Is Tadalafil a Controlled Substance?

Tadalafil is a prescription medication belonging to the phosphodiesterase type 5 (PDE5) inhibitors. This medication is most often used to treat erectile dysfunction, but it is also used to treat benign prostatic hyperplasia (enlarged prostate) or pulmonary artery hypertension. Tadalafil relaxes smooth muscles and increases blood flow, which can result in an erection in response to sexual stimulation. Tadalafil offers flexible dosing and can be used daily or as needed, depending on the indication. Is tadalafil a controlled substance? This medication carries a low risk for abuse or dependence, and, though it requires a prescription, it is not a controlled substance.

What Is Tadalafil?

Tadalafil is a prescription-only medication that belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. This medication is most commonly known for its use in treating erectile dysfunction, but it also treats other medical conditions, including benign prostatic hyperplasia and pulmonary artery hypertension. Tadalafil comes in several doses and is marketed under different brand names, including Cialis and Adcirca.

How Does Tadalafil Work?

Tadalafil works by blocking the phosphodiesterase type 5 (PDE5) enzyme. This enzyme can be found in multiple tissues throughout the body, including a part of the penis known as the corpus cavernosum. Blocking the PDE5 enzyme allows certain smooth muscles in the body to relax and increases blood flow. In the penis, the increased blood flow leads to an erection in response to sexual stimulation.

What Is Tadalafil Used for?

Tadalafil is approved by the Food and Drug Administration (FDA) for erectile dysfunction, benign prostatic hyperplasia, and pulmonary artery hypertension. Erectile dysfunction is the inability to get or maintain an erection that is strong enough to achieve sexual performance. Tadalafil is a popular medication for erectile dysfunction because it is long-acting and doesn’t have a lot of unfavorable side effects. Tadalafil can also be taken as a low-dose daily medication (2.5mg-5mg) or as a higher-dose (10mg-20mg) as-needed medication for erectile dysfunction, which gives it the advantage of allowing for more spontaneous sexual encounters. Benign prostatic hyperplasia is often called an enlarged prostate. This condition can cause difficulty urinating, a weak urinary stream, frequent urination, and excessive urination at night. 

When used to treat benign prostatic hyperplasia, tadalafil is usually given as a daily dose (2.5mg-5mg). Its effects on the phosphodiesterase type 5 enzyme relax the prostate and bladder muscles, making urination easier and reducing symptoms. Tadalafil is unique among the PDE5 inhibitors in that it is the only medicine in the class approved to treat benign prostatic hyperplasia. Pulmonary artery hypertension is a condition characterized by elevated blood pressure in the pulmonary arteries. This condition can be serious and even life-threatening. Pulmonary artery hypertension can cause right heart strain or right heart failure. It usually causes shortness of breath, especially with exercise. When used to treat pulmonary arterial hypertension, tadalafil is usually taken at higher daily doses (20-40mg). The medication relaxes the blood vessels, lowers blood pressure in the pulmonary arteries, and may improve exercise tolerance. Tadalafil is sometimes used off-label for other indications such as Raynaud’s phenomenon and other cardiovascular disorders, but it is not approved by the FDA for these uses. You should only take it under your healthcare provider's advice.

How Quickly Does Tadalafil Work?

Tadalafil works pretty quickly. It usually takes around 30 to 60 minutes to work, but in some cases, it may start working as soon as 16 minutes. The drug's concentration in the bloodstream usually reaches its peak around 2 hours after taking the medication. Lower doses of tadalafil may take 3-5 days to reach a steady level in the bloodstream. For pulmonary artery hypertension, improvement in pulmonary artery blood pressures is usually seen by 16 weeks. Tadalafil is not impacted by food, which gives it an advantage over some of the other medications in the class. The long duration of action, as well as the flexibility with dosing, makes it a good choice for many people who have erectile dysfunction.

How Long Does Tadalafil Last?

Tadalafil has earned the nickname “the weekend pill.” This is because it has a long half-life, lasting up to 36 hours. The duration of tadalafil's effect can vary due to factors such as age and underlying health conditions. Because of its long duration of action, tadalafil should not be taken more often than prescribed by your healthcare provider. You should also talk to your healthcare provider about all of your medications and health conditions because tadalafil may not be safe for everyone.

What Are the Side Effects of Tadalafil?

Like any medication, tadalafil may have side effects. In addition to lowering blood pressure in the lungs, tadalafil may also lower blood pressure in other parts of the body. This can lead to dizziness and other symptoms. If you take blood pressure medication, check with your healthcare provider about whether you should monitor your blood pressure while taking it. Other common side effects of tadalafil include:

• Headaches
• Heartburn and indigestion
• Abdominal pain
• Back pain and muscle aches
• Nasal congestion
• Flushing

Tadalafil may also be associated with more serious side effects. Some of these include:

• Hearing loss
• Vision changes
• Dizziness
• Low blood pressure
• Rash or hives
• Swelling of the lips, tongue, or throat
• Difficulty breathing
• Pain in the arms or legs
• A prolonged erection lasting more than 4 hours (priapism)

If you experience serious side effects from tadalafil, you should talk to a healthcare provider or seek emergency medical attention. Tadalafil shouldn’t be used with certain medications due to the increased risk of side effects.

Is Tadalafil a Controlled Substance?

Tadalafil requires a prescription, but is tadalafil a controlled substance? In short, no.

What Is a Controlled Substance?

A controlled substance designates any medication, drug, or chemical that is regulated by the government. For a controlled substance, the manufacture, possession, and use are all regulated. This is usually because the drug has the potential for abuse, harm, dependency, or addiction. Controlled substances are regulated to try to protect the safety and health of the public in order to prevent addiction or misuse of the drugs. Controlled substances are generally categorized into classes based on the level of regulation they require, their potential for abuse and danger, and their legitimate medical uses. The United States schedules these substances into five categories under the Controlled Substances Act.

• Schedule I: These substances have no accepted medical use and are considered to have a high potential for abuse and dependency. This includes drugs such as heroin and ecstasy.
• Schedule II: These substances have acceptable medical uses, but they require strict regulation due to their high potential for abuse and dependency. This often includes pain medications such as morphine or oxycodone, or stimulants such as amphetamines
• Schedule III: These substances still have a risk of physical or psychological dependence and may be abused, but the risk is lower. Anabolic steroids and medications that contain codeine fall into this category
• Schedule IV: These drugs have a lower potential for abuse than Schedule III substances, but are still a risk. Anxiety medications such as diazepam or alprazolam are in this group
• Schedule V: These substances have the lowest potential for abuse but are not free of risk. Medications such as pregabalin fall into this group.

Other countries may have different regulations and classifications for substances they consider risky. Controlled substances often have limits on how many refills can be prescribed as well as how long refills last. They may also have requirements on recordkeeping, and healthcare providers that prescribe controlled substances may be subject to certain requirements. The regulations on controlled substances are typically monitored by the Drug Enforcement Administration (DEA) in the United States. Not all prescriptions are controlled substances. Only medications that have been determined to be a risk for abuse or dependency require additional oversight. Some controlled substances have no accepted medical use and are illegal to manufacture, possess, or distribute. These substances may be allowed in very limited research settings.

Why Is It Necessary for a Drug to Be Labeled a Controlled Substance?

Controlled substances have to meet specific criteria. They have been scientifically or legally determined to have the potential to pose a risk to the general public. The risk may be due to being highly likely to cause physical or psychological dependence, having the potential to be misused, or being potentially abused. Medications that are labeled as controlled substances have been shown to potentially be abused or misused, or they may cause physical or psychological dependence. Dependence means that you may develop withdrawal symptoms if you stop using the substance. Abuse describes the intentional use of the substance in a way that was not intended. This is usually because the substance has some psychological or physiological benefit. Another factor in whether a substance is scheduled is whether it has legitimate accepted medical uses. If a substance has a high potential for abuse and no legitimate medical use, it is generally categorized as Schedule I. These are often illegal to manufacture, prescribe, or have in your possession except under very restricted approved research settings.

How Is Tadalafil Currently Classified?

The United States classifies drugs as either controlled or prescription. All controlled substances with legitimate medical uses require a prescription. However, not all prescription medications are classified as controlled substances. As previously mentioned, controlled substances are classified as categories I-V depending on their risk of abuse and legitimate medical uses. Tadalafil does not fall into any of the controlled substance categories. The medication does require a prescription from a licensed healthcare provider, but it is not regulated by the DEA. It is regulated by the FDA, which has approved it for erectile dysfunction, benign prostatic hyperplasia, and pulmonary artery hypertension. Tadalafil doesn’t have a significant potential for abuse, dependence, or misuse. Internationally, tadalafil is classified similarly to how it is in the United States. Most countries classify tadalafil as prescription-only, rather than as a scheduled or more tightly regulated substance.

The Legal Status of Tadalafil

Almost every country has tadalafil legally classified as a prescription-only medication. This means that to legally obtain and use tadalafil, you must have a valid prescription written by a licensed healthcare provider. This is because, while tadalafil is a safe medication, it does have the potential for serious side effects that must be considered. A licensed healthcare provider is trained to evaluate whether tadalafil is medically appropriate for you and to monitor for potential interactions with other medications or health conditions in order to ensure it is safe for you to use. Whether you are considering the generic or the name-brand medication, you must have a valid prescription. In the United States, the decision to label tadalafil as prescription-only is determined by the Food and Drug Administration (FDA). The FDA is responsible for regulating the approval of medications, as well as their labeling, manufacturing, and marketing. They review studies on the safety and efficacy of medications to ensure that medications are safe before they go to market. Healthcare providers are required to consider the medical history, other medications, and appropriateness of tadalafil and other prescription medications before prescribing.

Pharmacies are legally permitted to dispense tadalafil only if they have received a valid prescription, either via approved electronic prescription portals or on paper. Most pharmacies have adopted electronic prescribing to prevent fraudulent prescriptions. The FDA approved tadalafil in November 2003 for the treatment of erectile dysfunction. Further studies led to its approval for pulmonary arterial hypertension in 2009. It was the second medication in the class approved for this use after sildenafil, which was approved in 2005. In 2011, tadalafil received approval for use as a treatment for benign prostatic hyperplasia after it was shown to be effective in reducing lower urinary tract symptoms such as urinary frequency and nighttime urination. It is the only medication in its class to be approved for the treatment of benign prostatic hyperplasia. Because it is not a controlled substance, tadalafil is not regulated by the United States Drug Enforcement Administration under the Controlled Substances Act. After careful review, tadalafil has not been found to lack a legitimate medical use. Additionally, tadalafil has not been demonstrated to have a significant potential for abuse, dependence, or addiction. Tadalafil has been evaluated in clinical studies and has been monitored after its market release, as other drugs are. There does not appear to be significant recreational misuse of the medication. Other countries have made similar determinations in their classification of tadalafil. Most countries in Europe and Asia have classified tadalafil as a prescription-only medication but not a controlled substance.

Online and International Pharmacies

There has been a significant increase in online and international pharmacies advertising cheaper medication costs. Many of these pharmacies are legitimate and operate within legal boundaries. These pharmacies typically offer telehealth consultations with licensed healthcare providers through virtual platforms. These healthcare providers evaluate the patient and then write a valid prescription. Other online platforms may dispense tadalafil illegally without a valid prescription. These organizations are generally not well-regulated, and the safety and authenticity of prescriptions through these platforms are not guaranteed. Use of these platforms is not recommended, as they may have adverse side effects or outcomes. Rising medical costs have also led people to seek prescriptions from international pharmacies. Obtaining tadalafil and other medications from overseas or international pharmacies can be risky, as the FDA prohibits importing medications for personal use except under specific circumstances.

FAQs

 

Is Cialis a controlled substance?

So is Cialis controlled? No, Cialis, the brand name for tadalafil, is not a controlled substance. It is regulated as a prescription-only medication, but it does not have the stricter regulations required by the Controlled Substances Act. Cialis has not been determined to have the increased potential for abuse, misuse, physical or psychological dependence, or addiction that would make it necessary to classify it as a controlled substance. Cialis can only be dispensed if you have a valid prescription from a licensed healthcare provider.

Is Viagra a controlled substance in the US?

Viagra is not a controlled substance, but does require a prescription. Viagra, the brand name for sildenafil, is another phosphodiesterase-5 inhibitor. Like tadalafil, Viagra is not a controlled substance in the United States. The Food and Drug Administration considers Viagra a prescription-only medication. It is not regulated under the stricter guidelines required by the Controlled Substances Act. Viagra has not been determined to carry the additional risk of abuse, dependence, or misuse that would make it considered a risk to public safety. In addition, Viagra has approved and accepted medical uses and a safety profile that has been determined to be acceptable. In order to obtain Viagra, you do have to have a valid prescription from a licensed healthcare provider, but it isn’t subject to the same restrictions on refills and oversight as controlled substances.

Can you buy tadalafil over the counter?

No, you cannot purchase tadalafil over the counter in the United States. To obtain the medication legally, you need a valid prescription from a licensed healthcare provider. While it may be tempting to order tadalafil from an online or international source, these sources often come without guarantees of quality, and you may not be able to determine whether what you receive is actually tadalafil. It's important to always get your tadalafil from a licensed pharmacy with a valid prescription to ensure that it is safe for you to use and that the dose is appropriate for your unique healthcare needs.

Is tadalafil safe to use?

Tadalafil is typically considered safe to use if prescribed by a licensed healthcare provider who has evaluated your unique health risks, conditions, and any other medications you may be taking. While most often used to treat erectile dysfunction, tadalafil may also be used to treat benign prostatic hyperplasia as well as pulmonary artery hypertension. Tadalafil may not be safe for people who have certain medical conditions, such as those who have recently had a heart attack or stroke, or people who have severe liver or kidney disease. Tadalafil may also not be safe for people taking certain medications, such as nitrates. It is important to tell your healthcare provider about all of your medications and health conditions to decrease the risk of serious side effects. Tadalafil can cause side effects such as headaches, flushing, stuffy nose, back pain, heartburn, indigestion, or muscle aches. These side effects are generally not serious. However, tadalafil also has serious potential side effects. If you experience vision changes, hearing changes, dizziness, low blood pressure, or a prolonged erection (priapism), you should seek advice from a healthcare provider immediately.

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Jillian Foglesong Stabile, MD FAAFP is a board-certified family physician. She practices full-scope family medicine in rural Eastern Washington state. Dr. Foglesong Stabile enjoys providing whole-life care ranging from prenatal care to hospice and end-of-life care.

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