Cialis Storage, Stability & Shelf Life: Evidence-Based Guide to Tadalafil Potency

At a glance

  • Medicine / tadalafil (Cialis), a prescription PDE5 inhibitor for ED and BPH [2]
  • Where to store / a cool, dry place such as a dresser drawer or closet shelf, away from hot appliances and the sink [1]
  • Bathroom cabinet / damp conditions can reduce effectiveness before the expiration date [1]
  • Product-specific storage / read the label on the package [1]
  • Expired medicine / FDA says do not use [1]
  • Extended-stability data / 88% of 3,005 lots of 122 products extended at least 1 year, average 66 months, highly variable [3]

How should Cialis tablets be stored?

Cialis is a prescription tadalafil tablet approved for erectile dysfunction, benign prostatic hyperplasia, and both together [2]. The FDA's consumer guidance is to store medicines in a cool, dry place such as a dresser drawer, storage box, closet shelf or kitchen cabinet, away from hot appliances and the sink. It warns that a damp bathroom cabinet can reduce a medicine's effectiveness before the expiration date [1]. It also says some medicines cannot be exposed to high temperatures and that the label should be read for product-specific storage instructions [1].

For solid medicines in general, water absorption can increase molecular mobility and lead to solid-state reactions such as hydrolysis, oxidation, cyclization and deamidation [4]. That is a general chemistry principle, not a tadalafil-specific measurement.

What do stability studies show about shelf life?

The closest general data come from the Shelf Life Extension Program, which the FDA administers for the Department of Defense. In an analysis of 3,005 lots from 122 drug products, 88% of lots were extended at least 1 year beyond their original expiration date, with an average extension of 66 months, but the extra stability was highly variable [3]. That is a general finding across many products, not a shelf-life figure for a particular tadalafil tablet.

Can you use Cialis after its expiration date?

The FDA has required expiration dates on prescription and over-the-counter medicines since 1979 and calls the date a critical part of deciding whether a product is safe and will work as intended [1]. It says expired medicines can be less effective or risky because of a change in chemical composition or a decrease in strength, and that once the date has passed the medicine may no longer be safe and effective. Its consumer guidance is not to use expired medicine [1].

The Shelf Life Extension Program shows that some lots can remain stable beyond their labeled date, but stability varied by lot and could only be assured by periodic testing of each lot [3]. That is not something a person can check at home.

How should expired or unwanted tadalafil be disposed of?

The FDA lists drug take-back locations and prepaid mail-back envelopes as preferred disposal routes. When those are not available, it says to check whether the medicine is on the FDA flush list and otherwise follow its instructions for discarding the medicine in household trash [1].

Frequently asked questions

Does Cialis expire?
Yes. Cialis is a prescription medicine and carries an expiration date. The FDA says expired medicines can be less effective or risky and advises against using them [1].
What temperature should Cialis be stored at?
The FDA says to read the label for product-specific storage instructions. Its general advice for medicines is a cool, dry place away from heat and damp [1].
Can I keep Cialis in the bathroom?
The FDA warns that damp bathroom cabinets can reduce a medicine's effectiveness before its expiration date and recommends a dresser drawer, closet shelf or other cool, dry place instead [1].
Can I use expired Cialis if it looks normal?
The FDA says an expired medicine may not be safe or effective, and its guidance is not to use expired medicines [1].
Can tablets stay stable past the printed date?
Some lots of many drug products stayed stable well beyond their labeled dates in a government testing program, but stability varied widely by lot and was assured only by periodic testing [3].

References

  1. Don’t Be Tempted to Use Expired Medicines | FDA. Don’t Be Tempted to Use Expired Medicines | FDA
  2. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  3. Lyon RC, Taylor JS, Porter DA, Prasanna HR, Hussain AS. Stability profiles of drug products extended beyond labeled expiration dates. J Pharm Sci. 2006;95(7):1549-60. Stability profiles of drug products extended beyond labeled expiration dates
  4. Byrn SR, Xu W, Newman AW. Chemical reactivity in solid-state pharmaceuticals: formulation implications. Adv Drug Deliv Rev. 2001;48(1):115-36. Chemical reactivity in solid-state pharmaceuticals: formulation implications
Evidence overview for cialis tadalafil: Cialis Storage, Stability & Shelf Life: Evidence-Based Guide to Tadalafil Potency