{
 "query": "levothyroxine",
 "ingredient": "levothyroxine",
 "slug": "levothyroxine",
 "rxcui": "10582",
 "brands": [
  "Synthroid",
  "Levoxyl",
  "Unithroid",
  "Euthyrox",
  "Tirosint",
  "Levo-T",
  "Thyquidity",
  "Ermeza"
 ],
 "names": [
  "levothyroxine",
  "levothyroxine sodium",
  "levothyroxine sodium anhydrous"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 309,
   "INTRAVENOUS": 13,
   "SUBLINGUAL": 5
  },
  "boxed_warning": "WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine 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 ( ) , 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 Levothyroxine Sodium Tablets 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 ( , 10 ).",
  "indications_and_usage": "Hypothyroidism Levothyroxine Sodium Tablets are 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 Levothyroxine Sodium Tablets are 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 \u2022 Levothyroxine Sodium Tablets are 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 Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions ( 5.1 )] . \u2022 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. Levothyroxine Sodium Tablets are L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for: \u2022 Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary...",
  "contraindications": "Levothyroxine Sodium Tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.4)] . \u2022 Uncorrected adrenal insufficiency ( 4 )",
  "warnings_and_cautions": "\u2022 Serious risks related to overtreatment or undertreatment with Levothyroxine Sodium Tablets: Titrate the dose of Levothyroxine Sodium Tablets carefully and monitor response to titration. ( 5.1 ) \u2022 Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate Levothyroxine Sodium Tablets at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. ( 2.3 , 5.2 , 8.5 ) \u2022 Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. ( 5.3 ) \u2022 Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of Levothyroxine Sodium Tablets treatment. ( 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 mineral...",
  "warnings": "",
  "adverse_reactions": "Adverse reactions associated with Levothyroxine Sodium Tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions ( 5 ) and Overdosage ( 10 )] . They include the following: \u2022 General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating \u2022 Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia \u2022 Musculoskeletal: tremors, muscle weakness, muscle spasm \u2022 Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest \u2022 Respiratory: dyspnea \u2022 Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests \u2022 Dermatologic: hair loss, flushing, rash \u2022 Endocrine: decreased bone mineral density \u2022 Reproductive: menstrual irregularities, impaired fertility Seizures have been reported rarely with the institution of levothyroxine therapy. Adverse Reactions in Pediatric Patients Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage () 11/2023 Dosage and Administration ( 2.2 , 2.3 ) 11/2023 Warnings and Precautions ( 5.1 , 5.4 ) 11/2023",
  "information_for_patients": "Inform the patient of the following information to aid in the safe and effective use of Levothyroxine Sodium Tablets: Dosing and Administration \u2022 Instruct patients to take Levothyroxine Sodium Tablets only as directed by their healthcare provider. \u2022 Instruct patients to take Levothyroxine Sodium Tablets as a single dose, preferably on an empty stomach, one-half to one hour before breakfast. \u2022 Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take Levothyroxine Sodium Tablets within 4 hours of these agents. \u2022 Instruct patients to notify their healthcare provider if they are pregnant or breastfeeding or are thinking of becoming pregnant while taking Levothyroxine Sodium Tablets. Important Information \u2022 Inform patients that it may take several weeks before they notice an improvement in symptoms. \u2022 Inform patients that the levothyroxine in Levothyroxine 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 Levothyroxine Sodium Tablets should not be used as a primary or ...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "levothyroxine sodium",
  "manufacturer": "Preferred Pharmaceuticals, Inc.",
  "application_number": "NDA021116",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260521",
  "set_id": "3519c765-2077-4f23-8644-a6242ddbf743",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 435024,
  "serious": 283649,
  "death": 31445,
  "hospitalization": 133250,
  "primary_suspect": 433880,
  "top_reactions": [
   [
    "Fatigue",
    40115
   ],
   [
    "Nausea",
    29389
   ],
   [
    "Diarrhoea",
    27584
   ],
   [
    "Headache",
    26750
   ],
   [
    "Drug Ineffective",
    26056
   ],
   [
    "Off Label Use",
    22649
   ],
   [
    "Dyspnoea",
    21647
   ],
   [
    "Dizziness",
    20675
   ],
   [
    "Pain",
    20358
   ],
   [
    "Asthenia",
    18325
   ],
   [
    "Arthralgia",
    18137
   ],
   [
    "Malaise",
    17144
   ],
   [
    "Fall",
    15852
   ],
   [
    "Vomiting",
    15813
   ],
   [
    "Insomnia",
    13300
   ]
  ],
  "by_year": {
   "2019": 41623,
   "2020": 41002,
   "2021": 35395,
   "2022": 33560,
   "2023": 30547,
   "2024": 21841,
   "2025": 30783,
   "2026": 15221
  },
  "by_year_primary": {
   "2019": 41596,
   "2020": 40971,
   "2021": 35261,
   "2022": 33293,
   "2023": 30291,
   "2024": 21725,
   "2025": 30590,
   "2026": 15128
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260806",
   "reason": "Subpotent Drug",
   "firm": "ACCORD HEALTHCARE, INC.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 96,
 "drugsfda": {
  "applications": 34,
  "nda": 14,
  "anda": 20,
  "first_approval": "20000821",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 37,
  "labeling_recent": 9,
  "sponsors": [
   "ABBVIE",
   "ACCORD HLTHCARE",
   "ALEMBIC",
   "ALVOGEN",
   "AMNEAL",
   "ANI PHARMS",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/21/2000"
 },
 "trials": {
  "total": 338,
  "completed": 199,
  "terminated": 28,
  "with_results": 45,
  "industry": 48,
  "phase3": 37,
  "results_share": 0.22613065326633167,
  "terminated_share": 0.08284023668639054
 },
 "pubmed": {
  "rct": 175,
  "meta": 57,
  "recent_rct": 41,
  "cochrane": [
   {
    "pmid": "24941398",
    "title": "Levothyroxine or minimally invasive therapies for benign thyroid nodules",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 579638.3300000001,
  "records": 24141,
  "by_name": [
   [
    "Synthroid",
    232611.76
   ],
   [
    "Tirosint",
    214536.76
   ],
   [
    "Unithroid",
    132489.81
   ]
  ],
  "names_checked": [
   "levothyroxine",
   "Synthroid",
   "Levoxyl",
   "Unithroid",
   "Euthyrox",
   "Tirosint",
   "Levo-T",
   "Thyquidity",
   "Ermeza"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 48650486,
  "beneficiaries": 10236905,
  "spend": 842684081.2399999,
  "by_brand": [
   {
    "brand": "Levothyroxine Sodium",
    "claims": 43253940,
    "per_claim": 10.732443438,
    "is_generic": true
   },
   {
    "brand": "Synthroid",
    "claims": 4990576,
    "per_claim": 69.750026614,
    "is_generic": false
   },
   {
    "brand": "Levoxyl",
    "claims": 157517,
    "per_claim": 38.741789521,
    "is_generic": false
   },
   {
    "brand": "Unithroid",
    "claims": 94138,
    "per_claim": 44.028191272,
    "is_generic": false
   },
   {
    "brand": "Euthyrox",
    "claims": 69130,
    "per_claim": 7.0092667438,
    "is_generic": false
   },
   {
    "brand": "Tirosint",
    "claims": 63867,
    "per_claim": 259.65710085,
    "is_generic": false
   },
   {
    "brand": "Tirosint-Sol",
    "claims": 11238,
    "per_claim": 231.54154832,
    "is_generic": false
   },
   {
    "brand": "Levo-T",
    "claims": 9029,
    "per_claim": 19.80184295,
    "is_generic": false
   },
   {
    "brand": "Thyquidity",
    "claims": 984,
    "per_claim": 261.43466463,
    "is_generic": false
   },
   {
    "brand": "Ermeza",
    "claims": 67,
    "per_claim": 259.91701493,
    "is_generic": false
   }
  ],
  "per_claim": 17.321185265035172
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "levothyroxine",
  "matched": "levothyroxine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 67443,
  "fills": 48650486,
  "per_million": 1386.275976770304,
  "ratio": 0.5006504631846851,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,386 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "175 randomized trials and 57 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "Only 23% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 80,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 68 Class II, 2 Class III across 20 generic makers (-7)",
    "9 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $579,638 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (20 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 71,
 "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, nausea, diarrhoea, headache. 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.)"
 ]
}