{ "query": "amlodipine", "ingredient": "amlodipine", "slug": "amlodipine", "rxcui": "17767", "brands": [ "Norvasc", "Katerzia", "Norliqva", "Sdamlo" ], "names": [ "amlodipine", "amlodipine benzoate", "amlodipine besylate" ], "classes": [ { "id": "C08CA", "name": "Dihydropyridine derivatives" } ], "alternatives": [ "clevidipine", "felodipine", "isradipine", "lacidipine", "lercanidipine", "levamlodipine", "manidipine", "mepirodipine", "nicardipine", "nifedipine", "nilvadipine", "nimodipine", "nisoldipine", "nitrendipine" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 230 }, "boxed_warning": "", "indications_and_usage": "Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) Amlodipine besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes manag...", "contraindications": "Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine ( 4 )", "warnings_and_cautions": "Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine besylate tablets to patients with severe hepatic impairment.", "warnings": "", "adverse_reactions": "Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 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, 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. Amlodipine besylate tablets have been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate tablets was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine besylate tablets were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate tablets (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine besylate tablets because of adverse reacti...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "", "information_for_patients": "", "spl_medguide": "", "clinical_studies": "14.1 Effects in Hypertension Adult Patients The antihypertensive efficacy of amlodipine besylate tablets has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine besylate tablets and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect. Tolerance was not demonstrated in patients studied for up to 1 year. The 3 parallel, fixed dose, dose response studies showed that the reduction in supine and standing blood pressures was dose-related within the recommended dosing range. Effects on diastolic pressure were similar in young and older patients. The effect on systolic pressure was greater in older patients, perhaps because of greater baseline systolic pressure. Effects were similar in black patients and in white patients. Pediatric Pati...", "brand_name": "amlodipine besylate", "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC", "application_number": "NDA019787", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20221018", "set_id": "f3482709-c5c3-4bd0-8067-ad57f31bb525", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 354049, "serious": 263513, "death": 36244, "hospitalization": 138874, "primary_suspect": 352363, "top_reactions": [ [ "Fatigue", 23187 ], [ "Diarrhoea", 20095 ], [ "Nausea", 18691 ], [ "Dyspnoea", 18136 ], [ "Drug Ineffective", 17040 ], [ "Off Label Use", 16737 ], [ "Dizziness", 14727 ], [ "Headache", 14392 ], [ "Acute Kidney Injury", 13688 ], [ "Pain", 13603 ], [ "Fall", 12513 ], [ "Vomiting", 12140 ], [ "Asthenia", 11995 ], [ "Death", 11341 ], [ "Malaise", 11141 ] ], "by_year": { "2019": 36774, "2020": 34051, "2021": 30384, "2022": 28053, "2023": 26949, "2024": 25867, "2025": 26824, "2026": 13744 }, "by_year_primary": { "2019": 36733, "2020": 33996, "2021": 30272, "2022": 27644, "2023": 26646, "2024": 25585, "2025": 26555, "2026": 13555 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20230627", "reason": "Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.", "firm": "Lupin Pharmaceuticals Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20181003", "reason": "Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.", "firm": "InvaGen Pharmaceuticals, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20170505", "reason": "PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.", "firm": "Ascend Laboratories LLC", "status": "Terminated" }, { "class": "Class III", "date": "20160219", "reason": "CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.", "firm": "Lupin Limited", "status": "Terminated" }, { "class": "Class III", "date": "20160219", "reason": "CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.", "firm": "Lupin Limited", "status": "Terminated" }, { "class": "Class III", "date": "20141001", "reason": "Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.", "firm": "Zydus Pharmaceuticals USA Inc", "status": "Terminated" } ], "recall_total": 6, "drugsfda": { "applications": 46, "nda": 5, "anda": 40, "first_approval": "19920731", "rems": false, "rems_last": "", "labeling_supplements": 20, "labeling_recent": 2, "sponsors": [ "ACCORD HLTHCARE", "ALKEM", "AMNEAL", "AMNEAL PHARMS NY", "AUROBINDO PHARMA", "AZURITY", "BRILLIAN PHARMA", "CHARTWELL RX" ], "unapproved": false, "first_approval_fmt": "07/31/1992" }, "trials": { "total": 727, "completed": 517, "terminated": 52, "with_results": 166, "industry": 460, "phase3": 179, "results_share": 0.32108317214700194, "terminated_share": 0.07152682255845942 }, "pubmed": { "rct": 865, "meta": 31, "recent_rct": 65, "cochrane": [] }, "payments": { "year": "2024", "usd": 10749.630000000001, "records": 66, "by_name": [ [ "Norvasc", 8107.0 ], [ "Norliqva", 1579.03 ], [ "Katerzia", 1063.6 ] ], "names_checked": [ "amlodipine", "Norvasc", "Katerzia", "Norliqva", "Sdamlo" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 50227407, "beneficiaries": 12201827, "spend": 332292912.52, "by_brand": [ { "brand": "Amlodipine Besylate", "claims": 50204110, "per_claim": 6.2881127565, "is_generic": true }, { "brand": "Norvasc", "claims": 20746, "per_claim": 696.96179071, "is_generic": false }, { "brand": "Katerzia", "claims": 1715, "per_claim": 879.61837318, "is_generic": false }, { "brand": "Norliqva", "claims": 836, "per_claim": 760.87700957, "is_generic": false } ], "per_claim": 6.615768807655151 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "amlodipine", "matched": "amlodipine", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 65695, "fills": 50227407, "per_million": 1307.95125458099, "ratio": 0.47236366524546847, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "1,308 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 (1.1x)" ], "weight": 0.35 }, "evidence": { "score": 64, "letter": "C", "why": [ "865 randomized trials and 31 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 32% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 95, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 0 Class II, 5 Class III across 40 generic makers (-1)", "2 label changes approved since 2021 (-4)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $10,750 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 (40 applications)", "14 same-class alternatives exist" ], "weight": 0.1 } }, "total": 90, "grade": "A", "questions": [ "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea, dyspnoea. 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 clevidipine, felodipine, isradipine? 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.)" ] }