FDA-Approved Weight Loss Drugs: 8 Options
Key Takeaways:
The Food and Drug Administration (FDA) has approved some medications for weight loss. If a medication is FDA-approved, it means the FDA has determined it’s safe and effective for a certain use.
FDA-approved weight loss drugs are usually approved for people with obesity or overweight with a weight-related health condition.
Here are some of your options.
Wegovy ® contains the active ingredient semaglutide, a glucagon-like peptide-1 ( GLP-1 ) receptor agonist. The once-weekly injection works by:
These changes can help you eat more whole foods and minimize overeating, promoting weight loss.
Wegovy ® is FDA-approved for weight loss and long-term weight management in people with obesity or overweight with a weight-related condition, like:
Wegovy ® — like many FDA-approved weight loss drugs — is prescribed alongside eating more nutritious foods and doing more physical activity to promote weight loss. It’s also designed with long-term use in mind, so you may be able to take the medication to maintain a healthy body weight in the long run.
Effectiveness: Research shows that taking Wegovy ® and making lifestyle changes for 68 weeks leads to an average weight loss of almost 15 percent.
Side effects:
Common side effects of Wegovy ® include:
How to use: Once-weekly injection.
Zepbound ® contains the active ingredient tirzepatide, a GLP-1 receptor agonist and a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist.
It’s FDA-approved for weight loss and chronic weight management in people with obesity or overweight who have a weight-related health condition. The medication works by suppressing your appetite and making you feel fuller.
It might be more effective than semaglutide. One study found that people taking semaglutide for 72 weeks lost an average of almost 14 percent of their body weight. People taking tirzepatide for 72 weeks lost an average of about 20 percent.
Effectiveness: People taking 15 milligrams (mg) of Zepbound ® and making lifestyle changes lost an average of almost 21 percent of their body weight over 72 weeks.
Zepbound ® side effects include:
Saxenda ® contains the active ingredient liraglutide, another GLP-1. Again, it works by reducing your appetite and making you feel fuller, helping you eat more whole foods and the right portion sizes.
It’s FDA-approved for weight reduction in people 12 and older with a body weight greater than 60 kilograms (about 132 pounds) and obesity, or adults with overweight and a weight-related condition.
Liraglutide might not be as effective as semaglutide or tirzepatide. One review of studies found that 2.4 mg of semaglutide led to about 27.5 pounds of weight loss compared to 3 mg of liraglutide, which led to roughly 11.5 pounds of weight loss.
Effectiveness:
One study found that taking Saxenda ® for a year led to losing about 15 pounds more than a placebo group. Saxenda ® was even more effective when combined with exercise. Participants who exercised and took Saxenda ® lost about 6 additional pounds.
Saxenda ® side effects include:
How to use: Daily injection.
→ Compare the two: Saxenda ® vs. Wegovy ®
Qsymia is a pill FDA-approved for weight loss in people with obesity or overweight who have a weight-related health condition.
It contains two medications: topiramate and phentermine. When combined, these medications work to reduce appetite and increase fullness.
One study found that people taking Qsymia and making lifestyle changes for 28 weeks lost about 20 pounds.
Qsymia side effects include:
How to use: Daily pill taken in the morning.
Xenical contains the active ingredient orlistat, a lipase inhibitor. It works by reducing how much fat your body absorbs from foods.
The medication is FDA-approved for weight loss and weight maintenance in people with a body mass index (BMI) of 30 or more or 27 or higher with a weight-related condition. It’s also FDA-approved to help prevent weight regain after prior weight loss.
Clinical trials show that people taking Xenical for a year lost an average of about 13 pounds.
Xenical side effects include:
How to use: Take three times a day with a meal containing fat or up to one hour after the meal.
→ Find out your BMI: The Hims BMI Calculator
Alli also contains orlistat, but it’s available over the counter (OTC) in a lower dose than Xenical.
It’s FDA-approved for weight loss in adults when used alongside eating a reduced-calorie, low-fat diet.
Alli’s prescribing information states that for every 5 pounds you lose from diet alone, Alli can help you lose an extra 2 to 3 pounds. Most people lose 5 to 10 pounds over 6 months on Alli.
Side effects of Alli include:
How to use: Take three times a day with each main meal containing fat.
Adipex-P contains the active ingredient phentermine, which works by suppressing your appetite.
This medication is FDA-approved for people with a BMI of 30 or more or 27 or more with a weight-related condition. It’s used as a short-term weight loss treatment because there’s a risk of dependency.
A healthcare provider might prescribe it for 3 to 6 weeks , depending on how your body responds to the medication.
People taking 15 mg of phentermine lost about 13 pounds over 28 weeks.
Adipex-P tablets and capsules contain 37.5 mg of phentermine.
Side effects of Adipex-P include:
How to use: Daily pill taken before breakfast or 1 to 2 hours after breakfast. In some cases, a healthcare provider might prescribe half a tablet twice a day.
Imcivree contains the active ingredient setmelanotide. It’s a melanocortin-4 receptor (MC4R) agonist, meaning it acts on melanocortin-4 receptors in your brain, which are involved in regulating hunger and fullness.
This medication is for people with obesity caused by genetic disorders. It’s FDA-approved for weight loss and weight maintenance in adults and kids ages 2 and above with obesity due to :
One clinical trial found that people with Bardet-Biedl syndrome taking Imcivree for 52 weeks lost an average of about 8 percent of their starting BMI.
Imcivree side effects include:
→ Learn more: Does Weight Loss Medication Work?
- FDA-approved weight loss medications include injections (Wegovy ® , Zepbound ® , etc.) and pills, like Qsymia ® and Xenical ® .
- Most weight loss drugs are FDA-approved for people with obesity or overweight with a weight-related health condition.
- A healthcare provider can help you find the best weight loss medication for you.
- Suppressing appetite
- Reducing food cravings
- Making you feel fuller
- Type 2 diabetes
- Sleep apnea
- Heart disease
- High cholesterol (dyslipidemia)
- High blood pressure (hypertension)
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Abdominal pain
- Dizziness
- Insomnia
- Dry mouth
- Tingling
- Fatty or oily stools
- Gas with discharge
- Increased bowel movements
- Needing to poop urgently
- Gas with oily spotting
- Loose stools
- More frequent bowel movements that are hard to control
- Restlessness
- High blood pressure in the lungs (primary pulmonary hypertension)
- Bardet-Biedl syndrome (BBS)
- Pro-opiomelanocortin (POMC) deficiency
- Proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency
- Leptin receptor (LepR) deficiency
- Headache
- Depression
- Spontaneous erections
- Injection site reactions
1. Wegovy ®
Wegovy ® contains the active ingredient semaglutide, a glucagon-like peptide-1 ( GLP-1 ) receptor agonist. The once-weekly injection works by:
These changes can help you eat more whole foods and minimize overeating, promoting weight loss.
Wegovy ® is FDA-approved for weight loss and long-term weight management in people with obesity or overweight with a weight-related condition, like:
Wegovy ® — like many FDA-approved weight loss drugs — is prescribed alongside eating more nutritious foods and doing more physical activity to promote weight loss. It’s also designed with long-term use in mind, so you may be able to take the medication to maintain a healthy body weight in the long run.
Effectiveness: Research shows that taking Wegovy ® and making lifestyle changes for 68 weeks leads to an average weight loss of almost 15 percent.
Side effects:
Common side effects of Wegovy ® include:
How to use: Once-weekly injection.
- Suppressing appetite
- Reducing food cravings
- Making you feel fuller
- Type 2 diabetes
- Sleep apnea
- Heart disease
- High cholesterol (dyslipidemia)
- High blood pressure (hypertension)
- Nausea
- Vomiting
- Constipation
- Diarrhea
- Abdominal pain
2. Zepbound ®
Zepbound ® contains the active ingredient tirzepatide, a GLP-1 receptor agonist and a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist.
It’s FDA-approved for weight loss and chronic weight management in people with obesity or overweight who have a weight-related health condition. The medication works by suppressing your appetite and making you feel fuller.
It might be more effective than semaglutide. One study found that people taking semaglutide for 72 weeks lost an average of almost 14 percent of their body weight. People taking tirzepatide for 72 weeks lost an average of about 20 percent.
Effectiveness: People taking 15 milligrams (mg) of Zepbound ® and making lifestyle changes lost an average of almost 21 percent of their body weight over 72 weeks.
Side effects:
Zepbound ® side effects include:
How to use: Once-weekly injection.
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
3. Saxenda ®
Saxenda ® contains the active ingredient liraglutide, another GLP-1. Again, it works by reducing your appetite and making you feel fuller, helping you eat more whole foods and the right portion sizes.
It’s FDA-approved for weight reduction in people 12 and older with a body weight greater than 60 kilograms (about 132 pounds) and obesity, or adults with overweight and a weight-related condition.
Liraglutide might not be as effective as semaglutide or tirzepatide. One review of studies found that 2.4 mg of semaglutide led to about 27.5 pounds of weight loss compared to 3 mg of liraglutide, which led to roughly 11.5 pounds of weight loss.
Effectiveness:
One study found that taking Saxenda ® for a year led to losing about 15 pounds more than a placebo group. Saxenda ® was even more effective when combined with exercise. Participants who exercised and took Saxenda ® lost about 6 additional pounds.
Side effects:
Saxenda ® side effects include:
How to use: Daily injection.
→ Compare the two: Saxenda ® vs. Wegovy ®
- Nausea
- Vomiting
- Constipation
- Diarrhea
4. Qsymia
Qsymia is a pill FDA-approved for weight loss in people with obesity or overweight who have a weight-related health condition.
It contains two medications: topiramate and phentermine. When combined, these medications work to reduce appetite and increase fullness.
Effectiveness:
One study found that people taking Qsymia and making lifestyle changes for 28 weeks lost about 20 pounds.
Side effects:
Qsymia side effects include:
How to use: Daily pill taken in the morning.
- Dizziness
- Insomnia
- Constipation
- Dry mouth
- Tingling
5. Xenical
Xenical contains the active ingredient orlistat, a lipase inhibitor. It works by reducing how much fat your body absorbs from foods.
The medication is FDA-approved for weight loss and weight maintenance in people with a body mass index (BMI) of 30 or more or 27 or higher with a weight-related condition. It’s also FDA-approved to help prevent weight regain after prior weight loss.
Effectiveness:
Clinical trials show that people taking Xenical for a year lost an average of about 13 pounds.
Side effects:
Xenical side effects include:
How to use: Take three times a day with a meal containing fat or up to one hour after the meal.
→ Find out your BMI: The Hims BMI Calculator
- Fatty or oily stools
- Gas with discharge
- Increased bowel movements
- Needing to poop urgently
6. Alli
Alli also contains orlistat, but it’s available over the counter (OTC) in a lower dose than Xenical.
It’s FDA-approved for weight loss in adults when used alongside eating a reduced-calorie, low-fat diet.
Effectiveness:
Alli’s prescribing information states that for every 5 pounds you lose from diet alone, Alli can help you lose an extra 2 to 3 pounds. Most people lose 5 to 10 pounds over 6 months on Alli.
Side effects:
Side effects of Alli include:
How to use: Take three times a day with each main meal containing fat.
- Gas with oily spotting
- Loose stools
- More frequent bowel movements that are hard to control
7. Adipex-P
Adipex-P contains the active ingredient phentermine, which works by suppressing your appetite.
This medication is FDA-approved for people with a BMI of 30 or more or 27 or more with a weight-related condition. It’s used as a short-term weight loss treatment because there’s a risk of dependency.
A healthcare provider might prescribe it for 3 to 6 weeks , depending on how your body responds to the medication.
Effectiveness:
People taking 15 mg of phentermine lost about 13 pounds over 28 weeks.
Adipex-P tablets and capsules contain 37.5 mg of phentermine.
Side effects:
Side effects of Adipex-P include:
How to use: Daily pill taken before breakfast or 1 to 2 hours after breakfast. In some cases, a healthcare provider might prescribe half a tablet twice a day.
- Restlessness
- Dizziness
- Insomnia
- Dry mouth
- Diarrhea
- Constipation
- High blood pressure in the lungs (primary pulmonary hypertension)
8. Imcivree
Imcivree contains the active ingredient setmelanotide. It’s a melanocortin-4 receptor (MC4R) agonist, meaning it acts on melanocortin-4 receptors in your brain, which are involved in regulating hunger and fullness.
This medication is for people with obesity caused by genetic disorders. It’s FDA-approved for weight loss and weight maintenance in adults and kids ages 2 and above with obesity due to :
Effectiveness:
One clinical trial found that people with Bardet-Biedl syndrome taking Imcivree for 52 weeks lost an average of about 8 percent of their starting BMI.
Side effects:
Imcivree side effects include:
How to use: Daily injection.
→ Learn more: Does Weight Loss Medication Work?
- Bardet-Biedl syndrome (BBS)
- Pro-opiomelanocortin (POMC) deficiency
- Proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency
- Leptin receptor (LepR) deficiency
- Nausea
- Headache
- Diarrhea
- Abdominal pain
- Vomiting
- Depression
- Spontaneous erections
- Injection site reactions
FDA-Approved Weight Loss Drugs: Final Thoughts
If you’re looking for FDA-approved weight loss drugs , you’re not short on options.
Here’s a final rundown of what you need to know:
A healthcare provider can help you find the best FDA-approved weight loss drug for you.
In some cases, your provider may recommend a medication FDA-approved for another condition, like diabetes, but prescribed off-label for weight loss — such as Ozempic ® and Mounjaro ® . But there are plenty of FDA-approved weight loss drugs if you’d prefer to stick to those.
- There are FDA-approved weight loss injections. Those include Wegovy ® , Zepbound ® , and Saxenda ® .
- There are FDA-approved weight loss pills. These include Qsymia, Xenical, Alli, Adipex-P, and Imcivree.
- The best weight loss medication for you depends on many factors. Your weight, goals, current health problems, and personal preference for injectable medications vs. pills all come into play when determining the best obesity treatment.
FAQs
Get answers to frequently asked questions about weight loss drugs FDA-approved for obesity and overweight.
What is the best over-the-counter weight loss pill that’s FDA-approved?
The best over-the-counter weight loss pill that’s FDA-approved is Alli — in fact, it’s the only one. Alli works by reducing the amount of fat your body absorbs from foods. A pharmacist can make sure it’s right for you.
What are the criteria for weight loss drugs?
The criteria for weight loss drugs vary from medication to medication. For the most part, you need to have obesity or overweight with a weight-related condition — like high blood pressure or high cholesterol — to qualify for a weight loss drug.
Are FDA-approved weight loss drugs covered by insurance?
FDA-approved weight loss drugs aren’t always covered by insurance. Many insurance providers don’t offer coverage for weight loss drugs. If they do, you’ll likely need a BMI above a specific number or a medical condition to get coverage.
→ Learn more: Are Weight Loss Drugs Covered by Insurance?
What weight loss drugs are FDA-approved?
Weight loss drugs that are FDA-approved include:
→ Read next: Diabetes Medications for Weight Loss
This article is for informational purposes only and does not constitute medical advice. The information contained herein is not a substitute for and should never be relied upon for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment. Learn more about our editorial standards .
18 Sources
Hims & Hers has strict sourcing guidelines to ensure our content is accurate and current. We rely on peer-reviewed studies, academic research institutions, and medical associations. We strive to use primary sources and refrain from using tertiary references. See a mistake? Let us know at blog@forsaluvia.co !
- Wegovy ®
- Zepbound ®
- Saxenda ®
- Qsymia
- Xenical
- Alli
- Adipex-P
- Imcivree
- Adipex-P (phentermine hydrochloride USP) CIV for oral use. (2012). https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf
- Alli orlistat 60 mg capsules weight loss aid, 90 capsules starter pack. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021887lbl.pdf
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- Aronne LJ, et al. (2013). Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. https://onlinelibrary.wiley.com/doi/10.1002/oby.20584
- Aronne LJ, et al. (2025). Tirzepatide as compared with semaglutide for the treatment of obesity. https://www.nejm.org/doi/full/10.1056/NEJMoa2416394
- Bansal AB, et al. (2024). Orlistat. https://www.ncbi.nlm.nih.gov/books/NBK542202/
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- Qsymia (phentermine and topiramate extended-release capsules), for oral use, CIV. (2024). https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022580s025lbl.pdf
- Saxenda® (liraglutide) injection, for subcutaneous use. (2025). https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206321s022lbl.pdf
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- Wilding JPH, et al. (2021). Once-weekly semaglutide in adults with overweight or obesity. https://www.nejm.org/doi/10.1056/NEJMoa2032183
- Xenical (orlistat) capsules, for oral use. (2022). https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf
- Xie Z, et al. (2022). Efficacy and safety of liraglutide and semaglutide on weight loss in people with obesity or overweight: A systematic review. https://www.tandfonline.com/doi/full/10.2147/CLEP.S391819
- Zepbound® (tirzepatide) injection, for subcutaneous use. (2025). https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217806s031lbl.pdf