indication
Meaning of indication: Regulators approve drugs for named indications, yet prescribing outside that list is legal, common, and described as off-label use.
Definition of indication
An indication is the reason a treatment, test or procedure is used: the symptom, sign or diagnosed condition that justifies it in a particular situation. Describing a drug as indicated for something means it has an established, formally reviewed role there. The opposite term, contraindication, names a circumstance in which the same intervention is not appropriate.
How does an approved indication come about?
A company seeking approval for a medication submits evidence for one specific use in one defined population, usually from a clinical trial program designed around that question. If the regulator agrees, that wording enters the label. Everything on the label was tested; nothing else was. Adding a second indication later requires a fresh submission with its own evidence, which is why a drug in widespread use for one purpose may carry no approval at all for another purpose it is commonly used to serve.
What are the related terms?
| Term | What it means |
|---|---|
| Indication | A recognized reason to use the intervention |
| Off-label use | Use for a condition, age group or amount outside the approved label |
| Relative contraindication | A reason for caution; the benefit may still outweigh the risk |
| Absolute contraindication | A circumstance in which the intervention is not used at all |
Why does off-label use exist?
Approval follows commercial and regulatory incentives, while practice follows evidence wherever it accumulates. Older drugs whose patents expired have no sponsor willing to fund a new submission, so established uses never reach the label. Children are enrolled in trials far less often than adults, so a great deal of pediatric prescribing is off-label by necessity. Rare diseases rarely support a trial large enough to satisfy a regulator. Off-label therefore says nothing about whether an intervention works; it says the label has not been updated. The same logic applies beyond drugs, since a scan, an operation or a blood test each has situations in which it answers a real question and situations in which it adds only cost and incidental findings.
Used in a sentence
The medication's indication for this condition supported its inclusion in the treatment plan.
Good to know
A medication used outside its formally approved indications is described as being used off-label, a distinction that is separate from whether the medication is considered effective for that use in clinical practice.