Adverse Event

Evento Adverso

In 9 languages

LanguageTerm
EnglishAdverse Event
Spanish (Español) Evento Adverso
Chinese (中文) 不良事件
Korean (한국어) 이상 반응
Vietnamese (Tiếng Việt) Sự cố bất lợi
Filipino (Tagalog) Masamang Kaganapan
Portuguese (Português) Evento Adverso
Thai (ภาษาไทย) เหตุการณ์ไม่พึงประสงค์
Japanese (日本語) 有害事象

What it means

An adverse event is any unexpected or harmful medical occurrence that happens during or after a medical treatment, drug therapy, or clinical trial—whether or not it is caused by the treatment itself. Examples include an unexpected drug side effect, an allergic reaction, a fall in the hospital, or a new symptom that develops during a study. Healthcare providers and clinical trial sponsors are required to report serious adverse events to the FDA and relevant oversight boards. If you experience an unexpected health problem during treatment, report it to your doctor immediately. You may also file a report with the FDA's MedWatch program. Adverse events can affect your insurance coverage if the event leads to additional medical care.

How to say it

Sentences a patient might use with a doctor, nurse, pharmacist, or insurer:

I reported an adverse event to my doctor after starting the new medication.

Informé un evento adverso a mi médico después de comenzar el nuevo medicamento.

The clinical trial team said they must report any adverse event to the FDA.

El equipo del ensayo clínico dijo que deben reportar cualquier evento adverso a la FDA.

My insurer denied the claim, saying the hospitalization was due to an adverse event.

Mi aseguradora negó el reclamo, diciendo que la hospitalización fue por un evento adverso.

Where you'll see it

clinical trial consent formFDA MedWatch reporthospital incident reportmedical records

Related terms

Sources

US Glossary Español A–Z US Codes United States

Last reviewed: September 2026