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What Are Compounded Medications?

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What happens when a medicine you’re prescribed and taking regularly isn’t available anymore?

Not having access to the medicine you need is a scary feeling, and it’s a fear that may come true—there have been widespread shortages of some prescription weight loss medications in recent years. In times like this, many turn to a doppelganger version of a drug made independently in designated pharmacies.

Are these drugs, known as compounded drugs, a true solution to medicine shortages or just a temporary bandage? Below, we go deeper into what you should know about compounded medicines. 

What is compounded medicine?
A compounded medicine is created by a licensed pharmacist or other healthcare professional by mixing or altering the ingredients of a drug to create a customized medication for an individual. 

Someone may be prescribed a compounded drug if they need the active ingredients of a medicine, but can’t take it in its approved form for a specific reason, including:

  • Customizing the dosage or strength of a medication
  • Removing a medically unnecessary ingredient that can cause allergies, such as gluten or dye
  • Changing the form of a medicine, such as from a solid tablet to a liquid. 

Additionally, when specific FDA-approved drugs are in shortage, compounding pharmacies are allowed by the FDA to produce compounded versions under special laws and special conditions. This helps people who need access to those medications continue to get access. 

They are intended to be essentially the same as their FDA-approved counterparts. But, by their very nature, they’re not—compounded drugs are not FDA-approved. 

Are compounded drugs (and pharmacies) regulated?
Compounded drugs do not specifically go through the formal FDA approval process for new or generic drugs. While that means that FDA employees don’t personally test each compounded medicine for efficacy and safety, they do have some oversight of the facilities in which they're made.

Two main types of pharmacies make compounded medications: state-licensed compounding pharmacies and outsourcing pharmacies registered with the FDA. State boards of pharmacy lead day-to-day oversight of state-licensed pharmacies, while the FDA can assist with surveillance and inspections upon request. The FDA directly oversees outsourcing pharmacies.

There is a possibility someone taking a compounded version of a medication may experience less efficacy, different side effects, or different dosing. Someone who takes compounded medicines may also be required to self-dose, which means it's on them to measure the correct amount of medicine into a syringe. All of this adds another layer of risk to the patient.

There have been incidents where people have died or gotten ill after taking contaminated compounded drugs. Specifically with compounded weight loss medication injections, emergency calls for potential poisonings or overdoses increased by nearly 500% from the year before (159 in 2024 vs 32 in 2023).

Compounded weight loss medicines are not for everyone
Something that you may not think of when deciding on a weight loss medication with your healthcare provider is how often, if at all, the medication is in shortage. That may put you in a position in which you’re bouncing between a branded medication and a compounded version of it.

CONTRAVE is FDA-approved, not in shortage, and available by talking to a healthcare provider in person or online. Learn more about branded CONTRAVE (and how to check if yours is the real deal).

 

CON-2169-001 08/24
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Important Safety Information
What is CONTRAVE?
See More 

CONTRAVE can cause serious side effects including:

Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.

CONTRAVE is a prescription weight-loss medicine that may help some adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.

Important Safety Information
See More
CONTRAVE can cause serious side effects including:
Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.
What is CONTRAVE?
See More
CONTRAVE 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:
Important Safety Information
What is CONTRAVE?
See Less 

CONTRAVE can cause serious side effects including:

Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.

While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes.

Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping.

CONTRAVE is not approved for use in children under the age of 18.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti‐seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE.

Tell your healthcare provider about all of your medical conditions, including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CONTRAVE may cause serious side effects, including:

  • Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away.

  • Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death.

    Get emergency medical help right away if you take opioids and you:

    • have trouble breathing

    • become very drowsy with slowed breathing

    • have slow, shallow breathing

    • feel faint, very dizzy, confused, or have unusual symptoms

  • Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid, including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.

  • Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.

  • Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE.

  • Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.

  • Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.

  • Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle‐closure glaucoma and to get treatment to prevent it if you are at risk.

  • Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE.

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is CONTRAVE?

CONTRAVE is a prescription weight-loss medicine that may help some adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.

CONTRAVE should be used with a reduced-calorie diet and increased physical activity.

It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke.

It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products.

CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation).

Please see Full Prescribing Information, including Medication Guide, for CONTRAVE.