OMEPRAZOLE AND SODIUM BICARBONATE

N/A

Manufactured by Santarus, Inc..

6,647 FDA adverse event reports analyzed

Last updated: 2026-04-15

About OMEPRAZOLE AND SODIUM BICARBONATE

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

Top Adverse Reactions

CHRONIC KIDNEY DISEASE788 reports
ACUTE KIDNEY INJURY456 reports
RENAL FAILURE431 reports
END STAGE RENAL DISEASE212 reports
RENAL INJURY195 reports
DRUG INEFFECTIVE185 reports
NAUSEA167 reports
GASTROOESOPHAGEAL REFLUX DISEASE155 reports
PAIN136 reports
HEADACHE127 reports
FATIGUE125 reports
DIARRHOEA113 reports
TUBULOINTERSTITIAL NEPHRITIS101 reports
DYSPNOEA90 reports
ANXIETY88 reports
DIZZINESS81 reports
VOMITING81 reports
DEPRESSION77 reports
NEPHROGENIC ANAEMIA73 reports
HYPERTENSION71 reports
MALAISE68 reports
ABDOMINAL PAIN67 reports
DEATH67 reports
ABDOMINAL PAIN UPPER66 reports
ARTHRALGIA64 reports
OFF LABEL USE63 reports
PRURITUS60 reports
WEIGHT DECREASED60 reports
REBOUND ACID HYPERSECRETION59 reports
RENAL IMPAIRMENT59 reports
ASTHENIA54 reports
BACK PAIN52 reports
CONSTIPATION52 reports
COUGH51 reports
NEPHROPATHY50 reports
PAIN IN EXTREMITY49 reports
PRODUCT USE ISSUE48 reports
CHEST PAIN47 reports
FALL47 reports
DYSPEPSIA45 reports
INSOMNIA45 reports
PNEUMONIA44 reports
FEELING ABNORMAL40 reports
INCORRECT PRODUCT ADMINISTRATION DURATION40 reports
RASH40 reports
MUSCLE SPASMS39 reports
INJURY38 reports
TREMOR38 reports
WEIGHT INCREASED38 reports
CHOLECYSTITIS CHRONIC37 reports
HYPERPARATHYROIDISM SECONDARY37 reports
ANAEMIA36 reports
CONDITION AGGRAVATED36 reports
HYPOAESTHESIA36 reports
OSTEOPOROSIS36 reports
SINUSITIS36 reports
DECREASED APPETITE34 reports
SOMNOLENCE34 reports
NEPHROLITHIASIS33 reports
URINARY TRACT INFECTION33 reports
ABDOMINAL DISCOMFORT32 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION32 reports
PRODUCT DOSE OMISSION ISSUE32 reports
INJECTION SITE PAIN31 reports
PYREXIA31 reports
DRUG HYPERSENSITIVITY30 reports
GAIT DISTURBANCE29 reports
BLOOD PRESSURE INCREASED28 reports
DRUG DOSE OMISSION28 reports
INCORRECT DOSE ADMINISTERED28 reports
OEDEMA PERIPHERAL28 reports
RENAL DISORDER27 reports
CEREBROVASCULAR ACCIDENT26 reports
DEHYDRATION26 reports
EMOTIONAL DISTRESS26 reports
RENAL CYST26 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE25 reports
FLUSHING25 reports
HYPERHIDROSIS25 reports
MEMORY IMPAIRMENT25 reports
MYOCARDIAL INFARCTION25 reports
NASOPHARYNGITIS25 reports
ABDOMINAL DISTENSION24 reports
BLOOD GLUCOSE INCREASED24 reports
HYPERTENSIVE NEPHROPATHY24 reports
MUSCULAR WEAKNESS24 reports
PERIPHERAL SWELLING24 reports
ARTHRITIS23 reports
MYALGIA23 reports
OROPHARYNGEAL PAIN23 reports
POLLAKIURIA23 reports
CHRONIC KIDNEY DISEASE MINERAL AND BONE DISORDER22 reports
GALLBLADDER DISORDER22 reports
HYPERSENSITIVITY22 reports
PRODUCT QUALITY ISSUE22 reports
VISION BLURRED22 reports
VISUAL IMPAIRMENT22 reports
DYSPHAGIA21 reports
JOINT SWELLING21 reports
NEUROPATHY PERIPHERAL21 reports

Report Outcomes

Out of 2,764 classified reports for OMEPRAZOLE AND SODIUM BICARBONATE:

Serious 63.1%Non-Serious 36.9%

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

Female1,676 (68.1%)
Male780 (31.7%)
Unknown4 (0.2%)

Reports by Age

Age 5647 reports
Age 5944 reports
Age 6342 reports
Age 5138 reports
Age 6438 reports
Age 5737 reports
Age 6137 reports
Age 5836 reports
Age 7036 reports
Age 5535 reports
Age 6935 reports
Age 5234 reports
Age 6533 reports
Age 6733 reports
Age 4929 reports
Age 6228 reports
Age 7128 reports
Age 5027 reports
Age 5327 reports
Age 6827 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 AND SODIUM BICARBONATE?

This profile reflects 6,647 FDA FAERS reports that mention OMEPRAZOLE AND 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 AND SODIUM BICARBONATE?

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

Who manufactures OMEPRAZOLE AND SODIUM BICARBONATE?

Labeling and FAERS entries often list Santarus, Inc.. in connection with OMEPRAZOLE AND 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.