RIFAXIMIN

N/A

Manufactured by Salix Pharmaceuticals, Inc.

37,072 FDA adverse event reports analyzed

Last updated: 2026-04-14

About RIFAXIMIN

RIFAXIMIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Salix Pharmaceuticals, Inc.. The most commonly reported adverse reactions for RIFAXIMIN include DEATH, HOSPITALISATION, DIARRHOEA, OFF LABEL USE, THERAPY INTERRUPTED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RIFAXIMIN.

Top Adverse Reactions

DEATH3,983 reports
HOSPITALISATION1,704 reports
DIARRHOEA1,193 reports
OFF LABEL USE1,133 reports
THERAPY INTERRUPTED989 reports
AMMONIA INCREASED831 reports
NAUSEA802 reports
FATIGUE779 reports
HEPATIC ENCEPHALOPATHY762 reports
DRUG INEFFECTIVE713 reports
CONFUSIONAL STATE711 reports
INABILITY TO AFFORD MEDICATION679 reports
HEPATIC CIRRHOSIS657 reports
INSURANCE ISSUE623 reports
FALL607 reports
CONDITION AGGRAVATED603 reports
DIZZINESS517 reports
PRODUCT USE IN UNAPPROVED INDICATION517 reports
HEADACHE512 reports
PRODUCT USE ISSUE488 reports
HEPATIC FAILURE479 reports
ABDOMINAL PAIN471 reports
LIVER DISORDER469 reports
MALAISE465 reports
VOMITING465 reports
PNEUMONIA450 reports
DYSPNOEA441 reports
ABDOMINAL DISTENSION438 reports
ASTHENIA437 reports
RENAL FAILURE412 reports
PAIN376 reports
ASCITES358 reports
TREATMENT NONCOMPLIANCE358 reports
ABDOMINAL PAIN UPPER352 reports
THERAPY CESSATION350 reports
ACUTE KIDNEY INJURY339 reports
URINARY TRACT INFECTION327 reports
WEIGHT DECREASED318 reports
CONSTIPATION316 reports
ANAEMIA296 reports
DRUG DOSE OMISSION270 reports
PRURITUS254 reports
DEHYDRATION251 reports
MEMORY IMPAIRMENT248 reports
PYREXIA248 reports
SEPSIS241 reports
FEELING ABNORMAL238 reports
INTENTIONAL PRODUCT USE ISSUE234 reports
PERIPHERAL SWELLING228 reports
HOSPICE CARE227 reports
ARTHRALGIA222 reports
RASH217 reports
INSOMNIA216 reports
DECREASED APPETITE213 reports
WEIGHT INCREASED210 reports
MUSCLE SPASMS209 reports
OEDEMA PERIPHERAL205 reports
ILL DEFINED DISORDER199 reports
PRODUCT DOSE OMISSION ISSUE197 reports
ABDOMINAL DISCOMFORT192 reports
COUGH191 reports
BACK PAIN188 reports
TREMOR184 reports
HYPOTENSION183 reports
FLATULENCE179 reports
SOMNOLENCE177 reports
ENCEPHALOPATHY174 reports
ANXIETY173 reports
FLUID RETENTION171 reports
CHRONIC KIDNEY DISEASE166 reports
HEPATIC CANCER166 reports
IRRITABLE BOWEL SYNDROME162 reports
PAIN IN EXTREMITY159 reports
DRUG INTERACTION158 reports
GASTROINTESTINAL HAEMORRHAGE150 reports
LOSS OF CONSCIOUSNESS149 reports
LIVER TRANSPLANT147 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS144 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION143 reports
MENTAL STATUS CHANGES143 reports
DYSPHAGIA142 reports
NO ADVERSE EVENT141 reports
COVID 19140 reports
GENERAL PHYSICAL HEALTH DETERIORATION139 reports
CHEST PAIN137 reports
GAIT DISTURBANCE137 reports
DISEASE RECURRENCE134 reports
DEPRESSION133 reports
HAEMOGLOBIN DECREASED124 reports
CROHN^S DISEASE122 reports
ILLNESS122 reports
GASTROINTESTINAL DISORDER121 reports
INFECTION120 reports
FREQUENT BOWEL MOVEMENTS119 reports
GASTROINTESTINAL BACTERIAL OVERGROWTH119 reports
PLATELET COUNT DECREASED119 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION115 reports
GASTROOESOPHAGEAL REFLUX DISEASE115 reports
CEREBROVASCULAR ACCIDENT114 reports
RENAL DISORDER113 reports

Report Outcomes

Out of 19,889 classified reports for RIFAXIMIN:

Serious 77.8%Non-Serious 22.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female9,942 (52.2%)
Male9,087 (47.7%)
Unknown14 (0.1%)

Reports by Age

Age 66545 reports
Age 69523 reports
Age 65515 reports
Age 67484 reports
Age 68471 reports
Age 72469 reports
Age 71461 reports
Age 70442 reports
Age 73435 reports
Age 64413 reports
Age 63404 reports
Age 62398 reports
Age 74383 reports
Age 61372 reports
Age 57358 reports
Age 58357 reports
Age 76357 reports
Age 56354 reports
Age 60352 reports
Age 59336 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with RIFAXIMIN?

This profile reflects 37,072 FDA FAERS reports that mention RIFAXIMIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RIFAXIMIN?

Frequently reported terms in FAERS include DEATH, HOSPITALISATION, DIARRHOEA, OFF LABEL USE, THERAPY INTERRUPTED, AMMONIA INCREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RIFAXIMIN?

Labeling and FAERS entries often list Salix Pharmaceuticals, Inc. in connection with RIFAXIMIN. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.