (6%)

 

    Dyspnea

 

9 (6%)

 

7 (4%)

 

    Pyrexia

 

9 (6%)

 

5 (3%)

 

    Rash

 

7 (5%)

 

6 (4%)

        The following adverse reactions, presented by body system, have also been reported in the placebo-controlled clinical trial in greater than 2% but less than 5% of patients taking XIFAXAN 550 mg taken orally two times a day for hepatic encephalopathy. The following includes adverse events occurring at a greater incidence than placebo, regardless of causal relationship to drug exposure.

        Ear and Labyrinth Disorders: Vertigo

        Gastrointestinal Disorders: Abdominal pain lower, abdominal tenderness, dry mouth, esophageal variceal bleed, stomach discomfort

        General Disorders and Administration Site Conditions: Chest pain, generalized edema, influenza like illness, pain NOS

        Infections and Infestations: Cellulitis, pneumonia, rhinitis, upper respiratory tract infection NOS

        Injury, Poisoning and Procedural Complications: Contusion, fall, procedural pain

        Investigations: Weight increased

        Metabolic and Nutritional Disorders: Anorexia, dehydration, hyperglycemia, hyperkalemia, hypoglycemia, hyponatremia

        Musculoskeletal, Connective Tissue, and Bone Disorders: Myalgia, pain in extremity

        Nervous System Disorders: Amnesia, disturbance in attention, hypoesthesia, memory impairment, tremor

        Psychiatric Disorders: Confusional state

        Respiratory, Thoracic, and Mediastinal Disorders: Epistaxis

        Vascular Disorders: Hypotension

Postmarketing Experience

        The following adverse reactions have been identified during post approval use of XIFAXAN.  Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.   These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN. 

         Infections and Infestations  

        Cases of C. difficile-associated colitis have been reported [see Warnings and Precautions].

         General

        Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported.  These events occurred as early as within 15 minutes of drug administration.



REPORTS OF SUSPECTED XIFAXAN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Xifaxan. The information is not vetted and should not be considered as verified clinical evidence.

Possible Xifaxan side effects / adverse reactions in 88 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 88 year old female weighing 49.9 kg (109.8 pounds)

Reactions: Intestinal Obstruction, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Suspect drug(s):
Xifaxan
    Dosage: 400;600 mg (200 mg, 2 in 1 d; 3 in 1 d), oral
    Administration route: Oral
    Indication: Intestinal Obstruction
    Start date: 2009-01-01

Xifaxan
    Dosage: 400;600 mg (200 mg, 2 in 1 d; 3 in 1 d), oral
    Administration route: Oral
    Indication: Intestinal Obstruction
    Start date: 2008-01-01
    End date: 2009-01-01



Possible Xifaxan side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-10-31

Patient: 45 year old female weighing 68.0 kg (149.7 pounds)

Reactions: Upper Limb Fracture, Dizziness Postural, Muscular Weakness, Fall, Paraesthesia, Blood Potassium Decreased, Balance Disorder, Chest Pain, Insomnia, Ammonia Increased, Unevaluable Event, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Xifaxan

Other drugs received by patient: Diuretic; Celebrex; Propranolol; Lasix



Possible Xifaxan side effects / adverse reactions in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-10

Patient: 48 year old female weighing 74.8 kg (164.7 pounds)

Reactions: Angioedema

Suspect drug(s):
Xifaxan

Other drugs received by patient: Seroquel; Lisinopril; Prozac; Nasonex; Zyrtec; Epipen; Singulair; Metformin HCL; Norvasc; Amitriptyline HCL



See index of all Xifaxan side effect reports >>

Drug label data at the top of this Page last updated: 2011-12-28

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