Drug information for XIFAXAN
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
200MG
Prescription
(Reference Drug)
RIFAXIMIN
rifaximin
SALIX PHARMS
21361
2010-11-18 Letter
2010-11-17 Label
2010-03-08 Letter
2010-03-05 Label
2007-02-12 Letter
2007-02-02 Label
2004-08-27 Review
2004-06-01 Letter
2004-06-01 Label
TABLET; ORAL
550MG
Prescription
(Reference Drug)
RIFAXIMIN
rifaximin
SALIX PHARMS
22554
2011-07-26 Review
2011-07-26 Summary Review
2010-03-29 Letter
2010-03-26 Label
Drug Adverse Effects information for XIFAXAN
Role code
Indications
Reaction
# Reports
PS
HAEMOLYTIC URAEMIC SYNDROME
COLITIS ISCHAEMIC
2
PS
HAEMOLYTIC URAEMIC SYNDROME
INSULIN C-PEPTIDE DECREASED
1
PS
HAEMOLYTIC URAEMIC SYNDROME
PANCREATITIS
2
PS
HEPATIC CIRRHOSIS
AMMONIA INCREASED
1
PS
HEPATIC CIRRHOSIS
BALANCE DISORDER
1
PS
HEPATIC CIRRHOSIS
BLOOD POTASSIUM DECREASED
1
PS
HEPATIC CIRRHOSIS
CHEST PAIN
1
PS
HEPATIC CIRRHOSIS
DIZZINESS POSTURAL
1
PS
HEPATIC CIRRHOSIS
FALL
1
PS
HEPATIC CIRRHOSIS
INSOMNIA
1
PS
HEPATIC CIRRHOSIS
MUSCULAR WEAKNESS
1
PS
HEPATIC CIRRHOSIS
PARAESTHESIA
1
PS
HEPATIC CIRRHOSIS
SLEEP APNOEA SYNDROME
1
PS
HEPATIC CIRRHOSIS
UNEVALUABLE EVENT
1
PS
HEPATIC CIRRHOSIS
UPPER LIMB FRACTURE
1
PS
HEPATIC ENCEPHALOPATHY
THROMBOCYTOPENIA
1
PS
INTESTINAL OBSTRUCTION
ABDOMINAL PAIN UPPER
1
PS
INTESTINAL OBSTRUCTION
INTESTINAL OBSTRUCTION
1
PS
IRRITABLE BOWEL SYNDROME
ANGIOEDEMA
1
PS
SMALL INTESTINAL BACTERIAL OVERGROWTH
BLOOD POTASSIUM DECREASED
1
PS
SMALL INTESTINAL BACTERIAL OVERGROWTH
DRY MOUTH
1
PS
SMALL INTESTINAL BACTERIAL OVERGROWTH
MALNUTRITION
1
PS
SMALL INTESTINAL BACTERIAL OVERGROWTH
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
C
AMMONIA ABNORMAL
ABDOMINAL DISTENSION
1
C
AMMONIA ABNORMAL
BLOOD COUNT ABNORMAL
1
C
AMMONIA ABNORMAL
DIARRHOEA
1
C
AMMONIA ABNORMAL
ERUCTATION
1
C
AMMONIA ABNORMAL
FATIGUE
1
C
AMMONIA ABNORMAL
INFECTION
1
C
AMMONIA ABNORMAL
LOCAL SWELLING
1
C
AMMONIA ABNORMAL
WHITE BLOOD CELL DISORDER
1
C
ARTHRITIS
HEPATIC CIRRHOSIS
1
C
ARTHRITIS
HEPATIC ENZYME INCREASED
1
C
CONTRACEPTION
BILIARY DYSKINESIA
1
C
CONTRACEPTION
GALLBLADDER DISORDER
1
C
CONTRACEPTION
PAIN
1
C
CROHN'S DISEASE
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
2
C
DEPRESSION
BLOOD BILIRUBIN INCREASED
1
C
DEPRESSION
INFLUENZA LIKE ILLNESS
1
C
DEPRESSION
JAUNDICE
1
C
DEPRESSION
PYREXIA
1
C
DEPRESSION
SKIN ODOUR ABNORMAL
1
C
DIARRHOEA
HEPATIC CIRRHOSIS
1
C
DIARRHOEA
HEPATIC ENZYME INCREASED
1
C
FOLATE DEFICIENCY
HEPATIC CIRRHOSIS
1
C
FOLATE DEFICIENCY
HEPATIC ENZYME INCREASED
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
BILIARY DYSKINESIA
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
GALLBLADDER DISORDER
1
C
GASTROOESOPHAGEAL REFLUX DISEASE
PAIN
1
C
HEPATIC NEOPLASM MALIGNANT
ABDOMINAL DISTENSION
1
C
HEPATIC NEOPLASM MALIGNANT
BLOOD COUNT ABNORMAL
1
C
HEPATIC NEOPLASM MALIGNANT
BLOOD PRESSURE INCREASED
1
C
HEPATIC NEOPLASM MALIGNANT
CEREBRAL HAEMORRHAGE
1
C
HEPATIC NEOPLASM MALIGNANT
DEATH
1
C
HEPATIC NEOPLASM MALIGNANT
DIARRHOEA
2
C
HEPATIC NEOPLASM MALIGNANT
ERUCTATION
1
C
HEPATIC NEOPLASM MALIGNANT
FATIGUE
1
C
HEPATIC NEOPLASM MALIGNANT
INFECTION
1
C
HEPATIC NEOPLASM MALIGNANT
LOCAL SWELLING
1
C
HEPATIC NEOPLASM MALIGNANT
LOSS OF CONSCIOUSNESS
1
C
HEPATIC NEOPLASM MALIGNANT
RASH PRURITIC
1
C
HEPATIC NEOPLASM MALIGNANT
UNRESPONSIVE TO STIMULI
1
C
HEPATIC NEOPLASM MALIGNANT
WHITE BLOOD CELL DISORDER
1
C
HEPATITIS C
ANAEMIA
3
C
HYPERTENSION
ARRHYTHMIA
1
C
HYPERTENSION
BLOOD PRESSURE INCREASED
1
C
HYPERTENSION
CEREBRAL HAEMORRHAGE
1
C
HYPERTENSION
DEATH
1
C
HYPERTENSION
DIARRHOEA
1
C
HYPERTENSION
DYSPNOEA
1
C
HYPERTENSION
HEPATIC CIRRHOSIS
1
C
HYPERTENSION
HEPATIC ENZYME INCREASED
1
C
HYPERTENSION
HYPERTENSION
1
C
HYPERTENSION
LOSS OF CONSCIOUSNESS
1
C
HYPERTENSION
RASH PRURITIC
1
C
HYPERTENSION
UNRESPONSIVE TO STIMULI
1
C
HYPOTHYROIDISM
HEPATIC CIRRHOSIS
1
C
HYPOTHYROIDISM
HEPATIC ENZYME INCREASED
1
C
MENSTRUAL CYCLE MANAGEMENT
BILIARY DYSKINESIA
1
C
MENSTRUAL CYCLE MANAGEMENT
GALLBLADDER DISORDER
1
C
MENSTRUAL CYCLE MANAGEMENT
PAIN
1
C
MICTURITION URGENCY
HEPATIC CIRRHOSIS
1
C
MICTURITION URGENCY
HEPATIC ENZYME INCREASED
1
C
PAIN
BILIARY DYSKINESIA
1
C
PAIN
GALLBLADDER DISORDER
1
C
PAIN
HEPATIC CIRRHOSIS
1
C
PAIN
HEPATIC ENZYME INCREASED
1
C
PAIN
PAIN
1
C
POLYARTHRITIS
INJECTION SITE PAIN
1
C
PRODUCT USED FOR UNKNOWN INDICATION
CHEST PAIN
3
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSGEUSIA
3
C
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
1
C
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
3
C
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC CIRRHOSIS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC ENZYME INCREASED
1
C
PRODUCT USED FOR UNKNOWN INDICATION
INFLUENZA LIKE ILLNESS
3
C
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
3
C
PRODUCT USED FOR UNKNOWN INDICATION
NO THERAPEUTIC RESPONSE
3
C
PRODUCT USED FOR UNKNOWN INDICATION
REBOUND EFFECT
3
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE
1
C
PRODUCT USED FOR UNKNOWN INDICATION
THROAT TIGHTNESS
1
C
PRODUCT USED FOR UNKNOWN INDICATION
VIRAL LOAD INCREASED
3
C
PULMONARY ARTERIAL HYPERTENSION
GASTROINTESTINAL HAEMORRHAGE
2
C
PULMONARY ARTERIAL HYPERTENSION
OESOPHAGEAL HAEMORRHAGE
2
C
PULMONARY ARTERIAL HYPERTENSION
URINARY TRACT INFECTION
2
C
VITAMIN SUPPLEMENTATION
HEPATIC CIRRHOSIS
1
C
VITAMIN SUPPLEMENTATION
HEPATIC ENZYME INCREASED
1
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