What is the black triangle in pharmacy? A Guide to Additional Monitoring

October 11, 2025 •

4 min read

Since its EU-wide implementation in 2013, the black inverted triangle (▼) has marked medicines under additional monitoring. So, what is the black triangle in pharmacy? It's a key part of post-marketing drug surveillance designed to collect more real-world safety data after a product is authorized for widespread use.

Quick Summary

The black triangle in pharmacy signifies a medicine is under intensive monitoring for new safety information, prompting enhanced adverse reaction reporting to build a robust safety profile.

Key Points

Enhanced Surveillance: The black triangle signifies that a medicine is under additional, more intensive monitoring by regulatory authorities after its initial authorization.
Encourages Reporting: It serves as a prompt for healthcare professionals and patients to actively report any suspected adverse drug reactions (ADRs).
New or Newly Used Medicines: The symbol applies to new medicines, biosimilars, and existing medicines with new indications, delivery systems, or patient populations.
Not a Sign of Unsafety: The black triangle does not imply that a medicine is unsafe; rather, it highlights the need to collect more data from its widespread use.
Located in Leaflets: The symbol is found inside the patient information leaflet and the Summary of Product Characteristics, not on the outer packaging.
Limited Real-World Data: Its purpose is to gather more information on potential rare or long-term side effects that may not have been identified during limited clinical trials.
Temporary Status: The status is temporary, lasting until the medicine's safety profile is deemed sufficiently established through collected reports.

Understanding Additional Monitoring

In the European Union, the United Kingdom, and Australia, a black inverted triangle (▼) is used to denote that a medicine is under additional monitoring. This is a crucial element of pharmacovigilance, the science relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. Before a new medicine is authorized for public use, it undergoes rigorous testing through clinical trials involving a limited number of patients for a defined period. While these trials establish the drug's efficacy and reveal common side effects, they cannot always detect rare or long-term adverse reactions that may only become apparent when the medicine is used by a much larger and more diverse patient population.

Additional monitoring serves as a vital safeguard. It acts as a prompt for healthcare professionals and patients to pay close attention and report any suspected adverse reactions, no matter how minor they may seem. This reporting helps regulatory bodies, such as the European Medicines Agency (EMA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Australia's Therapeutic Goods Administration (TGA), to build a comprehensive safety profile of the new product. It's important to stress that the black triangle does not mean the medicine is unsafe; rather, it indicates an increased interest in gathering further safety data.

Which Medicines Receive a Black Triangle?

A medicine is assigned a black triangle for several key reasons. These reasons are based on the need for more comprehensive real-world safety data following the initial clinical trials. The criteria for designating a medicine for additional monitoring include:

New Active Substances: Any medicine containing a new active substance that has been recently authorized for use.
Biosimilar Medicines: These are similar, but not identical, copies of an existing biological medicine. Additional monitoring helps gather data on any differences in safety and effectiveness in a wide population.
New Combinations: Medicines that combine two or more existing active substances into a new formulation.
New Routes of Administration: An existing medicine that is now approved for a different way of being administered, such as from an oral pill to an inhaled solution.
New Drug-Delivery Systems: The use of a new system to deliver a drug to the body.
New Patient Populations: When an established medicine is approved for use in a new group of patients, for example, extending the use of an adult medicine to children.

Where Will You Find the Black Triangle?

For patients, it's crucial to know that the black triangle symbol is not located on the outer packaging of the medicine. Instead, it is prominently displayed within the patient information leaflet (PIL) and the Summary of Product Characteristics (SmPC). The symbol is accompanied by standardized text that states: “▼ This medicinal product is subject to additional monitoring,” along with a reminder to report side effects. Healthcare professionals are also made aware of this status through prescribing guides like the British National Formulary (BNF) and electronic medicine compendiums.

The Role of Reporting Side Effects

The black triangle scheme's success hinges on the active participation of both healthcare professionals and patients in reporting adverse drug reactions (ADRs). This is a collective responsibility known as a yellow card scheme in the UK and Australia (related to reporting forms) and through national reporting systems in the EU. In the U.S., the equivalent reporting system is the FDA's MedWatch program. By reporting any suspected side effect, regardless of its severity or perceived connection to the medicine, users contribute to a larger dataset that regulatory agencies use to detect new safety concerns swiftly. This continuous feedback loop helps confirm the medicine's benefit/risk profile and ensures any previously unknown side effects are identified and addressed.

Black Triangle vs. Standard Drug Monitoring

All medicines are monitored after authorization, but the black triangle indicates a higher level of scrutiny. Here is a comparison:


Feature	Black Triangle Drug	Standard Drug
Monitoring Intensity	Intensively monitored; enhanced reporting encouraged.	Standard pharmacovigilance monitoring.
Information Availability	Limited data available from real-world, large-scale use.	Established, extensive data on safety profile.
Reporting Emphasis	Strong encouragement for healthcare professionals and patients to report all suspected side effects.	Reporting focused on serious or unusual suspected adverse reactions.
Symbol Presence	Inverted black triangle (▼) in the patient information leaflet and prescribing guides.	No specific symbol in the patient information leaflet indicating additional monitoring.
Status Duration	Temporary; reviewed periodically (e.g., after 2 years in the UK) and removed when safety is well-established.	Permanent authorization, with ongoing, but not intensified, surveillance.

How Long Does a Medicine Retain Its Status?

The black triangle status is not permanent. The period of additional monitoring depends on the regulatory assessment of the gathered data. For instance, in the UK, the MHRA typically reviews a product's status after two years, and the status is often retained for a period of five years. However, there is no fixed timeline, and the symbol is only removed once the safety profile of the medicine is considered sufficiently well-established. This ensures that regulators have a robust dataset before reducing the intensity of monitoring.

Conclusion

In summary, the black triangle in pharmacy is a signal for vigilance, not alarm. It marks a critical period of enhanced surveillance for newly authorized medicines or existing medicines used in new ways. By encouraging and enhancing the reporting of suspected side effects, the black triangle scheme ensures that patient safety remains the highest priority in the post-marketing phase of a medicine's lifecycle. Active participation in this reporting process by both patients and healthcare providers is essential for building a complete picture of a medicine's safety and effectiveness in the real world. For more information on the EU scheme, you can consult the European Medicines Agency's overview.

Frequently Asked Questions

No, a black triangle does not mean the medicine is unsafe. It indicates that the medicine is under 'additional monitoring' by regulatory bodies to gather more comprehensive safety data from real-world use.

You will find the inverted black triangle symbol (▼) inside the medicine's patient information leaflet and the Summary of Product Characteristics. It does not appear on the medicine's outer packaging.

You should report any suspected side effects to your doctor or pharmacist. You can also report directly to your country's national reporting system, such as the Yellow Card scheme in the UK or through MedWatch in the US.

Medicines are given black triangle status if they are new, biosimilar, have a new combination of active substances, a new route of administration, or are used in a new patient population. This is because more safety data is needed for these specific situations.

The black triangle scheme is primarily used in the European Union, the United Kingdom, and Australia. While the principle of additional monitoring is similar globally, other countries like the US use different systems for post-market surveillance.

The duration is not fixed. A medicine's status is reviewed periodically by regulatory agencies and is only removed once its safety profile is well-established through gathered reports.

A black triangle drug receives a higher level of intensive monitoring due to less real-world data, with strong encouragement for reporting all suspected side effects. A standard drug has an established safety profile and undergoes routine monitoring.