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Xifaxan (Rifaximin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xifaxan (Rifaximin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (31)
Death (6)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Renal Failure (5)Colitis Ischaemic (3)Staphylococcal Infection (3)Pancreatitis (3)Enterococcal Infection (2)Hepatic Failure (2)Headache (2)Fall (2)Bacterial Prostatitis (2)Oedema Peripheral (2)Abdominal Distension (2)Dizziness (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Xifaxan (Rifaximin). For a complete list or a specific selection of reports, please use the links above.

Possible Xifaxan side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 76 year old male, weighing 51.7 kg (113.7 pounds)

Reactions: Stomatitis, Oral Mucosal Erythema, Dehydration

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-20

Patient:

Reactions: Diarrhoea, Diarrhoea Haemorrhagic, Muscle Spasms

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 43 year old female

Reported by a physician from Germany on 2012-07-12

Patient: 43 year old female

Reactions: Thrombocytopenia

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 52 year old male

Reported by a physician from France on 2012-06-26

Patient: 52 year old male

Reactions: Renal Failure, Prostatitis, Staphylococcal Infection, Enterococcal Infection, Altered State of Consciousness, Infectious Peritonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 44 year old female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 44 year old female, weighing 76.2 kg (167.6 pounds)

Reactions: Abdominal Pain, Nausea, Diarrhoea, Abdominal Distension, Dizziness

Drug(s) suspected as cause:
Nexium
    Dosage: 1 capsule -40 mg- twice a day po
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2012-05-09
    End date: 2012-01-01

Nexium
    Dosage: 1 capsule -40 mg- twice a day po
    Administration route: Oral
    Indication: Gastrointestinal Disorder
    Start date: 2012-05-09
    End date: 2012-01-01

Xifaxan
    Dosage: 2 tablets -400 mg- three times a day po
    Administration route: Oral
    Indication: Gastrointestinal Disorder
    Start date: 2012-06-07
    End date: 2012-06-18

Xifaxan
    Dosage: 2 tablets -400 mg- three times a day po
    Administration route: Oral
    Indication: Overgrowth Bacterial
    Start date: 2012-06-07
    End date: 2012-06-18



Possible Xifaxan side effects in 50 year old male

Reported by a physician from France on 2012-05-30

Patient: 50 year old male

Reactions: Abdominal Distension, Pyrexia, Headache, Umbilical Hernia, Peptostreptococcus Test Positive, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan

Other drugs received by patient: Aldactone; Lasix; Noroxin; Propranolol LP; Previscan; Levothyroxine Sodium; Hydrocortisone



Possible Xifaxan side effects in 62 year old male

Reported by a physician from France on 2012-05-30

Patient: 62 year old male

Reactions: Klebsiella Infection, Bacterial Prostatitis, Staphylococcal Infection, Coma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan

Other drugs received by patient: Duphalac; Vitamin D; Aldactone; Propranolol; Humalog; Atorvastatin; Pantoprazole Sodium; Lovenox; Lasix; Ferrous Sulfate TAB; Vitamin B6; Vitamin B1 TAB; Lantus



Possible Xifaxan side effects in 52 year old male

Reported by a physician from France on 2012-05-30

Patient: 52 year old male

Reactions: Bacterial Prostatitis, Renal Failure, Bacteraemia, Staphylococcal Infection, Enterococcal Infection, Leukocyturia, Altered State of Consciousness, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 64 year old female

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: 64 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Gastric Perforation, Duodenal Perforation

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-16

Patient: 72 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Confusional State, Activities of Daily Living Impaired, Oedema Peripheral, Dizziness, Asthenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xifaxan
    Dosage: 1 tablet 550 mg twice a day po
    Administration route: Oral
    Indication: Hepatic Encephalopathy
    Start date: 2012-03-01
    End date: 2012-05-04

Xifaxan
    Dosage: 1 tablet 550 mg twice a day po
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-03-01
    End date: 2012-05-04



Possible Xifaxan side effects in 58 year old female

Reported by a physician from United States on 2012-05-07

Patient: 58 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Xifaxan

Other drugs received by patient: Maxalt; Proair HFA; Novolog; Levaquin; Ciprofloxacin; Dexlansoprazole



Possible Xifaxan side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-24

Patient: 65 year old female

Reactions: Renal Failure, Hepatic Cirrhosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 65 year old female

Reactions: Renal Failure, Hepatic Cirrhosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: female, weighing 110.2 kg (242.5 pounds)

Reactions: Vomiting, Hiatus Hernia, Drug Ineffective, Coma, Foot Fracture, Malaise, Hepatic Encephalopathy, Hepatotoxicity, Abnormal Loss of Weight, Gastrooesophageal Reflux Disease, Feeling Abnormal, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nucynta
    Dosage: 100 mg 10 times a day
    Administration route: Oral
    Indication: Arthritis
    Start date: 2011-06-01

Nucynta ER
    Dosage: 100 mg twice a day
    Administration route: Oral
    Indication: Arthritis
    Start date: 2011-10-01

Morphine
    Dosage: 40 mg as needed
    Administration route: Oral
    Indication: Arthritis
    Start date: 2011-07-01
    End date: 2011-10-01

Nucynta
    Dosage: 100 mg 6 times a day
    Administration route: Oral
    Start date: 2009-01-01
    End date: 2011-06-01

Nucynta ER
    Dosage: 250 mg twice a day
    Administration route: Oral
    End date: 2012-03-29

Prilosec
    Dosage: 40 mg daily
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2011-08-01

Prilosec
    Dosage: 40 mg daily
    Administration route: Oral
    Indication: Hiatus Hernia
    Start date: 2011-08-01

Xifaxan
    Administration route: Oral
    Indication: Hepatic Encephalopathy
    Start date: 2012-02-01

Topamax
    Dosage: 100 mg twice a day
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2010-01-01
    End date: 2012-02-01

Morphine
    Dosage: 15 mg four times a day
    Administration route: Oral
    Start date: 2012-03-30



Possible Xifaxan side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: male, weighing 87.1 kg (191.6 pounds)

Reactions: Pneumonia, Fatigue, Oedema Peripheral, Pulmonary Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in

Reported by a individual with unspecified qualification from United States on 2012-04-10

Patient:

Reactions: Intercepted Drug Dispensing Error

Drug(s) suspected as cause:
Xifaxan

Xifaxan



Possible Xifaxan side effects in 45 year old female

Reported by a pharmacist from United States on 2012-04-09

Patient: 45 year old female, weighing 73.0 kg (160.6 pounds)

Reactions: Drug Clearance Decreased, Enterocolitis Haemorrhagic, White Blood Cell Count Decreased, Heparin-Induced Thrombocytopenia, Urinary Tract Infection, Hypometabolism, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enoxaparin
    Dosage: 1200 mg (400 mg, 1 in 8 hr)
    Indication: Hepatic Encephalopathy Prophylaxis
    Start date: 2010-02-01
    End date: 2010-02-01

Xifaxan
    Dosage: 1200 mg (400 mg, 1 in 8 hr)
    Indication: Hepatic Encephalopathy Prophylaxis
    Start date: 2010-02-01
    End date: 2010-02-01

Other drugs received by patient: Azathioprine; Pantoprazole; Hydrocortisone; Budesonide; Heparin



Possible Xifaxan side effects in 60 year old male

Reported by a physician from United States on 2012-03-16

Patient: 60 year old male

Reactions: Platelet Count Decreased, Hepatic Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Xifaxan

Other drugs received by patient: Aldactone; Lactulose; Furosemide; Nadolol



Possible Xifaxan side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient: male

Reactions: Hemiplegia, Headache, Cerebrovascular Accident, Cerebral Haemorrhage, Terminal State

Adverse event resulted in: death

Drug(s) suspected as cause:
Xifaxan
    Administration route: Oral
    Indication: Hepatic Cirrhosis
    Start date: 2011-10-01

Xifaxan
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-10-01



Possible Xifaxan side effects in 47 year old male

Reported by a pharmacist from United States on 2012-02-10

Patient: 47 year old male

Reactions: Craniocerebral Injury, Fall, Haematoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-31

Patient: 60 year old female

Reactions: Blood Pressure Increased, Urine Output Decreased, Hepatic Failure, Haemodialysis, Weight Increased, Renal Impairment, Renal Failure, Hepatorenal Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan
    Dosage: 1100 mg (550 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Hepatic Encephalopathy
    Start date: 2011-01-01
    End date: 2012-01-17

Lisinopril
    Indication: Blood Pressure
    End date: 2012-01-17

Other drugs received by patient: Lasix; Spironolactone



Possible Xifaxan side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-01-26

Patient: 82 year old male, weighing 77.1 kg (169.6 pounds)

Reactions: Clostridial Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan
    Dosage: xifaxan 550mg.
    Administration route: Oral
    Indication: Ammonia Abnormal
    Start date: 2011-03-27
    End date: 2012-01-10

Xifaxan
    Dosage: xifaxan 550mg.
    Administration route: Oral
    Indication: Cardiac Cirrhosis
    Start date: 2011-03-27
    End date: 2012-01-10



Possible Xifaxan side effects in 60 year old female

Reported by a physician from United States on 2012-01-23

Patient: 60 year old female

Reactions: Blood Pressure Increased, Renal Impairment

Drug(s) suspected as cause:
Lisinopril
    Indication: Blood Pressure Increased
    End date: 2012-01-17

Xifaxan
    Dosage: 1100 mg (550 mg,2 in 1 d),oral
    Administration route: Oral
    Indication: Hepatic Encephalopathy
    Start date: 2011-01-01
    End date: 2012-01-17

Other drugs received by patient: Spironolactone; Lasix



Possible Xifaxan side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-01-06

Patient: 27 year old female, weighing 51.2 kg (112.6 pounds)

Reactions: Colitis Ischaemic, Insulin C-Peptide Decreased, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan
    Dosage: oral
    Administration route: Oral
    Indication: Clostridium Test Positive
    Start date: 2011-06-14
    End date: 2011-06-20

Keppra
    Start date: 2011-06-07
    End date: 2011-06-20

Soliris
    Dosage: (900 mg), intravenous
    Indication: Haemolytic Uraemic Syndrome
    Start date: 2011-06-01
    End date: 2011-09-03

Ramipril
    Start date: 2011-06-15
    End date: 2011-07-01

Azithromycin
    Start date: 2011-06-17
    End date: 2011-07-01

Other drugs received by patient: Insulin



Possible Xifaxan side effects in 66 year old female

Reported by a pharmacist from United States on 2011-12-29

Patient: 66 year old female

Reactions: Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan



Possible Xifaxan side effects in 63 year old female

Reported by a consumer/non-health professional from United States on 2011-12-21

Patient: 63 year old female, weighing 40.8 kg (89.8 pounds)

Reactions: Wrong Technique in Drug Usage Process, Blood Potassium Decreased, DRY Mouth, Malnutrition

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan
    Dosage: 1100 mg (550 mg,2 in 1 d),oral ; 550 mg (550 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Small Intestinal Bacterial Overgrowth
    Start date: 2011-12-10
    End date: 2011-12-14

Xifaxan
    Dosage: 1100 mg (550 mg,2 in 1 d),oral ; 550 mg (550 mg,1 in 1 d),oral
    Administration route: Oral
    Indication: Small Intestinal Bacterial Overgrowth
    Start date: 2011-12-09
    End date: 2011-12-10

Other drugs received by patient: Ativan



Possible Xifaxan side effects in 27 year old female

Reported by a physician from Germany on 2011-11-18

Patient: 27 year old female, weighing 51.2 kg (112.6 pounds)

Reactions: Colitis Ischaemic, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azithromycin
    Start date: 2011-06-17
    End date: 2011-07-01

Xifaxan
    Dosage: oral
    Administration route: Oral
    Start date: 2011-06-14
    End date: 2011-06-20

Soliris
    Dosage: (900 mg), intravenous
    Indication: Haemolytic Uraemic Syndrome
    Start date: 2011-06-01
    End date: 2011-09-03

Keppra
    Start date: 2011-06-07
    End date: 2011-06-20

Ramipril
    Start date: 2011-06-15
    End date: 2011-07-01

Other drugs received by patient: Insulin



Possible Xifaxan side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-11-18

Patient: 27 year old female, weighing 51.2 kg (112.6 pounds)

Reactions: Colitis Ischaemic, Insulin C-Peptide Decreased, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xifaxan
    Dosage: oral
    Administration route: Oral
    Start date: 2011-06-14
    End date: 2011-06-20

Azithromycin
    Start date: 2011-06-17
    End date: 2011-07-01

Soliris (Injection FOR Infusion)
    Dosage: (900 mg), intravenous
    Indication: Haemolytic Uraemic Syndrome
    Start date: 2011-06-01
    End date: 2011-09-03

Ramipril
    Start date: 2011-06-15
    End date: 2011-07-01

Keppra
    Start date: 2011-06-07
    End date: 2011-06-20

Other drugs received by patient: Insulin



Possible Xifaxan side effects 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

Drug(s) suspected as cause:
Xifaxan

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



Possible Xifaxan side effects 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

Drug(s) suspected as cause:
Xifaxan

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

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