FDA label

What is Tirosint used for?

Tirosint 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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Tirosint, capsule

Indications and Usage, quoted from the label by IBSA Pharma Inc. (NDA021924). Cross-references to other label sections are left out.

Hypothyroidism
TIROSINT is indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
TIROSINT is indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
TIROSINT 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 TIROSINT may induce hyperthyroidism.
TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

Source: DailyMed label, set id 7a7ade79-0165-4e31-b84e-667416c00c7e, version 13, effective March 25, 2026. NDC 71858-0005, one of 15 listings for this product.

Tirosint, solution

Indications and Usage, quoted from the label by IBSA Pharma Inc. (NDA206977). Cross-references to other label sections are left out.

Hypothyroidism
TIROSINT-SOL 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
TIROSINT-SOL 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
Tirosint-SOL 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 TIROSINT-SOL may induce hyperthyroidism.
Tirosint-SOL is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

Source: DailyMed label, set id 5d378add-f13d-40f2-99dc-0f2340ab44b7, version 18, effective March 27, 2026. NDC 71858-0105, one of 15 listings for this product.