Like pharmaceuticals, the FDA requires dietary supplement manufacturers to report any known adverse drug events, reactions, side effects and medication errors. Confusion is caused when these terms are used interchangeably. Though they seem similar, the terms do have different meanings.
Adverse Drug Events (ADE)
An Adverse Drug Event is any injury resulting from the use of a drug or supplement. This includes any improper use of the product, such as an overdose or an error in the prescription.
Adverse Drug Reaction (ADR)
An Adverse Drug Reaction is direct harm caused by the drug or supplement taken at normal dose. An example of an Adverse Drug Reaction would be a rash.
The term Side Effect is often used interchangeably with Adverse Drug Reaction, but Side Effects are known and expected reactions that can occur with normal dosage. Any effects other than the therapeutic outcome, such as tiredness, are Side Effects. Unlike ADEs and ADRs, Side Effects aren’t likely to inflict serious harm.
Medication Errors occur in the prescribing, administering or adherence to following instructions of taking the drug by the patient. Medication Errors may not necessarily cause harm, but when they do, the ADE or ADR must be documented and reported.