NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

N/A

Manufactured by Ajanta Pharma USA Inc.

107 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ajanta Pharma USA Inc.. The most commonly reported adverse reactions for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM include OFF LABEL USE, ASTHENIA, BLOOD PRESSURE INCREASED, COUGH, GASTROINTESTINAL DISORDER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM.

Top Adverse Reactions

OFF LABEL USE3 reports
ASTHENIA2 reports
BLOOD PRESSURE INCREASED2 reports
COUGH2 reports
GASTROINTESTINAL DISORDER2 reports
NAUSEA2 reports
ADJUSTMENT DISORDER1 reports
AFFECT LABILITY1 reports
ANGINA PECTORIS1 reports
ANXIETY1 reports
APHASIA1 reports
ARRHYTHMIA1 reports
ARTERIAL OCCLUSIVE DISEASE1 reports
ARTHRITIS1 reports
ATELECTASIS1 reports
BLADDER MASS1 reports
BLADDER NEOPLASM1 reports
BLOOD PRESSURE SYSTOLIC INCREASED1 reports
BURSITIS1 reports
CARDIAC FAILURE CONGESTIVE1 reports
CAROTID ARTERY THROMBOSIS1 reports
CATARACT1 reports
CEREBROVASCULAR ACCIDENT1 reports
CHEST DISCOMFORT1 reports
COLON CANCER1 reports
CONFUSIONAL STATE1 reports
CONTRAINDICATED PRODUCT ADMINISTERED1 reports
COORDINATION ABNORMAL1 reports
CREPITATIONS1 reports
CYSTITIS1 reports
DIARRHOEA1 reports
DRUG INEFFECTIVE1 reports
DYSARTHRIA1 reports
DYSPHAGIA1 reports
EATING DISORDER1 reports
ERECTILE DYSFUNCTION1 reports
EYE PAIN1 reports
FALL1 reports
FATIGUE1 reports
FEELING JITTERY1 reports
FLANK PAIN1 reports
GANGRENE1 reports
HEADACHE1 reports
HEMIPARESIS1 reports
HEMIPLEGIA1 reports
HYPERCHOLESTEROLAEMIA1 reports
HYPERHIDROSIS1 reports
IMPAIRED WORK ABILITY1 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1 reports
INFECTION1 reports
INFLUENZA1 reports
INFLUENZA LIKE ILLNESS1 reports
INFUSION SITE BRUISING1 reports
INTENTIONAL PRODUCT USE ISSUE1 reports
INTERSTITIAL LUNG DISEASE1 reports
MALAISE1 reports
MOTOR DYSFUNCTION1 reports
MUSCLE SPASTICITY1 reports
MUSCULAR WEAKNESS1 reports
MUSCULOSKELETAL STIFFNESS1 reports
NASOPHARYNGITIS1 reports
NEOPLASM MALIGNANT1 reports
NEUROLOGIC NEGLECT SYNDROME1 reports
NIGHTMARE1 reports
OCULAR HYPERAEMIA1 reports
PAIN1 reports
PAIN IN EXTREMITY1 reports
PALPITATIONS1 reports
PERSONALITY DISORDER1 reports
PHOTOPHOBIA1 reports
PLATELET COUNT ABNORMAL1 reports
PLEURITIC PAIN1 reports
PNEUMONIA1 reports
POOR VENOUS ACCESS1 reports
PRODUCT AVAILABILITY ISSUE1 reports
PRODUCT USE IN UNAPPROVED INDICATION1 reports
PROSTATOMEGALY1 reports
PSORIASIS1 reports
PYREXIA1 reports
RENAL DISORDER1 reports
RESPIRATORY TRACT CONGESTION1 reports
RHEUMATOID ARTHRITIS1 reports
RHEUMATOID NODULE1 reports
RHINORRHOEA1 reports
SCLERITIS1 reports
SEDATION1 reports
SENSORY LOSS1 reports
SINUS CONGESTION1 reports
SINUS DISORDER1 reports
SINUSITIS1 reports
SKIN EXFOLIATION1 reports
SKIN HAEMORRHAGE1 reports
SNEEZING1 reports
SPINAL LAMINECTOMY1 reports
SYNOVIAL CYST1 reports
TENDERNESS1 reports
TENOSYNOVITIS STENOSANS1 reports
ULCER1 reports
URINARY TRACT INFECTION1 reports
VEIN COLLAPSE1 reports

Report Outcomes

Out of 8 classified reports for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM:

Serious 100.0%Non-Serious 0.0%

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

Female6 (75.0%)
Male2 (25.0%)

Reports by Age

Age 582 reports
Age 411 reports
Age 441 reports
Age 531 reports
Age 651 reports
Age 661 reports
Age 811 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 NAPROXEN AND ESOMEPRAZOLE MAGNESIUM?

This profile reflects 107 FDA FAERS reports that mention NAPROXEN AND ESOMEPRAZOLE MAGNESIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NAPROXEN AND ESOMEPRAZOLE MAGNESIUM?

Frequently reported terms in FAERS include OFF LABEL USE, ASTHENIA, BLOOD PRESSURE INCREASED, COUGH, GASTROINTESTINAL DISORDER, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NAPROXEN AND ESOMEPRAZOLE MAGNESIUM?

Labeling and FAERS entries often list Ajanta Pharma USA Inc. in connection with NAPROXEN AND ESOMEPRAZOLE MAGNESIUM. 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.