What the label lists and what reports show
Thyrotropin alfa side effects
Thyrotropin alfa's FDA label: “The most common adverse reactions (>5%) reported in clinical trials were nausea and headache.” FAERS holds 1,027 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (128 reports).
- No generic listed
Check it at the source: the thyrotropin alfa FDA label on DailyMed (effective February 24, 2023, Genzyme Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>5%) reported in clinical trials were nausea and headache.
Table 1: Summary of Adverse Reactions by THYROGEN and Thyroid Hormone Withdrawal in Pooled Clinical Trials (≥1% of Patients in any Phase)
| Preferred Term | THYROGEN (N=481) n (%) | Thyroid Hormone Withdrawal (N=418) n (%) |
|---|---|---|
| Nausea | 53 (11) | 2 (<1) |
| Headache | 29 (6) | 0 |
| Fatigue | 11 (2) | 2 (<1) |
| Vomiting | 11 (2) | 0 |
| Dizziness | 9 (2) | 0 (0.0) |
| Asthenia | 5 (1) | 1 (<1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions (>5%) reported in clinical trials were nausea and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to THYROGEN in 481 thyroid cancer patients who participated in a total of 6 clinical trials of THYROGEN: 4 trials for diagnostic use and 2 trials for ablation. In clinical trials, patients had undergone near-total thyroidectomy and had a mean age of 46.1 years. Thyroid cancer diagnosis was as follows: papillary (69.2%), follicular (12.9%), Hurthle cell (2.3%) and papillary/follicular (15.6%). Most patients received 2 intramuscular injections of 0.9 mg of THYROGEN injection gin 24 hours apart [see Clinical Studies (14.1 , 14.2) ]. The safety profile of patients who have undergone thyroidectomy and received THYROGEN as adjunctive treatment for radioiodine ablation of thyroid tissue remnants for well-differentiated thyroid cancer did not differ from that of patients who received THYROGEN for diagnostic purposes. …
Source: FDA drug label, Genzyme Corporation, effective February 24, 2023 (SPL set b52dfa36-f90b-4e19-9b5e-26db9d04df2b), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,027 reports list thyrotropin alfa among the medicines taken, 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. Of the 22 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Thyrotropin alfa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions