pharmacopeia
GET
/api/v1/drug/liothyronine

Boxed warning

NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including liothyronine sodium tablets, 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 liothyronine sodium tablets, 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 ).

2D structure
(2S)-2-amino-3-[4-(4-hydroxy-3-iodophenoxy)-3,5-diiodophenyl]propanoic acid
SMILES C1=CC(=C(C=C1OC2=C(C=C(C=C2I)C[C@@H](C(=O)O)N)I)I)O
InChIKey AUYYCJSJGJYCDS-LBPRGKRZSA-N

Mechanism of action

Sourced from openFDA

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA.

Thyroid Hormone Receptor

Indications

Sourced from openFDA
  • Liothyronine sodium tablets are an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyrotropin (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.ICD-10: E03.9, E05.90

Contraindications

Sourced from openFDA
  • Liothyronine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ] .contraindicated

Dosage & administration

Sourced from openFDA

Administer liothyronine sodium tablets orally once daily and individual dosage according to patient response and laboratory findings ( 2.1 ) See full prescribing information for recommended dosage for hypothyroidism ( 2.2 ) TSH suppression in well-differentiated thyroid cancer ( 2.3 ) and for thyroid suppression test ( 2.4 ) When switching a patient to liothyronine sodium tablets, discontinue levothyroxine therapy and initiate liothyronine sodium tablets at a low dosage. Gradually increase the dose according to the patient's response ( 2.5 ) Adequacy of therapy determined with periodic monitoring of TSH and T3 levels as well as clinical status ( 2.6 ) 2.1 General Principles of Dosing The dose of liothyronine sodium tablets for hypothyroidism or pituitary Thyroid-Stimulating Hormone (TSH) suppression depends on a variety of factors including: the patient's age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food and the specific nature of the condition being treated [see Dosage and Administration (2.2 , 2.3 , 2.4) , Warnings and Precautions (5) , and Drug Interactions (7) ] . Dosing must be individualized to account for these factors and dose adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters [see Dosage and Administration (2.4) ] . Administer liothyronine sodium tablets orally once daily. 2.2 Recommended Dosage for Hypothyroidism Adults The recommended starting dosage is 25 mcg orally once daily.

Warnings & precautions

Sourced from openFDA

Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate liothyronine sodium tablets at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation ( 2.3 , 5.1 , 8.5 ) Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. ( 5.2 ) Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of liothyronine sodium tablets treatment ( 5.3 ) Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism. ( 5.4 ) Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy ( 5.5 ) Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density.

Adverse reactions

Sourced from openFDA

Adverse reactions associated with liothyronine sodium tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4) and Overdosage (10) ] . They include the following: General : fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating Central nervous system : headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia Musculoskeletal : tremors, muscle weakness and cramps Cardiovascular : palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest Respiratory : dyspnea Gastrointestinal : diarrhea, vomiting, abdominal cramps, elevations in liver function tests Dermatologic : hair loss, flushing Endocrine : decreased bone mineral density Reproductive : menstrual irregularities, impaired fertility Most common adverse reactions for liothyronine sodium tablets are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Adverse Reactions in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving thyroid replacement therapy.

Use in specific populations

Sourced from openFDA

Pregnancy may require the use of higher doses of thyroid hormone ( 2.2 , 8.1 ) 8.1 Pregnancy Risk Summary Experience with liothyronine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see Data ). There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy. Since TSH levels may increase during pregnancy, TSH should be monitored and liothyronine sodium tablets dosage adjusted during pregnancy (see Clinical Considerations ) . There are no animal studies conducted with liothyronine during pregnancy. Liothyronine sodium tablets should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Maternal hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, gestational hypertension, pre-eclampsia, stillbirth, and premature delivery.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption T3 is almost totally absorbed, 95 percent in 4 hours. The hormones contained in the natural preparations are absorbed in a manner similar to the synthetic hormones.

Overdosage

Sourced from openFDA

The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5.4) and Adverse Reactions (6) ] . In addition, confusion and disorientation may occur. Cerebral embolism, seizure, shock, coma, and death have been reported. Symptoms may not necessarily be evident or may not appear until several days after ingestion. Reduce the liothyronine sodium tablets dose or temporarily discontinued if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

Approval history

Sourced from openFDA
  • May 8, 1956NDANDA010379King Pharms
  • Aug 17, 2005ANDAANDA076923Xgen Pharms
  • Mar 20, 2009ANDAANDA090097Dr Reddys Labs Sa
  • Nov 29, 2012ANDAANDA200295Sigmapharm Labs Llc
  • Apr 20, 2016ANDAANDA091382Sun Pharm
  • Oct 26, 2018ANDAANDA211510Teva Pharms Usa
  • Jan 22, 2021ANDAANDA214803Zydus Lifesciences
  • Feb 6, 2024ANDAANDA218070Biocon Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
8,569 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective95211%
  2. 2Headache87510%
  3. 3Fatigue8379.8%
  4. 4Nausea5786.7%
  5. 5Dyspnoea5556.5%
  6. 6Pain4795.6%
  7. 7Hypertension4645.4%
  8. 8Malaise4395.1%
  9. 9Weight Increased4375.1%
  10. 10Hypothyroidism4295.0%
  11. 11Feeling Abnormal4194.9%
  12. 12Dizziness3944.6%
  13. 13Diarrhoea3844.5%
  14. 14Off Label Use3644.2%
  15. 15Asthma3544.1%

Literature

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Recent PubMed references pinned to Liothyronine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 863 ClinicalTrials.gov registrations naming Liothyronine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Liothyronine work?
Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA.
What is Liothyronine used for?
According to FDA labeling, Liothyronine carries indications including: Liothyronine sodium tablets are an L-triiodothyronine (T3) indicated for: Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) Pituitary Thyrotropin (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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Liothyronine?
Liothyronine is classified as l-Triiodothyronine, Thyroid Hormone Receptor Agonists, Cellular Synthetic Activity Alteration, Increased Gluconeogenesis, Increased Metabolic Rate.
What are the brand names for Liothyronine?
Liothyronine is marketed under brand names including Cytomel, Liomny, Thyrolar.
What are the contraindications for Liothyronine?
Liothyronine labeling lists contraindications including: Liothyronine sodium tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ] .. Always consult the full prescribing information and a clinician.
Note. Data for liothyronine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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