Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforations [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Heart Failure and Edema [see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] Anaphylactic Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.9) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.10) ] Fetal Toxicity [see Warnings and Precautions (5.11) ] Hematologic Toxicity [see Warnings and Precautions (5.12) ] Active Bleeding [see Warnings and Precautions (5.15) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.18) ] Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.19) ] Bone Fracture [see Warnings and Precautions (5.20) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.21) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.23) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.24) ] Fundic Gland Polyps [see Warnings and Precautions (5.28) ] Most common adverse reactions in clinical trials (>5%) are gastritis and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals Inc.
at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Clinical Trials Experience with naproxen and esomeprazole magnesium delayed release tablets Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reactions reported below are specific to the clinical trials with naproxen and esomeprazole magnesium delayed-release tablets.
The safety of naproxen and esomeprazole magnesium delayed-release tablets were evaluated in clinical studies involving 2317 patients (aged 27 to 90 years) and ranging from 3 to 12 months.
Patients received either 500 mg/20 mg of naproxen and esomeprazole magnesium delayed-release tablets twice daily (n=1157), 500 mg of enteric-coated naproxen twice daily (n=426), or placebo (n=246).
The average number of naproxen and esomeprazole magnesium delayed-release tablets doses taken over 12 months was 69 6 ±
The table below lists all adverse reactions, regardless of causality, occurring in > 2% of patients receiving naproxen and esomeprazole magnesium delayed-release tablets and higher in the naproxen and esomeprazole magnesium delayed-release tablets group than control from two clinical studies (Study 1 and Study 2).
Both of these studies were randomized, multi-center, double-blind, parallel studies.
5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity.
Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure.
( 5.4 , 7 ) Heart Failure and Edema : Avoid use of naproxen and esomeprazole magnesium delayed-release tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Like all medications, Naproxen And Esomeprazole Magnesium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: