Thyrotropin Alfa side effects: what 1,027 FDA adverse event reports show

Thyrotropin Alfa · Thyrogen · 22 reaction terms · 236 drug–reaction co-reports · data 2026-09-14

Drug class

Thyroid Stimulating Hormone

FDA label (Established Pharmacologic Class)

Brand names

Thyrogen

openFDA label

Who reports

1,027 reports · 34% serious · 23 with death outcome · 75% female

openFDA FAERS counts, all years, deduplication not applied

Used for

THYROGEN ® 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.

FDA label, Indications and Usage

What it is

Thyrotropin alfa, a recombinant human thyroid stimulating hormone, is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 21 strongest signals

Labeled adverse reaction 1Likely indication confounding 2Reporting / coding artifact 7Lab value / disease marker 3Not in label — unassessed 8

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug administered at inappropriate site	23	44.0 29.4–65.9ROR 45.0 · χ² 922 / p 7e-203	42.5 EB05 29.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Blood thyroid stimulating hormone increased	18	39.9 25.2–63.1ROR 40.6 · χ² 643 / p 4e-142	38.3 EB05 25.6 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=11	no trial data cached
Product administered at inappropriate site	21	23.6 15.5–36.1ROR 24.1 · χ² 433 / p 2e-96	23.2 EB05 15.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Blood calcium decreased	12	21.7 12.4–38.2ROR 22.0 · χ² 217 / p 2e-49	20.8 EB05 12.3 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 45.6	no trial data cached
Thyroid cancer	12	20.2 11.5–35.5ROR 20.5 · χ² 201 / p 8e-46	19.3 EB05 11.2 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.3	no trial data cached
Appendicitis	9	19.8 10.3–37.9ROR 20.0 · χ² 142 / p 4e-33	18.3 EB05 9.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Pharyngeal swelling	8	17.1 8.6–34.1ROR 17.2 · χ² 105 / p 5e-25	14.9 EB05 6.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Hyperthyroidism	11	15.5 8.6–28.0ROR 15.7 · χ² 135 / p 1e-31	14.1 EB05 7.4 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.9	no trial data cached
Mass	9	13.1 6.8–25.1ROR 13.2 · χ² 89 / p 2e-21	10.9 EB05 5.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 31.9	no trial data cached
Rotator cuff syndrome	8	12.7 6.4–25.3ROR 12.8 · χ² 75 / p 3e-18	10.1 EB05 4.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 24.7	no trial data cached
Metastases to lung	7	12.4 5.9–25.9ROR 12.5 · χ² 62 / p 1e-15	9.3 EB05 4.1 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 21.0	no trial data cached
Product preparation error	12	11.8 6.7–20.8ROR 12.0 · χ² 109 / p 1e-25	10.2 EB05 5.6 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Incorrect route of product administration	9	10.9 5.7–21.0ROR 11.0 · χ² 72 / p 1e-17	8.6 EB05 4.3 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached
Blood pressure systolic increased	9	9.4 4.9–18.0ROR 9.5 · χ² 59 / p 7e-15	7.2 EB05 3.8 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 15.3	no trial data cached
Blood pressure fluctuation	10	8.5 4.6–15.7ROR 8.6 · χ² 59 / p 9e-15	6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 18.0	no trial data cached
Tendonitis	6	7.9 3.5–17.5ROR 7.9 · χ² 29 / p 3e-8	5.4 EB05 2.6 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.9	no trial data cached
Drug effect less than expected	5	7.2 3.0–17.4ROR 7.3 · χ² 21 / p 2e-6	4.8 EB05 2.2 · IC025 +0.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Local swelling	5	5.8 2.4–13.8ROR 5.8 · χ² 15 / p 5e-5	4.0 EB05 1.9 · IC025 +0.4	Not in label — unassessed	serious PRR 3.6	no trial data cached
Product storage error	24	5.7 3.8–8.4ROR 5.8 · χ² 88 / p 3e-21	5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	92% clinician	no trial data cached
Expired product administered	9	5.5 2.9–10.6ROR 5.6 · χ² 29 / p 3e-8	4.4 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Incorrect route of drug administration	5	2.8 1.2–6.8ROR 2.8 · χ² 4 / p 0.020	2.4 EB05 1.2 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 14.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product storage error	24	5.7 3.8–8.4ROR 5.8 · χ² 88 / p 3e-21	5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	92% clinician	no trial data cached
Drug administered at inappropriate site	23	44.0 29.4–65.9ROR 45.0 · χ² 922 / p 7e-203	42.5 EB05 29.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Product administered at inappropriate site	21	23.6 15.5–36.1ROR 24.1 · χ² 433 / p 2e-96	23.2 EB05 15.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Blood thyroid stimulating hormone increased	18	39.9 25.2–63.1ROR 40.6 · χ² 643 / p 4e-142	38.3 EB05 25.6 · IC025 +3.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=11	no trial data cached
Product preparation error	12	11.8 6.7–20.8ROR 12.0 · χ² 109 / p 1e-25	10.2 EB05 5.6 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Thyroid cancer	12	20.2 11.5–35.5ROR 20.5 · χ² 201 / p 8e-46	19.3 EB05 11.2 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.3	no trial data cached
Blood calcium decreased	12	21.7 12.4–38.2ROR 22.0 · χ² 217 / p 2e-49	20.8 EB05 12.3 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 45.6	no trial data cached
Hyperthyroidism	11	15.5 8.6–28.0ROR 15.7 · χ² 135 / p 1e-31	14.1 EB05 7.4 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.9	no trial data cached
Blood pressure fluctuation	10	8.5 4.6–15.7ROR 8.6 · χ² 59 / p 9e-15	6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 18.0	no trial data cached
Expired product administered	9	5.5 2.9–10.6ROR 5.6 · χ² 29 / p 3e-8	4.4 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Blood pressure systolic increased	9	9.4 4.9–18.0ROR 9.5 · χ² 59 / p 7e-15	7.2 EB05 3.8 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 15.3	no trial data cached
Incorrect route of product administration	9	10.9 5.7–21.0ROR 11.0 · χ² 72 / p 1e-17	8.6 EB05 4.3 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached
Mass	9	13.1 6.8–25.1ROR 13.2 · χ² 89 / p 2e-21	10.9 EB05 5.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 31.9	no trial data cached
Appendicitis	9	19.8 10.3–37.9ROR 20.0 · χ² 142 / p 4e-33	18.3 EB05 9.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Rotator cuff syndrome	8	12.7 6.4–25.3ROR 12.8 · χ² 75 / p 3e-18	10.1 EB05 4.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 24.7	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Drug administered at inappropriate site — n=23, PRR 44.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Thyrotropin Alfa?

In FDA FAERS, the most frequently co-reported reaction terms for Thyrotropin Alfa are drug administered at inappropriate site, blood thyroid stimulating hormone increased, thyroid cancer, blood calcium decreased, hyperthyroidism, blood pressure fluctuation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Thyrotropin Alfa have an FDA boxed warning?

No. The FDA label retrieved for Thyrotropin Alfa has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Thyrotropin Alfa causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID b52dfa36-f90b-4e19-9b5e-26db9d04df2b, effective 20230224; matched on openfda.generic_name.exact:"THYROTROPIN ALFA")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 22 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.