Quick answers
- What is Phendimetrazine tartrate used for?
- The FDA-approved label (Phendimetrazine Tartrate, Kvk-Tech, Inc, December 6, 2024) says: “Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Phendimetrazine tartrate?
- The “Adverse Reactions” section of the FDA label (Phendimetrazine Tartrate, Kvk-Tech, Inc, December 6, 2024) begins: “Cardiovascular: Palpitations, tachycardia, elevated blood pressure, ischemic events. 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 case of this valvulopathy has been reported when phendimetrazine tartrate has been used alone.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Phendimetrazine tartrate have a boxed warning?
- No. None of the 17 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Phendimetrazine tartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Phendimetrazine tartrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Phendimetrazine tartrate?
- 10 companies list prescription products of Phendimetrazine tartrate in the FDA NDC Directory, including Bryant Ranch Prepack, KVK-Tech, Inc. and A-S Medication Solutions.
What Phendimetrazine tartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. …
— FDA label: Phendimetrazine Tartrate, Kvk-Tech, Inc, effective December 6, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Phendimetrazine Tartrate, Kvk-Tech, Inc; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 17 FDA labels for this medicine have a boxed warning.
Phendimetrazine tartrate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Cardiovascular: Palpitations, tachycardia, elevated blood pressure, ischemic events. 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 case of this valvulopathy has been reported when phendimetrazine tartrate has been used alone.
Read more of this section
Central Nervous System: Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal: Dryness of the mouth, nausea, diarrhea, constipation, stomach pain. Genitourinary: Urinary frequency, dysuria, changes in libido.
— FDA label: Phendimetrazine Tartrate, Kvk-Tech, Inc, effective December 6, 2024. Read the full label on DailyMed →
Phendimetrazine tartrate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Usual Adult Dosage: 1 tablet (35 mg) twice a day or three times a day one hour before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases, ½ tablet (17.5 mg) per dose may be adequate. Dosage should not exceed 2 tablets three times a day.
— FDA label: Phendimetrazine Tartrate, Kvk-Tech, Inc, effective December 6, 2024. Read the full label on DailyMed →
When Phendimetrazine tartrate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Known hypersensitivity or idiosyncratic reactions to sympathomimetics. Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate and severe hypertension, hyperthyroidism, and glaucoma. Highly nervous or agitated patients. Patients with a history of drug abuse. Patients taking other CNS stimulants, including monoamine oxidase inhibitors.
— FDA label: Phendimetrazine Tartrate, Kvk-Tech, Inc, effective December 6, 2024. Read the full label on DailyMed →
Phendimetrazine tartrate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Acute overdosage with phendimetrazine tartrate may manifest itself by the following signs and symptoms: unusual restlessness, confusion, belligerence, hallucinations, 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.
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Poisoning may result in convulsions, coma, and death. The management of overdosage is largely symptomatic. It includes sedation with a barbiturate. If hypertension is marked, the use of a nitrate or rapid-acting alpha receptor-blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations for its use.
— FDA label: Phendimetrazine Tartrate, Kvk-Tech, Inc, effective December 6, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet · Capsule, extended release |
|---|---|
| Route | Oral |
| Prescription products | 20 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| phendimetrazine tartrate 105 mg capsule, extended release | Generic | $3.41 per capsule |
| phendimetrazine tartrate 35 mg tablet | Generic | $0.1326 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack5 products
- KVK-Tech, Inc.3 products
- A-S Medication Solutions3 products
- NuCare Pharmaceuticals, Inc.3 products
- Elite Laboratories, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Calvin Scott & Co., Inc.1 product
- Virtus Pharmaceuticals, LLC1 product
- Acertis Pharmaceuticals, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018074 PHENDIMETRAZINE TARTRATE | Acertis Pharms | April 16, 1979 | 28, latest November 13, 2020 2020: Manufacturing (CMC) · 2019: Labeling · 2012: Labeling |
Generic approvals (3)
- ANDA085588Acertis Pharms · August 19, 1977
- ANDA040762Elite Labs Inc · January 28, 2008
- ANDA091042Kvk Tech · August 31, 2010
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 979543, 979549 |
|---|---|
| SPL set ID of the quoted label | 07bf3488-09e7-436f-af3f-94c35a7be025 |
| FDA labels (SPL) | 17 |
| FDA applications | NDA018074, 3 ANDA |
| Active ingredients (FDA) | PHENDIMETRAZINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- ObesityCondition named on the label: hospitals that treat it
- Bryant Ranch PrepackMaker or distributor
- KVK-Tech, Inc.Maker or distributor
- A-S Medication SolutionsMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Phendimetrazine Tartrate, Kvk-Tech, Inc, effective December 6, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →