Pharmacovigilance · Pharmacology

An adverse drug reaction (ADR) is best defined as:

  1. An unintended effect at normal therapeutic doses
  2. Any medication error during drug prescribing or administration
  3. A predictable pharmacological effect
  4. A placebo-related response
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Correct answer: An unintended effect at normal therapeutic doses

An adverse drug reaction is a harmful and unintended response to a drug at normal doses used for prophylaxis, diagnosis, or treatment. It excludes overdose, misuse, or medication errors unless specifically defined otherwise.

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