{
 "query": "clopidogrel",
 "ingredient": "clopidogrel",
 "slug": "clopidogrel",
 "rxcui": "32968",
 "brands": [
  "Plavix"
 ],
 "names": [
  "clopidogrel",
  "clopidogrel bisulfate"
 ],
 "classes": [
  {
   "id": "B01AC",
   "name": "Platelet aggregation inhibitors excl. heparin"
  }
 ],
 "alternatives": [
  "abciximab",
  "aloxiprin",
  "aspirin",
  "cangrelor",
  "cilostazol",
  "dipyridamole",
  "epoprostenol",
  "eptifibatide",
  "iloprost",
  "indobufen",
  "prasugrel",
  "selexipag",
  "ticagrelor",
  "ticlopidine",
  "tirofiban",
  "treprostinil",
  "triflusal",
  "vorapaxar"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 55
  },
  "boxed_warning": "WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE The effectiveness of clopidogrel results from its antiplatelet activity, which is dependent on its conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19 [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ]. Clopdigorel at recommended doses forms less of the active metabolite and so has a reduced effect on platelet activity in patients who are homozygous for nonfunctional alleles of the CYP2C19 gene, (termed \"CYP2C19 poor metabolizers\"). Tests are available to identify patients who are CYP2C19 poor metabolizers [see Clinical Pharmacology (12.5) ]. Consider use of another platelet P2Y 12 inhibitor in patients identified as CYP2C19 poor metabolizers. WARNING: DIMINISHED ANTIPLATELET EFFECT IN PATIENTS WITH TWO LOSS-OF-FUNCTION ALLELES OF THE CYP2C19 GENE See full prescribing information for complete boxed warning. \u2022 Effectiveness of clopidogrel depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. ( 5.1 , 12.3 ) \u2022 Tests are available to identify patients who are CYP2C19 poor met...",
  "indications_and_usage": "Clopidogrel is a P2Y 12 platelet inhibitor indicated for: \u2022 Acute coronary syndrome 1. For patients with non\u2013ST-segment elevation ACS (unstable angina [UA]/non\u2013ST-elevation myocardial infarction [NSTEMI]), clopidogrel has been shown to reduce the rate of myocardial infarction (MI) and stroke. ( 1.1 ) 2. For patients with ST-elevation myocardial infarction (STEMI), clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.1 ) \u2022 Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel has been shown to reduce the rate of MI and stroke. ( 1.2 ) 1.1 Acute Coronary Syndrome (ACS) \u2022 Clopidogrel is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non\u2013ST-segment elevation ACS (unstable angina [UA]/non\u2013ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel should be administered in conjunction with aspirin. \u2022 Clopidogrel is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel shoul...",
  "contraindications": "\u2022 Active pathological bleeding, such as peptic ulcer or intracranial hemorrhage ( 4.1 ) \u2022 Hypersensitivity to clopidogrel or any component of the product ( 4.2 ) 4.1 Active Bleeding Clopidogrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. 4.2 Hypersensitivity Clopidogrel is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see Adverse Reactions (6.2) ].",
  "warnings_and_cautions": "\u2022 CYP2C19 inhibitors: Avoid concomitant use of omeprazole or esomeprazole. ( 5.1 ) \u2022 Bleeding: Clopidogrel increases risk of bleeding. ( 5.2 ) \u2022 Discontinuation: Premature discontinuation increases risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. ( 5.3 ) \u2022 Thrombotic thrombocytopenic purpura (TTP) has been reported. ( 5.4 ) \u2022 Cross-reactivity among thienopyridines has been reported. ( 5.5 ) 5.1 Diminished Antiplatelet Activity in Patients with Impaired CYP2C19 Function Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is achieved through an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by genetic variations in CYP2C19 [see Boxed Warning ]. The metabolism of clopidogrel can also be impaired by drugs that inhibit CYP2C19, such as omeprazole or esomeprazole. Avoid concomitant use of clopidogrel with omeprazole or esomeprazole because both significantly reduce the antiplatelet activity of clopidogrel [see Drug Interactions (7.1) ]. 5.2 General Risk of Bleeding P2Y12 inhibitors (thienopyridines), including clopidogrel, increase the risk of bleeding. P2Y12 i...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed below and elsewhere in the labeling: \u2022 Bleeding [see Warnings and Precautions (5.2) ] \u2022 Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.4) ] Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or 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 and durations of follow- up, 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. Clopidogrel has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. The clinically important adverse reactions observed in trials comparing clopidogrel plus aspirin to placebo plus aspirin and trials comparing clopidogrel alone to aspirin alone are discussed below. Bleeding CURE In CURE, clopidogrel use with aspirin was associated wi...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patients to read FDA approved patient labeling (Medication Guide). Discontinuation Advise patients not to discontinue clopidogrel without first discussing it with the healthcare provider who prescribed it [see Warnings and Precautions (5.3) ]. Bleeding Advise patients that they: \u2022 will bruise and bleed more easily \u2022 will take longer than usual to stop bleeding \u2022 must report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine [see Warnings and Precautions (5.2) ] Thrombotic Thrombocytopenic Purpura Instruct patients to get prompt medical attention if they experience symptoms of TTP that cannot otherwise be explained [see Warnings and Precautions (5.4) ]. Invasive Procedures Advise patients to inform physicians and dentists that they are taking clopidogrel before any surgery or dental procedure [see Warnings and Precautions (5.2 , 5.3) ]. Proton Pump Inhibitors Advise patients not to take omeprazole or esomeprazole while taking clopidogrel. Dexlansoprazole, lansoprazole, and pantoprazole had less pronounced effects on the antiplatelet activity of clopidogrel than did omeprazole or esomeprazole [see Drug Interactions (7.1) ]. The brands listed ...",
  "spl_medguide": "Medication Guide Clopidogrel Tablets, USP (Kloe pid' oh grel) Read this Medication Guide before you start taking clopidogrel tablets and each time you get a refill. There may be new information. This Medication Guide 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 clopidogrel tablets? 1. Clopidogrel tablets may not work as well in people who: \u2022 have certain genetic factors that affect how the body breaks down clopidogrel. Your doctor may do genetic tests to make sure clopidogrel tablet is right for you. \u2022 take certain medicines, especially omeprazole (Prilosec \u00ae ) or esomeprazole (Nexium \u00ae ). Your doctor may change the medicine you take for stomach acid problems while you take clopidogrel tablets. 2. Clopidogrel tablets can cause bleeding which can be serious and can sometimes lead to death. Clopidogrel is a blood thinner medicine that lowers the chance of blood clots forming in your body. While you take clopidogrel tablets: \u2022 you may bruise and bleed more easily \u2022 you are more likely to have nose bleeds \u2022 it will take longer for any bleeding to stop Call your doctor right...",
  "clinical_studies": "14.1 Acute Coronary Syndrome CURE The CURE study included 12,562 patients with ACS without ST-elevation (UA or NSTEMI) and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia. Patients were required to have either ECG changes compatible with new ischemia (without ST-elevation) or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal. Patients were randomized to receive clopidogrel (300 mg loading dose followed by 75 mg once daily) or placebo, and were treated for up to one year. Patients also received aspirin (75 mg to 325 mg once daily) and other standard therapies such as heparin. The use of GPIIb/IIIa inhibitors was not permitted for three days prior to randomization. The patient population was largely White (82%) and included 38% women, and 52% age \u226565 years of age. Only about 20% of patients underwent revascularization during the initial hospitalization and few underwent emergent or urgent revascularization. The number of patients experiencing the primary outcome (CV death, MI, or stroke) was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a...",
  "brand_name": "Clopidogrel",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA204165",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240501",
  "set_id": "330702d9-842c-416d-9b11-b4a9b707e9b2",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 149618,
  "serious": 123053,
  "death": 15554,
  "hospitalization": 69897,
  "primary_suspect": 148685,
  "top_reactions": [
   [
    "Dyspnoea",
    7722
   ],
   [
    "Fatigue",
    7233
   ],
   [
    "Gastrointestinal Haemorrhage",
    6607
   ],
   [
    "Myocardial Infarction",
    6348
   ],
   [
    "Diarrhoea",
    6196
   ],
   [
    "Dizziness",
    5810
   ],
   [
    "Drug Ineffective",
    5729
   ],
   [
    "Nausea",
    5689
   ],
   [
    "Acute Kidney Injury",
    5315
   ],
   [
    "Off Label Use",
    5292
   ],
   [
    "Fall",
    5135
   ],
   [
    "Asthenia",
    4932
   ],
   [
    "Anaemia",
    4842
   ],
   [
    "Death",
    4699
   ],
   [
    "Cerebrovascular Accident",
    4306
   ]
  ],
  "by_year": {
   "2019": 16843,
   "2020": 13567,
   "2021": 11063,
   "2022": 9168,
   "2023": 8578,
   "2024": 8731,
   "2025": 9064,
   "2026": 4203
  },
  "by_year_primary": {
   "2019": 16825,
   "2020": 13554,
   "2021": 11002,
   "2022": 8897,
   "2023": 8389,
   "2024": 8572,
   "2025": 8935,
   "2026": 4125
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210802",
   "reason": "Presence of foreign matter",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181210",
   "reason": "Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181107",
   "reason": "Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 26,
  "nda": 1,
  "anda": 25,
  "first_approval": "19971117",
  "rems": false,
  "rems_last": "20120418",
  "labeling_supplements": 30,
  "labeling_recent": 3,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS TOTOWA",
   "ALKEM LABS LTD",
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "APOTEX INC",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/17/1997"
 },
 "trials": {
  "total": 1291,
  "completed": 690,
  "terminated": 110,
  "with_results": 171,
  "industry": 350,
  "phase3": 232,
  "results_share": 0.24782608695652175,
  "terminated_share": 0.08520526723470179
 },
 "pubmed": {
  "rct": 983,
  "meta": 281,
  "recent_rct": 111,
  "cochrane": [
   {
    "pmid": "29240976",
    "title": "Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular events",
    "year": "2017"
   },
   {
    "pmid": "21249668",
    "title": "Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular disease",
    "year": "2011"
   },
   {
    "pmid": "17636787",
    "title": "Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular disease",
    "year": "2007"
   },
   {
    "pmid": "10796426",
    "title": "Thienopyridine derivatives (ticlopidine, clopidogrel) versus aspirin for preventing stroke and other serious vascular events in high vascular risk patients",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "clopidogrel",
   "Plavix"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 13594375,
  "beneficiaries": 3410818,
  "spend": 160036576.52,
  "by_brand": [
   {
    "brand": "Clopidogrel",
    "claims": 13582037,
    "per_claim": 11.325857346,
    "is_generic": false
   },
   {
    "brand": "Plavix",
    "claims": 12338,
    "per_claim": 503.19038661,
    "is_generic": false
   }
  ],
  "per_claim": 11.772264375522965
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20151106",
   "title": "FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm471286.htm",
   "kind": "drug",
   "matched": "clopidogrel"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "clopidogrel",
  "matched": "clopidogrel",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 21632,
  "fills": 13594375,
  "per_million": 1591.2463794768057,
  "ratio": 0.5746750649044945,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 62,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2015 (-8)",
    "1,591 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 (1.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 83,
   "letter": "B",
   "why": [
    "983 randomized trials and 281 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 25% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 25 generic makers (-4)",
    "3 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 (25 applications)",
    "18 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "In 2015 the FDA issued a safety communication about this drug (FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of). Does that risk apply to me?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, gastrointestinal haemorrhage, myocardial infarction. How would we recognize and handle those?",
  "Why this one over abciximab, aloxiprin, aspirin? 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.)"
 ]
}