Are OTC Statins Available? Not Yet, But They Could Be Soon
Key takeaways:
Statins are a group of first-choice medications that treat high cholesterol. They’re currently only available with a prescription. But the makers of Crestor (rosuvastatin) are looking into making a low-dose version available over the counter (OTC).
Many people who could benefit from a statin aren’t currently taking one. An OTC statin option could help improve access to these life-saving medications.
Statins are generally safe medications but there are risks to consider. Guidance on using statins safely will still be needed for them to become available OTC.
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Table of contents
Expert guidelines on taking statins, a group of first-choice medications for managing high cholesterol, have changed over the years. In 2022, for example, experts changed the criteria for when prescribers should start their patients on a statin for the first time. But one thing has stayed the same: Many people who could benefit from statins don’t take them.
To help improve access to these treatments, efforts are underway to make statins available over the counter (OTC). Here, we’ll cover safety concerns and discuss when we might see the first OTC statins on pharmacy shelves.
Are statins available over the counter?
No, not at this time. But AstraZeneca, the maker of Crestor (rosuvastatin), may seek FDA approval for an OTC version of Crestor in the near future. This OTC version would likely be limited to a low-dose (5 mg) pill for adults. In contrast, prescription Crestor comes in doses up to 40 mg and is also approved for use in children.
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Approving an OTC statin would help improve access to it. Researchers estimate that less than half of people who are eligible for a statin are taking one. Additional research points to disparities in statin use. Among people with similar heart risk factors, women and people who are Black or Hispanic are less likely to be prescribed statins.
The underuse of statins is a big deal. Statins have a proven track record of not just lowering cholesterol, but lowering the risk of heart attacks, strokes, and even overall deaths.
What needs to be done for the FDA to approve an OTC statin?
In 2025, the FDA finalized new rules for approving OTC medications with “additional conditions.” If the FDA approves a medication in this way, the product’s label will need to alert people about the conditions required to purchase it. For instance, it may direct you to visit the product’s website to determine if the medication is OK for you to take. This new rule may boost an OTC statin’s chances of approval.
Statin manufacturers have previously tried getting FDA approval for OTC statins. But the FDA had concerns about people taking these medications inappropriately.
AstraZeneca is taking steps to address the FDA’s concerns about unsafe use of OTC statins. They sponsored a study to evaluate a web-based application that people could use to figure out if they should take low-dose Crestor. After entering basic information, such as age and medical history, the app gave one the following responses:
“OK to use”
“Ask a doctor”
“Do not use”
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Slightly more than 90% of participants used the app correctly to assess their need for a statin. The app asked questions based on the guidelines healthcare professionals use when prescribing a statin. Additionally, 98% of people who started Crestor took it correctly during the study.
If approved, an OTC statin would likely be kept “behind the counter.” This would ensure people are speaking with a pharmacist before being able to purchase it. And it would help prevent people from taking a statin if they don’t need one.
What are the risks and benefits of statins going OTC?
The primary benefit of statins going OTC is to help make them easily available to adults who need medication to lower cholesterol. Most statins, including low-dose Crestor, lower low-density lipoprotein (LDL, or “bad” cholesterol) by about 30% to 50%.
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Over time, too much LDL can cause artery-clogging plaque buildup. This can raise your risk of stroke and heart attack. Research suggests that statins can lower the risk of heart events by 25% and decrease the risk of death by 10%.
There are possible downsides and risks to consider if statins become available OTC, including:
People may take statins when they don’t need or shouldn’t take them.
Low-dose OTC statins may not be a high enough dose to manage high cholesterol for some people.
People may not have a healthcare professional’s guidance on drug interactions and side effects.
OTC statins could cost more for some people than prescription versions.
Getting statins without a medical visit could mean that other health issues and routine screenings are being overlooked.
There may be language or cultural barriers that still prevent some people who need a statin from getting one.
Are statins safe?
Yes, statins are safe for most people to take. But there are cases where you shouldn’t take a statin, including if you’re pregnant, nursing, or have severe liver problems.
It’s common to experience side effects when taking a statin. Commonly reported ones include muscle pain, headache, and stomach-related discomfort. Most side effects are mild and get better on their own. Serious side effects include muscle, liver, or kidney damage, but these are very rare.
Some research shows statins can raise blood glucose (sugar). This can lead to (or worsen) Type 2 diabetes. But for most people, the benefit of treating high cholesterol outweighs the possibility of this risk.
What should you consider before starting an OTC statin?
If an OTC statin becomes available, you should first consider whether you need to take it. If your overall heart risks are low, you might be able to manage your cholesterol levels by making lifestyle changes, such as diet and exercise. It’s a good idea to speak with a pharmacist before starting an OTC statin. They can help you determine if you could benefit from taking one.
Before starting a statin, it’s also important to know:
Whether it interacts with your other medications or supplements
Whether you should avoid grapefruit juice while taking it
The best time of day to take it
What to do if you experience side effects
When to have your cholesterol levels rechecked
Each statin has differences that set it apart from others in its class. If an OTC statin becomes available, your pharmacist can provide you more detail about how to take it and manage interactions and side effects.
Are there any currently available OTC alternatives to prescription statins?
No, there are no OTC medications that could take the place of a statin. Some OTC medications and supplements, such as niacin or red yeast rice, may make small improvements to your cholesterol numbers. But these don’t lower cholesterol as much as statins and lifestyle changes can. And they have their own interactions and side effects to consider.
A small randomized, controlled trial compared low-dose Crestor with supplements touted for having positive effects on cholesterol. The tested supplements included:
Cinnamon
Fish oil
Garlic
Plant sterols
Turmeric
Red yeast rice
Crestor lowered LDL more than a placebo (a pill with no medication in it). But none of the supplements lowered LDL more than a placebo. Low-dose Crestor also lowered LDL more than any of the supplements.
Keep in mind that this study was small and only ran for about 1 month. It’s possible that if the study was larger or lasted longer, there may have been a cholesterol benefit for the supplements. But it’s clear these supplements aren’t on par with statins when it comes to lowering cholesterol.
The bottom line
Currently, statins aren’t available over the counter (OTC). But this could change in the future. The makers of Crestor (rosuvastatin) are exploring whether to develop an OTC version of this statin. Newer FDA rules may help provide a path for OTC statins to be approved. If an OTC statin is approved, it will likely be kept behind the pharmacy counter. And some type of screening process may be required for you to purchase it.
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References
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