Prescription medicine
Thyrotropin alfa Brand names: Thyrogen
Thyrotropin alfa (Thyrogen) is a prescription medicine with an FDA approval on record since 1998. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the thyrotropin alfa FDA label on DailyMed (effective February 24, 2023, Genzyme Corporation); the BLA 20898 record on Drugs@FDA; every thyrotropin alfa label on DailyMed.
Highlights of the record
FDA label of February 24, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTHYROGEN ® is a thyroid stimulating hormone indicated for: Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.
Forms and strengths
- 0.9 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- November 30, 1998 Thyrogen, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest February 16, 2016
- FAERS reports
- 1,027 through July 30, 2026
What is thyrotropin alfa used for?
From the label: indications and usageTHYROGEN ® is a thyroid stimulating hormone indicated for: Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. ( 1.1 ) Limitations of Use: THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal. Even when THYROGEN-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease. […]
FDA pharmacologic class: Thyroid Stimulating Hormone.
Source: FDA drug label (Thyrogen), Genzyme Corporation, effective February 24, 2023 (SPL set b52dfa36-f90b-4e19-9b5e-26db9d04df2b), via openFDA; the full label on DailyMed
Is there a generic for thyrotropin alfa (Thyrogen)?
No generic thyrotropin alfa is approved (Drugs@FDA, October 8, 2026).
- 1998 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has thyrotropin alfa been recalled?
The FDA's Enforcement Report lists 1 recall naming thyrotropin alfa since 2016: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 16, 2016 | Class II | Genzyme Corporation | Presence of Particulate Matter: Glass particles found in the product after reconstitution. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for thyrotropin alfa?
The FDA Adverse Event Reporting System holds 1,027 reports that list thyrotropin alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 161 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Thyrotropin alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other