Phentermine-Topiramate

Warning

To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Qsymia REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (including decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as diethylpropion); or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, glaucoma, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), heart disease (such as chest pain, heart attack, heart murmur, fast/irregular heartbeat, heart valve problems), mental/mood problems (such as depression, thoughts of suicide, severe anxiety/agitation), high blood pressure in the lungs (pulmonary hypertension), stroke, overactive thyroid (hyperthyroidism), seizures, kidney disease (including kidney stones), liver disease, a certain metabolic imbalance (metabolic acidosis), a diet high in fat and low in carbohydrates (ketogenic diet).

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

If you have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication during treatment with this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness and high blood pressure. Dizziness can increase the risk of falling.

Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating. Consult your doctor or pharmacist for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. You will need to have a negative pregnancy test before starting this medication. You will also need to take a pregnancy test every month while on this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Topiramate passes into breast milk. It is unknown if phentermine passes into breast milk. However, similar drugs pass into breast milk. This medication may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

Dizziness, drowsiness, dry mouth, difficulty sleeping, tiredness, tingling of the hands/feet, joint pain, constipation, and metallic taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: temporary difficulty concentrating/finding words/remembering things, signs of kidney stones (such as painful urination, fever, chills, pink/bloody urine), rapid breathing, fast/slow/irregular heartbeat, bone pain/broken bones, loss of consciousness, change in sexual ability/interest, unusual bleeding/bruising.

A small number of people who take anticonvulsants for any reason (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Rarely, topiramate may cause a very serious eye problem, generally within 1 month of starting treatment. If untreated, this eye problem can lead to permanent blindness. Get medical help right away if any of these side effects occur: sudden vision changes (such as decreased vision, blurred vision), eye pain/redness.

This medication can rarely cause a serious metabolic problem (high amount of ammonia in the blood), especially if you are also taking valproic acid. Tell your doctor right away if you experience sudden/unexplained tiredness, vomiting, or mental changes (such as decreased alertness).

Get medical help right away if you have any very serious side effects, including: severe headache, trouble speaking, seizure, weakness on one side of the body.

This drug may rarely cause serious (sometimes fatal) lung or heart problems (pulmonary hypertension, heart valve problems). The risk may increase with longer use of this medication and use of other appetite-suppressant drugs/herbal products along with this drug. Stop taking this medication and get medical help right away if you have any very serious side effects, including: chest pain, difficulty breathing with exercise/decreased ability to exercise, fainting, swelling of the legs/ankles/feet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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Information expires December 2024.