Qsymia® (phentermine and topiramate extended release capsules) CIV
Who should not use this medicine?
Do not take Qsymia if you:
- 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.
Important safety information
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.
Call your health care provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- 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 health care provider right away if you have any new eye symptoms.
Common side effects of Qsymia in adults include:
- numbness or tingling in the hands, arms, feet, or face (paraesthesia)
- dizziness
- change in the way foods taste or loss of taste (dysgeusia)
- trouble sleeping (insomnia)
- constipation
- dry mouth
Common side effects of Qsymia in children 12 years and older include:
- depression
- dizziness
- joint pain
- fever
- flu
- ankle sprain
What are the possible side effects of Qsymia?
Mood changes and trouble sleeping
Qsymia may cause depression or mood problems, and trouble sleeping. Tell your health care 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 health care provider if symptoms occur.
Slowing of growth
Qsymia may slow the increase in height in children 12 years and older, when used for a long time.
Increases of acid in bloodstream (metabolic acidosis)
If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia (rickets), 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:
- feel tired
- not feel hungry (loss of appetite)
- feel changes in heartbeat
- have trouble thinking clearly
Decrease in kidney function
Qsymia may cause a decrease in kidney function. Your health care provider should do a blood test to measure your kidney function before and during treatment with 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 health care 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, or blood in your urine, call your health care 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.
Low potassium
Qsymia can increase your risk of low potassium levels. Your health care provider should do a blood test to measure the level of potassium in your blood before and during treatment with Qsymia.
Serious skin reactions
Qsymia may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome). Qsymia may also cause a rash with blisters and peeling skin over much of the body that may cause death (Toxic Epidermal Necrolysis). Call your health care provider right away if you develop a skin rash or blisters.
Allergic reaction to FD&C Yellow No. 5
Qsymia capsules contain the inactive ingredient FD&C Yellow No. 5 (tartrazine) which can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.
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 LLC at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch..
Please read the Qsymia Medication Guide, Full Prescribing Information and Risk of Birth Defects with Qsymia Patient Brochure.