FAQs + Downloads
The following downloadable resources are available to help you:
- Qsymia Medication Guide
The most important information you need to know about Qsymia
- Qsymia Full Prescribing Information
Detailed information about Qsymia and its use
- Risk of Birth Defects with Qsymia Patient Brochure
An overview of the potential fetal risks of Qsymia and information about recommended pregnancy testing and effective birth control for females who are able to become pregnant while taking Qsymia.
- Medical Necessity Form
Your health insurance may not routinely cover prescription treatments for overweight and obesity. Your health insurer may require documentation of medical necessity when specific treatments are prescribed before deciding to pay for these treatments. You can print out the Medical Necessity Form and bring it to your doctor to begin the process.
FREQUENTLY ASKED QUESTIONS
This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any additional questions about Qsymia, talk to your healthcare provider.
What is the most important information I should know about Qsymia?
For other side effects, also see "What are the possible side effects of Qsymia?"
- Birth defects (cleft lip/cleft palate). If you take Qsymia during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant
- Have a negative pregnancy test before taking Qsymia and every month while taking Qsymia
- Use effective birth control (contraception) consistently while taking Qsymia. Talk to your healthcare provider about how to prevent pregnancy
If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to:
- FDA MedWatch at 1-800-FDA-1088, and
- The Qsymia Pregnancy Surveillance Program at 1-888-998-4887
- Qsymia can increase your heart rate at rest. Your healthcare provider should check your heart rate while you take Qsymia. Tell your healthcare provider if you experience, while at rest, a racing or pounding feeling in your chest lasting several minutes when taking Qsymia
- Suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may cause you to have suicidal thoughts or actions
- Thoughts about suicide or dying
- Attempts to commit suicide
- New or worse depression
- New or worse anxiety
- Feeling agitated or restless
- Panic attacks
- Trouble sleeping (insomnia)
- New or worse irritability
- Acting aggressive, being angry, or violent
- Acting on dangerous impulses
- An extreme increase in activity and talking (mania)
- Other unusual changes in behavior or mood
- Serious eye problems which include:
- Any sudden decrease in vision, with or without eye pain and redness
- A blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma)
These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms.
What is Qsymia?
Qsymia is a prescription medicine that contains phentermine and topiramate extended-release that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off.
- Qsymia should be used with a reduced calorie diet and increased physical activity
- It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke
- It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products
- It is not known if Qsymia is safe and effective in children under 18 years old
QSYMIA IS A FEDERALLY CONTROLLED SUBSTANCE (CIV) BECAUSE IT CONTAINS PHENTERMINE AND CAN BE ABUSED OR LEAD TO DRUG DEPENDENCE. KEEP QSYMIA IN A SAFE PLACE, TO PROTECT IT FROM THEFT. NEVER GIVE YOUR QSYMIA TO ANYONE ELSE, BECAUSE IT MAY CAUSE DEATH OR HARM THEM. SELLING OR GIVING AWAY THIS MEDICINE IS AGAINST THE LAW.
- Are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment
- Have glaucoma
- Have thyroid problems (hyperthyroidism)
- Are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days
- Are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. See the end of the Medication Guide for a complete list of ingredients in Qsymia
- Are pregnant or planning to become pregnant
- Have had a heart attack or stroke
- Have or have had an abnormal heart rhythm
- Have or have had depression, mood problems, or suicidal thoughts or behavior
- Have eye problems, especially glaucoma
- Have a history of metabolic acidosis (too much acid in the blood) or a condition that puts you at higher risk for metabolic acidosis such as
- Chronic diarrhea, surgery, a diet high in fat and low in carbohydrates (ketogenic diet), weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia), or decreased bone density
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Qsymia taken with other medicines may affect how each medicine works and may cause side effects.
- Birth control pills. Tell your healthcare provider if your menstrual bleeding changes while you are taking birth control pills and Qsymia
- Water pills (diuretics) such as hydrochlorothiazide (HCTZ)
- Any medicines that impair or decrease your thinking, concentration, or muscle coordination
- Carbonic anhydrase inhibitors [such as ZONEGRAM® (zonisamide), DIAMOX® (acetazolamide) or NEPTAZANE® (methazolamide)]
- Seizure medicines such as Valproic acid (DEPAKENE® or DEPAKOTE®)
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking to your healthcare provider.
- Take Qsymia exactly as your healthcare provider tells you to take it
- Your healthcare provider should start you on a diet and exercise program when you start taking Qsymia. Stay on this program while you are taking Qsymia
- Your healthcare provider will tell you how much Qsymia to take and when to take it
- Do not stop taking Qsymia without talking to your healthcare provider. Stopping Qsymia suddenly can cause serious problems, such as seizures. Your healthcare provider will tell you how to stop taking Qsymia slowly
- Before you take Qsymia, check to make sure that you are taking the right dose
- If you take too much Qsymia, call your healthcare provider or go to the nearest emergency room right away
- Do not get pregnant while taking Qsymia. See "What is the most important information I should know about Qsymia?"
- Do not drink alcohol while taking Qsymia. Qsymia and alcohol can affect each other, causing side effects such as sleepiness or dizziness
- Do not drive a car or 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
- See "What is the most important information I should know about Qsymia?"
- Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. Tell your healthcare provider if symptoms occur
- Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Tell your healthcare provider if symptoms occur
- Increases of acid in bloodstream (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qsymia.
- Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking Qsymia and while you take Qsymia
- Possible seizures if you stop taking Qsymia too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop Qsymia too fast. Your healthcare provider will tell you how to stop taking Qsymia slowly
- Kidney stones. Drink plenty of fluids when taking Qsymia to help decrease your chances of getting kidney stones. If you get severe side or back pain, and/or blood in your urine, call your healthcare provider
- Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition
- Numbness or tingling in the hands, arms, feet, or face (paraesthesia)
- Change in the way foods taste or loss of taste (dysgeusia)
- Trouble sleeping (insomnia)
- Dry mouth
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of Qsymia. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to VIVUS at 1-888-998-4887 or FDA at 1-800-FDA-1088.
- Store Qsymia at room temperature 59°F to 77°F (15°C to 25°C)
- Keep Qsymia and all medicines out of the reach of children
General information about 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.
The Medication Guide summarizes important information about Qsymia. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Qsymia that is written for healthcare professionals.
For more information, go to www.QsymiaREMS.com or call 1-888-998-4887.
- Active ingredients: phentermine hydrochloride and topiramate extended-release.
- Inactive ingredients: methylcellulose, sucrose, starch, microcrystalline cellulose, ethyl cellulose, povidone, gelatin, talc, titanium dioxide, FD&C Blue #1, FD&C Red #3, FD&C Yellow #5 and #6, and pharmaceutical black and white inks