Diethylpropion

FDA label, OMNIVIUM PHARMACEUTICALS LLC., oral, effective 2025-09-19. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

DOSAGE AND ADMINISTRATION Diethylpropion Hydrochloride Extended Release Tablets, 75 mg: One extended-release 75 mg tablet daily, swallowed whole, in midmorning. Geriatric use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See PRECAUTIONS , Geriatric Use ).

Drug interactions

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Label text (2 paragraphs)

Drug Interactions Because diethylpropion hydrochloride extended release tablets, 75 mg are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors (See CONTRAINDICATIONS ). Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated. Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias.

The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.

Contraindications

Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension (See PRECAUTIONS ). Agitated states. Patients with a history of drug abuse. Use in combination with other anorectic agents is contraindicated. During or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crises may result.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

E

Likelihood score E: Unlikely cause of clinically apparent liver injury.

Diethylpropion is a sympathomimetic amine and anorectic agent used for the short-term therapy of obesity. Diethylpropion has not been linked to either serum enzyme elevations or to clinically apparent acute liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Diethylpropion (NIDDK, public domain)Chapter updated Jan 3, 2018

Pregnancy and lactation

Pregnancy

Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 1.6 times the human dose (based on mg/m 2 ) and have revealed no evidence of impaired fertility or harm to the fetus due to diethylpropion hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Spontaneous reports of congenital malformations have been recorded in humans, but no causal relationship to diethylpropion has been established. Non-Teratogenic Effects.

Abuse with diethylpropion hydrochloride during pregnancy may result in withdrawal symptoms in the human neonate.

Lactation

Nursing Mothers Since diethylpropion hydrochloride and/or its metabolites have been shown to be excreted in human milk, caution should be exercised when diethylpropion hydrochloride extended release tablets, 75 mg are administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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