RABEPRAZOLE SODIUM

N/A

Manufactured by Waylis Therapeutics LLC

58,263 FDA adverse event reports analyzed

Last updated: 2026-04-14

About RABEPRAZOLE SODIUM

RABEPRAZOLE SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Waylis Therapeutics LLC. The most commonly reported adverse reactions for RABEPRAZOLE SODIUM include CHRONIC KIDNEY DISEASE, RENAL FAILURE, ACUTE KIDNEY INJURY, NAUSEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RABEPRAZOLE SODIUM.

Top Adverse Reactions

CHRONIC KIDNEY DISEASE4,877 reports
RENAL FAILURE3,419 reports
ACUTE KIDNEY INJURY2,604 reports
NAUSEA1,619 reports
DRUG INEFFECTIVE1,541 reports
END STAGE RENAL DISEASE1,309 reports
PAIN1,173 reports
DIARRHOEA1,165 reports
DYSPNOEA1,159 reports
DEATH1,123 reports
TUBULOINTERSTITIAL NEPHRITIS1,118 reports
HEADACHE1,100 reports
FATIGUE1,049 reports
DIZZINESS997 reports
ARTHRALGIA952 reports
VOMITING801 reports
FALL793 reports
OFF LABEL USE776 reports
PNEUMONIA775 reports
MALAISE773 reports
ANXIETY718 reports
COUGH696 reports
ASTHENIA674 reports
PYREXIA655 reports
GASTROOESOPHAGEAL REFLUX DISEASE647 reports
RASH647 reports
HYPERTENSION628 reports
PAIN IN EXTREMITY610 reports
WEIGHT DECREASED605 reports
ABDOMINAL PAIN596 reports
CHEST PAIN576 reports
INSOMNIA561 reports
ANAEMIA558 reports
CONSTIPATION549 reports
PRURITUS536 reports
DEPRESSION535 reports
ABDOMINAL PAIN UPPER509 reports
BACK PAIN496 reports
CONDITION AGGRAVATED494 reports
MYOCARDIAL INFARCTION457 reports
OEDEMA PERIPHERAL452 reports
DECREASED APPETITE432 reports
MYALGIA396 reports
RENAL INJURY391 reports
WEIGHT INCREASED378 reports
HYPOAESTHESIA377 reports
HYPOTENSION372 reports
URINARY TRACT INFECTION368 reports
ABDOMINAL DISCOMFORT366 reports
FEELING ABNORMAL365 reports
DRUG HYPERSENSITIVITY352 reports
BLOOD PRESSURE INCREASED349 reports
HYPERSENSITIVITY347 reports
CARDIAC FAILURE CONGESTIVE341 reports
DYSPEPSIA340 reports
ASTHMA335 reports
GAIT DISTURBANCE333 reports
ARTHRITIS317 reports
PLATELET COUNT DECREASED317 reports
MUSCLE SPASMS312 reports
PARAESTHESIA311 reports
RENAL IMPAIRMENT310 reports
DEHYDRATION309 reports
ABDOMINAL DISTENSION308 reports
JOINT SWELLING302 reports
CONFUSIONAL STATE299 reports
RHEUMATOID ARTHRITIS294 reports
ERYTHEMA293 reports
PALPITATIONS286 reports
TREMOR281 reports
CHEST DISCOMFORT277 reports
CEREBROVASCULAR ACCIDENT273 reports
SOMNOLENCE272 reports
ATRIAL FIBRILLATION271 reports
DRUG INTOLERANCE268 reports
INTERSTITIAL LUNG DISEASE261 reports
NEPHROGENIC ANAEMIA258 reports
BLOOD GLUCOSE INCREASED255 reports
NASOPHARYNGITIS251 reports
DRUG INTERACTION250 reports
CARDIAC FAILURE248 reports
HYPERHIDROSIS240 reports
HAEMOGLOBIN DECREASED235 reports
SINUSITIS235 reports
VISION BLURRED233 reports
LOSS OF CONSCIOUSNESS231 reports
INJURY230 reports
WHITE BLOOD CELL COUNT DECREASED230 reports
ALOPECIA227 reports
INJECTION SITE PAIN227 reports
MEMORY IMPAIRMENT226 reports
MIGRAINE222 reports
THERAPEUTIC PRODUCT EFFECT DECREASED222 reports
DIABETES MELLITUS219 reports
ALANINE AMINOTRANSFERASE INCREASED218 reports
PULMONARY EMBOLISM218 reports
PLEURAL EFFUSION217 reports
URTICARIA217 reports
CHILLS215 reports
BALANCE DISORDER214 reports

Report Outcomes

Out of 26,738 classified reports for RABEPRAZOLE SODIUM:

Serious 80.6%Non-Serious 19.4%

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

Female13,366 (62.3%)
Male8,067 (37.6%)
Unknown19 (0.1%)

Reports by Age

Age 61391 reports
Age 65390 reports
Age 67378 reports
Age 63371 reports
Age 69364 reports
Age 68353 reports
Age 73353 reports
Age 75350 reports
Age 70344 reports
Age 59342 reports
Age 66340 reports
Age 76339 reports
Age 60337 reports
Age 64333 reports
Age 71326 reports
Age 62323 reports
Age 72308 reports
Age 78307 reports
Age 55306 reports
Age 58304 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 RABEPRAZOLE SODIUM?

This profile reflects 58,263 FDA FAERS reports that mention RABEPRAZOLE SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RABEPRAZOLE SODIUM?

Frequently reported terms in FAERS include CHRONIC KIDNEY DISEASE, RENAL FAILURE, ACUTE KIDNEY INJURY, NAUSEA, DRUG INEFFECTIVE, END STAGE RENAL DISEASE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RABEPRAZOLE SODIUM?

Labeling and FAERS entries often list Waylis Therapeutics LLC in connection with RABEPRAZOLE SODIUM. 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.