Public record

Liothyronine: the public record

7 tables from US federal sources. Latest data date: Nov 11, 2026.

Each table is computed from the named federal dataset as of its data date; the method is under each one.

Label

FDA label facts for liothyronine

The FDA label read for liothyronine (Liothyronine Sodium, application NDA010379) was last revised on 2026-06-04. It carries a boxed warning headed "WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.

FDA label facts for liothyronine: the figures
MeasureValueNote
Label revision date2026-06-04
Label readLiothyronine SodiumNDA010379, brand-name application
Boxed warningYesheading as printed: "WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS"
Pregnancy sectionPresent
Lactation sectionPresent
Pediatric use sectionPresent
Geriatric use sectionPresent

Source: FDA drug label via openFDA, viewable on NIH DailyMed, data as of Nov 11, 2026

How this was calculated

Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.

Scope: One label: the newest prescription label for single-ingredient liothyronine from an original manufacturer

Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.

Download the data (CSV)

Approvals

FDA approval history for liothyronine

The earliest FDA approval on file for a liothyronine product is 1956-05-08. Drugs@FDA lists 12 applications for it and 24 approved supplements, the most recent on 2025-08-01.

FDA approval history for liothyronine: the figures
MeasureValueNote
Earliest FDA approval on file1956-05-08
Applications with an approval on file12
New drug applications (NDA)2
Generic applications (ANDA)10
Approved supplements24label, manufacturing and efficacy changes
Most recent supplement approval2025-08-01
Sponsoring companies11

Source: FDA, Drugs@FDA, data as of Nov 11, 2026

How this was calculated

Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.

Scope: Applications with a single-ingredient liothyronine product in Drugs@FDA, all sponsors and strengths

Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.

Download the data (CSV)

Patents and generics

Patents and generic approvals for liothyronine

The FDA Orange Book lists 10 approved generic applications for liothyronine, the first approved on 1982-01-25. No unexpired patents are listed for it.

Patents and generic approvals for liothyronine: the figures
MeasureValueNote
Brand-name applications (NDA)2
Approved generic applications (ANDA)10first approved 1982-01-25
Companies with a generic not marked discontinued7
Listed patents not yet expired0
Earliest approval date on filebefore 1982
Products not marked discontinued22 of 28

Source: FDA, Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), data as of Oct 9, 2026

How this was calculated

Selected Orange Book products whose only active ingredient is this substance, then counted applications by type and the distinct patents and exclusivities listed against them. Expired patents are left out.

Scope: All single-ingredient liothyronine products in the Orange Book, every brand and strength, files dated 2026-10-09

An approved generic or an expired patent does not show that a generic is on sale. Launch timing also depends on litigation, settlements and supply. Biologics and compounded products are not in the Orange Book.

Download the data (CSV)

Medicare Part D

Medicare Part D spending on liothyronine

Medicare Part D spending on liothyronine products was $29.7M in 2024 across 757,453 claims, compared with $37.3M in 2023 (-20.4%). Average spending per claim was $39.16, before rebates.

Medicare Part D spending on liothyronine: the figures
MeasureValueNote
Total spending, 2024$29.7M
Total spending, 2023$37.3M
Change in spending, 2023 to 2024-20.4%
Claims (prescription fills), 2024757,453
Average spending per claim, 2024$39.16
Liothyronine Sodium*: spending, 2024$29.3M748,503 claims
Cytomel: spending, 2024$414,4788,950 claims

Source: CMS, Medicare Part D Spending by Drug, data as of 2024

How this was calculated

Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.

Scope: Every single-ingredient liothyronine product in Part D (Liothyronine Sodium*, Cytomel), 2024.

Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.

Download the data (CSV)

Adverse event reports

Most reported events in FDA adverse event reports for liothyronine

Through 2026-10-28, FDA had received 11,357 adverse event reports for liothyronine, 5,471 of them marked serious by the reporter. The symptom terms named most often were fatigue (1,136), headache (1,097) and nausea (809).

Most reported events in FDA adverse event reports for liothyronine: the figures
MeasureValueNote
All reports received11,357
Reports the reporter marked serious5,471death, hospitalisation, disability or similar outcome
Fatigue1,136 reports
Headache1,097 reports
Nausea809 reports
Dyspnoea639 reports
Pain616 reports

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, data as of Oct 28, 2026

How this was calculated

Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example drug ineffective) were left out of the list.

Scope: Reports where FDA recorded liothyronine as a single-ingredient active substance (any brand), all years to 2026-10-28

FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.

Download the data (CSV)

Recalls

FDA drug recalls naming liothyronine

FDA enforcement reports list 50 drug recall entries naming liothyronine from 2013 to 2023-12-20. 46 of them are for compounded or other unlisted products and 4 for products FDA lists under a label. The most common stated reason was potency out of specification (26 of 50).

FDA drug recalls naming liothyronine: the figures
MeasureValueNote
Recall entries on record50
For products FDA lists under an approved or registered label4
For compounded or other unlisted products46matched by the name in the product description
Class I (most serious)11
Class II38
Class III1
Most recent recall reported2023-12-20
Most common stated reasonpotency out of specification26 of 50 entries

Source: FDA, Enforcement Reports (drug recalls) via openFDA, data as of Nov 10, 2026

How this was calculated

Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.

Scope: Recalls of single-ingredient liothyronine products, plus compounded or unlisted products whose description names it

Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.

Download the data (CSV)

Clinical studies

Registered clinical studies of liothyronine

ClinicalTrials.gov lists 908 registered studies that name liothyronine as an intervention as of 2026-11-11. Of these, 117 are recruiting, 485 are completed and 46 are phase 3 studies.

Registered clinical studies of liothyronine: the figures
MeasureValue
Registered studies908
Recruiting now117
Not yet recruiting50
Completed485
Terminated, withdrawn or suspended60
Phase 3 (including phase 2/3)46
Phase 2 (including phase 1/2)92
Phase 166

Source: NIH National Library of Medicine, ClinicalTrials.gov, data as of Nov 11, 2026

How this was calculated

Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.

Scope: Studies whose intervention field matches liothyronine, any condition, any country, all statuses

A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.

Download the data (CSV)

Articles on Liothyronine