Indication is a medical condition for which a medicine is used. This can include the treatment, prevention, and diagnosis of a disease. For example, diabetes mellitus is the indication for Insulin. A drug may be indicated for multiple conditions, e.g., the drug Methotrexate is indicated in the treatment of certain cancers, rheumatoid arthritis, and lupus. At least one indication is listed on the drug label for each medication ( on-label indications). Still, many medications are also used to treat or prevent conditions not explicitly listed on the drug label ( off-label indications). On-label indications are FDA-approved, while off-label are not. Manufacturers cannot market their drugs for indications that the FDA has not approved. For example, the antidepressant Amitriptyline is used off-label for treating fibromyalgia.
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