Does Tadalafil Expire?

Most of us don’t spend much time worrying about how long our medications will last on our shelves, but most of us have, at some point, found a long-forgotten bottle in the back of our medicine shelves. It seems that costs keep rising, and it can be tempting to use those medications and ignore the date on the bottle. So, you’ve found a bottle of expired Cialis in the cabinet. Does tadalafil expire, or can you take it regardless of the use-by date? Let’s discuss what you need to know about tadalafil's shelf life and storage.

What Is Tadalafil?

Tadalafil belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. It is a prescription medication approved by the Food and Drug Administration (FDA) to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary artery hypertension.

The History of Tadalafil

The initial drug application for tadalafil was filed in 2000. In 2003, the medication was approved for the treatment of erectile dysfunction under the brand name Cialis. Due to the long half-life, tadalafil gained popularity as the “weekend drug” for erectile dysfunction.

In 2008, it received approval for once daily use for erectile dysfunction, allowing people more flexibility and spontaneity for sexual activity. In 2009, tadalafil received approval under the brand name Adcirca for the treatment of pulmonary arterial hypertension. In 2011, Cialis was approved for once daily use to treat benign prostatic hypertrophy.

How Does Tadalafil Work?

Tadalafil is most commonly used to treat erectile dysfunction, though it is also indicated to treat benign prostatic hyperplasia and pulmonary artery hypertension. It works by targeting how blood flows to the penis.

An erection typically occurs during sexual stimulation. The body accomplishes this by releasing a chemical called nitric oxide into the penis. This activates an enzyme called cyclic guanosine monophosphate (cGMP), which relaxes the smooth muscles lining the blood vessels in the penis, increasing blood flow and causing an erection.

The phosphodiesterase type 5 enzyme breaks down cGMP, which relaxes smooth muscles and ends the erection. Tadalafil and other phosphodiesterase type 5 inhibitors inhibit the phosphodiesterase type 5 enzyme, prolonging the action of cGMP. This means that there is more blood flow in the penis, and the erection may be firmer and last longer.

Tadalafil is a unique medication among phosphodiesterase type 5 inhibitors because it lasts longer than other medications in the class. It works for up to 36 hours, allowing more spontaneous sexual activity. Other medications in the class, such as Sildenafil, last around four to six hours.

How is Tadalafil Taken?

Tadalafil is taken orally and comes in doses ranging from 2.5mg to 40mg daily, depending on the reason for taking it. The exact dosage and how frequently tadalafil should be taken depend on whether it is taken for erectile dysfunction, benign prostatic hyperplasia, or pulmonary artery hypertension. For as-needed use, the medication is typically taken at 10 or 20mg at least 30 minutes before sexual activity.

Daily doses of tadalafil are generally 2.5 to 5mg daily for erectile dysfunction or benign prostatic hyperplasia. For people with pulmonary arterial hypertension, higher daily doses are generally used.

For people who have or anticipate having sex more frequently (twice a week or more), the daily dose of tadalafil may be preferred to the as-needed dose. This allows people to be more spontaneous in their sexual activity and may decrease side effects, though tadalafil is generally well-tolerated.

Another advantage of tadalafil is that it can be taken with or without food. Food does not significantly impact how tadalafil works or is absorbed by the body. Tadalafil should only be taken as directed by a healthcare provider. While it can be taken with or without food, tadalafil should not be taken with alcohol as it can increase the risk of side effects. Additionally, not all foods are safe for use with tadalafil. Some foods, such as grapefruit, can impact how tadalafil works.

What Are the Side Effects of Tadalafil?

Like all medications, tadalafil can cause side effects. Most of the side effects are mild and don’t affect the ability to use the medication. Some side effects can be more serious and warrant evaluation by a healthcare provider.

Tadalafil is associated with several potential side effects. The common side effects include:

• Headache
• Indigestion or heartburn
• Back pain
• Muscle pain
• Flushing
• Nasal congestion

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

• Prolonged erection (priapism)
• Low blood pressure
• Changes to vision
• Allergic reactions such as itching, swelling, or rash
• Pain in the arms or legs
• Trouble breathing

These side effects may be impacted by the expiration date of tadalafil. While tadalafil does not necessarily go bad, Cialis may lose effectiveness over time.

What Affects the Safety of Tadalafil?

Tadalafil can potentially interact with several medications. It can interact with certain types of food. Grapefruit is an example of a medication that can interfere with how tadalafil works and how likely it is to cause side effects. Grapefruit may also interfere with several other medications. This is because it contains compounds that can interfere with enzymes that metabolize medications in the intestines and liver. In fact, most of tadalafil’s medication interactions are related to this enzyme, the CYP3A4 enzyme.

Nitrates

You’ll often see warnings on phosphodiesterase type 5 inhibitors, including tadalafil, about not using them if you take nitrates. Nitrates are often used to treat heart conditions such as angina or coronary artery disease. Nitrates work by relaxing blood vessels, thereby improving blood flow to the heart. Because phosphodiesterase type 5 inhibitors also relax blood vessels (causing vasodilation), they can cause dangerous drops in blood pressure when taken together. For this reason, healthcare providers generally don’t recommend taking phosphodiesterase type 5 inhibitors if you take nitrates.

Other Phosphodiesterase Type 5 Inhibitors

It’s typically not recommended to use multiple types of phosphodiesterase type 5 inhibitors at the same time. Similar to nitrates, using multiple medications from the same class can increase the risk of side effects as well as potentially cause dangerous drops in blood pressure. Other medications in the phosphodiesterase type 5 inhibitor class include Viagra (sildenafil), Levitra (vardenafil), and Stendra (avanafil). All of these medications take different times to work and have different durations, but they all work through the same mechanism of action, so they shouldn’t be used together.

GC Stimulators

Guanylate cyclase (GC) stimulators are medications that are used to treat pulmonary artery hypertension and sometimes heart failure. Both classes of medications work on the same nitric oxide-cGMP pathway and relax blood vessels by causing vasodilation. Combining GC simulators and tadalafil can increase the risk of side effects by elevating cGMP levels. This can result in dangerously low blood pressure and make it more likely for you to develop dizziness, fainting, or cardiovascular problems.

When Does Tadalafil Expire?

The United States Food and Drug Administration (FDA) requires that all prescription and over-the-counter medications have an expiration date. This requirement, implemented in 1979, was designed to help consumers determine whether a medication is safe and will work as intended. Over time, medications may become less effective or contaminated with harmful bacteria.

The expiration date for Cialis, or any other medication, can typically be found on the medicine bottle. The bottle will generally display “Use By,” “Exp,” or a similar label, followed by a date. If you find an old package of tadalafil (or any other medication, for that matter) on your shelves, check the expiration date before taking it to ensure it is still safe to use.

The expiration date for tadalafil, like most other medications, is the last day the manufacturer can guarantee the medication's potency, safety, and efficacy. This assumes that the medication has been stored as recommended by the manufacturer. For tadalafil that is commercially manufactured and sold through traditional pharmacies, the expiration date is usually two to three years after the date of manufacture. The expiration date is determined through carefully conducted stability testing that assesses how well the tadalafil active ingredient withstands various environmental conditions, such as temperature, humidity, and light exposure.

After the expiration date, the manufacturer can no longer guarantee that tadalafil is safe or effective. The medication may no longer work as intended and, in some cases, may even be dangerous (though this is uncommon with tadalafil). Most of the time, if tadalafil has expired or is not stored properly, the medication will become less effective. So if that tadalafil on your shelf has expired, it is best to dispose of it properly.

What is the Shelf Life of Tadalafil?

Like most medications, tadalafil is tested to determine how long it remains effective. This shelf life is the length of time a medication remains effective when stored properly under the manufacturer's recommended conditions. What is the shelf life of tadalafil? Tadalafil loses effectiveness over time; the shelf life of Cialis tablets is usually 2 to 3 years from the date of manufacture.

Even within its shelf life, tadalafil's effectiveness may be affected by storage conditions. Tadalafil should typically be stored at room temperature, away from heat, direct sunlight, and moisture. Usually, you’ll want to leave tadalafil in the packaging that you received from the pharmacy until you are ready to use it. If you are concerned that the packaging has been tampered with or compromised, talk to a pharmacist or your healthcare provider for advice. If you have questions about how best to store tadalafil, check with your pharmacist or the instructions on the packaging.

How Is the Shelf Life of a Medication Determined?

Medication shelf life is determined by the pharmaceutical company that manufactures the medication. During development, they perform a series of tests called stability testing. The United States Food and Drug Administration sets the guidelines for this testing. Stability testing involves exposing the medication to various conditions, such as different temperatures, humidity levels, and light exposure, to determine how it behaves.

The medication is tested at various intervals to determine whether there are changes in potency, purity, or appearance, as well as which breakdown products occur. This information helps determine the best way to store medication to ensure that it stays effective. It also helps answer the question, When does tadalafil expire. Ultimately, this testing helps ensure that, when you take tadalafil or any other medication, it is safe and effective to use before its expiration date.

Most expired medications become less effective rather than becoming toxic. This is because the primary effect of time is the degradation of medications' active ingredients. Most of the byproducts of this breakdown are not harmful, except for failing to produce the intended effects. There are a few medications that may become toxic, but pharmaceutical companies work to design less risky formulations. Typically, if your medication has expired, the most likely consequence is that it won’t work as well as it should.

What Affects Cialis Shelf Life?

The shelf life of Cialis is affected by several factors, including:

• Temperature
• Humidity
• Exposure to light
• Exposure to air
• The formulation of the medication (tablet, gel, etc.)

In addition to checking the tadalafil expiration date, it is important to ensure the medication is stored as recommended on the packaging. Medications stored improperly may not only lose their effectiveness but also change over time, potentially breaking down into harmful byproducts.

Is it OK to Take Expired Tadalafil?

Because the expiration date of medications like tadalafil is based on stability testing conducted by the manufacturer, the manufacturer guarantees that the medication will maintain its full potency and safety until that date if stored under the recommended conditions. After that, medications may lose effectiveness as the active ingredient degrades.

Using a medication like tadalafil after its expiration date may mean it doesn’t work as intended. This may lead to the medication not working as expected for erectile dysfunction, benign prostatic hyperplasia, or pulmonary artery hypertension. There may also be a theoretical risk that the medicine will break down into harmful products, which could increase the risk of potentially harmful effects.

For most people, taking expired tadalafil is not life-threatening. Medications to treat erectile dysfunction are life-improving, but they are not life-saving drugs. However, for those who take tadalafil for pulmonary artery hyperplasia, taking expired medication may be life-threatening. Pulmonary artery hypertension carries significant long-term health risks. Using expired medications may also be riskier for people who have other health conditions because, if drug potency is inconsistent, there could be unexpected interactions or side effects. If medications are improperly stored, there may be an increased risk of contamination.

Most medicines won’t become toxic after their expiration date. Still, the FDA recommends against taking any medication after its expiration date because the efficacy and safety of the medication can not be guaranteed beyond that date. So, while taking Cialis after its expiration date is unlikely to harm you, it is not recommended in most cases.

What Happens if I Take Expired Cialis?

Taking expired Cialis may raise questions about how well the medication may work or how safe it is. While taking Cialis after its expiration date may not cause harm, there are definitely factors to consider. So what exactly happens if I take expired Cialis?

First, the medication may degrade over time, especially if stored improperly. This means that Cialis may lose potency over time as the active ingredient, tadalafil, breaks down. The medication may not be as effective. For someone taking the medication for erectile dysfunction, decreased effectiveness may mean a softer erection. On the other hand, someone who takes the medication for benign prostatic hyperplasia may experience urinary retention, urinary tract infections, stones of the bladder or kidneys, or even kidney damage. For people taking tadalafil for pulmonary artery hypertension, the decreased effectiveness can be even more dangerous; dizziness, chest pain, and even fatal arrhythmias may occur.

Second, as medications degrade, toxic byproducts may develop. This can cause an increased risk of adverse reactions from the medication. This is a smaller risk and is more theoretical than decreased efficacy. The answer to the question "Does tadalafil go bad?" is probably not, but it is possible.

Another potential concern is contamination. Many medications have stabilizing agents and preservatives that help maintain their safety over time. As these break down, there is an increased risk that the medications may become contaminated with harmful germs such as bacteria.

Can you take expired tadalafil? While taking expired Cialis is unlikely to harm you, depending on your reason for taking the medication, your safest option is to get a new prescription or take a non-expired medication to ensure you are getting the correct dose for the desired effect.

How to Safely Store and Dispose of Tadalafil

In addition to the expiration date, proper storage and disposal of tadalafil are important to ensuring it stays effective and safe and produces the intended effect. Proper storage also decreases the likelihood that someone or something, such as a child or pet, will get hold of the medication and accidentally ingest it. Safe storage of all medications is vitally important. The CDC estimates that there were more than 36,000 emergency department visits among children aged 5 or younger due to unsupervised medication exposures.

Safe Storage of Tadalafil

Tadalafil should be stored in the original packaging. This will help prevent it from being exposed to moisture, air, or light. The medication should not be removed from the packaging until you are ready to take it.

It is recommended that Cialis be stored at room temperature (68-72 degrees Fahrenheit). It should not be stored near a sink or in a bathroom. The humidity and temperature fluctuations in these environments may cause the medication to break down more quickly.

Tadalafil and all medications should be stored out of reach of children and in areas that cannot be accessed by pets. The medication may be dangerous if taken by someone it was not prescribed to. Locking medications or storing them on a high shelf can decrease the risk of accidental ingestion.

Safe Disposal of Tadalafil

When your tadalafil prescription has expired, or if your healthcare provider has discontinued it or you no longer need to take it, you should dispose of the medication properly. Don’t flush medications down the toilet or pour them down a drain. This can lead to contamination of water systems and potentially harm wildlife.

Many pharmacies and community organizations have organized drug take-back programs. These programs allow people to drop off unused or expired medications at designated locations. They will then be properly disposed of in an environmentally responsible manner. Some programs offer pre-paid envelopes that allow you to mail your medications to an organization that will dispose of them. The Drug Enforcement Agency (DEA) provides a website where you can find a location near you.

The DEA also coordinates a Drug Take-Back Day that provides locations for you to drop off your unused or expired medications.

If you don’t have access to a drug take-back location or a pre-paid envelope, you can dispose of medications safely in your household trash. To do this, the FDA recommends:

• Mixing the medication with dirt, cat litter, or used coffee grounds
• Put the mixture into a sealed plastic bag
• Throw it in your household trash for disposal

When disposing of medications, make sure to scratch out your personal information on the pill bottle before disposal.

FAQs

 

Does Tadalafil go bad?

Yes, tadalafil can go bad. Like all medications, tadalafil has an expiration date. It may not spoil like food in the refrigerator, but tadalafil can lose effectiveness after its expiration date and may no longer be safe to take.

Because the degradation of the medication may not be as obvious as spoiled milk, it is important to check the expiration date on the package to ensure the medication is still safe to take. The expiration date marks the end of the period the manufacturer has determined is safe and effective for use.

Does Cialis lose effectiveness over time?

Yes, Cialis can lose effectiveness over time. The manufacturer tests the stability of medications and uses this information to set the expiration date.

As it ages past its expiration date, the active ingredient, tadalafil, may break down, making the pills less effective. This can have serious consequences depending on the reason you have been prescribed the medication.

What to do with 3-year-old Cialis?

So, what should you do with that bottle of 3-year-old Cialis? Check the expiration date. Cialis is generally good for 2-3 years after manufacture. If you’re past that date, dispose of the medication safely.

Consider using one of the FDA drug take-back locations or a pre-paid mail-in envelope. If that isn’t an option, mix the pills with kitty litter or used coffee grounds, seal them in a plastic bag, and throw them in your garbage can.

Is 5-year-old Cialis still good?

Nope. Cialis is only good for about 2-3 years after it is manufactured, so that 5-year-old Cialis is not still good. If the packaging says that you’re past the expiration date, dispose of the medication safely using an FDA drug take-back location, a pre-paid mail-in envelope, or proper disposal in your trash by mixing the pills with kitty litter or used coffee grounds and sealing it in a plastic bag.

Will a 10-year Cialis work?

That 10-year-old Cialis in the back of your medicine cabinet is well past its prime and may no longer be safe or effective. The manufacturer uses rigorous stability testing to determine the shelf-life of these medications, establishing an expiration date that ensures that the medication is safe for you to use and will work as intended. Past that date, they no longer guarantee that the medication is safe or effective. When a medication is past its expiration date, chemical changes may have occurred, decreasing its effectiveness or even making it toxic to consume. This can lead to poor treatment outcomes and unexpected side effects.

So if you’ve found that 10-year-old package of Cialis at the back of your medicine cabinet, your best bet is to safely dispose of the medication by using an FDA drug take-back location, a pre-paid mail-in envelope, or proper disposal in your trash by mixing the pills with kitty litter or used coffee grounds and sealing it in a plastic bag. This prevents someone from misusing the medication or taking it accidentally.

Once you’ve safely disposed of that old prescription, talk to your healthcare provider about getting a new prescription to ensure you get the results you are looking for.

Can old Cialis hurt you?

Old Cialis probably won’t hurt you in most cases, especially if the medication has been stored properly. But it’s not likely to help either. It’s important to remember that as medications age, their effectiveness can decrease significantly. If you are taking the medication for benign prostatic hyperplasia or pulmonary artery hypertension, the risks of those old Cialis pills may be more serious. Using a medication that is past its prime can result in ineffective symptom control or even long-term health consequences. For erectile dysfunction, the real risk is not getting the desired results. This can be discouraging or disappointing. It can even impact your mental health and your relationship with your partner.

Though there is a slight risk of the medication breaking down into toxic byproducts, to be safe, it is best to dispose of the medication by using an FDA drug take-back location, a pre-paid mail-in envelope, or proper disposal in your trash by mixing the pills with kitty litter or used coffee grounds and sealing it in a plastic bag.

Then talk to your healthcare provider about getting a fresh prescription for optimal results.

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Medication is expensive, and the financial burden can prevent many people from being able to get the treatment they need to improve their health. If your healthcare provider has recommended medication to treat erectile dysfunction, benign prostatic hypertrophy, pulmonary artery hypertension, or any other medical problem, you may be looking for options for lowering costs. Prescription drug prices can vary widely. Fortunately, there are resources available to help you save money. If you are looking to compare medication prices, consider visiting WellRx. Affordable access to medication is critical for managing your chronic conditions and maintaining your quality of life.

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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. Her favorite thing about family medicine is being able to provide multigenerational care to families.

References

https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines

https://www.ncbi.nlm.nih.gov/books/NBK559276/?report=printable

https://pmc.ncbi.nlm.nih.gov/articles/PMC7040264/

https://health.clevelandclinic.org/can-you-take-expired-medicine

https://ejhp.bmj.com/content/32/1/1.6.abstract

https://pmc.ncbi.nlm.nih.gov/articles/PMC10834166/

https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-and-answers?srsltid=AfmBOoplL5MAKBE1JFDYzsvswqz4IgWkY7HaaeuIUet3PLvk9mGBlat6

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-cialis-tadalafil?srsltid=AfmBOoplL5MAKBE1JFDYzsvswqz4IgWkY7HaaeuIUet3PLvk9mGBlat6

https://www.ncbi.nlm.nih.gov/books/NBK558920/

https://pmc.ncbi.nlm.nih.gov/articles/PMC2643112/

https://pubmed.ncbi.nlm.nih.gov/20001434/

https://www.ncbi.nlm.nih.gov/books/NBK513278/

https://pubmed.ncbi.nlm.nih.gov/11879261/

https://www.ncbi.nlm.nih.gov/books/NBK549843/

https://www.sciencedirect.com/science/article/abs/pii/S0731708518328887

https://pmc.ncbi.nlm.nih.gov/articles/PMC3589309/

https://www.thecardiologyadvisor.com/features/erectile-dysfunction-drugs-and-nitrates/

https://www.ncbi.nlm.nih.gov/books/NBK537151/