Adverse reaction notification

Adverse Reaction Notification

Unintended reaction to a medicinal product:


  • Adverse reaction;
  • Severe adverse reaction;
  • Unexpected adverse reaction
  • Abuse;
  • Dosage error;
  • Misuse of medicines;
  • Off-label use;
  • Overdose;
  • Occupational exposure;
  • Lack of therapeutic effect.




  • Related to the outcome of the adverse reaction, being defined by the criteria described for a severe adverse reaction.


  • Based on the intensity of the adverse reaction, being classified as moderate and severe.


  • Refers to the clinical judgment that evaluates the possibility of a product / drug being responsible for the appearance of an adverse reaction. Once a causal link is established, a decision will be taken which will eventually result in a communication to the Competent Authorities and other health professionals, which will lead to the implementation of appropriate safety measures.

    Spontaneous Notification

  • Spontaneous reporting of adverse reactions by healthcare professionals and patients represents valuable information that needs to be collected, interpreted and then returned to the medical community and patients. This ensures access to the correct and updated information on drug safety. This allows the detection of more rare or specific adverse effects related to certain ethnies, geographic regions or diverse clinical contexts. Assessment of safety signals is essential in the notification process.