Qsymia FDA Approval History
Last updated by Judith Stewart, BPharm on June 29, 2022.
FDA Approved: Yes (First approved July 17, 2012)
Brand name: Qsymia
Generic name: phentermine and topiramate
Dosage form: Extended-Release Capsules
Previous Name: Qnexa
Company: Vivus, Inc.
Treatment for: Weight Loss (Obesity/Overweight)
Qsymia (phentermine and topiramate) is a sympathomimetic amine anorectic and anticonvulsant combination for use in chronic weight management.
- Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:
- adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
- Pediatric patients aged 12 years and older with BMI in the 95th percentile or greater standardized for age and sex.
- adults with an initial body mass index (BMI) of:
- Phentermine is an amphetamine analogue with anorectic activity that is widely used as an anti-obesity medication. Topiramate is an anticonvulsant that is thought to have an effect on the satiety response and appetite suppression. In combination, these two agents act synergistically to promote weight loss while using lower doses than usually required for each drug alone, in an effort to reduce the adverse side effects of each medication when given at their normal full dose.
- Qsymia extended-release capsules are taken orally, once daily in the morning.
- Qsymia warnings and precautions include embryo-fetal toxicity, increased heart rate, suicidal behavior and ideation, increased risk of ophthalmologic adverse reactions, mood and sleep disorders, cognitive impairment, slowing of linear growth, metabolic acidosis, decrease in renal function, and serious skin reactions.
- Common adverse reactions in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
- Common adverse reactions in pediatric patients aged 12 years and older include depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain.
Development timeline for Qsymia
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.