{
 "query": "omeprazole",
 "ingredient": "omeprazole",
 "slug": "omeprazole",
 "rxcui": "7646",
 "brands": [
  "Prilosec"
 ],
 "names": [
  "omeprazole",
  "omeprazole magnesium",
  "omeprazole sodium"
 ],
 "classes": [
  {
   "id": "A02BC",
   "name": "Proton pump inhibitors"
  }
 ],
 "alternatives": [
  "dexlansoprazole",
  "esomeprazole",
  "lansoprazole",
  "pantoprazole",
  "rabeprazole",
  "vonoprazan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 326
  },
  "boxed_warning": "",
  "indications_and_usage": "Omeprazole delayed-release capsules are proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Treatment of active benign gastric ulcer in adults ( 1.3 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older ( 1.4 ) Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older ( 1.5 ) Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older ( 1.6 ) Pathologic hypersecretory conditions in adults ( 1.7 ) 1.1 Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. 1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, ar...",
  "contraindications": "Patients with 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 clarithromycin and amoxicillin, when administered in combination with omeprazole. ( 4 ) Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions ( 5.2 )] or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria, [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )]. Proton pump inhibitors (PPIs), including omeprazole, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7 )] . For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts.",
  "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. 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 omeprazole and refer to specialist for evaluation ( 5.6 ) Interaction with Clopidogrel: Avoid concomitant use of omeprazole. ( 5.7 , 7 ) Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.8 ) Hypomagnesemia and Mineral Metabolism: Reported rarely with prolon...",
  "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) ] 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 ) ] Adults: Most common adverse reactions in adults (incidence \u2265 2%) are Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. ( 6 ) Pediatric patients (1 to 16 years of age): Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. ( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience with Omeprazole Monotherapy Because clinical trials are conducted under ...",
  "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). Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: Hypersensitivity reactions [see Contraindications ( 4 )] . 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 )] . Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.5 )]. Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.7 )] . Hypomagnesemia [see Warnings and Precautions ( 5.8 )] . Drug Interactions Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. John's Wort or rifampin; or, if they take high-dose methotrexate [see Warnings and Precautions ( 5.6 , 5.9 , 5.11 )] . Administration Take omeprazole delayed-release capsules before meals. Antacids may be used concomitantly with omeprazole delayed-release capsules. Missed doses: If a dose is missed, administer as soon as possible. However, if the ...",
  "spl_medguide": "SPL MEDGUIDE MEDICATION GUIDE Omeprazole ( oh mep' ra zole) Delayed-Release Capsules, USP Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about omeprazole delayed-release capsules? You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed. Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole delayed-release capsules can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including omeprazole delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with omeprazole delayed-release capsules. Call your doctor if you have a decrease in the amount tha...",
  "clinical_studies": "14.1 Active Duodenal Ulcer In a multicenter, double-blind, placebo-controlled study of 147 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per protocol) at 2 and 4 weeks was significantly higher with omeprazole 20 mg once daily than with placebo (p \u2264 0.01). Treatment of Active Duodenal Ulcer % of Patients Healed 1. (p \u2264 0.01) Omeprazole 20 mg a.m. (n = 99) Placebo a.m. (n = 48) Week 2 41 1 13 Week 4 75 1 27 Complete daytime and nighttime pain relief occurred significantly faster (p \u2264 0.01) in patients treated with omeprazole 20 mg than in patients treated with placebo. At the end of the study, significantly more patients who had received omeprazole had complete relief of daytime pain (p \u2264 0.05) and nighttime pain (p \u2264 0.01). In a multicenter, double-blind study of 293 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per protocol) at 4 weeks was significantly higher with omeprazole 20 mg once daily than with ranitidine 150 mg b.i.d. (p < 0.01). Treatment of Active Duodenal Ulcer % of Patients Healed 1. (p < 0.01) Omeprazole 20 mg a.m. (n = 145) Ranitidine 150 mg twice daily (n = 148) Week 2 42 34 We...",
  "brand_name": "Omeprazole",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "ANDA091352",
  "pharm_class_epc": [
   "Proton Pump Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240227",
  "set_id": "0ef8d55f-6cae-4b58-844b-968d8e5b8c24",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 369477,
  "serious": 266740,
  "death": 31933,
  "hospitalization": 119980,
  "primary_suspect": 368003,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    36920
   ],
   [
    "Acute Kidney Injury",
    24579
   ],
   [
    "Fatigue",
    22461
   ],
   [
    "Nausea",
    21535
   ],
   [
    "Diarrhoea",
    21512
   ],
   [
    "Drug Ineffective",
    17594
   ],
   [
    "Renal Failure",
    16924
   ],
   [
    "Dyspnoea",
    16656
   ],
   [
    "Pain",
    16338
   ],
   [
    "Headache",
    16141
   ],
   [
    "Off Label Use",
    15641
   ],
   [
    "Dizziness",
    13725
   ],
   [
    "Vomiting",
    13405
   ],
   [
    "Death",
    11930
   ],
   [
    "Malaise",
    11545
   ]
  ],
  "by_year": {
   "2019": 49174,
   "2020": 35236,
   "2021": 28889,
   "2022": 23999,
   "2023": 21894,
   "2024": 18774,
   "2025": 21449,
   "2026": 10411
  },
  "by_year_primary": {
   "2019": 49123,
   "2020": 35200,
   "2021": 28761,
   "2022": 23627,
   "2023": 21585,
   "2024": 18590,
   "2025": 21257,
   "2026": 10265
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250630",
   "reason": "Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20211005",
   "reason": "CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130916",
   "reason": "Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.",
   "firm": "Kremers Urban Pharmaceuticals, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 36,
  "nda": 5,
  "anda": 31,
  "first_approval": "19890914",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 101,
  "labeling_recent": 8,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "APOTEX",
   "ASTRAZENECA",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "AZURITY",
   "BRECKENRIDGE",
   "DEXCEL"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/14/1989"
 },
 "trials": {
  "total": 1039,
  "completed": 729,
  "terminated": 87,
  "with_results": 192,
  "industry": 550,
  "phase3": 158,
  "results_share": 0.26337448559670784,
  "terminated_share": 0.08373435996150144
 },
 "pubmed": {
  "rct": 925,
  "meta": 16,
  "recent_rct": 20,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "omeprazole",
   "Prilosec"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 28886485,
  "beneficiaries": 7510589,
  "spend": 369970723.85,
  "by_brand": [
   {
    "brand": "Omeprazole",
    "claims": 28883231,
    "per_claim": 12.6972756,
    "is_generic": true
   },
   {
    "brand": "Prilosec",
    "claims": 3254,
    "per_claim": 993.35575599,
    "is_generic": false
   }
  ],
  "per_claim": 12.807744654636936
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20120208",
   "title": "Proton Pump Inhibitors - Clostridum difficile -associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm290510.htm",
   "kind": "class",
   "matched": "proton pump inhibitor"
  },
  {
   "date": "20110302",
   "title": "PPIs - Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm245011.htm",
   "kind": "class",
   "matched": "proton pump inhibitor"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "omeprazole",
  "matched": "omeprazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 50112,
  "fills": 28886485,
  "per_million": 1734.790508433269,
  "ratio": 0.6265157054794867,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) about this drug's class since 2010 (-8)",
    "1,735 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "925 randomized trials and 16 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 26% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 88,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 31 generic makers (-4)",
    "8 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (31 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, acute kidney injury, fatigue, nausea. How would we recognize and handle those?",
  "Why this one over dexlansoprazole, esomeprazole, lansoprazole? 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.)"
 ]
}