Medication Guide: The FDA Handout for Patients | Dose Track
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Medication guide

Also called Medication Guide, MG, patient labeling · Reviewed

Definition: A Medication Guide is FDA-approved patient labeling that must be handed to the patient with certain prescription drugs. FDA requires one when patient labeling could help prevent serious side effects, when a serious risk could change a decision to use the drug, or when following directions closely is crucial.

When FDA requires one

FDA lists three reasons a drug gets a Medication Guide:

  • patient labeling could help prevent serious adverse reactions;
  • the drug has serious risks, relative to its benefits, that could affect a patient's decision to start or keep using it;
  • patient adherence to the directions is crucial to the drug working.

The drug company writes it and FDA approves it. It must be given in paper form when the drug is dispensed, though a patient may ask for an electronic copy instead. The rules are in 21 CFR 208.

How it differs from other leaflets

FDA-approved patient labeling comes in three kinds: Medication Guides, Patient Package Inserts and Instructions for Use. Not every prescription drug has any of them. The printed sheets many pharmacies staple to the bag are different again. FDA calls those consumer medication information and says it does not review or approve them.

The Fosamax label, for example, is published as prescribing information plus a Medication Guide in one document.

Why it matters for your log

The Medication Guide is written in plain language and lists the warning signs the maker wants you to act on. It is a short companion to the full prescribing information, not a replacement.

Read more on Dose Track: Side effects from FDA labels · Fosamax side effects

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
Prescribing informationPrescribing information is the FDA-approved label for a prescription drug, written mainly for health care… Boxed warningA boxed warning is a warning printed inside a border at the top of a US prescription drug label. FDA uses… Off-label useOff-label use is using an FDA-approved drug in a way its label does not cover: for a different condition,…

Frequently asked questions

Is the pharmacy printout a Medication Guide?+
Not usually. FDA calls those sheets consumer medication information and does not review or approve them. A Medication Guide is FDA-approved labeling.
Do all prescription drugs have a Medication Guide?+
No. FDA requires one only for certain drugs, based on serious risks or the need to follow directions closely.

Sources

  1. FDA: Patient labeling resources (Medication Guides, Patient Package Inserts, Instructions for Use)
  2. Fosamax (alendronate) US prescribing information, DailyMed

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