LABELS · 5c1150d8-903d-4c39-aa66-5a095ee1b00a

Cytomel

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-05-18
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS • Thyroid hormones, including CYTOMEL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. • In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. • Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. • Thyroid hormones, including CYTOMEL, should not be used for the treatment of obesity or for weight loss. • Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity ( 6 , 7.7 , 10 ).

Indications and usage: exact source text

1 INDICATIONS AND USAGE CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) • Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) • Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) 1.1 Hypothyroidism CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyroid-Stimulating Hormone (TSH) Suppression CYTOMEL is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . 1.3 Thyroid Suppression Test CYTOMEL is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use • CYTOMEL 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 CYTOMEL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . • CYTOMEL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

Full extracted label fields

application numbers

NDA010379

boxed warning exact

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS • Thyroid hormones, including CYTOMEL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. • In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. • Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ] . WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS See full prescribing information for complete boxed warning. • Thyroid hormones, including CYTOMEL, should not be used for the treatment of obesity or for weight loss. • Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity ( 6 , 7.7 , 10 ).

brand names

Cytomel

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3

generic names

LIOTHYRONINE SODIUM

5c1150d8-903d-4c39-aa66-5a095ee1b00a

indications and usage exact

1 INDICATIONS AND USAGE CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) • Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) • Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy ( 1.3 ) Limitations of Use : - Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. ( 1 ) - Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. ( 1 ) 1.1 Hypothyroidism CYTOMEL is indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. 1.2 Pituitary Thyroid-Stimulating Hormone (TSH) Suppression CYTOMEL is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . 1.3 Thyroid Suppression Test CYTOMEL is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use • CYTOMEL 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 CYTOMEL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . • CYTOMEL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.

indications and usage tables exact

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Pfizer Laboratories Div Pfizer Inc

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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exact text: 1 INDICATIONS AND USAGE CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) • Pituitary Thyroid-Stimulating Hormone (TSH)
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exact text: oid cancer . 1.3 Thyroid Suppression Test CYTOMEL is indicated as a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Limitations of Use • CYTOMEL 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 CYTOMEL may induce hyperthyroidism [see Warnings and Precautions (5.4) ] . • CYTOMEL is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
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Preserved source evidence · Not medical advice