OMEPRAZOLE, SODIUM BICARBONATE

N/A

Manufactured by CVS Pharmacy

2,134 FDA adverse event reports analyzed

Last updated: 2026-04-15

About OMEPRAZOLE, SODIUM BICARBONATE

OMEPRAZOLE, SODIUM BICARBONATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. The most commonly reported adverse reactions for OMEPRAZOLE, SODIUM BICARBONATE include CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY, RENAL FAILURE, RENAL INJURY, END STAGE RENAL DISEASE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OMEPRAZOLE, SODIUM BICARBONATE.

Top Adverse Reactions

CHRONIC KIDNEY DISEASE326 reports
ACUTE KIDNEY INJURY168 reports
RENAL FAILURE155 reports
RENAL INJURY91 reports
END STAGE RENAL DISEASE77 reports
DRUG INEFFECTIVE74 reports
GASTROOESOPHAGEAL REFLUX DISEASE45 reports
TUBULOINTERSTITIAL NEPHRITIS43 reports
NAUSEA41 reports
INCORRECT PRODUCT ADMINISTRATION DURATION39 reports
DEATH34 reports
HEADACHE32 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION30 reports
DYSPNOEA29 reports
REBOUND ACID HYPERSECRETION29 reports
FATIGUE27 reports
NEPHROGENIC ANAEMIA26 reports
DIARRHOEA25 reports
PRODUCT DOSE OMISSION ISSUE25 reports
PAIN22 reports
OFF LABEL USE21 reports
HYPERTENSION20 reports
PNEUMONIA20 reports
ANXIETY19 reports
PRURITUS19 reports
COUGH18 reports
DEPRESSION18 reports
MALAISE18 reports
NEPHROPATHY18 reports
RENAL IMPAIRMENT17 reports
ASTHENIA15 reports
COVID 1915 reports
DIZZINESS14 reports
INCORRECT DOSE ADMINISTERED14 reports
FALL13 reports
NASOPHARYNGITIS13 reports
TREMOR13 reports
WEIGHT DECREASED13 reports
ABDOMINAL DISCOMFORT12 reports
ABDOMINAL PAIN UPPER12 reports
CONSTIPATION12 reports
FEELING ABNORMAL12 reports
HYPERPARATHYROIDISM SECONDARY12 reports
ARTHRALGIA11 reports
DECREASED APPETITE11 reports
INFECTION11 reports
RASH11 reports
SINUSITIS11 reports
VOMITING11 reports
ABDOMINAL DISTENSION10 reports
ABDOMINAL PAIN10 reports
HYPERSENSITIVITY10 reports
BRONCHITIS9 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE9 reports
CONDITION AGGRAVATED9 reports
EYE PAIN9 reports
GASTRIC CANCER9 reports
ILLNESS9 reports
INFUSION RELATED REACTION9 reports
INSOMNIA9 reports
CHEST PAIN8 reports
INFLUENZA8 reports
MEMORY IMPAIRMENT8 reports
NEPHROLITHIASIS8 reports
PAIN IN EXTREMITY8 reports
SOMNOLENCE8 reports
URINARY TRACT INFECTION8 reports
WEIGHT INCREASED8 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS8 reports
ANAEMIA7 reports
BACK PAIN7 reports
DYSPEPSIA7 reports
DYSURIA7 reports
HYPERCHLORHYDRIA7 reports
HYPERTENSIVE NEPHROPATHY7 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION7 reports
MUSCLE SPASMS7 reports
OCULAR HYPERAEMIA7 reports
PERIPHERAL SWELLING7 reports
PRODUCT USE IN UNAPPROVED INDICATION7 reports
PRODUCT USE ISSUE7 reports
BLOOD CHOLESTEROL INCREASED6 reports
BLOOD PRESSURE INCREASED6 reports
CONTUSION6 reports
DEHYDRATION6 reports
DERMATITIS ATOPIC6 reports
DIABETES MELLITUS6 reports
DIALYSIS6 reports
DRUG EFFECT LESS THAN EXPECTED6 reports
GAIT DISTURBANCE6 reports
HOSPITALISATION6 reports
HYPOAESTHESIA6 reports
HYPOTENSION6 reports
INFUSION SITE PAIN6 reports
MYOCARDIAL INFARCTION6 reports
PRODUCT DOSE OMISSION6 reports
PRODUCT SUBSTITUTION ISSUE6 reports
RHEUMATOID ARTHRITIS6 reports
TACHYCARDIA6 reports
THROMBOSIS6 reports

Report Outcomes

Out of 916 classified reports for OMEPRAZOLE, SODIUM BICARBONATE:

Serious 61.5%Non-Serious 38.5%

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

Female477 (62.2%)
Male290 (37.8%)

Reports by Age

Age 5524 reports
Age 6015 reports
Age 5414 reports
Age 5814 reports
Age 5113 reports
Age 5913 reports
Age 6313 reports
Age 6613 reports
Age 4912 reports
Age 5712 reports
Age 5211 reports
Age 6511 reports
Age 6711 reports
Age 6410 reports
Age 469 reports
Age 569 reports
Age 508 reports
Age 618 reports
Age 628 reports
Age 688 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 OMEPRAZOLE, SODIUM BICARBONATE?

This profile reflects 2,134 FDA FAERS reports that mention OMEPRAZOLE, SODIUM BICARBONATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for OMEPRAZOLE, SODIUM BICARBONATE?

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

Who manufactures OMEPRAZOLE, SODIUM BICARBONATE?

Labeling and FAERS entries often list CVS Pharmacy in connection with OMEPRAZOLE, SODIUM BICARBONATE. 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.