{
 "query": "famotidine",
 "ingredient": "famotidine",
 "slug": "famotidine",
 "rxcui": "4278",
 "brands": [
  "Pepcid",
  "Zantac Reformulated Aug 2022"
 ],
 "names": [
  "famotidine"
 ],
 "classes": [
  {
   "id": "A02BA",
   "name": "H2-receptor antagonists"
  }
 ],
 "alternatives": [
  "cimetidine",
  "nizatidine",
  "ranitidine",
  "ranitidine bismuth citrate",
  "roxatidine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 347,
   "INTRAVENOUS": 12
  },
  "boxed_warning": "",
  "indications_and_usage": "Famotidine for oral suspension is indicated in adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of: peptic ulcer disease. GERD with or without esophagitis and ulcerations. Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of: GERD. Famotidine for oral suspension is a histamine-2 (H2) receptor antagonist indicated (1): In adults for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of DU recurrence. In pediatric p...",
  "contraindications": "Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. (4)",
  "warnings_and_cautions": "Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. (2.2, 5.1, 8.5, 8.6) GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. (5.2) 5.1 Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see DOSAGE AND ADMINISTRATION (2.2), CLINICAL PHARMACOLOGY (12.3)]. 5.2 Concurrent Gastric Malignancy In adults, symptomatic response to therapy with famotidine for oral suspension does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine for...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience 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 safety of famotidine for oral suspension has been established based on adequate and well controlled studies of another oral famotidine product [see CLINICAL STUDIES (14)]. The following is a summary of the adverse reactions reported in those studies. Oral famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients [see CLINICAL STUDIES (14)] . A total of 1442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. The population was 17 to 91 years old, fairly well distribute...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions; including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see WARNINGS AND PRECAUTIONS (5.1)] . Report symptoms immediately to a healthcare provider. QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see USE IN SPECIFIC POPULATIONS (8.6)] . Report new cardiac symptoms, such as palpitations, fainting and dizziness or light headedness immediately to a healthcare provider. Administration Advise patients to take and caregivers to administer: Famotidine for oral suspension once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Advise patients and caregivers: Famotidine for oral suspension may be taken with or without food. Famotidine for oral suspension may be given with antacids Manufactured for : Northstar Rx LLC Memphis, TN 38141 Manufactured by : Novitium Pharma LLC East Windsor, NJ 08520 Issued:07/2023 LB4608-00",
  "spl_medguide": "",
  "clinical_studies": "The safety and effectiveness of famotidine for oral suspension have been established based on adequate and well-controlled studies of another oral famotidine product . The following is a summary of the efficacy results reported in those studies. 14.1 Active Duodenal Ulcer In a U.S. multicenter, double-blind trial in adult outpatients with endoscopically confirmed duodenal ulcer (DU), orally administered famotidine was compared to placebo. As shown in Table 6, 70% of patients treated with famotidine 40 mg at bedtime were healed by Week 4. Most patients' DU healed within 4 weeks. Patients not healed by Week 4 were continued in the trial. By Week 8, 83% of patients treated with famotidine had healed DU, compared to 45% of patients treated with placebo. The incidence of DU healing with famotidine was greater than with placebo at each time point based on proportion of endoscopically confirmed healed DUs. Trials have not assessed the safety of famotidine in uncomplicated active DU for periods of more than 8 weeks. Table 6: Patients with Endoscopically Confirmed Healed Duodenal Ulcers Famotidine 40 mg at bedtime (N=89) Famotidine 20 mg twice daily (N=84) Placebo at bedtime (N=97) Week 2 3...",
  "brand_name": "Famotidine",
  "manufacturer": "NorthStar Rx LLC",
  "application_number": "ANDA215043",
  "pharm_class_epc": [
   "Histamine-2 Receptor Antagonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230907",
  "set_id": "04aaf296-f136-29d7-e063-6294a90affe1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 97599,
  "serious": 61881,
  "death": 8451,
  "hospitalization": 30142,
  "primary_suspect": 97381,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    6605
   ],
   [
    "Fatigue",
    6570
   ],
   [
    "Nausea",
    6551
   ],
   [
    "Diarrhoea",
    6163
   ],
   [
    "Off Label Use",
    5652
   ],
   [
    "Drug Ineffective",
    5125
   ],
   [
    "Acute Kidney Injury",
    4770
   ],
   [
    "Headache",
    4671
   ],
   [
    "Dyspnoea",
    4629
   ],
   [
    "Vomiting",
    3844
   ],
   [
    "Pain",
    3759
   ],
   [
    "Dizziness",
    3712
   ],
   [
    "Renal Failure",
    3674
   ],
   [
    "Death",
    3446
   ],
   [
    "Pneumonia",
    3053
   ]
  ],
  "by_year": {
   "2019": 7996,
   "2020": 9378,
   "2021": 9205,
   "2022": 9383,
   "2023": 9342,
   "2024": 10731,
   "2025": 11676,
   "2026": 6290
  },
  "by_year_primary": {
   "2019": 7993,
   "2020": 9376,
   "2021": 9192,
   "2022": 9344,
   "2023": 9277,
   "2024": 10702,
   "2025": 11634,
   "2026": 6269
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "CGMP Deviations",
   "firm": "Baxter Healthcare Corporation",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20251106",
   "reason": "Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20230501",
   "reason": "Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.",
   "firm": "Glenmark Therapeutics, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210120",
   "reason": "Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200617",
   "reason": "TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.",
   "firm": "HF Acquisition Co. LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20171003",
   "reason": "Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability in",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170724",
   "reason": "Failed Tablet/Capsule Specification; out of specification for tablet weight",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170502",
   "reason": "CGMP Deviations",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20140620",
   "reason": "Failed Impurity/Degradation Specification; 12-month stability time point",
   "firm": "Novel Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140424",
   "reason": "Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.",
   "firm": "Baxter Healthcare Corp.",
   "status": "Terminated"
  }
 ],
 "recall_total": 10,
 "drugsfda": {
  "applications": 103,
  "nda": 10,
  "anda": 88,
  "first_approval": "19861015",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 93,
  "labeling_recent": 2,
  "sponsors": [
   "ABBVIE",
   "ACTAVIS ELIZABETH",
   "AJANTA PHARMA LTD",
   "ALEMBIC PHARMS LTD",
   "ALKEM LABS LTD",
   "AMNEAL",
   "ANNORA PHARMA",
   "APOTEX"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/15/1986"
 },
 "trials": {
  "total": 161,
  "completed": 105,
  "terminated": 23,
  "with_results": 38,
  "industry": 77,
  "phase3": 24,
  "results_share": 0.3619047619047619,
  "terminated_share": 0.14285714285714285
 },
 "pubmed": {
  "rct": 260,
  "meta": 7,
  "recent_rct": 11,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "famotidine",
   "Pepcid",
   "Zantac Reformulated Aug 2022"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 14045191,
  "beneficiaries": 3926701,
  "spend": 179777659.62,
  "by_brand": [
   {
    "brand": "Famotidine",
    "claims": 14044674,
    "per_claim": 12.74384167,
    "is_generic": true
   },
   {
    "brand": "Pepcid",
    "claims": 517,
    "per_claim": 1536.8623985,
    "is_generic": false
   }
  ],
  "per_claim": 12.799944096167863
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 28605,
  "fills": 14045191,
  "per_million": 2036.6401567625533,
  "ratio": 0.7355280297067788,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "2,037 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.0x)",
    "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": 53,
   "letter": "D",
   "why": [
    "260 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 36% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 66,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 4 Class II, 3 Class III across 88 generic makers (-30)",
    "2 label changes approved since 2021 (-4)"
   ],
   "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 (88 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, fatigue, nausea, diarrhoea. 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 cimetidine, nizatidine, ranitidine? 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.)"
 ]
}