FDA label
What is Synthroid used for?
Synthroid contains levothyroxine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Hypothyroidism”
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Synthroid, tablet
Indications and Usage, quoted from the label by AbbVie Inc. (NDA021402). Cross-references to other label sections are left out.
Hypothyroidism
SYNTHROID is indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid -Stimulating Hormone, TSH) Suppression
SYNTHROID is indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use
- SYNTHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with SYNTHROID may induce hyperthyroidism.
- SYNTHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Source: DailyMed label, set id 1e11ad30-1041-4520-10b0-8f9d30d30fcc, version 1537, effective February 20, 2024. NDC 0074-3727, one of 12 listings for this product.
Questions
What is Synthroid used for?
The FDA label says: “Hypothyroidism”
What drug class is Synthroid?
FDA lists levothyroxine in the l-Thyroxine established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Synthroid
- Is Synthroid a controlled substance?Federal schedule
- Generic for SynthroidFDA Orange Book
- What is Levothyroxine used for?FDA label uses
- Is Levothyroxine a controlled substance?Federal schedule
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- Generic for ThyquidityFDA Orange Book
- Generic for Tirosint-solFDA Orange Book
- Generic for Levo-tFDA Orange Book
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- Generic for LevoxylFDA Orange Book
- Generic for Thyro-tabsFDA Orange Book
- Generic for UnithroidFDA Orange Book
- L-Thyroxines listFDA drug class
- Synthroid Medicare Part D coverageBy plan and state
- NDC 0074-3727Synthroid NDC record
- NDC 0074-4341Synthroid NDC record