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Intentional excessive use of one or more medicines without a therapeutic purpose and without a prescription, which can be persistent or sporadic, accompanied by harmful physical or psychological effects.

It is the exposure of the fetus/baby/child to a drug via the father (during conception) or mother (during conception, pregnancy, childbirth or breastfeeding) Cases of exposure via the father/mother must be reported with or without a reaction.

Any harmful or undesirable, unintentional response to a medicine, occurring in the doses usually used in humans for prophylaxis, diagnosis, therapy of disease or for the modification of physiological functions. Unlike the Adverse Event, the Adverse Reaction is characterized by the suspicion of a causal relationship between the medicine and the harmful or undesirable response. For reporting purposes, if an event is reported spontaneously, even if the relationship is unknown or undeclared, it meets the definition of an adverse reaction.

Any unfavorable medical event that may occur during treatment with a medicine, associated with a technical complaint involving the same medicine (e.g. changes in color, odor, taste, consistency).

Absence or reduction of the expected therapeutic response of the medicine, under the conditions of use indicated in the package leaflet.

Use of medicine in doses higher than the maximum recommended dose, i.e. in excess of the recommended dose.

Any preventable event that may cause or lead to the inappropriate use of medicines, or cause harm to a patient, while the medication is under the control of healthcare professionals, patients or consumers, involving unintentional use, with a therapeutic purpose, and may or may not have a prescription. This event can be related to professional practice, health products, procedures and systems, including prescription, verbal guidance, labeling, packaging and nomenclature of industrialized and manipulated products, dispensing, distribution, administration, education, monitoring and use.

Pharmacological, toxicological, clinical or laboratory response caused by the combination of the medicine with other medicines. It can also result from the medicine's interaction with food, chemical substances or diseases. The reliability of laboratory test results can be affected by drug interactions. Drug interaction can result in an increase or decrease in therapeutic effectiveness or the appearance of new related adverse events.

This includes intentional use in situations that differ from the leaflet of a medicine registered with Anvisa, for therapeutic purposes and on prescription. This can include differences in indication, age/weight range, dose, frequency, presentation or route of administration.