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Drug Info

Is Ozempic a controlled substance?

Ozempic isn’t technically a controlled substance, but there are concerns about its misuse
By | Nov. 22, 2024
An autoinjector pen for a drug like Ozempic: Is Ozempic a controlled substance?

Key takeaways

  • Ozempic is the brand-name form of semaglutide that is approved for treatment of Type 2 diabetes and used off-label for help with weight loss.

  • Ozempic is not a controlled substance, as determined by the Food and Drug Administration and Drug Enforcement Administration (DEA).

  • The DEA stratifies controlled substances into five different listings or schedules based on their degree of abuse potential and risk for physical or psychological dependence.

  • Multiple other weight loss drugs, including phentermine, are listed as controlled substances due to the risk of abuse.

  • Although not a controlled substance, Ozempic does seem to have a potential for misuse, fueled by people’s desire to lose weight.

In this article:

Ozempic (semaglutide) has made its way into headlines and water-cooler conversations largely due to its off-label use for weight loss more than its approved use for Type 2 diabetes mellitus. The glucagon-like peptide-1 (GLP-1) receptor agonist helps the pancreas release insulin and lowers blood sugar. It also mimics the GLP-1 hormone that tells your brain you’re full. As a result, weight loss may occur. 

The effectiveness of semaglutide in assisting weight loss efforts has created intense demand for the product, often leaving it in short supply. The high demand status and off-label use may lead to questioning of whether Ozempic is a controlled substance or drug that can be abused. Fortunately, it is not a controlled substance, but it is wise to know why and understand the restrictions on Ozempic’s use. 

What does the FDA consider a controlled substance?

The Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) are the two agencies at the heart of controlled substance governance. The FDA approves prescription drugs for use and indicates what health conditions the drugs help. If a drug demonstrates the possibility of causing mental or physical dependence and abuse, it is labeled as a controlled substance.

Since not all controlled substances have an equal risk of dependence and abuse, the DEA assigns each to a Schedule from I to V, with drugs on Schedule I having the highest abuse potential and Schedule V the least among controlled substances. 

  • Schedule I: These include drugs with no medically accepted use and a high risk of abuse, like ecstasy and heroin.
  • Schedule II: These include drugs with a high potential for abuse and severe dependence, including most opioid pain-relievers and stimulants for attention deficit hyperactivity disorder (ADHD). Cocaine, oxycodone, and Adderall (dextroamphetamine and amphetamine) are some of the members of this group.
  • Schedule III: These are drugs with a moderate to low potential for physical and psychological dependence. Examples include ketamine and testosterone.
  • Schedule IV: These are drugs with a low potential for abuse and a low risk of dependence. Examples include benzodiazepines like Xanax (alprazolam) and Ativan (lorazepam), as well as sedative-hypnotics like Ambien (zolpidem). 
  • Schedule V: These drugs have a lower potential for abuse than Schedule IV drugs. Examples include the antidiarrheal Lomotil (diphenoxylate and atropine) and nerve pain medication Lyrica (pregabalin).

Is Ozempic a controlled substance?

Ozempic is not a controlled substance. Abuse potential and physical or psychological dependence have not been demonstrated with Ozempic. Although it’s not labeled as a controlled substance or assigned to a schedule by the DEA, that doesn’t mean that there are no concerns of risk with its use. For instance, Ozempic is to be avoided by anyone with a history of pancreatitis or a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 syndrome (MEN2). The latter is actually the subject of a boxed warning on Ozempic’s label.

Weight loss drugs that are controlled substances

Unlike Ozempic, there are weight loss drugs listed by the DEA as having the potential for abuse. Specifically, central nervous system (CNS) stimulants (also called sympathomimetics) are used for weight management and are similar to amphetamines. Most are more affordable than Ozempic, and this has kept them in use. 

CNS stimulants suppress appetite and are approved for short-term use up to 12 weeks to assist with obesity treatment. In addition, their stimulation of the sympathetic nervous system can lead to increases in heart rate and blood pressure, which is why those with heart disease, a history of heart attack, or uncontrolled hypertension do not use these options. Controlled substance weight loss drugs include the following:

  • Adipex-P (phentermine): Listed as a Schedule IV drug by the DEA, phentermine remains a commonly prescribed weight loss treatment, but it is only approved for three months of use and has contraindications to its use that center around its abuse potential and cardiovascular risk.
  • Diethylpropion: The DEA also puts diethylpropion on Schedule IV, indicating some abuse potential, and the same contraindications as Adipex-P apply.
  • Benzphetamine: Having a higher abuse potential than the others, benzphetamine is classified as a Schedule III drug. It is labeled with similar warnings to Adipex-P and diethylpropion.
  • Phendimetrazine: Another Schedule III drug, phendimetrazine has the same contraindications and time constraints as the others listed above.
  • Qsymia (phentermine and topiramate): Combining the anticonvulsant topiramate, which has an appetite-suppressing effect, and the stimulant phentermine, Qsymia is FDA approved for chronic weight management. It lands on Schedule IV due to its phentermine component and has warnings about use in the setting of cardiovascular disease, in addition to concerns about topiramate side effects that include drowsiness, changes in sensation, and kidney stones.

Is there any risk for semaglutide misuse?

Semaglutide, under its brand names Ozempic and Wegovy, is not a controlled substance. Nonetheless, it can be misused. The desire to lose weight can drive people to use GLP-1 receptor agonists in an unapproved fashion, such as when they do not meet the FDA’s indications for use. For example, the FDA indication for Wegovy use for weight management is a body mass index (BMI) of at least 30 or a BMI of at least 27 with at least one weight-related comorbidity, such as hypertension or high cholesterol.

A study looking at markers of misuse found that semaglutide seems prone to it. Compounded versions of semaglutide are also of concern to the FDA for both legal and safety reasons. Compound versions are typically only permitted by law when there are official drug shortages. Otherwise, it is considered patent infringement. Besides legality concerns, compound medication also entails the risk of improper manufacturing by whichever entity is making the drug. 

Cases of individuals getting counterfeit semaglutide without a prescription have also been reported. Without medically supervised health care, the drug’s dangers could escalate. Users must be aware of risks like pancreatitis, thyroid cancer, gallbladder attacks, and intestinal complications.

We can expect more investigation into the degree of misuse or abuse potential with Ozempic. 

If you’re concerned about Ozempic misuse but want to know your weight loss options, a healthcare professional can help you explore your medical options and establish a concurrent diet and exercise plan.