{
 "query": "pantoprazole",
 "ingredient": "pantoprazole",
 "slug": "pantoprazole",
 "rxcui": "40790",
 "brands": [
  "Protonix"
 ],
 "names": [
  "pantoprazole",
  "pantoprazole (as pantoprazole sodium sesquihydrate)",
  "pantoprazole sodium"
 ],
 "classes": [
  {
   "id": "A02BC",
   "name": "Proton pump inhibitors"
  }
 ],
 "alternatives": [
  "dexlansoprazole",
  "esomeprazole",
  "lansoprazole",
  "omeprazole",
  "rabeprazole",
  "vonoprazan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 107,
   "INTRAVENOUS": 26
  },
  "boxed_warning": "",
  "indications_and_usage": "For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following: \u2022 Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) \u2022 Maintenance of Healing of Erosive Esophagitis ( 1.2 ) \u2022 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome ( 1.3 ) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis PROTONIX is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pat...",
  "contraindications": "\u2022 PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation 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) ] . \u2022 Proton pump inhibitors (PPIs), including PROTONIX, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . \u2022 Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles ( 4 ) \u2022 Patients receiving rilpivirine-containing products ( 4 , 7 )",
  "warnings_and_cautions": "\u2022 Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) \u2022 Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) \u2022 Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk of Clostridium difficile- associated diarrhea. ( 5.3 ) \u2022 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 ) \u2022 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 ) \u2022 Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PROTONIX and refer to specialist for evaluation. ( 5.6 ) \u2022 Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) \u2022 Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged tr...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in labeling: \u2022 Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] \u2022 Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.3) ] \u2022 Bone Fracture [see Warnings and Precautions (5.4) ] \u2022 Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] \u2022 Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] \u2022 Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7) ] \u2022 Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ] \u2022 Fundic Gland Polyps [see Warnings and Precautions (5.10) ] Most common adverse reactions are: \u2022 For adult use (>2%): headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. ( 6.1 ) \u2022 For pediatric use (>4%): URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The adverse reaction profiles for PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension an...",
  "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). Gastric Malignancy Advise patients to return to their healthcare provider if they have a suboptimal response or an early symptomatic relapse [see Warnings and Precautions (5.1) ] . Acute Tubulointerstitial Nephritis Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Contraindications (4) , Warnings and Precautions (5.2) ] . Clostridium difficile- Associated Diarrhea Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3) ] . Bone Fracture Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions Advise patients to discontinue PROTONIX and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5) ] . Cutaneous and Systemic Lupus Erythematosus Advise patients to immediately call their healthcare provider for any new ...",
  "spl_medguide": "MEDICATION GUIDE PROTONIX (pro-TAH-nix) (pantoprazole sodium) delayed-release tablets and PROTONIX (pro-TAH-nix) (pantoprazole sodium) for delayed-release oral suspension What is the most important information I should know about PROTONIX? You should take PROTONIX exactly as prescribed, at the lowest dose possible and for the shortest time needed. PROTONIX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. PROTONIX can cause serious side effects, including: \u2022 A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. \u2022 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. \u2022 Bone fractures (hip, wrist, or spine) . Bone fractures in the hip, wrist, o...",
  "clinical_studies": "Delayed-Release Tablets were used in the following clinical trials. 14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux Disease (GERD) Adult Patients A US multicenter, double-blind, placebo-controlled study of PROTONIX 10 mg, 20 mg, or 40 mg once daily was conducted in 603 patients with reflux symptoms and endoscopically diagnosed EE of grade 2 or above (Hetzel-Dent scale). In this study, approximately 25% of enrolled patients had severe EE of grade 3, and 10% had grade 4. The percentages of patients healed (per protocol, n = 541) in this study are shown in Table 8. Table 8: Erosive Esophagitis Healing Rates (Per Protocol) PROTONIX Placebo Week 10 mg daily (n = 153) 20 mg daily (n = 158) 40 mg daily (n = 162) (n = 68) 4 45.6% (p < 0.001) PROTONIX versus placebo 58.4% (p < 0.05) versus 10 mg PROTONIX 75.0% (p < 0.05) versus 10 mg or 20 mg PROTONIX 14.3% 8 66.0% 83.5% 92.6% 39.7% In this study, all PROTONIX treatment groups had significantly greater healing rates than the placebo group. This was true regardless of H. pylori status for the 40 mg and 20 mg PROTONIX treatment groups. The 40 mg dose of PROTONIX resulted in healing rates significantly greater than those ...",
  "brand_name": "Protonix Delayed-Release",
  "manufacturer": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
  "application_number": "NDA020987",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260518",
  "set_id": "08098cb2-c048-4640-f387-6beec4a38936",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 324341,
  "serious": 271381,
  "death": 35506,
  "hospitalization": 143115,
  "primary_suspect": 322807,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    29529
   ],
   [
    "Fatigue",
    24880
   ],
   [
    "Acute Kidney Injury",
    22841
   ],
   [
    "Nausea",
    21737
   ],
   [
    "Off Label Use",
    21600
   ],
   [
    "Diarrhoea",
    21137
   ],
   [
    "Dyspnoea",
    20784
   ],
   [
    "Drug Ineffective",
    19581
   ],
   [
    "Pain",
    18368
   ],
   [
    "Headache",
    15849
   ],
   [
    "Vomiting",
    15040
   ],
   [
    "Arthralgia",
    14323
   ],
   [
    "Renal Failure",
    14221
   ],
   [
    "Asthenia",
    13514
   ],
   [
    "Pyrexia",
    13508
   ]
  ],
  "by_year": {
   "2019": 41383,
   "2020": 33007,
   "2021": 30214,
   "2022": 27423,
   "2023": 23280,
   "2024": 24849,
   "2025": 24100,
   "2026": 11855
  },
  "by_year_primary": {
   "2019": 41363,
   "2020": 32967,
   "2021": 30079,
   "2022": 27068,
   "2023": 22981,
   "2024": 24581,
   "2025": 23859,
   "2026": 11713
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260326",
   "reason": "Discoloration: Firm received five (5) complaints stating that, \"Tablets discolored darker than normal and have lighter-colored spots.\"",
   "firm": "Hetero Labs Limited (Unit V)",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230905",
   "reason": "Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.",
   "firm": "BE PHARMACEUTICALS AG",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230314",
   "reason": "CGMP Deviations: Discoloration",
   "firm": "Hetero USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220725",
   "reason": "Discoloration",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220411",
   "reason": "CGMP deviations: tablets cracking",
   "firm": "Torrent Pharma 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 III",
   "date": "20210205",
   "reason": "Failed Impurity/Degradation Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20171204",
   "reason": "Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass",
   "firm": "AuroMedics Pharma LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161216",
   "reason": "Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161122",
   "reason": "Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 10,
 "drugsfda": {
  "applications": 48,
  "nda": 6,
  "anda": 42,
  "first_approval": "20000202",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 80,
  "labeling_recent": 8,
  "sponsors": [
   "ACTAVIS TOTOWA",
   "AJANTA PHARMA LTD",
   "ALEMBIC",
   "AMNEAL PHARMS",
   "ANNORA PHARMA",
   "APOTEX",
   "ASPIRO",
   "AUROBINDO PHARMA LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/02/2000"
 },
 "trials": {
  "total": 258,
  "completed": 169,
  "terminated": 27,
  "with_results": 49,
  "industry": 106,
  "phase3": 49,
  "results_share": 0.28994082840236685,
  "terminated_share": 0.10465116279069768
 },
 "pubmed": {
  "rct": 268,
  "meta": 7,
  "recent_rct": 12,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 14000.0,
  "records": 3,
  "by_name": [
   [
    "Protonix",
    14000.0
   ]
  ],
  "names_checked": [
   "pantoprazole",
   "Protonix"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 25612576,
  "beneficiaries": 6696216,
  "spend": 331545239.73,
  "by_brand": [
   {
    "brand": "Pantoprazole Sodium",
    "claims": 25600657,
    "per_claim": 12.533486825,
    "is_generic": true
   },
   {
    "brand": "Protonix",
    "claims": 11573,
    "per_claim": 920.25106541,
    "is_generic": false
   },
   {
    "brand": "Protonix IV",
    "claims": 346,
    "per_claim": 85.771473988,
    "is_generic": false
   }
  ],
  "per_claim": 12.944626878998818
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 60153,
  "fills": 25612576,
  "per_million": 2348.5728260991787,
  "ratio": 0.8481818143807759,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "2,349 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "268 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 29% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 62,
   "letter": "D",
   "why": [
    "Recalls since 2016: 1 Class I, 6 Class II, 3 Class III across 42 generic makers (-30)",
    "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 $14,000 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 (42 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, fatigue, acute kidney injury, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "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.)"
 ]
}