Published: 22 October 2025

Safety Information

Monitoring communication

Patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your healthcare professional. A monitoring communication does not mean that the medicine causes an adverse event.

M2 logo Estradot (estradiol) transdermal patches: reports of quality and efficacy concerns


22 October 2025

Medsafe is aware of quality and efficacy concerns from consumers associated with the use of Estradot (estradiol) patches. These concerns include:

  • return of menopausal symptoms
  • issues with patch adhesion.

Medsafe's initial investigation has not identified any product quality issues that explain the adhesion or lack of efficacy issues.

Sandoz, the sponsor of the patches, has investigated this issue and will communicate the outcome with relevant healthcare professionals. We have published this letter on the Dear Healthcare Professionals section of our website.

Products affected
More information
Medsafe's actions
Reporting

Products affected

Product name Sponsor
Estradot 25mcg/24hrs patch Sandoz
Estradot 50mcg/24hrs patch Sandoz
Estradot 75mcg/24hrs patch Sandoz
Estradot 100mcg/24hrs patch Sandoz

More information

Estradot (estradiol) is indicated as estrogen replacement therapy for menopause symptoms and prevention of postmenopausal osteoporosis.

The sponsor's investigation found that the products met all quality specifications. The sponsor tested samples from multiple batches (including batch 96622) and confirmed that the patches were within specifications. Similarly, the sponsor did not find any problems in the manufacturing or packaging processes. Note that the manufacturer of this product has not changed.

The sponsor emphasises the importance of applying the patches correctly. The package insert contains detailed instructions, including proper skin preparation and where and how to apply the patch. The letter to healthcare professionals also contains a copy of these instructions.

Not all medicines work for all people. If you are experiencing difficulties, please go back to your doctor to discuss other treatment options.

See also the Estradot (estradiol) consumer medicine information for more information about this medicine, including the known side effects.

Medsafe's actions

We are continuing to work with the company while monitoring any further reports.

Reporting

Please report quality issues with this medicine to:

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