{ "query": "esomeprazole", "ingredient": "esomeprazole", "slug": "esomeprazole", "rxcui": "283742", "brands": [ "Nexium" ], "names": [ "esomeprazole", "esomeprazole magnesium", "esomeprazole magnesium dihydrate", "esomeprazole magnesium trihydrate", "esomeprazole sodium", "esomeprazole strontium" ], "classes": [ { "id": "A02BC", "name": "Proton pump inhibitors" } ], "alternatives": [ "dexlansoprazole", "lansoprazole", "omeprazole", "pantoprazole", "rabeprazole", "vonoprazan" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 214, "INTRAVENOUS": 3 }, "boxed_warning": "", "indications_and_usage": "Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year to 17 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 1 year to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6 ) 1.1 Healing of Erosive Esophagitis (EE) Adults Esomeprazole magnesium for delayed release oral suspension is indicated...", "contraindications": "Esomeprazole magnesium for delayed release oral suspension is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ),Adverse Reactions ( 6.2 )]. For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium for delayed release oral suspension for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information. Proton pump inhibitors (PPIs), including Esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7 )]. Known hypersensitivity to substituted benzimidazoles or any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 ) Refer to the Contraindications section of the prescribing information for amoxicillin and clarithromycin, when administered in combination with esome...", "warnings_and_cautions": "Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.3 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue esomeprazole magnesium for delayed release oral suspension and refer to specialist for evaluation. ( 5.6 ) Interaction with Clopidogrel : Avoid concomitant use of esomeprazole magnesium for delayed release oral suspension. ( 5.7 ) Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption...", "warnings": "", "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 )] Bone Fracture [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.8 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.9 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.13 )] Most common adverse reactions ( 6.1 ): Adults (\u2265 18 years) (>1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. Pediatrics (1 to 17 years) (\u22652%) are: headache, diarrhea, abdominal pain, nausea, and somnolence. Pediatrics (1 month to less than 1 year) (>1%) are: abdominal pain, regurgitation, tachypnea, and increased ALT. To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because ...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patient's healthcare provider immediately if they experience signs and/or symptoms associated with suspected acute TIN [see Warnings and Precautions ( 5.2 )]. Clostridium difficile-Associated Diarrhea Advise the patient or caregiver to immediately call the patient's healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.3 )]. Bone Fracture Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient's healthcare provider [see Warnings and Precautions ( 5.4 )]. Severe Cutaneous Adverse Reactions Advise the patient or caregiver to discontinue esomeprazole magnesium for delayed release oral suspension and immediately call the patient's healthcare provider for at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity signs or symptoms associated with Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.5 )]. Cutaneous and Systemic Lupus Erythematosus Advis...", "spl_medguide": "MEDICATION GUIDE Esomeprazole magnesium (es-oh-MEP-ra-zole mag-NEE-zee-um) For Delayed Release Oral Suspension What is the most important information I should know about Esomeprazole magnesium For Delayed Release Oral Suspension? Esomeprazole magnesium For Delayed Release Oral Suspension may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole magnesium For Delayed Release Oral Suspension can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis) . Some people who take proton pump inhibitor (PPI) medicines, including Esomeprazole magnesium For Delayed Release Oral Suspension, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Esomeprazole magnesium For Delayed Release Oral Suspension. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. Bon...", "clinical_studies": "14.1 Healing of EE in Adults The healing rates of esomeprazole magnesium delayed-release capsules 40 mg, esomeprazole magnesium delayed-release capsules 20 mg, and omeprazole delayed-release capsules 20 mg (the approved dose for this indication) once daily were evaluated in adult patients with endoscopically diagnosed EE in four multicenter, double-blind, randomized studies. The healing rates at Weeks 4 and 8 were evaluated and are shown in Table 11: Table 11: EE Healing Rate (Life-Table Analysis) in Adults with EE Treated with Esomeprazole Magnesium Delayed-Release Capsules or Omeprazole Delayed-Release Capsules Once Daily in Four Clinical Studies Study No. of Patients Treatment Group EE Healing Rates Significance Level 1 1. log-rank test vs. omeprazole 20 mg Week 4 Week 8 1 588 Esomeprazole magnesium 20 mg 68.7% 90.6% N.S. 588 Omeprazole 20 mg 69.5% 88.3% 2 654 Esomeprazole magnesium 40 mg 75.9% 94.1% p < 0.001 656 Esomeprazole magnesium 20 mg 70.5% 89.9% p < 0.05 650 Omeprazole 20 mg 64.7% 86.9% 3 576 Esomeprazole magnesium 40 mg 71.5% 92.2% N.S. 572 Omeprazole 20 mg 68.6% 89.8% 4 1216 Esomeprazole magnesium 40 mg 81.7% 93.7% p < 0.001 1209 Omeprazole 20 mg 68.7% 84.2% N.S. = no...", "brand_name": "ESOMEPRAZOLE MAGNESIUM", "manufacturer": "Cipla USA Inc.", "application_number": "ANDA211752", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20240516", "set_id": "180490d1-c165-4bb9-96b1-12e727256e4e", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 169628, "serious": 136463, "death": 16205, "hospitalization": 56112, "primary_suspect": 169023, "top_reactions": [ [ "Chronic Kidney Disease", 35692 ], [ "Acute Kidney Injury", 21248 ], [ "Renal Failure", 15621 ], [ "End Stage Renal Disease", 10313 ], [ "Drug Ineffective", 9538 ], [ "Renal Injury", 9497 ], [ "Nausea", 9024 ], [ "Diarrhoea", 8601 ], [ "Off Label Use", 8172 ], [ "Fatigue", 7757 ], [ "Pain", 6985 ], [ "Headache", 6981 ], [ "Dyspnoea", 6449 ], [ "Gastrooesophageal Reflux Disease", 5923 ], [ "Malaise", 5876 ] ], "by_year": { "2019": 29126, "2020": 14408, "2021": 11188, "2022": 8863, "2023": 7527, "2024": 7896, "2025": 8287, "2026": 3683 }, "by_year_primary": { "2019": 29114, "2020": 14401, "2021": 11142, "2022": 8744, "2023": 7432, "2024": 7739, "2025": 8179, "2026": 3631 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20250513", "reason": "Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.", "firm": "Zydus Pharmaceuticals (USA) Inc", "status": "Ongoing" }, { "class": "Class II", "date": "20250513", "reason": "Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.", "firm": "Zydus Pharmaceuticals (USA) Inc", "status": "Ongoing" }, { "class": "Class III", "date": "20241114", "reason": "Labeling: Not Elsewhere Classified - Wrong NDC number", "firm": "Zydus Pharmaceuticals (USA) Inc", "status": "Ongoing" }, { "class": "Class III", "date": "20220621", "reason": "Superpotent Drug: Out of specification for assay at the 12-month timepoint.", "firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "status": "Terminated" }, { "class": "Class III", "date": "20220621", "reason": "Superpotent Drug: Out of specification for assay at the 12-month timepoint.", "firm": "SUN PHARMACEUTICAL INDUSTRIES INC", "status": "Terminated" }, { "class": "Class II", "date": "20201217", "reason": "Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline", "firm": "CIPLA", "status": "Terminated" }, { "class": "Class II", "date": "20201217", "reason": "Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline", "firm": "CIPLA", "status": "Terminated" }, { "class": "Class II", "date": "20201217", "reason": "Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline", "firm": "CIPLA", "status": "Terminated" }, { "class": "Class III", "date": "20200424", "reason": "Discoloration: product contains brown pellets", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20190206", "reason": "Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.", "firm": "Dr. Reddy's Laboratories, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20120702", "reason": "Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.", "firm": "ASTRA ZENECA Lp", "status": "Terminated" } ], "recall_total": 11, "drugsfda": { "applications": 66, "nda": 8, "anda": 58, "first_approval": "20010220", "rems": false, "rems_last": "", "labeling_supplements": 115, "labeling_recent": 16, "sponsors": [ "ACCORD HLTHCARE", "ALKEM LABS LTD", "AMNEAL PHARMS NY", "ASTRAZENECA", "ASTRAZENECA LP", "AUROBINDO PHARMA", "AUROBINDO PHARMA LTD", "BELCHER" ], "unapproved": false, "first_approval_fmt": "02/20/2001" }, "trials": { "total": 575, "completed": 383, "terminated": 35, "with_results": 87, "industry": 280, "phase3": 101, "results_share": 0.22715404699738903, "terminated_share": 0.06086956521739131 }, "pubmed": { "rct": 344, "meta": 15, "recent_rct": 42, "cochrane": [] }, "payments": { "year": "2024", "usd": 2463.22, "records": 105, "by_name": [ [ "Nexium", 2463.22 ] ], "names_checked": [ "esomeprazole", "Nexium" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 3010604, "beneficiaries": 762280, "spend": 184055957.13, "by_brand": [ { "brand": "Esomeprazole Magnesium", "claims": 2912529, "per_claim": 42.676494339, "is_generic": true }, { "brand": "Nexium", "claims": 97946, "per_claim": 609.81025565, "is_generic": false }, { "brand": "Esomeprazole Sodium", "claims": 129, "per_claim": 239.95697674, "is_generic": true } ], "per_claim": 61.13589071495288 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 19549, "fills": 3010604, "per_million": 6493.381394564015, "ratio": 2.345070142813233, "median": 2768.949753790441 }, "scores": { "safety": { "score": 93, "letter": "A", "why": [ "6,493 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)", "Death share in reports is near or below the FAERS average (1.0x)" ], "weight": 0.35 }, "evidence": { "score": 53, "letter": "D", "why": [ "344 randomized trials and 15 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 23% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 85, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 5 Class II, 5 Class III across 58 generic makers (-7)", "16 label changes approved since 2021: the safety story is still moving (-8)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $2,463 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (58 applications)", "6 same-class alternatives exist" ], "weight": 0.1 } }, "total": 84, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease. How would we recognize and handle those?", "Why this one over dexlansoprazole, lansoprazole, omeprazole? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }