Prescription medicine
Phentermine and topiramate Brand names: Qsymia
Phentermine and topiramate (Qsymia) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $3.06 per phentermine-topiramate ER 7.5-46 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule IV
Check it at the source: the phentermine and topiramate FDA label on DailyMed (effective April 22, 2026); the NDA 22580 record on Drugs@FDA; every phentermine and topiramate label on DailyMed.
Highlights of the record
FDA label of April 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageQSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indic
Forms and strengths
- 3.75 mg / 23 mg
- 7.5 mg / 46 mg
- 11.25 mg / 69 mg
- 15 mg / 92 mg
Extended-release capsule; capsule.
On the market
- Earliest approval on file
- July 17, 2012 Qsymia, Vivus Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first June 25, 2024; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 14, 2029 Qsymia capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $3.06 per capsule Phentermine-topiramate ER 7.5-46 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,790 through July 30, 2026
What is phentermine and topiramate used for?
From the label: indications and usageQSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity ( 1 ). […]
Conditions named in the indications of phentermine and topiramate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sympathomimetic Amine Anorectic.
Source: FDA drug label (Qsymia), Vivus LLC, effective April 22, 2026 (SPL set 40dd5602-53da-45ac-bb4b-15789aba40f9), via openFDA; the full label on DailyMed
What does the patient leaflet for phentermine and topiramate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about QSYMIA?QSYMIA can cause serious side effects, including: Birth defects. If you take QSYMIA during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate. Your baby may also be smaller than expected at birth. The long-term effects of this are not known. These defects can begin early in pregnancy, even before you know you are pregnant. Patients who are pregnant must not take QSYMIA. Patients who can become pregnant should: Have a pregnancy test before taking QSYMIA and every month while taking QSYMIA. Use effective birth control (contraception) consistently while taking QSYMIA. Talk to your health care provider about how to prevent pregnancy. If you become pregnant while taking QSYMIA, stop taking QSYMIA immediately and tell your health care provider right away. Health care providers and patients who become pregnant should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088 Because of the risk for birth defects (cleft lip and cleft palate), QSYMIA is available through a restricted program called the QSYMIA Risk Evaluation and Mitigation Strategy (REMS). QSYMIA is only available through certified pharmacies that participate in the QSYMIA REMS program. Your health care provider can give you information about how to find a certified pharmacy. For more information, go to www.QSYMIAREMS.com or call 1-888-998-4887. Suicidal thoughts or actions. Topiramate, an ingredient in QSYMIA, may cause you to have suicidal thoughts or actions. […]
From the patient leaflet: What should I avoid while taking QSYMIA?Do not get pregnant while taking QSYMIA. See " What is the most important information I should know about QSYMIA ". Do not drink too much alcohol while taking QSYMIA . QSYMIA and alcohol can affect each other causing side effects such as sleepiness or dizziness. Do not drive a car, operate heavy machinery, or do other dangerous activities until you know how QSYMIA affects you. QSYMIA can slow your thinking and motor skills and may affect vision.
From the patient leaflet: How should I store QSYMIA?Store QSYMIA at room temperature between 68°F to 77°F (20°C to 25°C). Keep QSYMIA in a tightly closed container. Keep QSYMIA dry and away from moisture. Keep QSYMIA and all medicines out of the reach of children. General Information about the safe and effective use of QSYMIA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QSYMIA for a condition for which it was not prescribed. Do not give QSYMIA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or health care provider for information about QSYMIA that is written for health professionals.
Source: FDA drug label (Qsymia), Vivus LLC, effective April 22, 2026 (SPL set 40dd5602-53da-45ac-bb4b-15789aba40f9), via openFDA; the full label on DailyMed
Is there a generic for phentermine and topiramate (Qsymia)?
The FDA approved the first generic phentermine and topiramate on June 25, 2024. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists phentermine and topiramate from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Qsymia capsules, the last expiring on June 14, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2024 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for phentermine and topiramate (Qsymia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.06 per Phentermine-topiramate ER 7.5-46 mg capsule, down 23% from $3.99 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Phentermine-topiramate ER 15-92 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Phentermine-topiramate ER 11.25-69 mg capsule | Generic | $3.09 per capsule | $92.72 | -30% |
| Phentermine-topiramate ER 15-92 mg capsule | Generic | $2.85 per capsule | $85.42 | -9% |
| Phentermine-topiramate ER 3.75-23 mg capsule | Generic | $2.99 per capsule | $89.58 | +14% |
| Phentermine-topiramate ER 7.5-46 mg capsule | Generic | $3.06 per capsule | $91.69 | -23% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the phentermine and topiramate label say about other medicines?
The phentermine and topiramate label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | drug interactions | Amitriptyline Clinical Impact Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate. Intervention Any adjustments in amitriptyline dose when used with QSYMIA should be made according to the patient's clinical response and not on the basis of amitriptyline levels … |
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. |
| Carbamazepine | drug interactions | Clinical Impact; Concomitant administration of phenytoin or carbamazepine with topiramate in patients with epilepsy, decreased plasma concentrations of topiramate by 48% and 40%, respectively, when compared to topiramate given alone [see ]. … |
| Divalproex | drug interactions | Antiepileptic Drugs Clinical Impact Concomitant administration of phenytoin or carbamazepine with topiramate in patients with epilepsy, decreased plasma concentrations of topiramate by 48% and 40%, respectively, when compared to topiramate given alone [see Clinical Pharmacology (12.3) ]. … |
| Hydrochlorothiazide | drug interactions | Clinical Impact; Concurrent use of QSYMIA with non-potassium sparing diuretics may potentiate the potassium-wasting action of these diuretics. Concomitant administration of hydrochlorothiazide alone with topiramate alone has been shown to increase the C max and AUC of topiramate by 27% and 29%, respectively. |
| Norethindrone | drug interactions | Clinical Impact; Co-administration of multiple-dose QSYMIA 15 mg/92 mg once daily with a single dose of oral contraceptive containing 35 µg ethinyl estradiol (estrogen component) and 1 mg norethindrone (progestin component), in obese otherwise healthy volunteers, decreased the exposure of ethinyl estradiol by 16% and … |
| Phenytoin | drug interactions | Clinical Impact; Concomitant administration of phenytoin or carbamazepine with topiramate in patients with epilepsy, decreased plasma concentrations of topiramate by 48% and 40%, respectively, when compared to topiramate given alone [see ]. … |
| Pioglitazone | drug interactions | Clinical Impact; A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and topiramate in a clinical trial. The clinical relevance of these observations is unknown. |
| Valproic acid | drug interactions | … by 48% and 40%, respectively, when compared to topiramate given alone [see ]. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy. … |
Source: FDA drug label (Qsymia), Vivus LLC, effective April 22, 2026 (SPL set 40dd5602-53da-45ac-bb4b-15789aba40f9), via openFDA; the full label on DailyMed
What do FAERS reports show for phentermine and topiramate?
The FDA Adverse Event Reporting System holds 5,790 reports that list phentermine and topiramate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 221 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,186, against a median of 271 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as phentermine and topiramate?
6 other medicines are given the same way (oral) and in the same FDA class as phentermine and topiramate or labeled mainly for the same use (weight management), the same class first. Weight management lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diethylpropion | Weight management | 13 labelers | $0.238 per tablet 25 mg tablet | No current entry |
| Phendimetrazine | Weight management | 11 labelers | $0.132 per tablet 35 mg tablet | No current entry |
| Benzphetamine | Weight management | 6 labelers | n/a | No current entry |
| Orforglipron | Weight management | none listed | $20.89 per tablet 0.8 mg tablet | No current entry |
| Orlistat | Weight management | none listed | $7.00 per capsule 120 mg capsule | No current entry |
| Bupropion and naltrexone | Weight management | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as phentermine and topiramate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to phentermine and topiramate
- 6 medicines for the same use
- Other sympathomimetic amine anorectics
- the pharmacologic class, with prices and generics
- Phentermine and topiramate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other