Listed medicines containing Valeriana officinalis requiring warning statements

In 2025, we initiated targeted reviews on selected listed medicines that required a warning statement because the medicine contains Valeriana officinalis as an active ingredient. 

The 3 ingredients that are subject to the warning statement are:

• Valeriana officinalis;
• valerian powder
• valerian dry.

What led to this review?

Listed medicines are only permitted to contain low risk ingredients from a pre-approved list. 

Although these ingredients are considered low risk to the general population, some consumers may experience potential unwanted side effects. 

One tool we use to ensure the safety of listed medicines, is requiring sponsors to add warning statements on medicine labels. 

Medicines that contain Valeriana officinalis as an active ingredient are required to display the following warning statement:

• 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

The absence of the required warning statement in medicines that contain Valeriana officinalis may result in consumers not being able to identify symptoms of early-stage liver injury and not take early actions to minimise further liver damage.

The warning statement was introduced on 1 March 2023 and is applicable to the labels of medicines listed in the Australian Register of Therapeutic Goods (ARTG) on or after 1 March 2023,or released for supply on or after 1 March 2024. 

As the transition period to comply with the warning statement requirement has ended, a selection of listed medicines containing Valeriana officinalis was targeted to determine whether they complied with the requirement.

What did we do?

Thirty listed medicines that contained Valeriana officinalis as an active ingredient were identified for review. 

We asked the sponsors of these medicines to provide the labels and websites that were being used for these medicines to check the presence of the required warning statement.

What did we find?

The sponsors of all 30 medicines (100%) responded to the TGA's request for information, of which 26 medicines (86%) were found to comply with the required warning statement. The compliance status of two medicines (7%) could not be determined as it was never manufactured.

Two medicines (7%) were identified as missing the required warning statement. Although a recall was considered for the affected batches still on the market, it was ultimately deemed unnecessary as no stock remained available. The labels for all future batches of these medicines have been corrected, or will be updated, to include the required warning statement.

The compliance review results for each medicine are published on the page Listed medicine compliance reports. To find the relevant review outcomes please search ‘valerian’ in the search bar.

Information for sponsors

If you are the sponsor of a listed medicine, you should:

• review the ingredients used in your medicine to ensure that any requirements and warning statements listed in the Therapeutic Goods (Permissible Ingredients) Determination are complied with
• be aware that missing warning statements on medicine labels may result in recall of non-compliant stock
• be aware that the requirements for ingredients in the Therapeutic Goods (Permissible Ingredients) Determination can change from time to time. It is the sponsor's responsibility to make sure that these changes are implemented to their medicine, and within the transition period if applicable
• be aware that repeatedly failing to comply with legislative requirements, such as not including the required warning statements on the label, could result in higher-level enforcement actions, including infringement notices or other penalties.