{
 "query": "liothyronine",
 "ingredient": "liothyronine",
 "slug": "liothyronine",
 "rxcui": "10814",
 "brands": [
  "Cytomel",
  "Liomny"
 ],
 "names": [
  "liothyronine",
  "liothyronine sodium"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 43,
   "INTRAVENOUS": 1
  },
  "boxed_warning": "WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS \u2022 Thyroid hormones, including LIOTHYRONINE SODIUM, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. \u2022 In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. \u2022 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. \u2022 Thyroid hormones, including liothyronine sodium, should not be used for the treatment of obesity or for weight loss. \u2022 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": "Liothyronine sodium is an L-triiodothyronine (T3) indicated for: \u2022 Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1.1 ) \u2022 Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer ( 1.2 ) \u2022 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 Liothyronine sodium 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 Liothyronine sodium is indicated as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer . 1.3 Thyroid Supp...",
  "contraindications": "Liothyronine sodium is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3) ] . Uncorrected adrenal cortical insufficiency ( 4 )",
  "warnings_and_cautions": "\u2022 Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate liothyronine sodium 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 ) \u2022 Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma ( 5.2 ) \u2022 Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of liothyronine sodium treatment ( 5.3 ) \u2022 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 ) \u2022 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 ) \u2022 Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mi...",
  "warnings": "",
  "adverse_reactions": "Adverse reactions associated with liothyronine sodium 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 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, menstru...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Dosing and Administration \u2022 Instruct patients that liothyronine sodium should only be taken as directed by their healthcare provider. \u2022 Instruct patients to notify their healthcare provider should they become pregnant or breastfeeding or are thinking of becoming pregnant, while taking liothyronine sodium. Important Information \u2022 Inform patients that the liothyronine in liothyronine sodium tablets is intended to replace a hormone that is normally produced by the thyroid gland. Generally replacement therapy is to be taken for life. \u2022 Inform patients that liothyronine sodium should not be used as a primary or adjunctive therapy in a weight control program. \u2022 Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations. \u2022 Instruct patients to notify their healthcare provider of any other medical conditions, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while taking liothyronine sodium. If patents are taking anticoagulants (blood thinners), their clotting ...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Liothyronine Sodium",
  "manufacturer": "Mylan Pharmaceuticals Inc.",
  "application_number": "NDA010379",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260604",
  "set_id": "115a84c2-0126-4dd7-816e-1873875f1e49",
  "has_boxed_warning": true,
  "boxed_labels": "26 of 26",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11126,
  "serious": 5355,
  "death": 313,
  "hospitalization": 2009,
  "primary_suspect": 11116,
  "top_reactions": [
   [
    "Drug Ineffective",
    1131
   ],
   [
    "Fatigue",
    1109
   ],
   [
    "Headache",
    1083
   ],
   [
    "Nausea",
    798
   ],
   [
    "Dyspnoea",
    630
   ],
   [
    "Off Label Use",
    619
   ],
   [
    "Pain",
    604
   ],
   [
    "Diarrhoea",
    539
   ],
   [
    "Malaise",
    537
   ],
   [
    "Hypertension",
    501
   ],
   [
    "Dizziness",
    497
   ],
   [
    "Weight Increased",
    486
   ],
   [
    "Feeling Abnormal",
    467
   ],
   [
    "Arthralgia",
    455
   ],
   [
    "Hypothyroidism",
    453
   ]
  ],
  "by_year": {
   "2019": 1028,
   "2020": 1101,
   "2021": 908,
   "2022": 1277,
   "2023": 847,
   "2024": 805,
   "2025": 785,
   "2026": 434
  },
  "by_year_primary": {
   "2019": 1028,
   "2020": 1101,
   "2021": 908,
   "2022": 1275,
   "2023": 846,
   "2024": 803,
   "2025": 785,
   "2026": 430
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20231204",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20231020",
   "reason": "Failed Impurities/Degradation Specifications.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20231020",
   "reason": "Failed Impurities/Degradation Specifications.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140422",
   "reason": "Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.",
   "firm": "SigmaPharm Laboratories LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 12,
  "nda": 2,
  "anda": 10,
  "first_approval": "19560508",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 0,
  "sponsors": [
   "BIOCON PHARMA",
   "DR REDDYS LABS SA",
   "KING PHARMS",
   "PH HEALTH",
   "PHARMOBEDIENT",
   "SIGMAPHARM LABS LLC",
   "SUN PHARM",
   "TEVA PHARMS USA"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/08/1956"
 },
 "trials": {
  "total": 901,
  "completed": 482,
  "terminated": 59,
  "with_results": 74,
  "industry": 118,
  "phase3": 46,
  "results_share": 0.15352697095435686,
  "terminated_share": 0.06548279689234185
 },
 "pubmed": {
  "rct": 28,
  "meta": 4,
  "recent_rct": 11,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "liothyronine",
   "Cytomel",
   "Liomny"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 757453,
  "beneficiaries": 196469,
  "spend": 29664663.16,
  "by_brand": [
   {
    "brand": "Liothyronine Sodium",
    "claims": 748503,
    "per_claim": 39.078247302,
    "is_generic": true
   },
   {
    "brand": "Cytomel",
    "claims": 8950,
    "per_claim": 46.31037095,
    "is_generic": false
   }
  ],
  "per_claim": 39.16370145738416
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2018,
  "fills": 757453,
  "per_million": 2664.191705623979,
  "ratio": 0.9621668656056118,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,664 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 21,
   "letter": "F",
   "why": [
    "28 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 15% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 10 generic makers (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (10 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, headache, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}