Benzphetamine
/api/v1/drug/benzphetamineMechanism of action
Sourced from openFDAMechanism-of-action classes: Adrenergic Receptor Interactions; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.
Indications
Sourced from openFDA- Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights.ICD-10: E66.9
Contraindications
Sourced from openFDA- Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.contraindicated
Dosage & administration
Sourced from openFDADosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient’s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 17 years of age.
Warnings & precautions
Sourced from openFDABenzphetamine hydrochloride tablets should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products. In a case-control epidemiological study, the use of anorectic agents was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. It should be noted that benzphetamine was not specifically studied in this case-control study. The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Benzphetamine hydrochloride tablets should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when benzphetamine has been used alone.
Adverse reactions
Sourced from openFDAThe following have been associated with the use of benzphetamine hydrochloride: Cardiovascular Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when benzphetamine hydrochloride tablets have been used alone. CNS Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug. Gastrointestinal Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances. Allergic Urticaria and other allergic reactions involving the skin. Endocrine Changes in libido.
Use in specific populations
Sourced from openFDAPregnancy Benzphetamine hydrochloride tablets are contraindicated in pregnancy.
Overdosage
Sourced from openFDAManifestations of Overdosage Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma. Treatment of Overdosage (See WARNINGS )--- Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following is based on experience with other anorexiants. Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases amphetamine excretion.
Approval history
Sourced from openFDA- Jul 20, 2010ANDAANDA090968Kvk Tech
- Dec 15, 2015ANDAANDA090346Epic Pharma Llc
FAERS reports
- 1Drug Ineffective436%
- 2Pyrexia218%
- 3Abdominal Pain19.1%
- 4Adverse Reaction19.1%
- 5Cerebrovascular Accident19.1%
- 6Decreased Appetite19.1%
- 7Drug Screen False Positive19.1%
- 8Energy Increased19.1%
- 9Fall19.1%
- 10Fluid Retention19.1%
- 11Hypokalaemia19.1%
- 12Malaise19.1%
- 13Monoplegia19.1%
- 14Phobia19.1%
- 15Product Availability Issue19.1%
Literature
Recent PubMed references pinned to Benzphetamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Role of d-amphetamine and d-methamphetamine as active metabolites of benzphetamine: Evidence from drug discrimination and pharmacokinetic studies in male rhesus monkeys.Pharmacology, biochemistry, and behavior · 2017 · Banks ML, Snyder RW, Fennell TR, et al.PMID 28373066DOI 10.1016/j.pbb.2017.03.008
- Multi-panel drugs detection in human serum for personalized therapy.Biosensors & bioelectronics · 2011 · Carrara S, Cavallini A, Erokhin V, et al.PMID 21497079DOI 10.1016/j.bios.2011.03.009
- Naphthylisopropylamine and N-benzylamphetamine derivatives as monoamine oxidase inhibitors.Bioorganic & medicinal chemistry · 2009 · Vilches-Herrera M, Miranda-Sepúlveda J, Rebolledo-Fuentes M, et al.PMID 19243954DOI 10.1016/j.bmc.2009.01.074
- Kinetics of oxidation of benzphetamine by compounds I of cytochrome P450 2B4 and its mutants.Journal of the American Chemical Society · 2009 · Sheng X, Zhang H, Im SC, et al.PMID 19209859DOI 10.1021/ja808982g
- Resonance Raman studies of cytochrome P450 2B4 in its interactions with substrates and redox partners.Biochemistry · 2008 · Mak PJ, Im SC, Zhang H, et al.PMID 18311926DOI 10.1021/bi800034b
- Theoretical study of the ligand-CYP2B4 complexes: effect of structure on binding free energies and heme spin state.Proteins · 2004 · Harris DL, Park JY, Gruenke L, et al.PMID 15146488DOI 10.1002/prot.20062
- Mechanistic studies with N-benzyl-1-aminobenzotriazole-inactivated CYP2B1: differential effects on the metabolism of 7-ethoxy-4-(trifluoromethyl)coumarin, testosterone, and benzphetamine.Archives of biochemistry and biophysics · 2004 · Kent UM, Pascual L, Roof RA, et al.PMID 15001392DOI 10.1016/j.abb.2004.01.007
- Determination of the rate of reduction of oxyferrous cytochrome P450 2B4 by 5-deazariboflavin adenine dinucleotide T491V cytochrome P450 reductase.Biochemistry · 2003 · Zhang H, Gruenke L, Arscott D, et al.PMID 14529269DOI 10.1021/bi034968u
Clinical trials
The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Benzphetamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- A Study to Evaluate the Safety of Exposure to Wegovy During PregnancyEnrolling by invitation · Observational · 1,139 enrolled · Novo Nordisk A/SNCT05503927updated 2026-06-09
Frequently asked questions
- How does Benzphetamine work?
- Mechanism-of-action classes: Adrenergic Receptor Interactions; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.
- What is Benzphetamine used for?
- According to FDA labeling, Benzphetamine carries indications including: Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Benzphetamine?
- Benzphetamine is classified as Sympathomimetic Amine Anorectic, Adrenergic Receptor Interactions, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Appetite Suppression, Bronchodilation, Increased Norepinephrine Activity, Increased Sympathetic Activity.
- What are the contraindications for Benzphetamine?
- Benzphetamine labeling lists contraindications including: Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.. Always consult the full prescribing information and a clinician.
benzphetamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.