• For “new” drugs - report all suspected reactions, including minor ones. (In many countries drugs are still considered “new” up to five years after marketing authorization);
• For established or well-known drugs - report all serious or unexpected (unusual) suspected ADRs;
• Report if an increased frequency of a given reaction is observed;
• Report all suspected ADRs associated with drug-drug, drug-food or drug-food supplements (including herbal and complementary products) interactions;
• Report ADRs in special fields of interest such as drug abuse and drug use in pregnancy and during lactation;
• Report when suspected ADRs are associated with drug withdrawals;
• Report ADRs occurring from overdose or medication error;
• Report when there is a lack of efficacy or when suspected pharmaceutical defects are observed.
Thus, report all suspected adverse reactions that you consider of clinical importance as soon as possible!