Is Frozen Testosterone Still Safe To Use?

In our latest question and answer, the pharmacist discusses if it is safe to use testosterone injection if it has been frozen.

Question

I take testosterone cypionate and it froze. Is it wasted now?

Asked by Jonathan On Nov 13, 2022

Answered by
Medical Content Reviewed By HelloPharmacist Staff

Published Nov 14, 2022
Last updated Apr 17, 2025

Key points

  • Testosterone cypionate injection should be stored between 59°F to 77°F, with temporary excursions permitted to 36°F to 86°F. It should not be frozen.
  • If your testosterone cypionate vial has been accidentally frozen, it should not be used. It may be degraded and become ineffective.

Answer

If your testosterone cypionate solution for injection accidentally froze, you should not use it since it has been stored outside the required storage conditions for the drug.

The prescribing information for testosterone cypionate states the drug should be stored as follows:

Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.
Testosterone Prescribing Information

Although I couldn't find any specific information regarding testosterone, studies have shown that medications in a liquid dosage form that have been frozen (and aren't intended to be) can degrade and/or be altered. This could potentially lead to serious side effects and a loss of effect.

One type of drug where this has been demonstrated is with insulin. One study showed that when certain types of insulin are frozen and thawed, there is evidence of drug degradation and "particle clumping".

Another example is with protein-based drugs, where freezing and thawing can produce 'shearing' forces on the drug molecules, rendering them ineffective. One such study stated the following:

During thawing, additional damage to proteins is caused by recrystallization process. Recrystallization exerts additional interfacial tension or shear on the entrapped proteins and hence causes additional damage to the latter.
Biotechnol Bioeng . 2003 Jun 20;82(6):684-90

A number of studies have also shown that several vaccines can be made ineffective by inadvertent freezing. The World Health Organization (WHO) has even provided guidance on how to avoid this.

What To Do If Your Testosterone Has Frozen

If the drug you are taking has accidentally frozen or was otherwise stored outside of the required storage conditions, you should discard the medication and not use it. This is the case for testosterone cypionate injection.

Even when we don't have specific information on a particular drug and how freezing could affect it, it should not be used. It could be ineffective or increase the risk of side effects if it were used.

Manufacturers base their storage requirements on stability tests, and if we don't know how a drug could be affected when stored outside the requirements, it is best not to use it. When it comes to using medication, it is important they are safe and effective, something that can't be guaranteed if the medication wasn't stored properly.

Be sure to work with your doctor and pharmacy regarding how to get a replacement vial.

Final Words

Thanks for reaching out!

References

  • Aide-memoire for prevention of freeze damage to vaccines, World Health Organization
  • Impact of Freeze/Thaw Process on Drug Substance Storage of Therapeutics, PubMed
  • The effects of freezing on commercial insulin suspensions, ScienceDirect
  • The Stability of Insulin in Crystalline and Amorphous Solids: Observation of Greater Stability for the Amorphous Form, Springer
  • Effect of freezing and thawing rates on denaturation of proteins in aqueous solutions, PubMed
  • Drugs and Drug Administration in Extreme Environments, Oxford Academic
  • TESTOSTERONE CYPIONATE INJECTION Prescribing Information, AccessFDA

About the Pharmacist

Dr. Brian Staiger, PharmD

Dr. Brian has been practicing pharmacy for over 13 years and has wide-ranging experiences in many different areas of the profession. From retail, clinical, program development, and administrative responsibilities, he's your knowledgeable and go-to source for all your pharmacy and medication-related questions! Dr. Brian Staiger also has herbalist training and educational certificates in the field of medical ethnobotany. Feel free to send him an email at [email protected]! You can also connect with Dr. Brian Staiger on LinkedIn.

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