Can you take expired ibuprofen?

Official answer

by Drugs.com

Although taking expired ibuprofen is not recommended by the manufacturer, the actual shelf-life is likely to be longer than that indicated by the expiry date, with FDA testing showing many drugs are active for years beyond their expiry date, although specific data on ibuprofen is not available. Within reason, an ibuprofen tablet that is a few months past its expiry date is probably safe to take. Ibuprofen that is years past its expiry date should not be taken.

Pharmaceutical companies are required by law to put an expiry date on their products, and ibuprofen is no exception. This is the period that the manufacturer can guarantee the product remains stable without deteriorating, and that it will work safely and as expected.

It can be expensive to test how long a medication can remain stable, and there is no financial incentive for companies to extend the shelf life of their product. Manufacturers are allowed to choose a time frame from 12 months to 5 years to test the stability of their drug, and once testing has shown it retains its potency for that length of time, then that expiry date can be stamped on the bottle or foil strip. This does not mean that the product doesn’t last for longer, it's just that they haven’t tested it to see if it lasts longer.

While ibuprofen may be okay to take a few months past its expiry date, taking it years past its expiry date cannot be recommended without further testing. Most of the information about drug expiration dates comes from a study initiated by the military and conducted by the Food and Drug Administration. The military has a substantial and expensive drug inventory that would require regular replacement when drugs expire. The study revealed that over 90% of over 100 drugs, including both prescription and over-the-counter medications, remained effective even 15 years after their expiration date. For the other 10% of drugs, the expiry date is critical and must be followed. Medications such as antibiotics, epinephrine, insulin, nitroglycerin, and pharmacy-compounded products are more likely to degrade and/or become ineffective with time and should not be used past their expiry dates.

What happens if you take expired ibuprofen?

The most likely outcome of taking expired ibuprofen is that it will not work because it has lost its potency (strength) with time or levels of impurities would increase due to a breakdown in their chemical structure. This is particularly true if they have not been stored properly such as being exposed to extreme heat or light. All medications contain active and inactive ingredients, and with time, or adverse storage conditions, these can become unstable, and convert to other substances that may pose a risk to your health. Ibuprofen contains an impurity called ibuprofen-related compound C (IRC-C). Testing of ibuprofen samples stored over 550 days at the International Space Station (ISS) that were within 3 months of their expiry date revealed 99.9% active ingredient and less than 0.001% IRC-C, well below the USP limit of 0.25% for this impurity. These results were consistent with another study that showed ibuprofen that had spent 2.5 years on the ISS passed API analysis for levels of IRC-C.

There is also a risk to some medicines from contamination due to the container they are stored in, especially if the container is made of plastic. Plastic is broken down by UV radiation through a process called photodegradation, and by oxidation and friction. Small bits of plastic lining the inside of your container can contaminate old ibuprofen tablets.

Can expiry dates be extended?

It is possible to extend the expiry date on some products with further testing. The U.S. government operates the Shelf Life Extension Program (SLEP) (established in 1986) and manufacturers can apply for an extension to their expiry date based on acceptable data from stability studies that are completed by following an approved NDA protocol.

The Government regularly extends expiry dates for medications that have been stockpiled in the interests of military and civilian health. This avoids the need to replace entire stockpiles every few years at significant expense if testing reveals product stability beyond their labeled shelf life.

Unfortunately, Federal and state laws prohibit pharmacists from dispensing expired drugs, which means millions of dollars worth of medicines are thrown away each year. Occasionally, the FDA may extend the expiry date of medications that are in short supply, but this is quite rare. There is a big movement to acknowledge the shortcomings of expiry dates and to develop a more robust system that would decrease medication wastage and cost.