Sildenafil (Viagra) typically has a shelf life of 2 years, but improper storage can reduce safety and efficacy through physical and chemical degradation of its active ingredient, Sildenafil Citrate. Manufacturers are legally liable to provide expiration dates and shelf-life information on their products after rigorous stability testing procedures, later corroborated by the FDA. Factors such as light, humidity, and original sealed packaging help retain the chemical stability and safety of Sildenafil, making proper storage essential in maximising its shelf-life.
The FDA and Pfizer (Viagra manufacturer) do not recommend using Sildenafil (Viagra) beyond its expiration date. Expired Sildenafil loses its potency and can pose severe health risks, including severe side effects and bacterial contamination. For maximum safety and longevity, store Sildenafil (viagra) in a cool, dry, dark place in its original packaging.
In this article, we will explore whether Viagra or Sildenafil (generic), a popular and dependable ED drug, actually expires. Let’s uncover what expiration dates mean and whether it’s safe to take Sildenafil (Viagra) after it expires.
Contents
What is the Shelf Life of Sildenafil (Viagra)?
Sildenafil (Viagra) has a shelf life of about 2 years from the date of manufacture. In other words, as long as it’s stored properly, Viagra can be safely used within this 2-year period. This 2-year shelf life was determined through extensive clinical trials and stability assays conducted and submitted by Pfizer (drug manufacturer) to the US Food and Drug Administration (FDA) for approval of Viagra sale in 1998.
Viagra is a popular brand of medication usually prescribed as treatment for erectile dysfunction (ED) in men. Developed by Pfizer, it belongs to a class of phosphodiesterase 5 inhibitors, containing an active salt known as Sildenafil citrate. This PDE5 inhibitor blocks the effects of the PDE5 enzyme and helps restore nitric oxide levels, a natural chemical relaxant that enhances penile blood flow to aid stronger erections.
Viagra, otherwise known as the “little blue pill”, has helped men regain their confidence in the bedroom by improving erectile function 9x compared to placebo, as reported by a recent study in The Journal of Sexual Medicine. Its superior efficacy backed by its proven track record helps men suffering from ED improve their overall sexual satisfaction. Generic versions of Viagra are also available as a cost-effective alternative, with the same active ingredient, Sildenafil Citrate. Popular generic versions such as Kamagra, Cenforce, Fildena, and Suhagra offer similar effectiveness as Viagra as well as similar associated risks and drug interactions.
Since 1979, the FDA has mandated the presence of expiration dates on all over-the-counter prescription medications. But how are the expiration dates determined? According to FDA regulations, drug manufacturers are required to provide stability testing data on their drug, along with a proposed expiration date and ideal storage conditions, whenever they apply for FDA approval. These rigorous tests are designed to provide quality assurance checks on the drug to ensure that it meets the industry standards in terms of safety, potency, quality, and integrity throughout its shelf life. The FDA also verifies the authenticity and significance of the studies conducted by the manufacturer before approving the drug’s sale.
Does Sildenafil lose potency over time before the expiry date?
Yes. Sildenafil (Viagra) can lose its potency and become less effective before its expiration date, if stored improperly. The storage of a medication significantly impacts its stability and pharmacokinetics. Storing the medication in temperatures above 25℃ (77℉) can degrade Sildenafil’s chemical components and may reduce its efficacy. Direct sunlight and humidity also modify the stability of the medication by allowing faster deterioration of the product. Sildenafil, if exposed to extended periods of sunlight, may lose its potency even faster than expected.
Poorly packaged Sildenafil (Viagra) can also allow sunlight, heat, and humidity to alter the physicochemical stability of the drug, leading to irreversible chemical changes that may reduce its strength and aggravate the risk of side effects.
What affects the effectiveness of sildenafil?
Sildenafil, like all drugs, prefers stable storage conditions which ensure that its potency and safety can be retained over time. Environmental factors, such as heat, humidity/moisture, light, and the vacuum seal in the original packaging, can significantly impact the effectiveness of Sildenafil. These factors can alter the stability of Sildenafil (Viagra) and can render physical, chemical, and microbiological changes that affect the integrity and efficiency of the ED drug. Stability testing conducted by the International Council for Harmonisation (ICH) on Sildenafil samples in environmentally controlled chambers resulted in the establishment of a shelf life, storage conditions, and expiration date based on real-time stability data.
The FDA does not recommend consuming Sildenafil (Viagra) past its specified expiration date. The expiration date refers to the date printed on the original sealed packaging from the manufacturer. It is important to note that pharmacies usually dispense Viagra from stock bottles according to the prescription, and once it is no longer in its original sealed packaging, its expiration date may no longer apply. The “official” rule of thumb is that Viagra prescriptions expire in one year since the date of prescription in most states. In other words, the medication inside your prescription bottle is safe to consume until your prescription expires. You can ask your pharmacist for the specific expiration date on your prescription label, just to be on the safe side.
How can you store sildenafil to maximise its effectiveness?
There are a few things you can do to maintain the effectiveness of Sildenafil (Viagra) and maximise its shelf-life. Controlled storage conditions can help preserve the potency and safety of Viagra. Follow the best storage practices to make Viagra or Sildenafil tablets last longer.
Check the expiration date on your prescription bottle before consumption. Be sure that it’s not past its expiration date to guarantee maximum efficacy and safety of the ED medication. Store Sildenafil (Viagra) in its original prescription bottle with a tightly closed lid. This helps in preventing moisture from getting in contact with the medication, which can degrade it over time.
Ideal long-term storage temperatures are between 25℃ and 30℃ (77℉ to 86℉). Keeping Sildenafil in ideal storage temperatures helps maintain the stability of the ED drug. Place it in a dry, dark area, away from sunlight or heat sources.
Avoid keeping Sildenafil in highly humid areas like bathrooms and kitchens. High humidity can accelerate the degradation process and can lead to bacterial growth and contamination, making it risky for consumption.
Avoid storing Sildenafil near sources of extreme temperatures, such as windows, air conditioners, radiators, refrigerators, or ovens, as they can impact the drug’s pharmacokinetic characteristics. Keep Sildenafil out of reach of children and pets.
Points to be included in the graphic:
- Original bottle with a sealed lid
- Temperatures between 25℃ and 30℃ (77℉ to 86℉).- Please be sure to mention both Celsius and Fahrenheit.
- Don’t store in bathrooms or the kitchen
- Avoid storage near extreme temperatures
- Out of reach of children and pets
What happens after the expiration of sildenafil?
Expiration date is a vital characteristic of any pharmaceutical drug as it represents the manufacturer’s guarantee of the stability, potency, safety, and efficacy of the drug until the expiration date.
Dr. Mansoor Khan, former FDA product quality research director, explains that pharmaceutical drugs must retain at least 90% of their potency at expiration, with the remaining 10% lost due to chemical degradation. He further adds that degradation products can cause adverse reactions or even cancer. In other words, the chemical stability and safety of the drug cannot be guaranteed by the manufacturer past its expiration date. Due to chemical degradation, Sildenafil may have reduced efficacy when consumed past its specified expiration date.
In addition to the chemical stability of the drug, expiration dates also affect the physical integrity of Sildenafil (Viagra). There could be visible changes in the drug’s colour, texture, smell, and taste, which is an indication that the medication is no longer effective or safe. It is important to continuously check for obvious signs of physical degradation periodically and store them properly to extend the drug’s longevity.
In some cases, the expiration dates do not automatically mean that the medication is unsafe right after it expires. It simply means that there is not enough quality research data to confirm the efficacy and safety profile of the drug beyond the expiration date. As a general rule of thumb, it is best to avoid consuming expired Sildenafil (Viagra).
Will expired sildenafil still be effective?
No. Expired Sildenafil will not be as effective as its chemical components would have already begun disintegrating, affecting its potency and compromising its safety. Sildenafil (Viagra) has an expiration date, approximately 2 years from its date of manufacture or 1 year if dispensed on prescription. The expiration date is established after rigorous rounds of stability testing, including long-term, accelerated stability testing to photostability assays, and forced degradation studies, which are substantiated and cross-checked by the FDA. If the drug undergoes any major modifications, such as changes in formulation, manufacturing process, preparation, or packaging, the manufacturer is legally liable to provide additional studies to corroborate the drug’s safety and efficacy to the respective drug regulatory authorities.
However, studies conducted by the military on expired medications in 1985 revealed that around 90% of the drugs remained safe and potent for years past the manufacturer’s recommended expiration dates. Upon this information, the FDA conducted tests on more than 100 drugs under the “Shelf Life Extension Program” and found that expiration dates were conservative and drugs could have a longer shelf life than previously indicated, as reported by Pentagon spokesperson Kenneth Bacon. Due to this newfound conclusion, the Air Force was able to save $49.3 million in drug replacements from their national stockpile in 1998.
Despite these tests, experts like Thomas McGinnis, Director of the FDA’s Pharmacy Affairs, advise against the assumption that expired drugs such as Sildenafil (Viagra) are effective and safe to consume. He adds that, as opposed to the sealed drugs in the original packaging, which are available in the national stockpile, regular consumers often do not have the original sealed packaging. Their medications might be dispensed from stock bottles from the pharmacy, which can expose them to humidity, light, and heat during dispensation and transit (for mail-order medications). Therefore, there is always an additional risk of reduced efficacy and serious unwanted side effects of expired medication. Consumers are advised to remain vigilant of the specified expiration date and to dispose of the expired drug to remain on the safe side.
Is it safe to use expired sildenafil?
No. You should not consume expired Sildenafil (Viagra). Expired SIldenafil may lose its efficacy due to chemical degradation. It means that, in the best-case scenario, Sildenafil may not work very well as an ED drug- if at all. Reduced efficacy is a tell-tale sign of expired medication. Expired Sildenafil can also cause photosensitivity (sensitivity to light) or tingling sensations.
In the worst-case scenario, you might experience minor side effects such as headaches, nausea, digestive issues, body aches, and a runny nose after consumption. Some serious side effects, such as breathing difficulties, priapism (prolonged erection for more than 4 hours), or sudden changes in vision and hearing, can also occur.
In rare cases, expired medication has also led to bacterial contamination, often invisible to the naked eye. This can cause serious infections and can have long-term harmful effects on your overall health. Always consider these risks before taking expired Sildenafil (Viagra).
Is it safe to use expired Sildenafil? -No
Best Case Scenario- Sildenafil works with reduced efficacy or not at all.
Worst Case Scenario- Minor side effects such as headaches, nausea, body aches & serious side effects such as breathing difficulties, priapism, and changes in vision and hearing.
Rare Cases- Bacterial contamination can pose serious long-term health risks.
(Feel free to add cliparts or words as per your expert opinion)
How to properly dispose of expired sildenafil (Viagra)
The FDA has established some guidelines that can help you dispose of expired Sildenafil (Viagra) safely with minimal risk to the environment.
- Check your medication label for proper disposal instructions from the manufacturer.
- Take advantage of your local drug take-back programs sponsored by the U.S Drug Enforcement Administration. Some communities also have their drug take-back locations, where you can drop off expired prescription Sildenafil (Viagra). You can check with your local law enforcement officials to find the closest location to you.
- Mail them to your pharmacy using a prepaid drug mail-back envelope, a convenient and secure disposal option. The envelopes are sold at various retail and online pharmacies, often at no extra cost. You can fill the envelope with your unused or expired medication and mail it through the U.S Postal Service.
- Some pharmacies also offer drop-off boxes or kiosks on-site to help you safely dispose of expired Sildenafil (Viagra).
- Never flush expired Sildenafil down the toilet, as flushing can cause environmental damage, as small amounts of expired drugs can be found in surface water (rivers, lakes) and drinking water supplies.
- At home, mix Sildenafil with some dirt, coffee grounds, and cat litter and pack it in a sealed plastic bag before discarding it in the trash. Mixing the medication with undesirable products makes it less appealing to children and pets, and even other people who might go through trash looking for drugs.
- Remember to scratch out all your personal information on your prescription bottle to protect your identity and privacy before disposing of it in the trash.
How to Check the Expiry of Sildenafil Tablets?
Manufacturers are legally required to print expiration dates on their medication packaging, be it on the blister pack or drug bottle. Sildenafil (Viagra) also has a similar expiration date and shelf life printed on its packaging. The printed expiration date represents the date up to which the manufacturer will assume legal liability if something went wrong with the product’s safety and efficacy. Manufacturers warn against using Sildenafil (Viagra) after the expiration date due to a general estimate that 10% of the active salt, Sildenafil Citrate, has already degraded and can seriously jeopardise the chemical integrity, pharmacokinetics, and safety profile of the drug.
To remain cautious and safe, you can carefully locate and check the expiration date on your prescription Sildenafil (Viagra) on:
- Blister packs: The expiration date is printed directly on the foil or plastic blister pack, which contains the pills.
- Drug Bottles: The expiration date is printed on the label of the bottle, often near the bottom or on the side.
- The expiration date can also be printed on the carton or outer box of the packaging containing Sildenafil (Viagra).
- If the label is missing or unclear, contact your pharmacist or healthcare provider to guide you. In some cases, they might exchange or refill your Sildenafil prescription with a visible expiration date.
What if you accidentally take expired Sildenafil?
If you accidentally consume expired Sildenafil, the key is not to panic. The active salt in Viagra and its generic versions, Sildenafil Citrate, breaks down over time and may result in reduced efficacy in results. This means you may not see the desired results of the Sildenafil (Viagra); it may take a longer onset time or may not work at all.
The degraded active ingredient can also cause unforeseen drug interactions in your body. You may experience minor side effects of expired Viagra, such as headaches, indigestion, and body aches. There is also a possibility of severe side effects such as breathing difficulties, diarrhea, priapism (painful, prolonged erection), and even seizures, although the probability of these occurrences is low with expired Sildenafil (Viagra).
Expired Sildenafil is also prone to bacterial contamination and mold, on account of continuous exposure to heat and humidity, which can result in serious illnesses.
If you accidentally take expired Sildenafil, consult your healthcare provider immediately to discuss the likelihood of serious side effects based on your medical history and the expiration date of Sildenafil (Viagra). In case of severe side effects, contact Emergency services immediately. Do not attempt to take more of the expired Sildenafil to compensate for reduced efficacy.
How long does sildenafil last in the body?
Sildenafil stays effective for about 4 hours at its peak. Most men can achieve an erection during this time with sexual stimulation. The effect can last longer, sometimes up to 12 hours, but it becomes weaker over time. A study, “Duration of action of sildenafil citrate in men with erectile dysfunction,” shows that 82% of men still respond after 8 hours and 45% respond after 12 hours. How long sildenafil lasts depends on factors like dosage, food intake, and personal health. As the body metabolizes the drug, its levels drop steadily, leaving little effect after half a day in most users.
About author
Add comment