{ "query": "phentermine", "ingredient": "phentermine", "slug": "phentermine", "rxcui": "8152", "brands": [ "Adipex-P", "Lomaira" ], "names": [ "phentermine", "phentermine hydrochloride", "phentermine resin" ], "classes": [ { "id": "A08AA", "name": "Centrally acting antiobesity products" } ], "alternatives": [ "cathine", "clobenzorex", "dexfenfluramine", "diethylpropion", "fenfluramine", "lorcaserin", "mazindol", "mefenorex", "setmelanotide", "sibutramine" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 114 }, "boxed_warning": "", "indications_and_usage": "Phentermine hydrochloride Tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index \u2265 30 kg/m 2 , or \u2265 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds \u00f7 2.2 = kg; inches \u00d7 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Weight (pounds) Height (feet, inches) 5'0\" 5'3\" 5'6\" 5'9\" 6'0\" 6'3\" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 The limited usefulness of agents of this class, including phentermine, [ see Clinical Pharmacology (12.1 , 12.2) ] should be measured against possible risk factors inherent in their use such as those ...", "contraindications": "History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors Hyperthyroidism Glaucoma Agitated states History of drug abuse Pregnancy [ see Use in Specific Populations (8.1) ] Nursing [ see Use in Specific Populations (8.3) ] Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) ( 4 ) During or within 14 days following the administration of monoamine oxidase inhibitors ( 4 ) Hyperthyroidism ( 4 ) Glaucoma ( 4 ) Agitated states ( 4 ) History of drug abuse ( 4 ) Pregnancy ( 4 , 8.1 ) Nursing ( 4 , 8.3 ) Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines ( 4 )", "warnings_and_cautions": "Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). ( 5.1 ) Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. ( 5.2 ) Rare cases of serious regurgitant cardiac valvular disease have been reported. ( 5.3 ) Tolerance to the anorectic effect usually develops within a few weeks. If this occurs, phentermine should be discontinued. The recommended dose should not be exceeded. ( 5.4 ) Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. ( 5.5 ) Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. ( 5.6 ) Concomitant alcohol use may result in an adverse drug reaction. ( 5.7 ) Use caution in patients with even mild hypertension (risk of increase in blood pressure). ( 5.8 ) A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. ( 5.9 ) 5...", "warnings": "", "adverse_reactions": "The following adverse reactions are described, or described in greater detail, in other sections: Primary pulmonary hypertension [ see Warnings and Precautions (5.2) ] Valvular heart disease [ see Warnings and Precautions (5.3) ] Effect on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions (5.5) ] Withdrawal effects following prolonged high dosage administration [ see Drug Abuse and Dependence (9.3) ] The following adverse reactions to phentermine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events. Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic Urticaria. Endocrine Impotence, changes in libido. Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Elite laboratories, Inc. at 1-888-852-6657 or FDA...", "drug_abuse_and_dependence": "9.1 Controlled Substance Phentermine is a Schedule IV controlled substance. 9.2 Abuse Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. 9.3 Dependence Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.", "controlled_substance": "9.1 Controlled Substance Phentermine is a Schedule IV controlled substance.", "recent_major_changes": "", "information_for_patients": "Patients must be informed that phentermine hydrochloride is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of phentermine with other drugs for weight loss is not recommended [ see Indications and Usage (1) and Warnings and Precautions (5.1) ]. Patients must be instructed on how much phentermine to take, and when and how to take it [ see Dosage and Administration (2) ]. Advise pregnant women and nursing mothers not to use phentermine [ see Use in Specific Populations (8.1 , 8.3) ]. Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to: Development of primary pulmonary hypertension [ see Warnings and Precautions (5.2) ] Development of serious valvular heart disease [ see Warnings and Precautions (5.3) ] Effects on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions (5.5) ] The risk of...", "spl_medguide": "", "clinical_studies": "In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with \"anorectic\" drugs lost more weight on the average than those treated with placebo and diet. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an \"anorectic\" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be...", "brand_name": "Phentermine Hydrochloride", "manufacturer": "TAGI Pharma, Inc.", "application_number": "ANDA200272", "pharm_class_epc": [], "route": [ "ORAL" ], "effective_time": "20251223", "set_id": "1993b181-f4f1-4451-92a0-7ed8f32598ba", "has_boxed_warning": false, "controlled": true, "mentions_rems": false }, "faers": { "total": 5887, "serious": 2964, "death": 289, "hospitalization": 1176, "primary_suspect": 5859, "top_reactions": [ [ "Drug Ineffective", 576 ], [ "Nausea", 455 ], [ "Fatigue", 378 ], [ "Pain", 338 ], [ "Headache", 337 ], [ "Anxiety", 262 ], [ "Off Label Use", 248 ], [ "Chronic Kidney Disease", 228 ], [ "Diarrhoea", 227 ], [ "Vomiting", 224 ], [ "Dizziness", 212 ], [ "Weight Increased", 193 ], [ "Arthralgia", 176 ], [ "Acute Kidney Injury", 174 ], [ "Depression", 166 ] ], "by_year": { "2019": 550, "2020": 550, "2021": 510, "2022": 424, "2023": 505, "2024": 370, "2025": 594, "2026": 244 }, "by_year_primary": { "2019": 550, "2020": 550, "2021": 510, "2022": 423, "2023": 490, "2024": 370, "2025": 582, "2026": 244 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20250509", "reason": "cGMP deviations", "firm": "KVK Tech, Inc.", "status": "Ongoing" }, { "class": "Class II", "date": "20200318", "reason": "CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed", "firm": "Aurobindo Pharma USA Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20170811", "reason": "Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .", "firm": "PD-Rx Pharmaceuticals, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20170803", "reason": "Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.", "firm": "KVK-Tech, Inc.", "status": "Terminated" }, { "class": "Class III", "date": "20150721", "reason": "Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station", "firm": "PD-Rx Pharmaceuticals, Inc.", "status": "Terminated" } ], "recall_total": 5, "drugsfda": { "applications": 100, "nda": 3, "anda": 83, "first_approval": "19730814", "rems": false, "rems_last": "", "labeling_supplements": 9, "labeling_recent": 0, "sponsors": [ "ABC HOLDING", "ABLE", "ACTAVIS ELIZABETH", "AUROBINDO PHARMA LTD", "AUROLIFE PHARMA LLC", "AVANTHI INC", "BARR", "CAMALL" ], "unapproved": false, "first_approval_fmt": "08/14/1973" }, "trials": { "total": 86, "completed": 54, "terminated": 10, "with_results": 35, "industry": 38, "phase3": 8, "results_share": 0.6481481481481481, "terminated_share": 0.11627906976744186 }, "pubmed": { "rct": 35, "meta": 2, "recent_rct": 7, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "phentermine", "Adipex-P", "Lomaira" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1850, "beneficiaries": 588, "spend": 10284.8, "by_brand": [ { "brand": "Phentermine HCl", "claims": 1850, "per_claim": 5.5593513514, "is_generic": true } ], "per_claim": 5.559351351351351 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 90, "letter": "A", "why": [ "Federally controlled substance: dependence and misuse risk (-10)", "Death share in reports is near or below the FAERS average (0.5x)" ], "weight": 0.35 }, "evidence": { "score": 35, "letter": "F", "why": [ "35 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)" ], "weight": 0.25 }, "regulatory": { "score": 96, "letter": "A", "why": [ "Recalls since 2016: 0 Class I, 2 Class II, 2 Class III across 83 generic makers (-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 (83 applications)", "10 same-class alternatives exist" ], "weight": 0.1 } }, "total": 80, "grade": "B", "questions": [ "This is a controlled substance. What is the plan for how long I take it and how I stop?", "The most-reported problems in FDA's adverse event data are nausea, fatigue, pain. How would we recognize and handle those?", "Why this one over cathine, clobenzorex, dexfenfluramine? 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.)" ] }