{
 "query": "amoxicillin",
 "ingredient": "amoxicillin",
 "slug": "amoxicillin",
 "rxcui": "723",
 "brands": [
  "Moxatag"
 ],
 "names": [
  "amoxicillin",
  "amoxicillin anhydrous",
  "amoxicillin sodium",
  "amoxicillin trihydrate"
 ],
 "classes": [
  {
   "id": "J01CA",
   "name": "Penicillins with extended spectrum"
  }
 ],
 "alternatives": [
  "amdinocillin",
  "amdinocillin pivoxil",
  "ampicillin",
  "azlocillin",
  "bacampicillin",
  "carbenicillin",
  "hetacillin",
  "methampicillin",
  "mezlocillin",
  "piperacillin",
  "pivampicillin",
  "sulbenicillin",
  "talampicillin",
  "temocillin",
  "ticarcillin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 369
  },
  "boxed_warning": "",
  "indications_and_usage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin Capsules are indicated in the treatment of infections due to susceptible (ONLY \u03b2-lactamase\u2013negative) isolates of the designated bacteria in the conditions listed below: Amoxicillin Capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 \u2013 1.5 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.6 , 1.7 ) 1.1 Infectio ns of the ear, nose, and throat \u2013 due to Streptococcus species, (\u03b1- and \u03b2-hemolytic isolates only), Streptococcus pneumoniae ...",
  "contraindications": "Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other \u03b2-lactam antibiotics (e.g., penicillins and cephalosporins). History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4 ).",
  "warnings_and_cautions": "Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. ( 5.1 ) Clostridium difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.2 ) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. 5.2 Clostridium difficile Associated Diarrhea Clostridium ...",
  "warnings": "",
  "adverse_reactions": "The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] CDAD [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules were diarrhea, rash, vomiting, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules were diarrhea, rash, vomiting, and nausea. Triple therapy: The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). Dual therapy: The most frequently reported adverse events for patients who received d...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "17.1 Information for Patients Patients should be advised that amoxicillin capsules may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Patients should be counseled that antibacterial drugs, including amoxicillin capsules, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin capsules or other antibacterial drugs in the future. Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after havin...",
  "spl_medguide": "",
  "clinical_studies": "14.1 H. pylori Eradication to Reduce the Ri sk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Triple therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6). Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7). All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has ...",
  "brand_name": "Amoxicillin",
  "manufacturer": "PD-Rx Pharmaceuticals, Inc.",
  "application_number": "ANDA065291",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251020",
  "set_id": "039d2677-b04f-436c-e063-6294a90ac519",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 72134,
  "serious": 58193,
  "death": 4461,
  "hospitalization": 26054,
  "primary_suspect": 71907,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    4872
   ],
   [
    "Acute Kidney Injury",
    4803
   ],
   [
    "Diarrhoea",
    3920
   ],
   [
    "Drug Hypersensitivity",
    3812
   ],
   [
    "Drug Ineffective",
    3546
   ],
   [
    "Nausea",
    3545
   ],
   [
    "Rash",
    3512
   ],
   [
    "Dyspnoea",
    3442
   ],
   [
    "Off Label Use",
    3394
   ],
   [
    "Fatigue",
    3215
   ],
   [
    "Renal Failure",
    3051
   ],
   [
    "Pain",
    3002
   ],
   [
    "Pruritus",
    2953
   ],
   [
    "Headache",
    2863
   ],
   [
    "Vomiting",
    2662
   ]
  ],
  "by_year": {
   "2019": 9702,
   "2020": 7858,
   "2021": 6246,
   "2022": 5440,
   "2023": 5532,
   "2024": 5456,
   "2025": 4838,
   "2026": 2444
  },
  "by_year_primary": {
   "2019": 9698,
   "2020": 7855,
   "2021": 6230,
   "2022": 5401,
   "2023": 5482,
   "2024": 5404,
   "2025": 4807,
   "2026": 2423
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20161104",
   "reason": "Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.",
   "firm": "West-Ward Pharmaceuticals Corp.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20160624",
   "reason": "Superpotent drug: Out of specification test result for assay during stability testing.",
   "firm": "Teva North America",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130618",
   "reason": "Discoloration:  This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.",
   "firm": "Teva Pharmaceuticals USA, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130426",
   "reason": "Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.",
   "firm": "Teva Pharmaceuticals USA, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130418",
   "reason": "Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.",
   "firm": "Sandoz Incorporated",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 69,
  "nda": 7,
  "anda": 50,
  "first_approval": "19740118",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 69,
  "labeling_recent": 10,
  "sponsors": [
   "APOTHECON",
   "AUROBINDO",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL",
   "CHARTWELL RX",
   "GLAXOSMITHKLINE",
   "HIKMA",
   "HIKMA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/18/1974"
 },
 "trials": {
  "total": 1085,
  "completed": 588,
  "terminated": 77,
  "with_results": 124,
  "industry": 176,
  "phase3": 180,
  "results_share": 0.2108843537414966,
  "terminated_share": 0.07096774193548387
 },
 "pubmed": {
  "rct": 814,
  "meta": 61,
  "recent_rct": 96,
  "cochrane": [
   {
    "pmid": "24338106",
    "title": "Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis media",
    "year": "2013"
   },
   {
    "pmid": "18843673",
    "title": "Once or twice daily versus three times daily amoxicillin with or without clavulanate for the treatment of acute otitis media",
    "year": "2008"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "amoxicillin",
   "Moxatag"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 9463530,
  "beneficiaries": 6486159,
  "spend": 29291993.59,
  "by_brand": [
   {
    "brand": "Amoxicillin",
    "claims": 9463530,
    "per_claim": 3.0952502491,
    "is_generic": true
   }
  ],
  "per_claim": 3.095250249114231
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "amoxicillin",
  "matched": "amoxicillin",
  "stewardship": [
   "KeyAccessGroup",
   "AccessGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 12634,
  "fills": 9463530,
  "per_million": 1335.0198076193556,
  "ratio": 0.4821394125306299,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,335 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "814 randomized trials and 61 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 21% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 50 generic makers (-6)",
    "10 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 (50 applications)",
    "15 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 91,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, acute kidney injury, diarrhoea, drug hypersensitivity. How would we recognize and handle those?",
  "Why this one over amdinocillin, amdinocillin pivoxil, ampicillin? 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.)"
 ]
}