What is an “off-label” drug?

Off-label drugs are medications that have been approved by the FDA for one specific condition, but are sometimes used by doctors for other purposes. While this is not uncommon, it is important to note that using a medication off-label may carry additional risks or side effects.

One example of this is sildenafil, also known as Viagra, which is FDA-approved in 25mg, 50mg, and 100mg doses for erectile dysfunction (ED). However, it is also approved in a 20mg tablet for treating pulmonary arterial hypertension. In some cases, doctors may prescribe five 20mg tablets of sildenafil instead of a 100mg Viagra tablet, which can be more cost-effective for patients. It's important to consult with a doctor before taking any medication, especially if it's being used off-label.

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