Does Ibuprofen Expire?

In our latest question and answer, the pharmacist discusses whether or not ibuprofen can expire and safety concerns regarding expired products.

Jan 24, 2018

Sam asked

Does ibuprofen expire?

Answer

Like all medication, ibuprofen (brand names Advil and Motrin) does expire after a set period of time. Expiration dates must be listed on the packaging of the medication and they are often listed as either the month and year, or as the month, day and year.

What Causes Ibuprofen To Degrade?

There are studies that indicate the ibuprofen, as a chemical compound, is susceptible to degradation from a variety of factors including:

  • Excess heat
  • Ultraviolet radiation
  • Moisture
  • Oxidative stress

Over time, these stressors will degrade ibuprofen and literature suggests that there are no less than 10 decomposition by-products from ibuprofen. The longer ibuprofen is past the listed expiration date, the more likely it is to have begun breaking down. One of the products of ibuprofen decomposition, (1-(4-isobutylphenyl)-1-ethanol), may have toxic effects, but the significance of this and the potential adverse effects it may cause if taken isn't known.

In addition to potential safety concerns, once ibuprofen begins to break down, it will not be as effective as it once was and therefore may not be useful in treating the symptoms it is intended for (e.g. pain, fever etc...)

Can You Take Expired Ibuprofen?

A common concern regarding expired drugs is whether or not they are still safe to take beyond the manufacturer listed expiration date. In most cases, it is not recommended to take expired medication, including expired ibuprofen.

The official USP (United States Pharmacopeia) defines the expiration date as the following:

"The date beyond which ideally stored medications in the unopened manufacturer’s storage container or in most circumstances, the opened and intact manufacturer’s storage container, should not be used.”

The main concern with expired drugs isn't generally a question of safety, but more a question of effectiveness. It is very rare for a drug to actually "go bad" in terms of causing physical harm. There are a few medications that may degrade into harmful components but there is little data regarding the components of ibuprofen degradation and whether or not they could potentially cause adverse effects (as mentioned above).

Most manufacturers set an expiration date about two to three years from the time of manufacture, as this is the length of time they conduct stability studies for. When an expiration date is set, the manufacturer needs to have data available that the medication will meet the requirements for safety and potency before that expiration date occurs. It's relatively likely that an expired medication may be good after the set expiation date, but the manufacturer only has data to support 2 to 3 years in most cases.

Most drugs could theoretically have expiration dates for longer periods of time, but there is little incentive for manufactures to perform extended stability studies. There is no financial incentive to do so and setting relatively short expiration dates requires the re-purchase of products after a set period of time.

As expired ibuprofen may not be as effective as it was when it was in-date, and because the breakdown of the compound may cause adverse events if ingested, it is not recommend to take expired ibuprofen. As ibuprofen is available over the counter and it relatively inexpensive, it is recommend to replace expired ibuprofen with a one, in-date product.

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