What does the black triangle mean on drugs? Decoding this crucial symbol

October 8, 2025 •

4 min read

Since 2013, all EU countries have used a black inverted triangle on medicine information leaflets to signify that a drug is under additional monitoring. But what does the black triangle mean on drugs and why is this symbol so important for patient safety and ongoing pharmacovigilance efforts?

Quick Summary

The black triangle symbol on medicine leaflets in Europe and Australia indicates the product is under intensive post-marketing safety monitoring. It encourages increased reporting of adverse drug reactions for newly approved or significantly changed medicines.

Key Points

Intensive Monitoring: The black triangle (▼) indicates that a medicine is under intensive monitoring by regulatory authorities like the EMA and MHRA.
Not an Unsafe Drug Warning: The symbol does not mean the medicine is unsafe; it simply means there is less real-world data available on it compared to older drugs.
Reasons for Monitoring: Medicines are monitored if they contain a new active substance, are biosimilars, have a new indication, or were approved under special circumstances.
Encourages Reporting: The symbol is a prompt for patients and healthcare professionals to report all suspected side effects, even minor ones, to help build the product's safety profile.
Reporting Systems: Reporting is done through national schemes, such as the Yellow Card scheme in the UK or directly to competent authorities in the EU.
Temporary Status: Black triangle status typically lasts for five years but can be extended if necessary, until the safety of the drug is well established through broader use.

The Role of Pharmacovigilance

Before a new medicine or vaccine is approved for use, it undergoes extensive testing through clinical trials. However, these trials involve a limited number of carefully selected patients under controlled conditions. The real-world setting, where a much larger and more diverse patient population uses the medicine, can reveal rare or long-term side effects that were not apparent during the initial trials. This is where pharmacovigilance—the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem—becomes critical. The black triangle is a direct tool of this process in several regions, including the European Union (EU), the UK, and Australia.

The Purpose Behind the Black Triangle Scheme

When a drug is given a black triangle (▼), it does not mean it is unsafe or that regulators have identified a problem. Rather, it is a proactive measure to encourage all patients and healthcare professionals to be particularly vigilant about reporting any suspected side effects. By doing so, they contribute valuable real-world data that helps regulatory bodies quickly identify any new safety issues that may emerge after the product is marketed.

Why Medicines Need Extra Monitoring

Several factors can lead to a medicine being placed under additional monitoring:

New active substances: This includes any medicine with a newly approved active ingredient.
Biosimilar medicines: These are biological medicines highly similar to an already approved biological medicine.
New routes of administration: An existing medicine may be used in a new way, such as a new injection method.
New combinations or delivery systems: This applies to new combinations of active substances or new drug-delivery systems.
Conditional or exceptional approval: Medicines approved under exceptional circumstances or with a conditional approval, where more data is required post-marketing.
New patient population: An existing medicine approved for a new group of patients, such as from adults to children.

Your Role: Reporting Adverse Reactions

Patients and healthcare professionals are strongly encouraged to report any suspected side effects from medicines displaying the black triangle, no matter how minor they may seem. This reporting is crucial for identifying rare or long-term issues that could not be detected in clinical trials. In the UK, this is done via the Yellow Card scheme. In the EU, reporting is submitted to national competent authorities, which then share the information with the European Medicines Agency (EMA). The black triangle symbol helps quickly identify which medicines should receive a higher priority for reporting, allowing for efficient analysis of emerging safety data.

Black Triangle vs. US System: A Comparison

While the concept of post-marketing surveillance is global, the visual cues differ between regions. In the EU, UK, and Australia, the black triangle is a standardized visual alert, but the US system relies on different methods. This table highlights the key distinctions.


Feature	EU / UK / Australia (Black Triangle Scheme)	United States (MedWatch)
Symbol	Displays an inverted black triangle (▼) on patient information leaflets and advertising material.	No specific visual symbol is used for additional monitoring on product information for patients.
Designated medicines	Applies to specific categories of medicines, such as those with new active substances, biosimilars, or new indications.	All medicines are monitored, but a distinct symbol is not used to identify those with less post-market data.
Reporting System	Encourages reporting of all suspected side effects, even minor ones, for black triangle products (e.g., Yellow Card scheme in UK).	Relies on the MedWatch program for voluntary reporting of serious suspected side effects and product problems.
Location of Symbol	Appears prominently in the patient information leaflet, the Summary of Product Characteristics (SPC) for healthcare professionals, and marketing materials.	Information on reporting is included in package inserts, but no special symbol is used to highlight new or monitored drugs.
Duration	The status typically lasts for five years, but can be longer if needed to collect sufficient safety data.	Monitoring is continuous and part of the product's entire lifecycle; no specific time period is tied to a symbol.

Conclusion: What to Remember About the Black Triangle

The black triangle is a clear signal that a medicine is under intensive, additional safety monitoring by regulatory authorities, but it is not a warning of a known risk. Its presence is a call to action for patients and healthcare professionals to report any and all suspected side effects, which helps build a comprehensive safety profile for the product over time. The black triangle represents a crucial component of modern pharmacovigilance, ensuring that patient safety remains the highest priority, particularly for newer treatments. By understanding and responding to this symbol, individuals can play an active role in enhancing the safety of medicines for the broader community.

For more information on the additional monitoring scheme, you can visit the European Medicines Agency website.

Frequently Asked Questions

Yes, a medicine with a black triangle is considered safe and has been approved by regulatory authorities. The symbol simply means it is under additional, closer monitoring to gather more real-world safety data.

The black triangle is applied to medicines containing new active substances, biosimilars, those with a new route of administration, or existing medicines used for a new patient group or indication.

The black triangle is found in the patient information leaflet (PIL) and the Summary of Product Characteristics (SPC) for healthcare professionals. It does not appear on the outer packaging of the medicine.

A medicine is typically assigned a black triangle for at least five years from its date of first supply or new indication approval. The status is reviewed periodically and removed once sufficient safety data has been collected.

You should report any suspected side effects to your doctor, pharmacist, or nurse. You can also report directly to your national medicines regulator using their reporting system (e.g., the Yellow Card scheme in the UK).

Clinical trials often involve a limited and highly selected patient population for a short duration. Post-marketing surveillance captures data from a larger, more diverse group, which helps identify rare or long-term side effects that may not have been detected during the trial phase.

No, the US Food and Drug Administration (FDA) does not use the black triangle symbol for additional monitoring. They use a different system for post-marketing surveillance and adverse event reporting through their MedWatch program.